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Latest From Brenda Sandburg
Biopharma and generic industries stand on opposing sides in case that could eliminate the patent challenge proceeding. Interactive timeline covers IPR's five-year history leading to oral arguments Nov. 27.
Draft guidance suggests comparing therapies for a rare disease to each other and active control, offers examples of novel efficacy endpoints and what therapies may qualify for breakthrough and RMAT designations.
Given risk of serious gastrointestinal disorder, Public Citizen argues there is no reason to keep the drugs on the market when so many alternative treatments are available
Federal appeals court affirms ruling that Apotex's biosimilars do not infringe Amgen's manufacturing process patent, but its applications have stalled at FDA for the past three years.
Janssen concludes the manufacturing processes for Renflexis do not infringe its Remicade patents, clearing Samsung and partner Merck from potential damages resulting from their at-risk launch of the biosimilar; innovator's legal action remains against Inflectra partners Pfizer and Celltrion.
Final guidance on evaluating drug effects on ability to operate a motor vehicle has been slightly modified in response to suggestions by Eisai, Pfizer and Merck.