FDA Advisory Committee Recommends Approval of Belatacept
- Details
- Category: Bristol-Myers Squibb
Bristol-Myers Squibb Company (NYSE:BMY) announced that the U.S. Food and Drug Administration's (FDA) Cardiovascular and Renal Drugs Advisory Committee has voted 13 to 5 to recommend approval of belatacept, a selective co-stimulation blocker, for the prophylaxis of acute rejection in de novo kidney transplant patients.
Initiation of Phase 2 Clinical Trial Investigating Three Individual HCV Antivirals
- Details
- Category: Abbott
Abbott (NYSE: ABT) and Enanta Pharmaceuticals announced the advancement of their Hepatitis C (HCV) collaboration into Phase 2 clinical trials. The trial will evaluate three HCV antiviral agents, including the investigational protease inhibitor ABT-450, part of the Abbott-Enanta collaboration, and polymerase inhibitors ABT-333 and ABT-072 currently being developed exclusively by Abbott.
Nycomed on track in 2009 with strong growth in Key Products
- Details
- Category: Nycomed
Nycomed was on track in 2009, with strong growth in Key Products and most emerging markets. Pantoprazole sales were resilient after the loss of exclusivity in May in 12 European countries, as a result of a tailored approach to each region.
GlaxoSmithKline responds to US Senate Committee on Finance report on Avandia
- Details
- Category: GlaxoSmithKline
GlaxoSmithKline (GSK) responded to the recently released Senate Committee on Finance's January 2010 "Staff Report on GlaxoSmithKline and the Diabetes Drug Avandia" (the "Staff Report") by releasing a White Paper.
Phase III study of Avastin in advanced stomach cancer did not meet primary endpoint
- Details
- Category: Roche
Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today the topline results from a global phase III trial investigating the use of Avastin (bevacizumab) in combination with Xeloda (capecitabine) or fluorouracil and cisplatin chemotherapy in patients with inoperable, advanced or metastatic gastric cancer (stomach cancer).
Pfizer's Prevnar 13 Recommended by CDC's Advisory Committee On Immunization Practices
- Details
- Category: Pfizer
Pfizer Inc (NYSE:PFE) announced that the United States Centers for Disease Control and Prevention's (CDC's) Advisory Committee on Immunization Practices (ACIP) has recommended the use of Prevnar 13™ for healthy children aged 2 months through 59 months for the prevention of invasive pneumococcal disease caused by the 13 pneumococcal serotypes included in the vaccine.
FDA Classifies Prolia(TM) (Denosumab) Complete Response Submission and Targets Action Date
- Details
- Category: Amgen
Amgen Inc. (Nasdaq: AMGN) announced that the U.S. Food and Drug Administration (FDA) has evaluated the content of the Company's Complete Response submission for Prolia(TM) (denosumab) in the treatment of postmenopausal osteoporosis and classified it as a Class 2 resubmission.
More Pharma News ...
- Lilly, Merck, And Pfizer Announce the Formation of the Asian Cancer Research Group, Inc.
- Novartis receives FDA approval of Menveo®
- US FDA approves Rituxan/MabThera for the most common type of adult leukemia
- GSK rejects conclusions of Senate Committee on Finance Staff Report on Avandia
- GSK rejects conclusions reported in The New York Times story on Avandia
- GlaxoSmithKline and XenoPort receive FDA Complete Response letter for Horizantâ¢
- Genzyme Reports Financial Results for Fourth Quarter of 2009 and Full Year