FDAnews Drug Daily Bulletin
Oct. 16, 2012 | Vol. 9 No. 203
The FDA appears to have a positive opinion of NPS Pharmaceuticals’ Gattex as a treatment for short bowel syndrome (SBS) patients, according to agency briefing documents.
The FDA is creating a task force to support development of new antibacterial drugs.
An international offensive against thousands of online peddlers of counterfeit and illicit drugs has resulted in the seizure of some 3.75 million units with an estimated value of $10.5 million.
Watson Pharmaceuticals said it received approval from the FDA for the generic version of Sanofi’s Avapro (irbesartan).
Merck announced results from a Phase II trial for odanacatib, an investigational cathepsin K inhibitor in development for the treatment of osteoporosis in post-menopausal women.
The FDA will review Depomed’s potential treatment for menopausal hot flashes and may decide its fate by next spring.
AstraZeneca, which has the worst-performing stock this year among Europe’s biggest drugmakers, will work with a research company in China to speed discovery of new medicines.
Pharmacyclics Triggers Another Significant Milestone Payment for Phase III Chronic Lymphocytic Leukemia Combination Trial
Pharmacyclics announced the international, randomized Phase III clinical trial of ibrutinib (PCI-32765) in combination with bendamustine and rituximab in patients with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma has enrolled its fifth patient.
Abbott Laboratories may be looking to acquire the manufacturing facilities of Russian drug maker Petrovax Pharm.
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