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A federal judge upheld the FDA’s decision to strip Ranbaxy of its tentative ANDA approvals for two drugs because of GMP problems at manufacturing facilities, but nonetheless blasted the agency, saying it never should have issued the approvals in the first place. Read More
Manufacturers of biosimilar insulin-containing products must demonstrate pharmacodynamic and pharmacokinetic similarity profiles to prove similar efficacy to their reference insulin, the European Medicines Agency says in final guidance issued this week. Read More
The FDA has approved United Therapeutics’ Unituxin in combination with three other drugs for children with neuroblastoma who have seen at least some response to prior combination therapies. Read More
A federal judge has ordered Reckitt Benckiser to release documents the company wanted to suppress in an ongoing FTC probe into allegations the company illegally delayed generic competition to its opioid-dependence treatment Suboxone. Read More
The FDA has won a consent decree against a Texas compounder barring the company, Specialty Compounding, from producing and selling sterile drugs until it fixes manufacturing quality deficiencies that led to past reports of bacterial contamination of its products. Read More
With the FDA beginning to approve biosimilars, the next major hurdle for the emerging sector will be in the courts, where brandmakers and would-be competitors are arguing over how they will approach patent infringement lawsuits, especially when it comes to sensitive manufacturing data. Read More