FDA

Dynavax drops Tolamba on trial failure

admin — Fri, 16 May 2008 06:59:58 -0400

Dynavax is dropping it's late-stage ragweed allergy drug Tolamba as it failed to meet its primary efficacy endpoint. While the drug showed a measurable clinical benefit, reducing total nasal symptom Read more...

ALSO NOTED: GSK releases new Cervarix data; FDA mulls DTC ads; and much more...

admin — Fri, 16 May 2008 06:59:50 -0400

> GlaxoSmithKline has released new Cervarix data that demonstrates the vaccine's ability to generate a high and sustained level of antibodies to neutralize the two most prevalent strains of Read more...

FDA picking up the pace on '08 approvals

admin — Thu, 15 May 2008 06:59:58 -0400

Last year's awful record of new drug approvals by the FDA has been followed by a burst of new activity. Pharmalot reports new analysis indicating 29 Read more...

ALSO NOTED: Ambrilia touts data; Amarin raises $60M; and much more...

admin — Wed, 14 May 2008 06:59:50 -0400

> Ambrilia Biopharma reported positive 24-week Phase III top-line results for prolonged-release formulation of Octreotide. Read more...

SPOTLIGHT: Novalar approval a small gain for big group

admin — Tue, 13 May 2008 06:59:53 -0400

Novalar Pharmaceuticals may not have made drug history when the FDA approved their new therapy to speed the return of sensation after dental procedures, but the private biotech has some ambitious Read more...

Roche posts new data backing Actemra for RA

admin — Mon, 12 May 2008 06:59:54 -0400

Roche has racked up more late-stage data backing Actemra as a new therapy for rheumatoid arthritis. Researchers say their fifth Phase III trial demonstrated that the therapy inhibited structural Read more...

FDA delays Entereg decision

admin — Fri, 09 May 2008 06:59:58 -0400

GlaxoSmithKline and Adolor's seemingly never-ending effort to win approval for Entereg has hit yet another delay. The FDA informed the companies that it would not make a decision by Saturday, the Read more...

Talecris' antibody drug gets priority review

admin — Fri, 09 May 2008 06:59:54 -0400

The FDA has granted priority review to Talecris' drug Gamunex, meaning the FDA will review its application in six months rather than the standard 10. Gamunex is an IGIV therapy that contains Read more...

Eisai wins expert panel's approval for new sedative

admin — Thu, 08 May 2008 06:59:57 -0400

Backed by a positive review from FDA staffers, an expert panel at the agency has recommended the agency approve Eisai's fospropofol disodium, a sedative designed for use in a number of procedures, Read more...

ALSO NOTED: Novartis buys bigger stake in Alnylam; FDA chastises ZymoGenetics' marketing campaign;and much more...

admin — Thu, 08 May 2008 06:59:50 -0400

> Novartis has scooped up a bigger share of Alnylam stock. The pharma giant now owns 13.3 percent of the company. Read more...