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The International Conference on Harmonisation has released a Q&A guide aimed at clarifying requirements for quality management, documentation, equipment cleaning and more in its Q7 guideline on GMPs for active pharmaceutical ingredients. Read More
The National Institutes of Health is working quickly to correct major lapses in its drug compounding unit so officials will be able to ask the FDA to register it as a cGMP manufacturing facility subject to periodic regulatory inspections. Read More
Valeant Pharmaceuticals is recalling more than 93,000 bottles of nifedipine extended-release 90 mg tablets throughout the U.S. because they dissolve too quickly. Read More
India’s national drugs authority is planning to hire 147 inspectors this year to ensure adherence to good manufacturing practice standards, although proper training will prove essential for success, one observer says. Read More
Eisai has received FDA approval of an expanded indication for its antiepileptic drug Fycompa as an adjunctive treatment for primary generalized tonic-clonic seizures in epilepsy patients 12 and older. Read More
Sandoz wasted no time in launching its generic version of Copaxone in the U.S. after the U.S. Court of Appeals for the Federal Circuit again invalidated Teva’s patent on the blockbuster multiple sclerosis drug. Read More
Citing cost concerns, the UK’s healthcare watchdog is recommending against Celgene’s Otezla alone or in combination with disease-modifying antirheumatic drug therapies for adults with active psoriatic arthritis. Read More
The European Commission has approved Bristol-Myers Squibb’s Opdivo as both a first-line and second-line treatment for adults with advanced melanoma, allowing the drug to be marketed in all 28 member states. Read More
Aimmune Therapeutics has won FDA breakthrough therapy designation for AR101, an oral immunotherapy for children and adolescents with peanut allergies. Read More