Pharma companies devote a lot of resources to winning over the U.K.'s drug price watchdog, the National Institute for Health and Care Excellence (NICE). Now, NICE says it will start looking beyond pharma companies for data, to get a more complete picture of whether new drugs are really worth their high costs.
A group of FDA advisers voted against recommending approval for a new combination blood-pressure treatment from Actavis, clouding the future of a prospect the company picked up in its $28 billion buyout of Forest Laboratories.
"Low T" products are characterized by a variety of different drug delivery technologies and mechanisms. In May, the FDA approved the first nasal gel for low testosterone. And in March, the agency finally approved Aveed as an injection given once to begin therapy, once four weeks later, and every 10 weeks after that.
The U.K.'s drug price watchdog, the National Institute for Health and Care Excellence, says that from now on, NICE will request clinical trial data directly from European regulatory authorities whenever it feels a company isn't providing adequate information to make sound coverage decisions, according to a statement.
Eli Lilly and Boehringer Ingelheim won European clearance for their biosimilar of Lantus, Sanofi's top-selling insulin product, but the treatment's full potential remains hamstrung by a U.S. patent challenge.
Boston Scientific was dealt a crushing blow in its vaginal mesh saga, as a Texas state jury ordered the devicemaker to pay $73 million to a woman who claimed chronic pain and injury from the company's vaginal mesh implant.
The pharma industry's free speech stand in a whistleblower lawsuit against Millennium Pharmaceuticals? Not so fast, says the Department of Justice. The First Amendment doesn't protect speech that spawns illegal conduct, federal prosecutors say in their own brief in the case.
Novo Nordisk may be nearing the regulatory finish line with an obesity-fighting dose of liraglutide, up for debate by the FDA's advisers this week.
Novo Nordisk is nearing the weight-loss finish line. Its obesity-fighting dose of liraglutide is up for debate by the FDA's expert advisors this week, and staff reviewers issued largely positive comments in documents filed Tuesday morning.
Merck tried to block two lawsuits claiming it lied about the efficacy of its mumps vaccine--but the pharma giant couldn't stop them. A federal judge in Pennsylvania refused to dismiss the lawsuits, filed by a pair of whistleblowers and a group of doctors and payers. Next stop: Trial.