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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
A coalition of pharma companies and medical researchers is proposing a framework for determining authorship of clinical trial publications, with the aim of increasing transparency and public trust in medical research. Read More
Future FDA guidance on developing drugs for specific indications will include key milestones to help manufacturers plan their product development programs and guide potential talks with the agency’s review division. Read More
Central nervous system drugs that treat conditions such as Alzheimer’s and Parkinson’s disease lag behind other drugs in clinical development and approval times, a recent report finds. Read More
The European Medicines Agency is lending support to an initiative to qualify biomarkers that can provide early warning of an investigational compound’s risks of causing drug-induced kidney injuries. Read More