release formulation news from FierceBiotech
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ALSO NOTED: Ambrilia touts data; Amarin raises $60M; and much more...
> Ambrilia Biopharma reported positive 24-week Phase III top-line results for prolonged-release formulation of Octreotide. Read more...
Orexigen claims success in weight-loss trial
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 Read more...
Press Release: Depomed Reaquires Rights to ProQuin XR
Press Release: Depomed Reaquires Rights to ProQuin XR
Read more...Press Release: Astellas Receives an Action Letter from FDA for NDA of FK506 MR in the U.S.
Press Release: Astellas Receives an Action Letter from FDA for NDA of FK506 MR in the U.S.
Read more...Press Release: Elbion Acquires Late-Stage Product Candidate For Treatment Of Alcohol Dependence
Press Release: Elbion Acquires Late-Stage Product Candidate For Treatment Of Alcohol Dependence
Read more...Press Release: Ambrilia Biopharma Announces European Licensing Partnership With TEVA
Ambrilia Biopharma Announces European Licensing Partnership With TEVA
Read more...Critical Therapeutics slashes staff in restructuring
Critical Therapeutics of Lexington, MA has announced plans to restructure, laying off more than half of its work force as it devotes itself to the commercial and clinical development of an asthma therapy. Critical Therapeutics says it will eliminate 63 jobs by the end of the year, leaving it with 59 employees. Many of those cuts are being made to a dedicated sales force for Zyflo. The company plans to concentrate …
Read more...Tramadol-ER fails in latest Phase III trial
Researchers at Canada's Cipher Pharmaceuticals are blaming an unexpectedly high placebo response for the failure of the pain drug Tramadol-ER in a new Phase III trial. Because of the placebo effect, says Cipher, the drug failed to achieve a statistically significant improvement among volunteers. But Cipher says it can still rely on a mountain of positive data from six completed pharmacokinetic studies and five Phase III studies to back up its NDA for the extended-release formulation. …
Read more...ALSO NOTED: Ono to start cancer trials; Ligand CEO steps down; and much more...
> The FDA has given Medarex, the U.S. partner of Japan's Ono Pharmaceuticals, permission to begin clinical trials of the experimental cancer drug ONO-4538/MDX-1106. The two developers have been engaged in a collaboration based on Ono's IP and Medarex's human antibody development system. Report
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Read more...ALSO NOTED: Celera moves to cut staff; FDA expands Emend use; FDA approves Perrigo gel; and much more...
> A restructuring at Celera Genomics will include laying off 180 staffers. Report
> The FDA has expanded its approval for Merck's nausea drug Emend to include cancer patients undergoing chemotherapy. Report
> Perrigo's stock ticked up on news that the FDA had approved …
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