Topic:

Regulatory

Latest Headlines

Latest Headlines

Even at a discount, Sanofi's pricey cancer drug Zaltrap can't win at NICE

The U.K.'s National Institute for Health and Care Excellence has spurned Sanofi's colon cancer treatment Zaltrap once again. And this time, the decision is final. The cost-effectiveness agency dismissed the French company's appeal, despite the offer of a discount.

FDA approves J&J to make bulk Doxil at closed Ben Venue plant

The FDA has now signed off on Janssen's process of manufacturing bulk Doxil at an Ohio facility. It is part of an "alternative manufacturing process" in which the company hands off fill and finish of the drug to another manufacturer.

Quest wins U.S. nod for rapid Dx test that helps identify encephalitis

Quest Diagnostics has gained expedited U.S. clearance for a new rapid test designed to help diagnose encephalitis.

St. Jude aims to jump-start the cardiac device space with new pacers and defibrillator leads

St. Jude Medical is confronting a flat pacemaker market and continued fallout from faulty defibrillator leads with a rollout of new products in both spaces. The hope: Next-generation improvements will spur new market interest and greater revenue.

Cost watchdogs demand efficacy data on new Bayer cancer drugs

German pharma giant Bayer got back-to-back bad news on two of its newest drugs, from two different countries, no less.

Eyeing rival mAb mob, Novartis touts PhIII secukinumab psoriasis data

Investigators for Novartis pumped out more positive Phase III data for its psoriasis therapy secukinumab over the weekend, adding some patient satisfaction scores on the self-injected treatment as the company positions this new product against a host of rivals that promise to quickly crowd the field.

Celgene wins FDA approval for its blockbuster arthritis contender apremilast

Celgene picked up the FDA's blessing for the much-debated apremilast, winning approval to market the oral drug as a treatment for psoriatic arthritis in step one of its blockbuster plan.

J&J, Medivir get EU nod for their hep C drug Olysio

The horse race for oral treatments of chronic hepatitis C entered another turn today as the European Union recommended approval of Olysio, the Johnson & Johnson and Medivir entry in the high-stakes derby, Bloomberg reports.

Novartis' vaccine unit gets a badly needed booster from the U.K.

The U.K.'s Joint Committee on Vaccination and Immunization (JCVI) is revising its stance on Novartis' meningitis B vaccine Bexsero. The jab, originally left off Britain's routine vaccination schedule, has gained the JCVI's nod, supplying a needed boost for the Swiss company's flailing vaccine unit.

Yes, U.S. med tech recalls have doubled since 2003--but so has the market

"Medical device recalls nearly doubled in a decade," proclaims The Wall Street Journal 's headline--a bit of data the FDA is expected to release Friday that seems likely to travel far on social media. Critics are already making hay, questioning the rigor of pre-market vetting at the FDA.