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The FDA has approved 35 novel new drugs so far this year, up from 27 products last year, with officials touting 2014 as the best year ever for rare disease treatment approvals. Read More
A recent FDA inspection of contract research organization GVK Biosciences’ Hyderabad, India, plant turned up no evidence of safety or efficacy concerns with US-bound generic therapies, a finding that is in sharp contrast to initial conclusions reached by European inspectors. Read More
A large public employer has filed a federal class-action lawsuit accusing Gilead Sciences of price gouging with its $1,000-a-pill hepatitis C drug Sovaldi. Read More
Investigators have temporarily halted a trial of NewLink Genetics’ experimental Ebola vaccine after several patients reported unexpected side effects. Read More
Merck’s new Gardasil 9 human papillomavirus vaccine won FDA approval to prevent various cancers and other illnesses caused by the sexually transmitted disease in young men and women. 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