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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
An FDA advisory committee Tuesday voted 12 to 1 to recommend approval of the Vertex Pharmaceuticals Orkambi combination therapy for patients 12 years and older with two copies of the most common cystic fibrosis mutation. Read More