Patent Docs: Biosimilars 2007 Conference

Patent Docs: Biosimilars 2007 Conference: " Scherago International, Inc. has organized the Biosimilars 2007 conference to be held on September 24-25, 2007 at George Washington University in Washington, D.C. The conference is intended to "air the issues" and "raise the questions" regarding legislation under consideration in Congress that would provide the Food and Drug Administration (FDA) with the authority to regulate biosimilars, as well as the application and use of biosimilars.

Among those scheduled to speak at the Conference are:

• Rep. Henry Waxman (D - CA)
• Tom DiLenge, Biotechnology Industry Organization (BIO)
• Dr. Takao Hayakawa, Japan Pharmaceuticals and Medical Devices Agency (PMDA)
• Dr. Janet Woodcock, FDA
• Dr. Scott Gottlieb, American Enterprise Institute (AEI)
• Dr. Ajaz Hussain, Sandoz, Inc.
• Dr. Steve Miller, Express Scripts
• Dr. Tina Morris, U.S. Pharmacopeia
• Dr. Curtis Meuse, National Institute of Standards and Technology (NIST)
• Dr. Keith Webber, FDA Center for Drug Evaluation and Research (CDER)
• Dr. Ganesh Venkataraman, Momenta Pharmaceuticals
• Dr. Robin Thorpe, National Institute for Biological Standards and Control (NIBSC)
• Dr. Steven Kozlowski, FDA Center for Drug Evaluation and Research (CDER)
• Juana Hughes, Merck Serono Latin America
• Alejandro Torrendell, Merck Serono Latin America

The organizers plan to add additional speakers, so attendees are encouraged to check the conference website as the conference program is finalized.

The registration fee ranges from $500 (university, government, or non-proft attendees) to $1,300 (industry attendees), for those registering prior to September 1, 2007. Those interested in registering for the conference can do so here.

"

Patent Docs: Ranbaxy and GlaxoSmithKline Settle Valtrex� Litigation

Patent Docs: Ranbaxy and GlaxoSmithKline Settle Valtrex� Litigation: "Ranbaxy Laboratories Ltd. announced today (July 26, 2007) that it had reached an agreement with GlaxoSmithKline in which GlaxoSmithKline would dismiss its patent infringement suit against Ranbaxy. GlaxoSmithKline had asserted its U.S. Patent No. 4,957,924, directed to Valacyclovir Hydrochloride, against Ranbaxy, which received final approval to market a generic version of the drug from the FDA in early February 2007. GlaxoSmithKline markets Valacyclovir Hydrochloride tablets under the trademark Valtrex�. Valtrex�, which is used to treat herpes virus infection, has total annual sales of $1.3 billion. Under the agreement, Ranbaxy will enter the U.S. market in late 2009 and will receive a license to GlaxoSmithKline's U.S. Patent Nos. 5,879,706 and 6,107,302."

BioCryst Initiates Phase II Clinical Trial to Evaluate Intravenous Peramivir in Patients Hospitalized With Influenza

BioCryst Initiates Phase II Clinical Trial to Evaluate Intravenous Peramivir in Patients Hospitalized With Influenza: "BIRMINGHAM, Ala., July 24 /PRNewswire-FirstCall/ -- BioCryst Pharmaceuticals, Inc. today announced the initiation of a Phase II clinical trial in hospitalized patients using an intravenous (i.v.) formulation of peramivir, the company's lead influenza neuraminidase inhibitor. The trial will compare the efficacy and safety of intravenous peramivir to orally administered oseltamivir in patients who require hospitalization due to acute influenza."

Sector Glance: Biotechnology - Forbes.com

Sector Glance: Biotechnology - Forbes.com: "NEW YORK -

Shares of biotechnology companies closed mainly lower Thursday despite positive earnings from Celgene Corp., as the overall market took its biggest fall of the year on concerns over mortgage and corporate lending.

While most biotechnology stocks stumbled, Celgene bucked the trend as its second-quarter profit surged on a 76 percent jump in sales. Meanwhile, Millennium Pharmaceuticals Inc. reported a flat loss for the quarter, sending shares lower.

The American Stock Exchange's biotechnology index fell 7.86 points to 781.55. The index tracks several bellwether stocks. The Nasdaq Stock Market's biotechnology index, which covers a broader range of small- and midcap stocks, fell 9.8 points to 807.50.

The Dow Jones industrials lost 311.50 points, or 2.3 percent, to close at 13,473.57. The Standard & Poor's 500 index closed the day down 35.43 points, or 2.3 percent, at 1,482.66."

Patent Law Jobs by Patently-O: Patent Counsel - Medicinal Chemistry Patent Attorney/Agent at Genentech

Patent Law Jobs by Patently-O: Patent Counsel - Medicinal Chemistry Patent Attorney/Agent at Genentech: "Patent Counsel - Medicinal Chemistry Patent Attorney/Agent at Genentech
Title: Medicinal Chemistry Patent Attorney/Agent at Genentech in South San Francisco

Description: Responsible for preparing and prosecuting a portfolio of medicinal chemistry patent applications (U.S and foreign) and providing, or assisting with, legal advice to clients for: patentability, freedom-to-operate, infringement and validity matters. Other responsibilities will include monitoring and analyzing competitive intellectual property, and may include managing collaboration IP, litigation support and IP-related transactional work.

Requirements: Successful candidate will have approximately 3-5 years of patent experience with highly developed skills in drafting and prosecuting medicinal chemistry applications and advising clients on patentability, freedom-to-operate, infringement and validity matters. Registration before the USPTO and an advanced degree in chemistry, or a related field, are essential as are strong verbal and written communication skills. A JD degree and transactional experience are a plus.

Contact: Apply for the job through the gene.com website and refers to requisition number 07-1000018459. Contact Maria Willett with questions (willett.maria@gene.com)

Employer Type: Large Corporation
Job Location: South San Francisco, CA"

Xconomy � Blog Archive � Reeves to Menino: Cambridge is the Brains of Biotech

Xconomy � Blog Archive � Reeves to Menino: Cambridge is the Brains of Biotech: "Boston’s mayor, Tom Menino, isn’t known for precise comments to the media (they don’t call him Mumbles for nothing) but something in Tuesday’s Boston Globe struck us as wacky, even for him. In an article about a big new lab that Joslin Diabetes Center is building in the Longwood Medical Area, Jeffrey Krasner wrote: “Menino said the project is a sign that the epicenter of the local biotech cluster may be moving from Kendall Square in Cambridge to the Longwood area in Boston.”

“You’ve got to be kidding me,” says the always-candid Willy Lensch, an Xconomist and himself a member of the Longwood biotech community. That pretty much summed up our feelings about it, particularly since we spent a shocking percentage of our time this spring competing with local biotech (and other) startups for office space in Kendall Square. But we thought we’d give Cambridge Mayor Ken Reeves a chance to respond as well.

Reeves, in an e-mail, was a bit more diplomatic: “Boston remains the important ‘Hub’ in Massachusetts, but there’s no doubt that Cambridge is the ‘brains’ of Biotech with M.I.T, Harvard, Biogen Idec, Genzyme, Novartis, and Vertex all headquartered in Cambridge.” Damn straight, Mr. Mayor."

FDA Reviewer Rips Nissens (DrugWonks)

FDA Reviewer Rips Nissens (DrugWonks): "

Robert Goldberg

I refer to Section 5.2 of the review of study which looks at the Nissen study:

N&W used the Peto method to compute odds ratios and confidence intervals. Trials with zeros in both arms are excluded from the analysis when using this approach as well as other approaches, such as the exact test used by this reviewer. In cases where only a few studies are excluded (as for MI where 4 studies
were excluded), the impact is minimal but when about half the trials are excluded (as is the case for the CV mortality endpoint in both N&W’s database and in the GSK database) there may be a greater impact on the results.(my emphasis...that's called withholding evidence.)

The latter point is illustrated with the database provided by GSK. This reviewer performed several analyses of the mortality data (both CV and all-cause; overall event rates less than 0.3%) and the results clearly show that the analytical approach can change non-significant results when including all the data (p>0.3) to borderline significant results when just considering those studies with at least one death (third
row of Table 3.1.2). The results for analyses using a continuity correction of 0.5 in each cell of those trials with zeros in either one arm or both arms are particularly striking with odds ratios close to one. "

This reviewer thinks that these results demonstrate the problems with any meta-analytic technique when data is extremely sparse and suggest that performing additional analyses may be warranted under these circumstances."

For the table and full discussion please go to:

http://www.fda.gov/ohrms/dockets/ac/07/briefing/2007-4308b1-00-index.htm"

Health Blog : Merck's Vioxx Warrior Gets Promoted

Health Blog : Merck's Vioxx Warrior Gets Promoted: "Merck’s general counsel Kenneth C. Frazier (pictured) becomes the latest lawyer to move from the staff ranks to a major operating role at a big drug maker. Pfizer’s CEO Jeff Kindler made the jump from the legal suite a year ago.

Frazier, architect of Merck’s defense against Vioxx lawsuits, is being promoted to president for global human health, the company said today.

It’s a big-time job. Starting Aug. 1, he’ll oversee more than 30,000 Merck workers and sales and marketing for the company world-wide. He replaces Peter L�scher, who recently left the company to become CEO of Siemens.

Frazier, 52, has won points among Merck defenders for his tell-it-to-the-judge style. He hasn’t settled any of the roughly 27,000 Vioxx lawsuits filed against the company following the withdrawal of the pain medicine. So far, the company has won 10 cases and lost five.

Frazier’s replacement as general counsel is Bruce Kuhlik, who joined the company in 2005 to help deal with the Vioxx litigation. He previously worked for PhRMA, the drug industry trade group."

Patent Prospector: Scratch & Sniff

Patent Prospector: Scratch & Sniff: "

Scratch & Sniff

Premier International sued Apple in 2005 for infringing 6,763,345 and 6,243,725 with the Apple iPod and iTunes. The patents claim building playlists. Apple is looking to build its own playlist for hearing the off-key hit of inequitable conduct.

Contois had sued Apple in June 2005 for iPod infringing 5,864,868, which claims a user interface for a media playing device. Apple settled.

On Monday, Apple alleged (motion) that James Hempleman, Premier honcho, lied about the '868 Contois patent, which was '345 prior art, in a desperate, and successful, push to get '345 granted.

During prosecution of the '345 patent, the examiner rejected all the pending claims over the Contois patent in three separate office actions . In response to the third of these office actions, Premier submitted a sworn declaration that contained materially false statements about Contois's disclosure . The declaration was made by James Hempleman - one of the named inventors, and the CEO and sole owner of Premier. The Examiner then allowed twenty-nine of the pending claims in the next office action, and withdrew all his previous rejections based on the Contois patent.

