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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
European generics makers are calling on the European Commission to boost job creation and economic growth in Europe by stimulating early export of generics and biosimilars to countries where no patent or supplementary protection certificates exist. Read More
The FDA increased its preapproval inspections of generics makers by 60 percent between fiscal years 2011 and 2013, but failed to conduct all of those requested by agency reviewers, a new report finds. Read More
A federal judge has ruled that the FDA was right in approving generic versions of Otsuka’s blockbuster antipsychotic Abilify, despite exclusivity remaining on at least one indication, removing any final obstacles to market entry of those drugs Read More
Three years after introducing a trio of guidances explaining how sponsors must demonstrate biosimilarity to existing biological drugs, the FDA continues to stress the need for a “stepwise” approach when seeking approval. Read More