Bladder Cancer

ALSO NOTED: Seattle Genetics to raise cash; Biocancell IIb trial approved;and much more...

Mon, 14 Jan 2008 06:59:50 -0500

> Seattle Genetics plans to raise cash by selling 10 million shares of its stock. Report

> The FDA has given Biocancell Therapeutics an OK to continue a Phase IIb trial on a new bladder cancer drug. Release

> Teva is exploring the possible sale of its animal health division. Release

> Qiagen says that it has won an antitrust ruling in a patent lawsuit with Third Wave Technologies. Release

> Adventrx Pharmaceuticals announced that ANX-530 demonstrated a statistically significant reduction in injection site reactions when compared to Navelbine. Release

> Sanofi and P&G say a collaborative development program for a 150 mg, once-monthly dose of the osteoporosis drug risedronate proved noninferior when compared with a 5 mg daily dose of the drug in a late-stage study. Release

> Is fibromyalgia an ill-gotten label that could only benefit drug companies? Or is it a real disease that needs treatment? Judging by the abrupt rise in prescriptions for the Pfizer drug Lyrica since it was approved for fibromyalgia treatment in June, it's real. But doctors are still arguing. Report

> In an interview with the Financial Times, Johnson & Johnson CEO Bill Weldon (photo) admits to a fascination with technology. Report

> The gig is up, the news is out. Merck and Schering-Plough announced the results of its big ENHANCE trial this morning. Report

And Finally... A UK study led by researchers at Cardiff University suggests that a chemical first found on Easter Island could treat the genetic disorder tuberous sclerosis, which causes tumors to grow in many of the organs of the body. Release

ALSO NOTED: FDA says no to Indevus; Nektar gets sweetened deal with Baxter; Akela pulls public offering; and much more...

Thu, 20 Dec 2007 06:59:50 -0500

> Indevus Pharmaceuticals says that the FDA has turned thumbs down on its new therapy for bladder cancer, a move that trimmed its stock value. Valstar was pulled from the market five years ago after an unstable ingredient was found in its original formulation. Indevus says that issue has been fixed, but regulators rejected its marketing application due to chemistry and manufacturing concerns. Deficiencies had been noted at a third-party manufacturing facility slated to make the drug. The company says it can sort out those problems in months and plans a new application with a request for a new inspection of the unnamed facility. Indevus obtained Valstar when it bought out Valera Pharmaceuticals earlier this year. Release

> Nektar Therapeutics has sweetened its deal with Baxter International to develop improved therapies for hemophilia. Under a pact extension, Nektar will be able to earn up to $44 million in upfront fees and milestones for its work on pegylated forms of hemophilia drugs. The new collaboration is an extension of a deal the two companies forged in 2005. Release

> Akela Pharma has become the latest biotech victim of a chilly market environment, abandoning its U.S. public offering as it explores alternative financing sources. Release

> Ligand Pharmaceuticals picked up a million-dollar milestone on Glaxo's submission of an NDA for Promacta. Release

> Vertex Pharmaceuticals is pondering the idea of consolidating its scattered operations in Cambridge into an office tower on the South Boston Waterfront. Report

> Novavax announced favorable interim results from a Phase I/IIa human clinical trial of its non-adjuvanted pandemic influenza virus-like particle vaccine candidate. Release

> Forbes Medi-Tech is asking shareholders to approve a reorganization that will allow it to undertake new financing options. Release

> Akers Biosciences chairman David Wilbraham has converted fees into 61,017 shares in the company. Report

> There's nothing like a whistleblower lawsuit to get a company riled. A former Pfizer exec has accused the company of using continuing medical education as stealth marketing for its cholesterol drug Lipitor. Report

> A copycat of Wyeth's Effexor XR could cut $500M off the company's sales. Report

> Now here's an op-ed Big Pharma can unite behind. In the Baltimore Sun, journalist and patient Naomi Wax assails the FDA for calling generic drugs exactly equivalent to their brand-name counterparts. Report

And Finally… Scientists have advanced a new nanotech process to engineer replacement blood vessels. Release

ALSO NOTED: BMS hands back drug rights; OncoMethylome in deal with GSK; Celgene shares take a bounce; and much more...

