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The FDA has approved AbbVie’s hepatitis C drug Viekira Pak under a breakthrough therapy designation, marking the fourth drug authorized in the past year to treat the chronic liver infection. Read More
The FDA wants everyone to know that it doesn’t have a drone program in place, nor is it exploring the technology for inspections or surveillance. Read More
A European Medicines Agency advisory panel has recommended approval of Orexigen’s weight-loss drug Mysimba, alongside diet and exercise in overweight or obese adults. Read More
Phase II trials of a much-lauded Ebola vaccine have been pushed back until at least the second week of February, after African regulators asked GlaxoSmithKline for more information about the upcoming studies. Read More
Drugmakers can now receive a priority review voucher for a separate product, and redeem it within three months, if they pursue development of Ebola treatments. Read More
The FDA plans to more than triple its staff in China from eight direct hires to 26, advancing a key agency goal of increasing the number of inspections it conducts in the country, the sixth largest exporter of drugs and biologics to the U.S. Read More
Starting next year, pharmaceutical wholesale distributors must submit annual reports that include detailed contact and state licensure information as well as any significant disciplinary actions taken by state or federal officials, the FDA says. Read More
Lax procedural documentation in quality control units topped the list of reasons why drugmakers received Form 483s in fiscal 2014, its ninth consecutive year at the top, while poor laboratory controls jumped to second place from fourth in the annual rankings of inspection observations. Read More
New Zealand’s regulatory authority is updating its uniform recall procedure for drugs, following a recent decision not to pursue a joint regulatory agency with Australia. Read More
AstraZeneca’s first-in-class ovarian cancer drug Lynparza will soon be available in Europe, following European Medicines Agency approval late this week. Read More