NICE knocks Bayer's Nexavar as CDF review continues
Add Bayer to the list of drugmakers that are feeling the heat from NICE’s Cancer Drugs Fund takeover.Friday, England’s cost watchdogs said in draft guidance that the German drugmaker’s liver cancer blockbuster Nexavar didn’t provide enough value for the price. And while the decision isn’t final, it’ll be up to Bayer, doctors and others to make their opinions on the preliminary recommendations known before NICE issues its round of guidance.
FDA Offers Advice on NDAs for Postoperative Local Anesthetics
Sponsors developing long-acting local postoperative anesthetics should consider including novel, clinically meaningful endpoints in their trial design, the FDA has said in new draft guidance. ...
Sarepta slides as FDA about-turn on panel clouds gene therapy approval path
Shares of Sarepta Therapeutics Inc slumped as much as 21% on Friday on uncertainty over its gene therapy for Duchenne muscular dystrophy after the U.S. health regulator reversed its decision on a p...
Amgen to cut 450 jobs in second round of layoffs this year
(Reuters) - Amgen Inc said on Thursday it would cut 450 jobs, or less than 2% of its workforce, making it the company's second round of layoffs this year amid intensifying pressure on drug prices ...