Mon, 26 Nov 2007 06:59:50 -0500

> Bristol-Myers Squibb has returned the rights to vinflunine to Pierre Fabre. The therapy was studied as a treatment for bladder cancer. Release

> Belgium's OncoMethylome Sciences has forged a pact with GlaxoSmithKline to develop DNA methylation biomarkers for use in developing personalized cancer therapies. Release

> Shares of Celgene got a bounce this morning after a Banc of America analyst give a thumb's up to the company's expanded line-up of cancer therapies with its acquisition of Pharmion. Katherine Kim concludes that Revlimid can earn $3.5 billion a year. Report

> Sanofi Pasteur says it's spending about $104 million on a Chinese manufacturing plant in hopes of launching flu shots locally by 2012. Report

> A new regulatory report gives us a peek at the recall of Roche's HIV remedy Viracept--and it's not a pretty picture. Report

> The FDA also plans to review Roche's Tamiflu and GlaxoSmithKline's Relenza at its advisory committee confab Nov. 27-28. At issue: the anti-influenza drugs' potential neurological side effects in kids. Report

The FDA is taking a second look at the safety of three asthma drugs used in kids: GlaxoSmithKline's Serevent and Advair, and Novartis' Foradil. Report

> QRxPharma has begun treating patients as part of the Phase III development program for its lead product candidate Q8003IR, an immediate release dual-opioid pain therapy. Release

> An M.D. and former speaker-on-behalf-of-a-drug tells his story in the New York Times Magazine, and it's an illuminating, behind-the-scenes look at how Dr. Daniel Carlat (photo) became Dr. Drug Rep.

And Finally… In a major study, transcranial magnetic stimulation proved effective in treating major depression. Report

ALSO NOTED: Halozyme inks tech pact; Bioniche gains SPA; Ariad shares on rise; and much more...

Mon, 10 Sep 2007 06:59:50 -0400

> Halozyme Therapeutics has agreed to put its technology to work to develop a new formulation of Baxter's Gammagard Liquid for subcutaneous delivery. Gammagard is used to treat primary immunodeficiency disorders and Baxter believes it could be more effective if delivered under the skin. Halozyme pockets $10 million upfront for the use of its Enhanze Technology in a pact worth a potential $47 million. Release

> Bioniche Life Sciences has hammered out a special protocol assessment agreement on a Phase III trial of its bladder cancer therapy. The pact clarifies the critical endpoints researchers will have to meet in order to gain an approval. Release

> Shares of Ariad Pharmaceuticals were on the rise this morning after the company announced a special protocol assessment deal with the FDA for oral deforolimus in patients with metastatic sarcomas. The drug is being developed with Merck. Report

> Lev Pharmaceuticals is touting positive results from a Phase III trial of Cinryze, a new therapy for hereditary angioedema. Release

> Endo Pharmaceuticals says that the FDA will make a decision on a new use for Frova by September 30. Release

> Merck has exercised an option for the exclusive use of Crucell's PER.C6 technology and an option for access to Crucell's AdVac vaccine technology in two infectious disease areas. Release

> Germany's MediGene has raised €15.6 million in a private placement. Release

> Anemia drugs just can't get a break. Now, the FDA is questioning whether the drugs--Amgen's Epogen and Aranesp and J&J's Procrit--actually improve kidney patients' quality of life. Report

> The atmosphere could be contentious when Bayer's Trasylol comes before an FDA advisory committee Wednesday. FiercePharma

> GlaxoSmithKline CEO Jean-Pierre Garnier struck back at critics over the weekend in an interview with London's Telegraph newspaper. He blamed a slide in the overall pharmaceuticals industry for the company's lackluster stock performance, which has drawn fire from investor groups. FiercePharma

And Finally… New research indicates that most people still behave pretty much like Neanderthals when it comes to choosing a mate. Release