In his deposition in this case, Mr. Hempleman admitted that Contois discloses features that he swore in his declaration were not disclosed. Mr. Hempleman further admitted in his deposition that his declaration was submitted in order to induce the Examiner's reliance. Moreover, Paul Vargo, the prosecuting attorney for the '345 patent, also admitted in his deposition that Contois discloses features that Mr . Hempleman swore in his declaration were not disclosed.

The Hempleman declaration states that Contois has no disclosure of downloading songs from a non-local computer, and it states that Contois does not disclosure the automatic creation of a list of songs that match a user-specified criteria, such as genre or composer. Mr. Hempleman, however, admitted in his deposition that Contois "refer[s] to media sources, media content on computers that are on the internet or worldwide web," and that "Contois allows the user to display a list of music . . . [a]nd to display it according to a characteristic like the selected composer." Exh. H [J. Hempleman depo . at 196 :3-8 and 207 :3-8] .

Apple is requesting "an in camera review [of privileged documents] to determine if the false declaration statements trigger the crime-fraud exception to the attorney-client privilege." If everyone involved are sniffed gamy, Apple wants "related follow-on discovery."

For the crime-fraud exception to apply, there must be a prima facie showing of actual, justifiable, and detrimental reliance on a materially false representation made in furtherance of a crime or fraud . In re Spalding Sports Worldwide, Inc., 203 F.3d 800, 807 (Fed. Cir. 2000). The Federal Circuit has further stated that a "party seeking to overcome the attorney-client privilege need not conclusively prove fraud, or necessarily submit direct evidence in order to make the required prima facie showing." Id. at 808.

"

Have I Been Misreading the FDA? (DrugWonks)

Have I Been Misreading the FDA? (DrugWonks): " Robert Goldberg

Gardiner Harris has GSK all but sued...no big surprise there since the trial attorneys have been putting together their game plan for months. But Avandia off the market?

Maybe I and others are fighting an uphill battle and Avandia will get creamed. Certainly the number crunchers take a "take no chances" approach to the TZDs which would mean depriving people of use of these drugs based on a fear of uncertainty which is in turn based on a lack of data. I think in this environment that might be enough to crush the TZD's into a purgatory.

What is disgusting is the double standard -- accusing the FDA of not acting fast enough when it is apparent that the process of constructing long term trial and evaluating it takes a long time and raising second guessers and sloppy studies from Nissen and Graham to heroic standards.

For what it's worth here are comments from other reviewers that sparked hope that the FDA might, just might, show some cojones....

"Finally, the observation that longer term studies in the meta-analysis had similar risks between rosiglitazone and comparators highlights the importance of looking to these long-term controlled studies to confirm this finding..."

And in a nod that some folks in the FDA know the value of a real world studies compared to churning claims data (that's you, long suffering Dr. Graham)....

"The interim results (mean followup of 3.75 years) from RECORD show that 6% of patients in the rosiglitazone group and 11% of patients in the metformin + sulfonylurea group have been switched to insulin.

The protocol does not specify the rationale for discontinuing rosiglitazone upon initiation of insulin, but the most likely explanation is that combination rosiglitazone and insulin therapy is contraindicated in the European Union.

Exposures to rosiglitazone may be longer than exposures to the comparator drugs (metformin and sulfonylurea), because rosiglitazone-treated patients can be treated with three oral anti-diabetic agents before switching to insulin whereas the non-rosiglitazone treated patients initiate insulin upon failing dual combination therapy"

This amendment was added because some patients strongly expressed reluctance to initiate insulin therapy. The protocol does not discuss how study personnel should manage other CV risk factors during the course of the study (e.g., blood pressure, lipids, and the use of aspirin). Because this is an open-label trial, differential management of these CV risk factors in the rosiglitazone and non-rosiglitazone treated patients could bias results."

In other words, insulin and Avandia combos were being avoided in the real world to begin with. As for the other risks, it would appear they are manageable by physicians but they may never get the chance and neither may GSK.

The killer is not the drug, its the politics of uncertainy. It's the risk of lawsuits and the limited tolerance of risk which I predict will drive up overall death due to diabetes if the SSRI policy by fear model applies here.

"

Sector Glance: Biotechnology - Forbes.com

Sector Glance: Biotechnology - Forbes.com: "NEW YORK -

Shares of biotechnology companies closed mainly lower Thursday despite positive earnings from Celgene Corp., as the overall market took its biggest fall of the year on concerns over mortgage and corporate lending.

While most biotechnology stocks stumbled, Celgene bucked the trend as its second-quarter profit surged on a 76 percent jump in sales. Meanwhile, Millennium Pharmaceuticals Inc. reported a flat loss for the quarter, sending shares lower.

The American Stock Exchange's biotechnology index fell 7.86 points to 781.55. The index tracks several bellwether stocks. The Nasdaq Stock Market's biotechnology index, which covers a broader range of small- and midcap stocks, fell 9.8 points to 807.50.

The Dow Jones industrials lost 311.50 points, or 2.3 percent, to close at 13,473.57. The Standard & Poor's 500 index closed the day down 35.43 points, or 2.3 percent, at 1,482.66."

Neogen Announces 3-for-2 Stock Split

Neogen Announces 3-for-2 Stock Split: "LANSING, Mich., July 26 /PRNewswire-FirstCall/ -- Neogen Corporation (Nasdaq: NEOG) today announced that its Board of Directors has approved a 3- for-2 stock split. With the split, shareholders of record on Aug. 15, 2007, will receive one additional share of stock for each two shares held. The stock split will be effected in the form of a stock dividend that will be paid in newly issued common stock on Sept. 4, 2007. As of today, Neogen has 9,350,000 shares of common stock outstanding. After the stock split, the company will have approximately 14,000,000 shares of common stock outstanding."

Health Blog : FDA Committee Won't Consider Controversial Avandia Study

Health Blog : FDA Committee Won't Consider Controversial Avandia Study: "Questions over whether GlaxoSmithKline’s diabetes drug Avandia contributes to heart-attack risk went from simmer to boil in May after the New England Journal of Medicine published online an analysis by the Cleveland Clinic’s Steven Nissen. He concluded that the drug was riskier than many had thought."

The Volokh Conspiracy - Lawsuit Challenging Qualifications of Deputy Patent & Trademark Office Director:

The Volokh Conspiracy - Lawsuit Challenging Qualifications of Deputy Patent & Trademark Office Director:: "The complaint is here; it alleges that Deputy PTO Director Margaret Peterlin lacks the statutorily required 'professional background and experience in patent or trademark law.'

I can't speak to whether the deputy director in fact lacks such background and experience. Her biography doesn't stress much of it, though it points to quite substantial general legal credentials; but according to the Washington Post, patent office spokeswoman Brigid Quinn reported that 'Peterlin has 'had direct involvement in oversight of the USPTO and every piece of patent, trademark and copyright-related legislation considered on the House floor over the past five years.''

I'm more interested in the institutional question here: What should courts do with vague criteria such as 'shall ... [have] a professional background and experience in patent or trademark law,' criteria that give no instructions about the level of background and experience required? I'm not an administrative law expert, but I'm inclined to say that this is the sort of judgment that is left to the Director (and, indirectly, to the Secretary of Commerce and the President, who can decide to remove the Deputy Director), not to courts. But I'd love to hear what administrative law experts have to say about this, and about other procedural questions that this lawsuit raises."

: "NEW DELHI: Riding on the success of Bt cotton, agriculture biotechnology has emerged as one of the fastest growing biotech industries in India in recent years, a latest report of the US Department of Agriculture (USDA) has said.

'It is the third largest contributor among various biotech sectors with total revenues of more than 229 million dollars in 2006-07 fiscal, registering a growth of 55 percent,' the report said.

Export revenue from agriculture biotechnology has grown to 11.6 million dollars in 2006-07 from around 8 million dollars in the previous year, it added.

The report, titled 'India Biotechnology' and prepared by Santosh Kumar Singh, claimed Bt cotton coverage has surged over the past five years to cover 70 percent of total cotton area in 2007. "

Biolex Therapeutics Announces Positive Phase 2a Results for Hepatitis C Product Candidate Locteron(TM)

Biolex Therapeutics Announces Positive Phase 2a Results for Hepatitis C Product Candidate Locteron(TM): "PITTSBORO, NC -- 07/26/07 -- Biolex Therapeutics today announced successful initial results from the SELECT-1 Phase 2a clinical trial of Locteron(TM), the first controlled-release interferon alfa being developed for the treatment of chronic hepatitis C. In the 12-week Phase 2a trial, the combination of the highest dose of Locteron evaluated and the antiviral drug ribavirin achieved an early virologic response (EVR) in 100% of the hepatitis C patients treated. Importantly, the study results also indicated that patients receiving Locteron experienced side effects that were less frequent and less severe than those previously reported in clinical trials for the currently marketed pegylated interferons and for albumin-fused interferon (Albuferon(TM)) currently under development. Biolex is co-developing Locteron with its partner OctoPlus N.V."

Threshold Pharmaceuticals Initiates Phase 1 Clinical Trial Evaluating TH-302 in Patients With Solid Tumors

Threshold Pharmaceuticals Initiates Phase 1 Clinical Trial Evaluating TH-302 in Patients With Solid Tumors: "REDWOOD CITY, Calif., July 26 /PRNewswire-FirstCall/ -- Threshold Pharmaceuticals, Inc. (Nasdaq: THLD), today announced that it has initiated a Phase 1 clinical trial evaluating the safety of TH-302, the Company's first hypoxia-activated prodrug (HAP), in patients with advanced solid tumors."

EntreMed Commences Leukemia Clinical Trial for MKC-1 in Canada

EntreMed Commences Leukemia Clinical Trial for MKC-1 in Canada: "ROCKVILLE, Md., July 24 /PRNewswire-FirstCall/ -- EntreMed, Inc. , a clinical-stage pharmaceutical company developing therapeutics for the treatment of cancer and inflammatory diseases, today announced that it has commenced a Phase 1 study of MKC-1 in leukemia patients at the Princess Margaret Hospital, University Health Network (UHN), Toronto, Canada. Dr. Karen Yee, Assistant Professor, University of Toronto, is the principal investigator for the clinical trial. EntreMed received a No Objection Letter (NOL) from the Therapeutic Products Directorate of Health Canada on its Clinical Trial Application to conduct the clinical trial in leukemia patients. A Canadian Clinical Trial Application (CTA) is similar to a United States (US) Investigational New Drug (IND) application."

