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The FDA expects to release rules on international clinical trials by the end of next year, according to HHS’ 2015 agenda, which was unveiled Nov. 24. Read More
Clinical studies evaluating the safety and tolerability of vaginal microbicide gels to prevent HIV infections should use a scoring system to measure the presence and severity of rash, swelling, immune response and damage to local tissue, FDA final guidance says. Read More
Reversing course, the UK’s healthcare cost agency now is recommending Janssen’s Stelara for psoriatic arthritis after the drugmaker agreed to provide the drug at a discount. Read More
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