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Canadian regulators will have sweeping new powers to order drug recalls, require labeling changes and postmarket studies, and release confidential business information under a rewrite of the country’s drug safety law. Read More
A compounding pharmacy pled guilty to manufacturing contaminated products that caused skin infections, the first compounder to be convicted of criminal charges for poor quality since the FDA gained new authority in 2013. Read More
The European Union has banned imports of Ranbaxy’s injectable antibiotic cephalosporin following an inspection by German regulators who found the company’s Dewas, India, facility was not in compliance with good manufacturing practices. Read More
Drugmakers and active pharmaceutical ingredient manufacturers in Europe that produce multiple products in one facility should justify exposure to contaminants and follow specific steps to clean equipment and reduce risks of cross-contamination, according to a new EU guideline. Read More
The House late last night approved nearly $1.7 billion in funding for FDA’s drug and biologics activities next year, a slight boost from current levels. Read More
For the first time, a brand drugmaker has defeated a generics firm’s patent challenge through the U.S. Patent and Trademark Office’s internal review board process, which started in 2012. Read More
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