Peter Zura's 271 Patent Blog: Manufacturing and Labor Strike Back on Patent Reform

Peter Zura's 271 Patent Blog: Manufacturing and Labor Strike Back on Patent Reform: "Amidst of a flurry of lobbying activity (one lobbyist joked that every shop in town was represented in the House Judiciary Committee room during the bill's markup) , Congress held informal meetings with diverse groups, including members of the manufacturing industry.

Manufacturing has been irked over the cool reception they've perceived during the Congressional hearings. William J. Jones, chairman of Cummins-Allison Corp. stated the following in an op-ed piece in the Chicago Tribune"

FDA Drug Approval Statistics

FDA Drug Approval Statistics: "It’s occurred to me to wonder just how many new drugs the US Food and Drug Administration (FDA) approves each year. The FDA is charged with the responsibility of ensuring the safety of foods, human and veterinary drugs, biological products, medical devices and cosmetics, for consumption and use by the American public. They also test electronic products for harmful radiation and, more recently, are investigating the safety of nanoparticles.

New product approvals can be viewed on the FDA website, listed by date and category (new drug applications, molecular entity drugs, accelerated/ priority or fast track applications). Statistics are given by fiscal year or calendar year, depending on the class you’re looking at.

When I looked under “What’s new by date” I found that this week alone, 4 products, listed under new and generic drug approvals, were approved, and several other products underwent labelling, formulation or other revisions. In the last fiscal year, 37 new drugs were submitted in the “fast track” approval program, designated for drugs to treat life-threatening illnesses that show exceptional potential to meet specific, as yet unaddressed, needs. 19 were approved, 6 denied, and the rest are pending. In the current calendar year (2007) 10 oncology (cancer) drugs have been approved."

Patent Prospector: Laboring over Patent Reform

Patent Prospector: Laboring over Patent Reform: "

Laboring over Patent Reform

The AFL-CIO, taking the manufacturing industries view, writes a letter to the Hill on the Patent Reform Act of 2007, hitting the high points of what's wrong with the bill.

Recently we have heard from a number of manufacturers regarding their concerns with certain sections ofH.R. 1908 and the effect it will have on the U.S. patent system. Many of our union members work in manufacturing, and we want to make sure that patent law reforms do not undermine our leadership in innovation, and that they help the American economy produce good new jobs and products at home.

The National Academies of Science (NAS) has suggested a set of improvements for the patent system. However, the Patent Reform Act of2007, while offering some needed changes, does not reflect the body of improvements suggested by NAS and would, in some ways, weaken our patent system. We are concerned in particular that two sections of the proposed legislation, the post-patent review process and apportionment of damages, may have a negative impact on innovation and research.

The courts already follow a multi-point system for considering damages. This system should remain intact, rather than be constricted to limit damage settlements. Similarly the bill would add a third step to the two existing post-patent review steps, potentially opening the door to serial patent challenges, which for some, can become a business strategy designed to elicit a settlement. For the firms facing challenges, it is often easier to outsource products to a vendor rather than deal with the legal process.

At a time when the Chinese government is constantly being challenged to live up to its intellectual property obligations, we do not want to take actions that may weaken ours. We urge you to take the concerns of the manufacturing sectors of these issues into account in developing the final version of the Patent Reform Act of 2007, H.R. 1908.

"

Biotech Blog � Expanding the bandwidth of life science investments: Increasing investment viability

Biotech Blog � Expanding the bandwidth of life science investments: Increasing investment viability: "rom what we have experienced, angel investors are shoring up the gap in new innovations coming forward. However, they seem to be more naive than VC’s in terms of due diligence prior to investing. Scientists from the company march in with charts and scientific graphs 99% of angel investors don’t know anything about. The rule they seem to forget is: there is ALWAYS a patient market, and there is ALWAYS a scientific platform - that undoubtedly has competition. Will any new life science innovation get a percentage of the whole market? Absolutely not. They will get a percentage of a percentage based on third party reimbursement and their label. We end up doing this work for our clients and typically the results are startling to them."

Fresh from the FDA Dockets (DrugWonks)

Fresh from the FDA Dockets (DrugWonks): "This from the Glaxo data submission. I can bet you won't see this reported anywhere else:"

Patent Law Blog (Patently-O): No Revival For "Unintentional" Missed National Stage Filing Date (Delay Must Be Unavoidable)

Patent Law Blog (Patently-O): No Revival For "Unintentional" Missed National Stage Filing Date (Delay Must Be Unavoidable): "ATA originally filed an Australian provisional patent application on July 8, 1997. Exactly one year later (on July 8, 1998) ATA filed its international PCT Application. In the US, a PCT applicant can wait 30 months to file its national stage application. ATA was actually given an extra two-days because the 30–month deadline of January 8, 2000 fell on a weekend.

Unfortunately, the January 10, 2000 deadline came and went — The PTO did not receive the national stage conversion until the next day January 11, 2000. By that time, however, the application had been abandoned."

Aspreva cuts a quarter of its jobs as it refocuses - FierceBiotech - Biotechnology Articles, Biotech Industry News, FDA Approval News

Aspreva cuts a quarter of its jobs as it refocuses - FierceBiotech - Biotechnology Articles, Biotech Industry News, FDA Approval News: "Canada's Aspreva Pharmaceuticals says that Chief Scientific Officer Richard Jones is leaving the company as the biotech cuts 33 jobs, or about a quarter of its work force. Company officials say they want to concentrate on their core functions. Aspreva recently completed a late-stage trial for an experimental therapy for myasthenia gravis and another trial for a treatment of lupus nephritis. Aspreva says it remains committed to a pact it has with Roche."

ADA Applauds Legislators for 'Meth Mouth' Bills

ADA Applauds Legislators for 'Meth Mouth' Bills: "WASHINGTON, July 26 /PRNewswire-USNewswire/ -- Dr. Robert Brandjord, immediate past president of the American Dental Association (ADA), joined legislators on Capitol Hill today to announce support of two federal bills aimed at preventing and treating 'meth mouth,' a condition where teeth can become blackened, stained, rotting and crumbling from methamphetamine addiction. The decay can occur rapidly, causing extensive tooth loss in as little as a year."

Cell Therapeutics inks deal to buy cancer drug developer - FierceBiotech - Biotechnology Articles, Biotech Industry News, FDA Approval News

Cell Therapeutics inks deal to buy cancer drug developer - FierceBiotech - Biotechnology Articles, Biotech Industry News, FDA Approval News: "Cell Therapeutics has struck a deal to buy Systems Medicine, a cancer drug developer, for $20 million down and up to $15 million for milestones. Tucson-based Systems Medicine is developing a genetically engineered drug called Brostallicin, which Cell Therapeutics believes is a 'perfect fit' for its pipeline. Cell Therapeutics CEO James Bianco told investors that the company is also close to acquiring a product with $15 million to $18 million in annual revenue. That would be a first for Cell Therapeutics, which hasn't pushed any drugs through the approval process yet. Its experimental therapy Xyotax has failed several trials."

Pfizer, Hydra strike $195M pain pact - FierceBiotech - Biotechnology Articles, Biotech Industry News, FDA Approval News

Pfizer, Hydra strike $195M pain pact - FierceBiotech - Biotechnology Articles, Biotech Industry News, FDA Approval News: "Cambridge, MA-based Hydra Biosciences has struck a deal with Pfizer Global Research & Development to collaborate on new pain therapies. Hydra stands to gain up to $195 million in up front and milestone payments--there's no breakdown on the numbers--for the first product developed from the Transient Receptor Potential channel family. Pfizer will fund all research and development work and gains exclusive commercialization rights to any product developed in the collaboration."

Biotech CEOs face rising fury of angry investors - FierceBiotech - Biotechnology Articles, Biotech Industry News, FDA Approval News

Biotech CEOs face rising fury of angry investors - FierceBiotech - Biotechnology Articles, Biotech Industry News, FDA Approval News: "The San Francisco Chronicle reports that a growing number of biotech execs have had to ward off the angry attacks of shareholder activists who protest the way they're running their companies. Case in point: PDL BioPharma CEO Mark McDade, who faced protests over his real estate deal for swanky new offices in Redwood City, CA. And hedge fund managers and other investors are turning up the heat on other CEOs with a questionable track record for handling money. Third Point LLC is responsible for much of this flak, mounting attacks on PDL, Ligand and Nabi. MedImmune and ImClone can both also attest to the trend."

Faster, Easier Quantification of Secreted IgG Antibodies

Faster, Easier Quantification of Secreted IgG Antibodies: "HAYWARD, Calif., July 26 /PRNewswire/ -- Guava Technologies, Inc. has launched newly revised Guava RapidQuant(TM) IgG Antibody Quantification Assays for mouse and human antibodies. Faster and easier than the average enzyme-linked immunosorbent assay (ELISA), the traditional approach for antibody quantification, RapidQuant Assays help users select of optimal clones from hybridoma screens."

New compounds in works for tuberculosis - FierceBioResearcher - Biotech research, Biotechnology research, Bioinformatics

New compounds in works for tuberculosis - FierceBioResearcher - Biotech research, Biotechnology research, Bioinformatics: "There's new evidence to support the theory that the enzyme protein kinase G offers a promising target in the fight against tuberculosis. The enzyme is secreted by the microbe that triggers TB and is believed to provide essential protection for the bug from the host's immune system, which tracks down and kills most pathogens. Scientists say they have a compound that can block the protein, but were worried about interfering with the action of other proteins also secreted by the microbe. Using X-ray crystallography, the researchers were able to pinpoint the exact method of inhibition and determined that it was unique to that one protein."

Scientists plot first moves for Project Checkmate - FierceBioResearcher - Biotech research, Biotechnology research, Bioinformatics

Scientists plot first moves for Project Checkmate - FierceBioResearcher - Biotech research, Biotechnology research, Bioinformatics: "A collaboration between the Scripps Research Institute and IBM to find new antidotes to flu before new mutations surface is making some initial progress. Dubbed Project Checkmate, scientists are using phage displays to identify antibodies that can be used to fight influenza. The project hopes to employ supercomputers to anticipate the way that the flu mutates and moves. Researchers could develop new drugs for new versions of the flu that had yet to surface in the public. Scientists are waiting to hear back on their grant application to the NIH."

