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German regulators have published a list of 80 generic medicines whose approvals were yanked after EU authorities expressed concerns with contract research organization GVK Biosciences. Read More
A federal judge has paved the way for generic entry of Cubist’s antibiotic Cubicin by 2016 after striking down four out of five patents challenged by Hospira. Read More
A House bill would for the first time require drugmakers to create and disclose an expanded access policy in exchange for receiving breakthrough therapy designation, redeeming a priority review voucher or having the drug become a qualified infectious disease product. Read More
The FDA is proposing revisions to an adverse events reporting form that includes for the first time a section for large compounders to submit events. Read More
The FDA plans to consolidate its 16 districts overseeing pharmaceuticals imports into either four or five districts under a reorganization plan that aims to make inspection policies and procedures more uniform regardless of port of entry. Read More
Pfizer’s blockbuster arthritis pain drug Celebrex is facing generic competition for the first time after Teva, Mylan and Actavis launched versions Wednesday. Read More
GPhA is pushing for more states to pass automatic biosimilar substitution laws next year using draft language that eliminates requirements to notify prescribers of a swap with the brand. Read More
European regulators have approved AstraZeneca and Nektar Therapeutics’ opioid-induced constipation drug Moventig for adults that have not responded to laxatives. Read More
Manufacturers of therapies in Japan that combine drugs with either a medical device or a cellular or tissue-based product must determine which category it falls under before filing a marketing application, according to a revised regulation. Read More