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Adding Bristol-Myers Squibb and AbbVie’s immune-based cancer drug elotuzumab to standard therapy extends remission rates for multiple myeloma patients by about four and a half months, compared with standard care alone, data from a late-stage study shows. Read More
The former chairman of the Senate Veterans Affairs Committee is pressing the VA to invoke a wartime provision to break the patents on Gilead Sciences’ pricey hepatitis C drug Sovaldi, after the agency stopped treating veterans because it had exceeded the more than $400 million budgeted for hep C treatment. Read More
The FDA has issued draft guidance spelling out in detail how to prepare and submit an IND if the sponsor is an investigator and not a commercial entity — saying sponsor-investigators often lack the regulatory know-how to submit a proper IND. Read More
The House Energy & Commerce Committee’s health subcommittee Thursday voted unanimously to pass the latest version of the 21st Century Cures Act, which aims to accelerate development of novel therapies to patients with rare diseases through modernized clinical trials and increased funding for research. Read More
The House Energy & Commerce Committee on Wednesday released its third discussion draft for the 21st Century Cures Act, reintroducing a provision that would give drugmakers an extra six months of marketing exclusivity when they adapt existing products to treat rare diseases. Read More
Ranbaxy is being accused in federal court of filing ANDAs with false documentation in an effort to block generic competitors from coming to market. Read More
AbbVie has been sued over an alleged pay-for-delay scheme involving its blockbuster testosterone drug AndroGel, two days after a federal court in Pennsylvania dismissed some claims in a similar suit filed last year by the Federal Trade Commission. Read More
Sponsors seeking EU authorization to market fixed-dose drug combinations should conduct multiarm, randomized, controlled trials comparing the FDC with its individual components, the European Medicines Agency says. Read More
The FDA wants sponsors of investigational drugs and biologics to use the Logical Observation Identifiers Names and Codes to identify laboratory results from clinical studies in regulatory submissions, and is asking for suggestions on how it might assist firms in adopting the codes. Read More
Baxter International is paying $900 million to acquire the Oncaspar product line from Italian drugmaker Sigma-Tau Finanziaria, in a deal that expands the drugmaker’s footprint in the growing oncology market for rare and orphan diseases. Read More