Synthetic biology spawns fresh approach to antibiotics - FierceBioResearcher - Biotech research, Biotechnology research, Bioinformatics

Synthetic biology spawns fresh approach to antibiotics - FierceBioResearcher - Biotech research, Biotechnology research, Bioinformatics: "The amazingly hot field of synthetic biology has now spawned an engineered virus that attacks bacteria. Timothy Lu, a doctoral student in the Harvard-MIT Division of Health Sciences and Technology, says he and colleagues created the virus by drawing from a library of genes. In this particular case, the researchers took a gene that produced the enzyme dispersin B and inserted it into the genome of the T7 virus. The enzyme is known to degrade bacteria's molecular 'scaffolding.' At a later stage, he says, the scientists should be able to design new viruses engineered to attack specific bacteria. And these new viruses could be used to create a new generation of antibiotics--as well as industrial cleaners."

ALSO NOTED: Fat cells could be used to replace silicone; Could Xenical fight cancer?; Anti-smoking drug may also combat alcohol - FierceBioResearcher

ALSO NOTED: Fat cells could be used to replace silicone; Could Xenical fight cancer?; Anti-smoking drug may also combat alcohol - FierceBioResearcher - Biotech research, Biotechnology research, Bioinformatics: "Scientists in the UK have used skin cells to stimulate the immune system in mice--an approach that could be used to fight a common form of cancer that afflicts children. Report"

Reduced insulin signaling may halt aging, disease - FierceBioResearcher - Biotech research, Biotechnology research, Bioinformatics

Reduced insulin signaling may halt aging, disease - FierceBioResearcher - Biotech research, Biotechnology research, Bioinformatics: "Genetically engineering mice to reduce the insulin signaling between the brain and the rest of the body increased their longevity as well as their quality of life, according to a new study. And finding a drug that can accomplish the same task in humans may well signal a new approach to combating the effects of age. A team of researchers at Children's Hospital Boston tested their hypothesis by engineering mice to reduce the level of the protein Irs2 in their brains. Those mice lived 18 percent longer even though they weighted more and had higher blood insulin levels. The scientists believe that by reducing insulin-like signaling in the brain, but not in the rest of the body, they postponed cancer, cardiovascular disease and other conditions linked to shorter life spans.

'The easiest way to keep insulin levels low in the brain is old-fashioned diet and exercise,' says team leader Morris White. But any drugs that would be developed to mimic that effect would have to target the brain only, as Irs2 is vitally needed in other parts of the body."

Patch to replace heart transplants? - FierceBioResearcher - Biotech research, Biotechnology research, Bioinformatics

Patch to replace heart transplants? - FierceBioResearcher - Biotech research, Biotechnology research, Bioinformatics: "Children's Hospital Boston has also been the center of new cardiovascular research. Another team there developed a patch that dispatches the growth stimulating protein periostin to damaged areas of heart muscle, spurring the growth of new tissue. Three months after insertion, the patch was still generating new protein while rats with induced heart attack damage had smaller injury areas and more blood vessels at work repairing damage. The researchers could also point to six million new cells, which outnumbered the cells destroyed by the heart attack. That same patch could be used to repair damaged hearts in adults or the hearts of children suffering from congenital cardiac issues. Researchers believe that this approach could eventually obviate the need for heart transplants."

ALSO NOTED: Geron faces critics' wrath;New diagnostics work targets prostate cancer; - FierceBioResearcher - Biotech research, Biotechnology research,

ALSO NOTED: Geron faces critics' wrath;New diagnostics work targets prostate cancer; - FierceBioResearcher - Biotech research, Biotechnology research, Bioinformatics: "The protein IKK-alpha, which is largely absent in a type of skin cancer, serves to guard a gene against mutations, according to researchers at the M.D. Anderson Cancer Center. 'Although IKK-alpha can protect the checkpoint gene 14-3-3-sigma from silencing, IKK-alpha itself is frequently impaired in cancer cells,' says Yinling Hu, Ph.D., senior author of the paper. 'We are going to define specific downstream targets of IKK-alpha involved in regulating DNA methylation of the checkpoint gene.' Release"

Health Blog : An Ugly Saga of Politics and AIDS Winds Down

Health Blog : An Ugly Saga of Politics and AIDS Winds Down: "Another ugly chapter in the annals of politics and medicine came to a close this morning, as eight years of prison ended for five Bulgarian nurses and a Palestinian doctor accused of willfully infecting Libyan children with the virus that causes AIDS.

Their release required hard lobbying by the European Union, a bit of diplomatic double-talk, and hundreds of millions in cash payments.

The nurses and doctor, who worked at a Libyan children’s hospital, were arrested in 1999 and charged with deliberately infecting some 400 children with HIV, the virus that causes AIDS. The defendants confessed to the crimes — but only after being tortured with electric shocks and beaten with cables and sticks, according to a 2006 editorial in the medical journal the Lancet"

Health Blog : Drug Companies Seize Tax Break, Cut Jobs

Health Blog : Drug Companies Seize Tax Break, Cut Jobs: "A temporary tax break that allowed U.S. corporations to bring home foreign profits at a very low tax rate two years ago was supposed to encourage the creation of new U.S. jobs. At least half of that deal sounded good to the drug industry.

Drug makers were the “biggest beneficiaries” of the program, bringing home $100 billion of offshore profits, the New York Times reports this morning. But during the same period, the industry, beset by expiring patents and lackluster pipelines, has laid off tens of thousands of U.S. workers.

Pharmaceutical companies have long pushed profits offshore in an effort to lower their tax bills. Much of the maneuvering is completely kosher, though it sometimes crosses the line. Last fall, the WSJ reported on how Merck created a Bermuda subsidiary that helped the company avoid $1.5 billion in taxes. Early this year, the company wound up paying $2.3 billion to the IRS to settle that dispute and a few others. Last year, the British drug maker GlaxoSmithKline paid more than $3 billion to settle a protracted dispute with the IRS over transfer pricing between overseas and U.S. subsidiaries.

Pfizer reported that it set aside only 2% of its 2006 profits for U.S. taxes, while Lilly set aside 6%, according to the Times. Lilly told the paper that it had legally avoided more than $2 billion in U.S. taxes because of the tax break, which has now expired. The company said it has invested $1.3 billion in its home state of Indiana. But it has also cut its U.S. work force by more than 8% since the beginning of 2005."

Health Blog : Japanese Takeout: Drug Making

Health Blog : Japanese Takeout: Drug Making: "Japan’s health ministry says the country’s drug market is in a “crisis situation.” Domestic drug makers are having trouble competing overseas and the world’s drug makers are passing over Japan when introducing new products.

nullIn a draft vision statement outlining policy for the next five years, the ministry notes that 13 of the world’s top 100 drugs in 2005 originated in Japan–not bad, by some measures, but not improving in recent years, either. “Since 2000, no major-league new drug has emerged from Japan,” it says. (Shionogi, which discovered the cholesterol drug Crestor, might disagree. AstraZeneca, which has its own pipeline problems, licensed world-wide rights to Crestor from Shionogi.)"

ALSO NOTED: Advanced Magnetics touts Phase III data; MicroIslet makes staffing changes; and much more... - FierceBiotech - Biotechnology Articles, Bio

ALSO NOTED: Advanced Magnetics touts Phase III data; MicroIslet makes staffing changes; and much more... - FierceBiotech - Biotechnology Articles, Biotech Industry News, FDA Approval News: "Advanced Magnetics has announced preliminary positive results from its fourth and final planned Phase III clinical trial of ferumoxytol as an intravenous iron replacement therapeutic in chronic kidney disease patients. Release"

Press Release: BioXell To Regain Rights To TREM Platform Following StrategicDecision By Merck - FierceBiotech - Biotechnology Articles, Biotech Indust

Press Release: BioXell To Regain Rights To TREM Platform Following StrategicDecision By Merck - FierceBiotech - Biotechnology Articles, Biotech Industry News, FDA Approval News: "Milan, Switzerland, July 20, 2007 - Milan, Italy, July 20, 2007 - BioXell S.p.A. today announced that it will regain rights to its TREM platform from its collaboration partner, Merck & Co., Inc. This follows a strategic decision by Merck to streamline its focus in this area. In view of scientific progress of TREM-1 for sepsis, BioXell intends to seek another pharmaceutical partner to continue development of the platform."

Health Blog : FDA Delays Decision on Wyeth Menopause Drug

Health Blog : FDA Delays Decision on Wyeth Menopause Drug: "The FDA said late yesterday it wasn’t ready to approve Pristiq, a drug derived from Wyeth’s antidepressant Effexor XR and intended to treat hot flashes and other symptoms of menopause, the WSJ reports.

The FDA told Wyeth to do a year-long study of the drug to see whether it is associated serious cardiovascular or liver problems, the company said this morning.

In trials, Pristiq has caused nausea and other side effects. And there have been a few signs that it may raise the risk of cardiovascular problems."

Biosecurity expert points to threat of smallpox attack - FierceBioResearcher - Biotech research, Biotechnology research, Bioinformatics

Biosecurity expert points to threat of smallpox attack - FierceBioResearcher - Biotech research, Biotechnology research, Bioinformatics: "Ian Ramshaw, the director of the National Centre for Biosecurity at the Australian National University, used a meeting held on the 30th anniversary of the eradication of smallpox to raise warnings that a bioterrorism attack using smallpox as a weapon is a distinct threat that nations should prepare for. A number of scientists bearing samples of smallpox vaccine disappeared in the wake of the breakup of the Soviet Union, says Ramshaw, raising the possibility that a rogue state could obtain samples for use in an attack. 'Perhaps we're ill-prepared at this stage because we don't have modern vaccines for small pox,' he told the group, 'something that we could introduce if it were released.'"

Venter's latest revelation could save the world - FierceBioResearcher - Biotech research, Biotechnology research, Bioinformatics

Venter's latest revelation could save the world - FierceBioResearcher - Biotech research, Biotechnology research, Bioinformatics: "The Times' Anjana Ahuja takes J. Craig Venter's latest revelation and breaks it down to some easily understood concepts. Venter is focused on creating synthetic life, taking 400 or so genes and making a microbe of his own design. Built properly, the microbe could be used to create a new generation of clean fuels. And his patent on the work, if granted, would give Venter control of those products and the vast riches they would produce. But the basic research could also point the way to a new generation of bioterror agents, which could have a dramatically different effect on the planet. Still, the work on life's simplest forms does also highlight the extraordinary collection of 30,000 genes that goes into creating a human."

Health Blog : Goldman Gets Into Hospital Software

Health Blog : Goldman Gets Into Hospital Software: "Goldman Sachs just sank $155 million in Picis, a Massachusetts company that sells software to hospitals, the Boston Globe reports."

