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In an effort to boost the integrity of the drug supply chain, the FDA has issued a final rule authorizing it to destroy drug imports valued at $2,500 or less that have been refused admission into the country. Read More
An interim report shows that, since 2013, the FDA has conducted nearly 90 meetings with more than 50 drug companies interested in producing biosimilar products — at a cost of $65.9 million. Read More
Amgen and Allergan claim their biosimilar candidate for Roche’s blockbuster Avastin is clinically equivalent in adult patients with advanced non-small cell lung cancer. Read More
Amgen is hoping a Delaware judge will be more agreeable than a California court as it sues Hospira to prevent the biosimilar maker from marketing its challenger to cancer treatment Epogen. Read More
In preparation for a September 2017 expiration, the FDA has scheduled a Dec. 18 public meeting to kick off reauthorizing the Biosimilar User Fee Act. Read More
The FDA has approved Impax’s generic versions of Valeant’s Mestinon Timespan tablets and Testred capsules, the first two products approved at the company’s Hayward, Calif., manufacturing plant following resolution of a 2011 warning letter. Read More
The two frontrunners for the Democratic presidential nomination, Hillary Clinton and Sen. Bernie Sanders of Vermont, released prescription drug policy proposals Sept. 22 that would cut prices and end pay-for-delay deals. Read More
Drugmakers are challenging the legality of FDA final guidance, calling for the design of generic tablets and capsules to be similar in size and shape to the reference drug to ensure patient acceptance. Read More
President Barack Obama on Sept. 15 nominated Robert Califf as the next FDA commissioner, capping a swift rise for the respected clinical researcher, who assumed the agency’s number two role — deputy commissioner for tobacco and medical products — in March. Read More
CDER Director Janet Woodcock came under fire Sept. 17 from senators demanding to know why the FDA is years behind Europe and Canada in establishing a workable program for biosimilars. Read More