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Nuvo Research has announced an update on its discussions with the FDA regarding the approvable letter the agency issued in December 2006 for Pennsaid, a non-steroidal anti-inflammatory drug (NSAID) for the treatment of osteoarthritis.
The results from a prespecified upper gastrointestinal safety analysis of the MEDAL trial comparing Merck's investigational selective Cox-2 inhibitor Arcoxia (etoricoxib) with diclofenac, the most widely prescribed non-steroidal anti-inflammatory drug (NSAID), were published in the Feb. 10 issue of The Lancet, Merck announced.
Gilead Sciences and Achillion Pharmaceuticals have announced their decision to discontinue the development of GS 9132, also known as ACH-806, for the treatment of hepatitis C viral (HCV) infection, based on preliminary data from a Phase Ib/II trial.
Phase II data published in the New England Journal of Medicine showed that patients with moderate to severe plaque psoriasis receiving subcutaneous injections of CNTO 1275 experienced significant clearance of skin disease and significant improvements in quality of life, Johnson & Johnson (J&J) announced.
Join RxTrials Institute and FDAnews Thursday, Feb. 15, for "Risk Strategies in Clinical Trial Contracts: How to Write Win-Win Indemnification Clauses." In this 90-minute interactive audioconference, attorney J. Michael Slocum will deliver strategies on how to efficiently and effectively negotiate problematic clinical trial agreement indemnification clauses. On Feb. 20, join FDAnews for "PAT Case Studies: Real-World Dos and Don'ts to Eliminate Defects." In this 90-minute audioconference with Q&A session, manufacturing process expert Philippe Cini will present two in-depth case studies demonstrating how PAT and quality by design principles were successfully applied.
The FDA has granted tentative approval to a generic fixed-dose, three-drug tablet for use as a complete antiviral treatment for HIV infection in adults.
Sanofi-aventis announced that the FDA has granted priority review to its supplemental new drug application (sNDA) for the anticoagulant Lovenox to treat acute ST-segment elevation myocardial infraction (STEMI), or acute heart attack.