Cell Therapeutics, Inc. Announces $20.25 Million Offering

Cell Therapeutics, Inc. Announces $20.25 Million Offering: "SEATTLE, July 26 /PRNewswire-FirstCall/ -- Cell Therapeutics, Inc. (CTI) (Nasdaq: CTIC; MTAX) today announced that it has entered into agreements to sell approximately $20.25 million of its 3% Convertible Preferred Stock and warrants in a registered offering to several institutional investors, including existing securities holders. CTI will sell Series C convertible preferred stock and warrants to investors at the negotiated price of $1,000 per share of Series C convertible preferred stock. The Preferred Stock will be convertible into shares of common stock beginning on or about July 27, 2007, at a conversion price of $3.90 per share. Purchasers will also receive warrants to purchase common stock in an amount equal to 50% of their total investment amount divided by $3.90, which warrants will have an exercise price of $4.53 per share, which is equal to the closing bid price of the Company's common stock as reported on the Nasdaq Global Market on July 25, 2007. The warran"

Orange Book Blog: Federal Circuit Affirms Invalidity of AstraZeneca's Toprol-XL Patent

Orange Book Blog: Federal Circuit Affirms Invalidity of AstraZeneca's Toprol-XL Patent: "On Monday, the Federal Circuit affirmed a district court summary judgment decision that AstraZeneca's U.S. Patent No. 5,081,154 is invalid for double patenting. The '154 patent claims metoprolol succinate, the active ingredient in Astra's blockbuster cardiovascular drug Toprol-XL. KV Pharmaceutical, Andrx, and Eon Labs have all filed ANDAs for generic Toprol-XL and are defendants in the litigation."

Health Blog : Insurers Put Money Behind Doctor Ratings

Health Blog : Insurers Put Money Behind Doctor Ratings: "Insurers across the country are crunching data on the performance of individual physicians, and they’re beginning to steer patients to certain docs — and away from others — based on the results, the Washington Post reports.

The industry says the effort will lead to better care at lower cost. Doctors say the ratings are often based on faulty data, and could lead doctors to cherry-pick healthy patients who are easiest to treat.

In Massachusetts, for example, six health plans pooled their data, giving them a database with 120 million claims. Some insurers in the state now charge higher co-pays for doctors who fare poorly in the analysis. A doctor whose co-pay went up $10 after he was demoted to a lower-quality tier tells the Post a patient asked sardonically: “Who did you kill?”

Doctors are rated based on quality of care and cost efficiency. Following widely accepted procedures such as getting diabetic patients to control blood sugar helps a doctor score well on quality of care; using a generic alternative to a brand-name drug wins points for cost efficiency, the Post writes."

Evogene and CIRAD Expand Their Cotton Collaboration

Evogene and CIRAD Expand Their Cotton Collaboration: "Evogene Ltd., a publicly quoted plant biotechnology company (TELAVIV: EVGN), and CIRAD, a French scientific organization, announce the expansion of their multi-year collaboration signed in 2004. The goal of the new project is to introduce Evogene's lead candidate, EVO133 gene, into cotton and to validate its improvement for drought tolerance.

Cotton is the third largest genetically modified crop by its importance, after soybean and corn, and provides 40% of the global fiber requirements. Cotton is grown on about 35 million hectares worldwide, 10 million hectares (28%) of which are grown with GM varieties. Cotton is largely grown in marginal agricultural areas where precipitations are low and drought resistance is often the first limiting factor for yield. Drought resistance is one of the key factors which can help dry areas stay competitive in the global cotton market.

EVO133 is Evogene's lead candidate gene for yield, and yield stability under drought, heat and salinity conditions. EVO133 has been tested in three seasons of field trials in processing tomato varieties and has demonstrated its potential to increase yield under normal conditions, reduce yield penalty under drought conditions as well as under salinity and heat stresses. The validation of EVO133 is also advancing in other target crops under other collaborations, which have been announced publicly, namely in Corn with Biogemma and Soybean with Mertec.

Ofer Haviv, Evogene President and CEO, stated: "Having identified our lead candidate for yield and yield stability, we are excited to advance towards obtaining promising results in the cotton crop. CIRAD's decades of experience in developing cotton varieties around the globe, makes it a very attractive partner for this project."

Bernard Hau, Head of the CIRAD Cotton Research Unit, stated: "The search for rustic varieties resisting to drought corresponds to the demand of the developing countries and its importance will increase with climate change. CIRAD is pleased to have established a partnership with the Israeli company EVOGENE, a partner offering new tools to efficiently address this theme. Part of this project is financed by the EUREKA initiative through the French National Agency for Research (ANR)."

"

SignOnSanDiego.com > News > Business -- Amylin reports $45 million loss

SignOnSanDiego.com > News > Business -- Amylin reports $45 million loss: "Amylin Pharmaceuticals reported a loss of $45 million, or 34 cents a share, for the quarter ended June 30, compared with a loss of $46.4 million, or 38 cents a share, in the same quarter 2006. The company said revenue grew 67 percent to $197 million on increased sales of its diabetes drugs Symlin and Byetta."

US presses ahead with patent reforms - ZDNet UK

US presses ahead with patent reforms - ZDNet UK: "On Thursday evening, the Senate Judiciary Committee approved by a 13-5 vote an amended version of the Patent Reform Act of 2007. Supporters say the proposal would go a long way towards staving off expensive court litigation, limiting what are perceived as excessive damage awards, and keeping questionable patents off the books in the first place."

Sector Snap: Drug Companies - Forbes.com

Sector Snap: Drug Companies - Forbes.com: "NEW YORK -

U.S. shares of GlaxoSmithKline PLC rose Wednesday on a buyback announcement that offset disappointing earnings news, while other companies in the sector were mixed.

Earlier, the world's second-largest drug company said its second-quarter profit edged 1.4 percent higher while revenue fell 2.4 percent. But news that the company is doubling its stock buyback program to 12 billion pounds ($24.7 billion) through 2009 sent shares higher.

Shares of GlaxoSmithKline rose $1.22, or 2.4 percent, to $52.52 in afternoon trading. The stock has traded between $50.58 and $59.98 in the past year.

The American Stock Exchange's Pharmaceutical Index, which tracks 15 major drug makers including GlaxoSmithKline, rose 1.09 points to 348.99.

Still, some analysts were pessimistic on GlaxoSmithKline.

Bear Stearns analyst Alexandra Hauber, in a note to investors, downgraded the stock to 'Underperform' from 'Peer Perform,' citing pressure from blockbuster diabetes drug Avandia and concerns over the company's drug pipeline.

Elsewhere in the sector, some drug companies rose on a combination of factors including earnings-related news."

Patent Docs: Organon and MRC Technology to Collaborate

Patent Docs: Organon and MRC Technology to Collaborate: "Organon and MRC Technology have announced an intent to collaborate in the development of a humanized antibody for treating various cancers. Under the agreement, MRC will use its CDR grafting technology to generate a humanized antibody based on one of Mrct_new_logo_2006_email Organon's murine antibodies as a candidate for clinical development. MRC will receive milestone payments and royalties based on sales of a commercialized product. Organon is a biopharmaceutical company that is expanding its interest in biotechnology to the fields of immunology and oncology. MRC Technology performs technology transfer activities for the UK Medical Research Council, and provides chemical and biology tools to assist pharmaceutical and biotech companies in drug discovery."

Patent Docs: USPTO News: Patent Office Sends KSR Training Guidelines to OMB

Patent Docs: USPTO News: Patent Office Sends KSR Training Guidelines to OMB: "Last Friday, the U.S. Patent and Trademark Office (USPTO) announced that it has sent draft obviousness examination guidelines to the Office of Management and Budget (OMB) for review. The draft training guidelines are to be used by examiners in determining whether a claimed invention is obvious in view of the Supreme Court's decision in KSR Int'l Co. v. Teleflex Inc.

The draft guidelines, which the Patent Office did not release, will be posted on the USPTO website after the OMB concludes its review. According to the USPTO release, however, the Patent Office will begin training examiners 'on implementation of KSR' while awaiting the results of the OMB review."

Patent Docs: USPTO News: New Continuation and Claims Rules to Be Published in Late Summer

Patent Docs: USPTO News: New Continuation and Claims Rules to Be Published in Late Summer: "The U.S. Patent and Trademark Office (USPTO) announced today (July 25, 2007) that the Office of Management and Budget (OMB) completed its review of the new continuation and claims rules earlier this month. More importantly, the Patent Office also announced that the continuation and claims rules would be published in the Federal Register sometime in the late summer. The rules will become effective at least 60 days after publication, and according to the USPTO release, no earlier than October 1, 2007.

While abstracts of the new continuation and claims rules can be found on the Federal Regulatory Information website, the abstracts provide few clues as to what the final rules will look like. The abstracts for the continuation and claims rules can be found here:

• New continuation rule: "Changes to Practice for Continuing Applications, Requests for Continued Examination Practice, and Applications Containing Patentably Indistinct Claims
• "New claims rule: "Changes to Practice for the Examination of Claims in Patent Applications"

"

FDA Oncologic Drugs Advisory Committee Recommends that FDA Wait for Overall Survival Results from Satraplatin Phase 3 Trial

FDA Oncologic Drugs Advisory Committee Recommends that FDA Wait for Overall Survival Results from Satraplatin Phase 3 Trial: "MARTINSRIED/MUNICH, Germany, July 24 /PRNewswire-FirstCall/ -- U.S. Subsidiary Headquarters at Princeton, N.J. -- GPC Biotech AG (Frankfurt Stock Exchange: GPC; TecDAX index; Nasdaq: GPCB) today announced that the Oncologic Drugs Advisory Committee (ODAC) for the U.S. Food and Drug Administration (FDA) recommended (12-0) that the FDA should wait for the final survival analysis of the SPARC trial before deciding whether the satraplatin application is approvable for the treatment of hormone-refractory prostate cancer patients whose prior chemotherapy has failed. The FDA is not bound by the recommendations of advisory committees but will consider their advice when reviewing an applicant's NDA."

MaRS Blog - Innovation and Commercialization in Canada � Blog Archive � From Collaboration to Personalized Medicine

MaRS Blog - Innovation and Commercialization in Canada � Blog Archive � From Collaboration to Personalized Medicine: "Recently published work by a global team of scientists led by researchers from the Ontario Institute for Cancer Research led to the first genetic predictor for colorectal cancer. Dozens more genetic studies are set to report findings later this year. For example, Pfizer is partnering with NIH on a $26 million initiative called the Genetic Association Information Network (GAIN). GAIN aims to determine the genetic causes of common diseases over the next three years. The information derived from GAIN will be publicly available to researchers world-wide. Unlike many previous gene-disease studies that yielded spurious results, the new studies involve thousands of patients and are likely to hold up."

