News

ALSO NOTED: Silenor positive in Phase III; BioSante wins FDA approval;and much more...

> A late stage trial of Somaxon's insomnia drug Silenor produced positive results for elderly patients with chronic pulmonary insomnia. Report

> BioSante has won FDA approval of Bio-E-Gel, which will be marketed under the name Elestrin for hot flashes. Release

> The FDA has approved SkyePharma's …

Press Release: Depomed Delivers Notice of Breach and Demand for Arbitration to Esprit Pharma

Press Release: Depomed Delivers Notice of Breach and Demand for Arbitration to Esprit Pharma

Press Release: Exelixis and Bristol-Myers Squibb Sign Collaboration Agreement for Oncology Compounds

Press Release: Exelixis and Bristol-Myers Squibb Sign Collaboration Agreement for Oncology Compounds

Press Release: Eli Lilly Responds to New York Times Article

INDIANAPOLIS, Dec 16, 2006 --Eli Lilly and Company, in a response to a story about Zyprexa in the December 17, 2006 edition of the New York Times, adds important facts and perspectives that were not evident in the story.

Press Release: Eli Lilly Announces Revised Merger Agreement With Icos

Press Release: Eli Lilly Announces Revised Merger Agreement With Icos

Press Release: Skyepharma Announces FDA Approves Foradil Certihaler

Press Release: Skyepharma Announces FDA Approves Foradil Certihaler

Press Release: BioSante Pharmaceuticals Receives FDA Approval Of Bio-E-Gel

Press Release: BioSante Pharmaceuticals Receives FDA Approval Of Bio-E-Gel

Expert panel rejects pleas for Hemopure trial

Rejecting the strenuous pleas of the U.S. Navy, an FDA advisory panel has rejected Biopure's bid to test the blood substitute Hemopure on civilian trauma patients. Voting 11 to eight against the move, the experts concluded that the risks exceeded the potential benefits of the trial. Blood substitutes are a highly controversial therapy, in large part because they need to be tested on trauma victims without their consent. The Navy has been backing Biopure's program, though, saying that a …

GSK wins EMEA approval for pandemic vaccine

The European Medicines Agency has given GlaxoSmithKline a thumb's up for Daronrix, its pandemic flu vaccine. The European Commission will now take up the issue. Glaxo's victory at the EMEA followed an extraordinarily swift development process, with clinical trials beginning in April. The drug developer filed what's called a mock-up dossier on the vaccine, asking for approval against one strain of the H5N1 virus. In the event of a potential pandemic, Glaxo would adapt the vaccine to work …

NJ lawmakers back $270M stem cell program

Tapping its bond program, the New Jersey legislature has agreed to borrow $270 million to back new research into stem cells. The bulk of that money will go to a stem cell research facility at Rutgers, a research center at Rutgers-Camden and the New Jersey Institute of Techology's stem cell research center. New Jersey has been a leader in supporting the controversial science, awarding the first actual cash support for stem cell research last year. California has a multibillion-dollar bond …

Novartis chooses Massachusetts for division HQ

Novartis has chosen Cambridge, MA as the location of its global vaccines and diagnostics division. The move will add 250 new employees to the 1,300 Novartis workers already employed at the company's Boston research division. Jorg Reinhardt, CEO of the Switzerland-based company, said Novartis was looking to capitalize on the thriving biotech cluster that has grown up around the Boston area. Massachusetts doesn't do much to compete …

Epigenomics hit hard as Roche drops collaboration

Shares of Germany's Epigenomics were hammered early today when Roche announced it was ending a collaboration to develop new cancer screening tests after determining Epigenomics' data did not meet its standards. Epigenomics CFO Oliver Schacht told reporters that the company was looking to license its programs in different cancers to different partners, rather than as a group. New deals are likely to take three to six months to complete. In the meantime, its shares plunged more than 50 …

SPOTLIGHT: FDA rejects Genasense


Already hammered by poor trial data, Genta announced today that the FDA had formally rejected its leukemia therapy Genasense. Genta's stock dropped more than 20 percent to 54 cents a share. Its stock had already been hurt by the news several days ago that the therapy had failed a trial. "We are keenly disappointed by this decision," Raymond Warrell, Genta's chief executive, said in a statement. "We believe that Genasense has amply demonstrated its efficacy and safety in patients with …

ALSO NOTED: Elan, Biogen submit Tysabri for Crohn's; Affymax prices IPO;and much more...

> Shares of Elan and Biogen Idec were on the rise this morning after the two developers announced that they had submitted Tysabri as a therapy for Crohn's disease. Report

> Affymax priced its IPO of 3.7 million shares at $25 a share. Release

> Advancis Pharmaceutical …

Press Release: GlaxoSmithKline Reaches Milestone in Its Flu Pandemic Vaccine Development Programme

Press Release: GlaxoSmithKline Reaches Milestone in Its Flu Pandemic Vaccine Development Programme

Press Release: Expert panel rejects Hemopure trial

Press Release: Expert panel rejects Hemopure trial

Press Release: MethylGene Will Not Pursue Additional Cinical Trials For MG98

Press Release: MethylGene Will Not Pursue Additional Cinical Trials For MG98

Press Release: Lipoxen Announces $75M Agreement With Baxter

Press Release: Lipoxen Announces $75M Agreement With Baxter

Press Release: Genta Receives Non-Approvable Notice for Application of Genasense

Press Release: Genta Receives Non-Approvable Notice for Application of Genasense

Press Release: Affymax Announces IPO

Press Release: Affymax Announces IPO