News

Press Release: Akorn Signs Exclusive Distribution Deal for Vaccine

Press Release: Akorn Signs Exclusive Distribution Deal for Vaccine

Press Release: Axial Biotech Announces $15.3 Million Series B Financing

Press Release: Axial Biotech Announces $15.3 Million Series B Financing

Press Release: Azoline Dose Ranging StudyMeets Primary and Secondary Endpoints

Press Release: Azoline Dose Ranging StudyMeets Primary and Secondary Endpoints

Press Release: CombinatoRx Says Arthritis Drug Misses Primary Endpoint

Press Release: CombinatoRx Says Arthritis Drug Misses Primary Endpoint

Press Release: Biocryst Pharmaceuticals Places Hold on Trial of IV Leukemia Drug

Press Release: Biocryst Pharmaceuticals Places Hold on Trial of IV Leukemia Drug

Editor's Corner


Just a quick reminder: We'll be doing an hour-long webinar tomorrow at 2 EST covering biodefense and infectious disease research in Maryland. The webinar also covers some of the incentives the state has on offer. Be sure to …

CSL sees positive trends in failed Phase II

Australia's CSL is steadfastly sticking by its experimental cholesterol drug, CSL-111, despite its announcement that the therapy had failed a primary goal of reducing arterial plaque by a statistically significant margin. Researchers believe that by raising HDL, or good cholesterol, they can reduce plaque. The 183-patient, Phase II study did demonstrate a reduction in plaque on an absolute basis, though that wasn't big enough to reach its goal. But several doctors who had a chance to …

FDA regulators question effectiveness of Provenge

Regulators at the FDA raised questions about the effectiveness of Dendreon's Provenge for prostate cancer in advance of an expert committee meeting on the therapy Thursday. Dendreon is banking on studies that show that patients taking Provenge lived on average an extra four and a half months. But regulators highlighted the fact that the drug did not attain certain effectiveness targets, adding that some data did support use of the therapy.

- read the AP

CombinatoRx reports failure in Phase II RA trial

CombinatoRx says that a mid-stage trial of its experimental drug CRx-139 for rheumatoid arthritis failed to hit its primary goal. But researchers emphasized that the therapy did achieve a number of secondary endpoints that warranted further analysis. The Cambridge, MA-based developer announced that "CRx-139 was not statistically significant versus 3mg prednisolone as measured by ACR 20 at day 70, CRx-139 did achieve statistical significance versus 3mg prednisolone alone as measured by ACR …

Aerovance closes $32M tranche in third round

Aerovance has closed a $32 million second tranche of its $60 million round of venture funds. Much of that money will be used to advance the asthma drug Aerovant into Phase IIb, scheduled to begin later this year. Aerovance said in a statement that it is looking for a strategic partner on Aerovant. The company's investors include Apax Partners, Clarus Ventures, Alta Partners, Lehman Brothers, NGN Capital and Burrill & Co. 

"With the Phase IIa data for our cystic fibrosis …

BioCryst shares slide on trial suspension news

Shares of BioCryst Pharmaceuticals took a beating this morning after the company announced it was halting the intravenous drug arm of a cancer trial after finding particles in the treatment solution. Shares slipped 11 percent on the news that researchers had found particles in batches of Fodosine during a cancer trial. Early tests indicated that the particles came from the stopper used in packaging the drug and that it would not have a contaminating effect. The company alerted the FDA and …

SPOTLIGHT: FDA sees long road for biosimilar approvals


A senior FDA administrator, Janet Woodcock, told lawmakers that it could be a decade or more before the agency could approve generic biotech drugs with the same kind of speed used for traditional meds today. That's likely to be music to the ears of big biotech outfits like Amgen and Genentech, which would be among the first affected by a new pathway to biosimilars. Report

ALSO NOTED: Sanofi-Aventis mulls BMS bid; FDA fast tracks Nuvelo therapy; and much more...

> A week after seeing its stock price battered on the news that preliminary data showed that AGI-1067 failed a large international trial, AtheroGenics made the case that the anti-inflammatory drug did hit secondary endpoints and could be used for other indications. Report

> The board of France's Sanofi-Aventis is reportedly split …

Press Release: Schering-Plough's Novel Oral Thrombin Receptor Antagonist Meets Primary Endpoint in Phase II Trial

Press Release: Schering-Plough's Novel Oral Thrombin Receptor Antagonist Meets Primary Endpoint in Phase II Trial

Press Release: Bayer Deal with Novartis Improves Profit Outlook for Betaseron Franchise

Press Release: Bayer Deal with Novartis Improves Profit Outlook for Betaseron Franchise

Press Release: Tolvaptan Misses Endpoint

Press Release: Tolvaptan Misses Endpoint

Press Release: Isis Pharmaceuticals Reports Positive Phase 2 Data for ISIS 301012

Press Release: Isis Pharmaceuticals Reports Positive Phase 2 Data for ISIS 301012

Press Release: Pfizer "Good Cholesterol" Drug Fails to Cut Plaque

Press Release: Pfizer "Good Cholesterol" Drug Fails to Cut Plaque

Press Release: Merck and Schering-Plough Corporation to Develop Combo Pill with Lipitor

Press Release: Merck and Schering-Plough Corporation to Develop Combo Pill with Lipitor