Patent Prospector: Dealing with KSR

Patent Prospector: Dealing with KSR: "Arguments to overcome obviousness rejection, particularly prior art combinations -

1. At least one claimed element is not “familiar”/known/shown in the art.
2. The claimed invention is not a combination of discrete elements at all.
3. The proposed combination of elements does not yield the claimed invention.
4. At least one claimed element functions differently from that in the prior art.
5. At least one claimed element was known only in substantially unrelated area.
6. It would take ingenuity, beyond one of 'ordinary skill in the art,' to combine elements. [Remembering that KSR renders one of ordinary skill as omnificent, as expert as any inventor.]
7. The number of alternative solutions for one claimed element was large or infinite. [This attempts to overcome a rejection on 'obvious to try.']
8. The result of the claimed combination would not have been predictable, or would not have had a reasonable expectation of success. [An unlikely sell without some evidence to point to.]
9. Secondary considerations: long-felt but unsolved need; commercial success; prior art expressions of doubt. Note that KSR reaffirmed Graham v. Deere."

Biotech Definitions: "Biotech Definitions

BIO-INFOMATICS: Information technology applied to biology. Software programs that process information derived from biological systems such as DNA sequence, cell mages, protein crystal structures, etc.

BIOTECHNOLOGY: the tools and technology that are used to make products from biological systems (cheese making), carry out processes using biological substances (enzyme-based processing such as wine making), or to modify biological systems in order to improve performance or produce bio-materials (breeding, tissue culture, cloning, transgenics).

Bt and Bt TOXINS: Compounds present in the bacteria bacillus thuringensis that helps protect bacteria from insects. Genes encoding bt-toxins have been transferred to plants to confer protection from insects. Bt-toxins are not harmful to humans.

CHROMOSOME: The self-replicating genetic structure of cells containing the DNA that bears the linear array of genes.

CLONE: An exact copy made of biological material such as a DNA segment (a gene or other region), a whole cell, or a complete organism.

DNA (deoxyribonucleic acid): The double-stranded molecule that encodes genetic information. It is made up of four different kinds of bases, which are abbreviated A, C, T, and G. A DNA fragment that is 10 bases long might have a sequence of, for example, ATCGTTCCTG. The particular sequence of bases encodes important information in an individual's genetic blueprint and is unique for each individual (except identical twins). The four bases are: adenine (A), guanine (G), cytosine (C), and thymine (T). In nature, base pairs form only between A and T and between G and C.

GENE: The fundamental unit of heredity. A gene is an ordered sequence located in a particular position on a particular chromosome that provides the code for a specific function or trait.

GENE EXPRESSION: The process by which a gene's coded information is converted into the structures present and operating in the cell.

GENE MAPPING: Determination of the relative positions of genes on a DNA molecule and in the genome.

GENETICS: The study of the patterns of inheritance of specific traits.

GENOME: All the genetic material in each organism.

GENOMIC SEQUENCE: The order of the DNA bases (A,C,G,T) that make up a particular fragment of DNA in a genome.

GMO: Genetically Modified Organism. Currently the label GMO and the term 'transgenic' are used to refer to organisms that have acquired novel genes from other organisms by laboratory 'gene transfer' methods. The term GMO is a poor label for transgenic organisms because all organisms are genetically modified. When a plant or animal species breeds with another one, genetic material is exchanged and results in the offspring. This can happen in the natural reproduction process or in a lab process.

rDNA (Recombinant DNA technology): Procedure used to cut and join together DNA segments in a cell-free system (an environment outside a cell or organism). Under appropriate conditions, a recombinant DNA molecule can enter a cell and replicate there, either autonomously or after it has become integrated into a cellular chromosome.

ROUNDUP READY: Roundup is a commercial chemical used to kill weeds. But since it kills many plants, producers have to be careful not to get it on the plants they want to grow. Some species of plants have been developed through biotechnology to have traits that protect them from Roundup.

TRANSGENIC: Taking genes from one species and inserting them into another species in order to get that trait expressed in the offspring. Usually when people say GMO, they really are referring to "transgenic" products."

Biotechnology in Texas

Biotechnology in Texas: "News Stories - see what has been covered

list bulletBiotech Projects at Texas A&M - find new ideas

list bullet Texas A&M Biotech Contact - call for biotech quotes

list bullet Definitions - help explain terms on deadline

list bulletTexas Biotech Summit - use publication for background"

Protalex Announces Preliminary Results in Phase I Clinical Trial

Protalex Announces Preliminary Results in Phase I Clinical Trial: "NEW HOPE, Pa.--(BUSINESS WIRE)--Protalex, Inc. (OTC BB: PRTX) announces that dosing has now completed for its expanded single-dose Phase I clinical trial of its lead compound, PRTX-100. This study was performed in healthy volunteers, and was designed primarily to increase the safety database for doses of 0.3 and 0.45 �g/kg of intravenously administered drug. Other objectives for this study were to better characterize the terminal clearance at higher doses, to evaluate a dose 50% higher than that dosed in the initial Phase I study, to evaluate several additional safety biomarkers, including platelet function, and to evaluate changes in monocyte and lymphocyte gene expression following PRTX-100 treatment."

The Fire of Genius � A New Essay

The Fire of Genius � A New Essay: "In April 2007, the Supreme Court, for the first time in 41 years, decided a case about the basic contours of patent law’s nonobviousness standard. The case, KSR, upends 25 years of Federal Circuit jurisprudence, and on a legal requirement that every patent must satisfy. In this essay, I show how KSR dismantles two predicates that have long shaped Federal Circuit nonobviousness cases — namely, the intertwined premises that hindsight-driven distortion is the gravest risk to an accurate nonobviousness requirement, and that the person of ordinary skill in the art (from whose perspective nonobviousness is judge) is singularly uncreative. In place of hindsight dread and the dullard artisan, the Supreme Court gives us caution against overpatenting and the creative artisan. Perhaps most important is that, consistent with these new predicates, the Supreme Court revives its holding from 1950 that a combination claim, i.e., a claim that simply remixes prior art technologies according to their established functions, must be scrutinized with great caution because it is likely unpatentable. I propose an evidentiary presumption framework to regularize KSR’s mandate."

Orexigen claims success in weight-loss trial - FierceBiotech - Biotechnology Articles, Biotech Industry News, FDA Approval News

Orexigen claims success in weight-loss trial - FierceBiotech - Biotechnology Articles, Biotech Industry News, FDA Approval News: "Orexigen Therapeutics says that a mid-stage trial of its weight-loss drug generated a statistically significant response compared to placebos. The study involving 620 patients concluded that the group taking its zonisamide-based formulation experienced an average 8.6 percent reduction in weight compared to a 1.1 percent drop in weight for the placebo group. Its shares were buoyed by the news."

Big Pharma brings home the cash, slices payroll - FierceBiotech - Biotechnology Articles, Biotech Industry News, FDA Approval News

Big Pharma brings home the cash, slices payroll - FierceBiotech - Biotechnology Articles, Biotech Industry News, FDA Approval News: "The Bush Administration was looking for new jobs when it announced a tax amnesty program aimed at encouraging multinationals to repatriate foreign profits. The New York Times reports that the drug industry was the most enthusiastic sector when it came to bringing the money home--to the tune of $100 billion. But instead of adding new jobs, the pharma companies have been cutting them. And now that the two-year program is over, the drug companies are once again turning to shelters to move their money into other markets. In some cases that involves designating other markets as more profitable than their U.S. market, even though the U.S. has traditionally served as pharma's global cash cow.

- read the article from The New York Times"

New hope for cross-species transplantation - FierceBioResearcher - Biotech research, Biotechnology research, Bioinformatics

New hope for cross-species transplantation - FierceBioResearcher - Biotech research, Biotechnology research, Bioinformatics: "Experiments using genetically-engineered pigs to make them compatible with the human immune system are raising expectations about the prospects of cross-species transplantation as an option for patients with diabetes and other currently incurable diseases. However, many scientific hurdles remain before the ultimate goal of inducing long-term tolerance of animal tissues and organs in human recipients, according to a special paper in the journal Transplantation."

Controlling brain protein may modulate stress, mood - FierceBioResearcher - Biotech research, Biotechnology research, Bioinformatics

Controlling brain protein may modulate stress, mood - FierceBioResearcher - Biotech research, Biotechnology research, Bioinformatics: "New research has shed fresh light on the role of the brain protein deltaFosB in combating depression and various emotional disorders. A team of scientists at UT Southwestern exposed mice to random shocks they couldn't escape from. Subsequently, they were allowed to escape the shocks, and the lag time each of the mice experienced in making their escape represents their level of 'behavioral despair.' The animals with the shortest lag time had the highest level of deltaFosB. Introducing the gene for deltaFosB also reduced their level of despair. High levels of deltaFosB were also linked to decreased activity of Substance P, a protein that regulates pain, stress and mood. The researchers published their findings in the journal Neuron."

Biotech pioneer bets a billion on Alzheimer's program - FierceBiotech - Biotechnology Articles, Biotech Industry News, FDA Approval News

Biotech pioneer bets a billion on Alzheimer's program - FierceBiotech - Biotechnology Articles, Biotech Industry News, FDA Approval News: "Orrie Friedman was one of the pioneers of biotechnology, but at 92 it's still way too early to start talking retirement. He's now betting that his company, Grand Pharma, can generate some excitement around the notion that silica-based compounds can dissolve amyloid plaques, which are associated with Alzheimer's. He's also betting that a new paper on their work will grab the attention of a deep-pocketed pharma company and that a successful development program will create a billion-dollar windfall. Oh, and he wants to give most of that money away."

FDA demands more data on Wyeth's Pristiq - FierceBiotech - Biotechnology Articles, Biotech Industry News, FDA Approval News

FDA demands more data on Wyeth's Pristiq - FierceBiotech - Biotechnology Articles, Biotech Industry News, FDA Approval News: "Wyeth was effectively stiff-armed by the FDA in its application for Pristiq, the first non-hormonal therapy to treat menopausal symptoms. In an approvable letter, regulators told the company that they want to see a one-year safety study done to gather more data on how the drug could affect patients' hearts and livers. That amounts to a major delay for Wyeth, but the drug company shows no sign of backing away from the therapy."

