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South Korean biosimilars firm Celltrion is challenging the validity of four Genentech patents for combination therapies to treat metastatic breast cancer. Read More
An industry group and two drugmakers have filed U.S. Supreme Court briefs backing Amgen’s request that a Federal Circuit ruling be partially affirmed to mandate that biosimilar makers share information and wait six months after an FDA approval to launch a therapy. Read More
Sanofi and Regeneron filed a complaint seeking a declaratory judgment that their eczema drug Dupixent, which is pending an FDA approval, does not infringe an Amgen patent on an unsuccessful asthma candidate. Read More
The Government and Accountability Office has agreed to grant a Senate request to conduct an investigation into the FDA’s handling of orphan drugs approvals. Read More
A Chinese API maker relied on manipulated data and incomplete records to make decisions on batch releases, prompting the FDA to issue a warning letter to the company over data integrity. Read More