OilOnline - The Original Online Source for the Oil Industry

OilOnline - The Original Online Source for the Oil Industry: "GloriOil is successfully applying biotechnology in mature fields in the Texas Panhandle and West Texas to improve recovery and reduce operating costs. Developed and proven in multiple fields in Asia since 2001, GloriOil's innovative, environmentally safe Enhanced Oil Recovery by Microbial Consortia (EORMC) process establishes a downhole bioreactor in the formation near the wellbore that has delivered substantial production gains from mature oil wells. In addition, field applications to date have noted a significant decrease in water cut while demonstrating an improvement in oil quality. A derivative technology has also been used to create an internal biofilm coating on downhole tubulars to prevent paraffin buildup."

Alzheimer's Drug Discovery Foundation Invites Scientists to Apply for Grant Award Program

Alzheimer's Drug Discovery Foundation Invites Scientists to Apply for Grant Award Program: "The Alzheimer's Drug Discovery Foundation (ADDF) invites scientists from the biotechnology industry and academia to apply for a grant award program entitled Novel Approaches to Drug Discovery for Alzheimer's Disease. The goal of the research program is to accelerate the discovery, development and clinical evaluation of effective therapies for Alzheimer's disease. This grant program is being made possible through a generous donation from Elan Corporation, plc (NYSE: ELN)."

Fourth ACTEMRA(TM) (tocilizumab) Phase III Study Demonstrates Significant Clinical Benefit in RA Patients

Fourth ACTEMRA(TM) (tocilizumab) Phase III Study Demonstrates Significant Clinical Benefit in RA Patients: "NUTLEY, N.J., July 25 /PRNewswire/ -- Roche today announced that results from the AMBITION (Actemra versus Methotrexate double-Blind Investigative Trial In mONotherapy) trial, the fourth multinational Phase III study of ACTEMRA(TM), not only successfully met its primary endpoint of non-inferiority in patients with moderate to severe rheumatoid arthritis (RA), but also demonstrated superiority over the standard effective dose regimen of methotrexate alone."

IPOX Schuster's New China IPO Index Focused On 'A' Shares - Seeking Alpha

IPOX Schuster's New China IPO Index Focused On 'A' Shares - Seeking Alpha: "Heather Bell (IndexUniverse) submits: IPOX Schuster LLC is doing something new. Again. The Chicago-based index provider, the only index provider to focus on initial public offerings (IPOs), has launched yet another IPO index-the IPOX China 30 A-Shares Index. It is the first of its kind, as IPOX Schuster's products have been in most of the markets they have entered."

PharmaLive: DSM Biologics and Crucell Announce PER.C6 Licensing Deal With LFB Biotechnologies.

PharmaLive: DSM Biologics and Crucell Announce PER.C6 Licensing Deal With LFB Biotechnologies.: "SITTARD/LEIDEN, The Netherlands, July 25, 2007 - DSM Biologics, a business unit of DSM Pharmaceutical Products and Dutch biotechnology company Crucell N.V. (Euronext, NASDAQ: CRXL; Swiss Exchange: CRX) today announced a non-exclusive PER.C6� research licensing agreement with Paris, France-based LFB Biotechnologies. LFB Biotechnologies will use Crucell's technology to develop undisclosed antibodies. No financial details were disclosed."

From the Sequencer to the Drugstore?. In the Pipeline:

From the Sequencer to the Drugstore?. In the Pipeline:: "And I realize that there's room to argue about the 'human genome project' part of the question, too, since many small companies (deCODE, Millennium, Incyte, etc.) did a lot of work of their own outside of the official HGP. But for argument's sake, let's throw the question open to all the genomic approaches. Examples?"

Patent Prospector: USPTO Rule Changes

Patent Prospector: USPTO Rule Changes: "The patent office is proceeding towards the details of implementing its rule changes for limiting continuations and number of claims examined. An internal (intra-agency) email follows.

OMB Approves Claims and Continuation Changes

On July 9, 2007, the Office of Management and Budget concluded its review of the Continuations and Claims rule changes. The final rules will be made public when they are published in the Federal Register, which is expected to be later this summer. The rules will become effective at least 60 days after publication in the Federal Register, and no earlier than October 1, 2007.

The abstracts of the rules currently available on the Federal Regulatory Information Web site here and here reflect the abstracts of the Continuations and Claims notices of proposed rule -making that were published in January, 2006.

An internal USPTO team is currently working on details of implementing the rule changes. Examiners and managers will be given information and training on the new rules once they are published in the Federal Register. Additionally, management is currently discussing with POPA the appropriate process for negotiating any impacts the rules package may have."

Health Blog : The Science of Peppers and Pain

Health Blog : The Science of Peppers and Pain: "There’s a biological reason we say spicy food is hot: The chemical that gives peppers their punch targets the same nerve-cell receptors as high temperatures.

"

Pharma Marketing Blog: Why Do DTC Ads - "Viva Viagra" included - Stink?

Pharma Marketing Blog: Why Do DTC Ads - "Viva Viagra" included - Stink?: "Lately, we've been witnessing a regression of sorts in the quality of DTC (Direct-to-Consumer) Rx drug ads. The recent 'Viva Viagra' ad, for example, is a throwback to the days before Congress was serious about banning DTC or imposing more restrictions on DTC (see 'Viva Viagra Ad is No Cure for Morte Sales').

The Viva Viagra campaign also reneges on Pfizer's pledge back in 2005 to focus more on disease awareness in its DTC advertising. At the time, I said that erectile dysfunction (ED) ads would be the litmus test for this change in policy (see 'Pfizer DTC Pledge: ED is Litmus Test'). Well, it seems that Pfizer has failed the test."

Health Blog : Glaxo's Earnings Steady, Despite Avandia's Fall

Health Blog : Glaxo's Earnings Steady, Despite Avandia's Fall: "Sales of GlaxoSmithKline’s suddenly controversial diabetes drug Avandia fell 22% during the second quarter, but the decline was offset by gains for other drugs, the company said today. Net income for the quarter rose 1.4% compared with same period last year, to $2.75 billion."

Patent Prospector: Silk Purse from a Sow's Ear

Patent Prospector: Silk Purse from a Sow's Ear: "The Patent Reform Act of 2007 is hopefully too wretched and controversial to become law, but it has laid out a trough for the swine known collectively as the Congress of the United States. As one onlooker observed, 'The controversy certainly is a good income stream for the politicians.' Invitations are flowing to interested parties to attend breakfasts and receptions at $1,000 on up, for the chance to hobnob for a moment with an esteemed Senator or Congressperson, mouthing patent-reform-this or patent-reform-that to a pair of deaf ears attached to a fattening piggy bank.

The cynical view is that the push for the Patent Reform Act of 2007 is nothing more than a hustle, a foredoomed rainmaking dance. Sen. Hatch has already acknowledged that the Act is a train running to be derailed. Sen. Patrick Leahy (D-Vermont), chairman of the Senate Judiciary Committee, and House Judiciary Howard Berman (D-Calif.), have been pushing hard; it makes one ponder how well their tills are filling for all the lobbying."

News: Arena Pharmaceuticals Initiates Phase 1 Clinical Trial Program of APD791 for the Treatment of Arterial Thrombosis. Genetic Engineering News - Bi

News: Arena Pharmaceuticals Initiates Phase 1 Clinical Trial Program of APD791 for the Treatment of Arterial Thrombosis. Genetic Engineering News - Biotechnology from Bench to Business: "SAN DIEGO, July 18 /PRNewswire-FirstCall/ -- Arena Pharmaceuticals, Inc. (Nasdaq: ARNA) today announced that it initiated dosing in a Phase 1 clinical trial evaluating APD791, Arena's orally administered, internally discovered drug candidate intended for the treatment of arterial thrombo-embolic diseases. This Phase 1 trial is planned to enroll up to 72 healthy adult volunteers and is primarily intended to evaluate the safety and tolerability of single ascending doses of APD791. In addition, the trial will also evaluate the pharmacokinetics and pharmacodynamics of APD791."

A Farewell to Tin. In the Pipeline:

A Farewell to Tin. In the Pipeline:: "'However, this brings me to a point of consideration - why are Stille coupling (reactions) more common in academic publications, and Suzuki more so in an industrial/commercial context?'"

ScienceDaily: Study Urges Compensation-based Approach To Drug Patent Compulsory Licensing

ScienceDaily: Study Urges Compensation-based Approach To Drug Patent Compulsory Licensing: "A Penn State researcher argues that ambiguous international rules outlining when and how governments may 'break' pharmaceutical patents may end up significantly reducing incentives for innovation while at the same time failing to increase access to medicines."

Health Blog : Building Family-Friendly ICUs

Health Blog : Building Family-Friendly ICUs: "Emory has melded an intensive-care unit with family living quarters, creating a testing ground for an emerging health-care strategy: turning friends and families into active members of the health-care team."

Want To Live Longer? Take New Drugs (DrugWonks)

Want To Live Longer? Take New Drugs (DrugWonks): "In another blow to those who want keep Americans taking old medicines by banning access to free samples, marketing, continuing medical education, off label use and other methods that increase new drug use, this from my former perch at the Manhattan Institute and Frank Lichtenberg:

'It is no surprise that Americans are living longer today than in previous generations. A typical baby born in 1900 was expected to live to about age 45. Today, life expectancy at birth is about 78. Less well known, however, is the fact that the gains in life expectancy have not been uniform across the country. In his new study—the first of its kind—Columbia University researcher Frank Lichtenberg set out to find out which states are the leaders, which ones are the laggards, and why."

Bioethics Crisis in China

Bioethics Crisis in China: "A series of food and drug quality issues worldwide has finally prompted action on the part of regulators in China, where the tainted products originated. Poisonous medicine in Panama, tainted pet food in North America and toothpaste in Central America, are only three examples of improper preparation, handling or other shortcomings in the production processes in the Chinese food and drug industry. The growing list of food and drug items has lead to a bioethics crisis of unprecidented proportions, in the Chinese State Food and Drug Administration, as government regulators try to weed out corruption and restore their reputation."

News: Scientists Find Compound that Targets Therapy-Resistant Cancer. Genetic Engineering News - Biotechnology from Bench to Business

News: Scientists Find Compound that Targets Therapy-Resistant Cancer. Genetic Engineering News - Biotechnology from Bench to Business: "Scientists at Fred Hutchinson Cancer Research Center report that a modified version of antimycin, called 2-Methoxy antimycin, is selective in killing cells that have high levels of Bcl-2 and Bcl-xL proteins. The over expression of these proteins in many types of cancer cells correlates with resistance to chemotherapy and radiation therapy, according to the team. Cells with normal levels of Bcl-2 or Bcl-xL are resistant to 2-Methoxy antimycin.

“Our compound, 2-Methoxy antimycin, is the only Bcl-2 inhibitor reported with gain of function activity, which provides a therapeutic window between cancer cells with high expression of the proteins versus cells with normal expression,” says David M. Hockenbery, M.D., principle investigator and a professor of medicine at the University of Washington Medical Center. “This effect was preserved when 2-Methoxy antimycin was used in combination with other agents and could lead to a targeted molecular therapy to enhance the effectiveness of cancer treatments.”

The researchers set up screening assays to look for small molecules or compounds that are selectively toxic to cells that over express Bcl-2 proteins. They found that higher expression of the target protein made cells more sensitive to the 2-Methoxy antimycin inhibitor."

Biotech Blog � Drug reimportation: Where are the dead Canadians?

Biotech Blog � Drug reimportation: Where are the dead Canadians?: "A common retort in the debate over drug reimportation is “Where are the dead Canadians?”

If the FDA deems that import of drugs from Canada is potentially dangerous, why aren’t Canadians dying from drugs they buy in Canada? Well, there’s an answer to that: Most Canadians buy their drugs from drugstores, not over the Internet. Individuals buying drugs from Internet pharmacies based in Canada or elsewhere are, in fact, at risk. The level of scrutiny and the ability to trace supply chains simply isn’t as rigorous as it is for pharmacies with strong national brands and physical stores.

So where are the dead Canadians? Here’s one: Marcia Bergeron succumbed to a combination of fake drugs acquired over the Internet."

QLT announces FDA filing and review of Aczone(TM) labeling supplement for removal of blood screening requirement

QLT announces FDA filing and review of Aczone(TM) labeling supplement for removal of blood screening requirement: "VANCOUVER, July 23 /PRNewswire-FirstCall/ - QLT Inc. announced today that the U.S. Food and Drug Administration (FDA) has accepted for filing and review QLT USA, Inc.'s labeling supplement (sNDA) for Aczone(TM) to request the removal of the glucose-6-phosphate dehydrogenase (G6PD) screening and blood monitoring requirements from its current label. A decision by the FDA on the label revision is expected by the end of March 2008."

EpiCept Announces Phase III Study of EpiCept(TM) NP-1 for the Treatment of Chemotherapy Induced Peripheral Neuropathy

EpiCept Announces Phase III Study of EpiCept(TM) NP-1 for the Treatment of Chemotherapy Induced Peripheral Neuropathy: "TARRYTOWN, N.Y., July 23 /PRNewswire-FirstCall/ -- EpiCept Corporation today announced that it will study EpiCept(TM) NP-1, its patented topical cream formulation of two FDA-approved drugs, 4% amitriptyline and 2% ketamine, for the treatment of chemotherapy induced peripheral neuropathy (CPN) in the ATTRACT-CPN Phase III Study (Assessment of Topical Treatment Response with Amitriptyline and Ketamine: Combination Trial in Chemotherapy Peripheral Neuropathy). The study will be conducted within a network of approximately 25 sites under the direction of the National Cancer Institute (NCI) funded Community Clinical Oncology Program (CCOP)."

GeekPress

GeekPress: "How AT&T has broken up and come back together. (Via Neatorama.)"

SPOTLIGHT: Targeted Genetics study on hold - FierceBiotech - Biotechnology Articles, Biotech Industry News, FDA Approval News

SPOTLIGHT: Targeted Genetics study on hold - FierceBiotech - Biotechnology Articles, Biotech Industry News, FDA Approval News: "Seattle-based Targeted Genetics has decided to put its lead drug trial on hold after one of the patients in the study became seriously ill. Researchers have stopped dosing volunteers in the early-stage trial for an experimental therapy for inflammatory arthritis--known as tgAAC94--and patients in the study are being monitored. Analysts noted that it's too early to tell if this is a temporary or permanent setback for Targeted Genetics."

Anticipate This! EP-Oh! (Information about the European Patent Office) �

Anticipate This! EP-Oh! (Information about the European Patent Office) �: "We recently were posed a question about European Patent Office (EPO) procedure. The question was: “What is a European patent and what rights does it confer?”

An issued EPO patent, while substantively reviewed and prosecuted, is nothing more than a conduit to enter European member states. Once the EPO reviews, approves, and issues the patent, the applicant has 3 months to supply to the desired member state’s industrial property office a translation of the patent in one of the member state’s official language or, where the State has prescribed the use of one specific official language, in that language. The period of three (3) months may be extended on a state-by-state basis. See European Patent Convention (EPC), Article 65. The only exception to the three-month rule appears to be Ireland, which allows the filing of a translation within six (6) months. Once the time period for filing a translation has lapsed, the EPO patent is deemed void ab initio in all member states in which a translation was not filed. That’s right, the EPO patent provides no protection in those countries and it is as if the application never existed."

Patent Docs: Mergers and Acquisitions Are Preferred Over IPO's

Patent Docs: Mergers and Acquisitions Are Preferred Over IPO's: "The biotech industry needs lots of capital for research, new product development, and lots of funds for daily operations. The current trend of mergers and acquisitions in the biotech industry arises in order to satisfy the needs of the industry. Many biotech firms have promising technologies and low stock prices, making such firms excellent takeover candidates. For large firms, mergers address excess capacity resulting from anticipated patent expirations and gaps in product pipelines. For small firms, mergers are excellent exit strategies and opportunities to have access to larger markets and more money."

The IN VIVO Blog

The IN VIVO Blog: "No drug is exempt from FDA’s ultra-conservative stand, it seems, even those, like GPC Biotech’s satraplatin (Orplatna), that allegedly improve survival among cancer patients with few if any treatment alternatives.

An oncology advisory committee (ODAC) yesterday recommended that FDA delay considering prostate cancer candidate satraplatin for approval until overall survival data from the company’s 950-patient SPARC study is available. This recommendation came despite interim analysis strongly supporting the efficacy and safety of satraplatin, which was granted priority FDA review in April 2007."

Health Blog : Lab Values Predict Mortality for Hospitalized Patients

Health Blog : Lab Values Predict Mortality for Hospitalized Patients: "Measuring just how well hospitals care for patients has proved tricky. Mortality measures, adjusted for risk, are one approach.

So what’s the best way to evaluate how likely hospitalized patients are to die? Lab tests, according to a paper in the current issue of the journal Medical Health.

Researchers–from Children’s Hospital of Philadelphia, the University of Pennsylvania and Cardinal Health, a distributor of drugs and medical supplies–compared lab data from 32 common tests against more detailed patient information. The standard benchmarks included patient vital signs, information laboriously extracted from patient chart notes and hospital billing data.

Lab data, it turned out, predicted in-hospital mortality best for most conditions studied. For stroke, chart data–specifically signs of altered mental status–were the best predictor."

Genstar inks $744M deal to buy PRA International - FierceBiotech - Biotechnology Articles, Biotech Industry News, FDA Approval News

Genstar inks $744M deal to buy PRA International - FierceBiotech - Biotechnology Articles, Biotech Industry News, FDA Approval News: "The private equity firm Genstar Capital has struck a deal to buy PRA International for $744 million, a premium of about 13 percent on PRA's stock price. The big CRO gets 50 days to solicit a better offer, but any new suitor would have to pay a $7.9 million break-up fee. The deal is expected to wrap in the fourth quarter."

WuXi PharmaTech files $120M IPO on NYSE - FierceBiotech - Biotechnology Articles, Biotech Industry News, FDA Approval News

WuXi PharmaTech files $120M IPO on NYSE - FierceBiotech - Biotechnology Articles, Biotech Industry News, FDA Approval News: "Putting an end to the rumors, China's WuXi PharmaTech, the country's largest CRO, has announced plans for a $120 million IPO on the New York Stock Exchange. The U.S. offering was spurred in part by the fact that most of the company's revenue is coming from American companies. Founded six years ago, WuXi has been growing fast as China takes a central place in the drug development world."

China pushes drug development as R&D soars - FierceBiotech - Biotechnology Articles, Biotech Industry News, FDA Approval News

China pushes drug development as R&D soars - FierceBiotech - Biotechnology Articles, Biotech Industry News, FDA Approval News: "China has already made tremendous inroads as a manufacturing center for the world. But now it's making enormous investments in R&D to propel the country into the top ranks of world innovators. China has already passed Japan for R&D spending, notes an article by the BBC. And it's turning to companies like Sinovac to develop new drugs. Sinovac is pushing a new bird flu therapy. China's R&D budget is growing at a rate of 20 percent a year, making it likely that a lot more Sinovacs will be created in the years ahead."

Merck snares NovaCardia in $350M buyout - FierceBiotech - Biotechnology Articles, Biotech Industry News, FDA Approval News

Merck snares NovaCardia in $350M buyout - FierceBiotech - Biotechnology Articles, Biotech Industry News, FDA Approval News: "Merck has bolstered its cardiovascular pipeline with a deal to buy NovaCardia for $350 million in cash. For Merck, the acquisition marks another step down its five-year plan to restructure the company. Buying up new therapies in development is a key part of that effort, and the competition for acquisitions has been steadily driving up valuations in the biotech world. NovaCardia has a drug--KW-3902--in late-stage studies for congestive heart failure.

'This acquisition continues to deliver on our strategy of targeted acquisitions in areas of unmet medical need in the therapeutic areas of strategic importance for Merck, such as cardiovascular diseases,' said Richard Kender, vice president of business development and corporate licensing at Merck."

GPC cancer drug voted down by FDA committee - FierceBiotech - Biotechnology Articles, Biotech Industry News, FDA Approval News

GPC cancer drug voted down by FDA committee - FierceBiotech - Biotechnology Articles, Biotech Industry News, FDA Approval News: "An FDA expert committee has dealt a blow to GPC Biotech, concluding unanimously that regulators should wait for survival data before approving its prostate cancer drug Orplatna (satraplatin). The news triggered a rout among investors as GPC's stock slid 42 percent, wiping out $310 million of valuation. Shares of Spectrum Pharmaceuticals as well as Pharmion, GPC's partners on the drug, both slipped.

The committee wants to see if volunteers taking the pill in a trial lived longer than the placebo arm. Interim data from last summer demonstrated no improvement in survival rates and the company says that it could be another year before the new batch of data would be available. GPC based its application on the potential benefit for patients who had not responded to other treatments. Progression-free survival for the group on the drug was 11.1 weeks compared to 9.7 weeks for patients taking a placebo."