Topic:

Regulatory

Latest Headlines

Latest Headlines

Court stands with FDA on its approach to antibiotics use in farm animals

Scientific evidence proves a correlation between nonmedical use of antibiotics to fatten farm animals and spikes in antibiotic-resistant infections. So why was a federal appeals court panel divided over whether these drugs can be added to animal feed even if the drugs aren't medically necessary? The short, simple answer is that the FDA has just been giving advice on the practice.

Upcoming study to dispute FDA's data on power morcellation risk

Dr. Elizabeth Pritts, director of the Wisconsin Fertility Institute, believes that the FDA is wildly overestimating the prevalence of uterine sarcoma in women undergoing hysterectomies and myomectomies for fibroid removal and worries that banning or restricting use of power morcellators will fail to address the problem, putting women undergoing the procedure at risk of upstaged cancer.

Gilead's Zydelig, J&J's Imbruvica will go toe-to-toe in EU with nod for CLL

Gilead Sciences, which this week got FDA approval for its new blood cancer drug Zydelig (idelalisib), has now gotten a recommendation for its use in Europe. But competitor Imbruvica from Johnson & Johnson, which got a head start in the U.S., also received a nod from EU authorities today.

Novo's blockbuster diabetes combo nears EU approval

A committee of European Medicines Agency advisers is recommending approval for Novo Nordisk's combination of a long-acting insulin and its blockbuster GLP-1 drug Victoza, setting the stage for a near-term approval of what's expected to be the diabetes giant's next big therapy.

Purdue earns a nod--and a quick slap--for abuse-resistant painkiller

The FDA has approved a new pain drug from Purdue Pharma that's intended to throw up a line of defense against the abuse of an extended-release reformulation of OxyContin. But all the approval seems to have accomplished is triggering some added eye-rolling from some of the experts fighting abuse.

FDA warns hospitals that Texas compounder's products are unsafe

Most companies voluntarily recall products, and sometimes even stop production, when they or the FDA find quality issues. In the case of a Texas compounder, the FDA has formally requested that it halt sterile drug work and pull back all of its sterile products.

FDA opens the door for a Novartis biosimilar of Amgen's Neupogen

The FDA accepted Novartis' application to sell a knockoff of Amgen's biological treatment Neupogen, making the company a pioneer among those looking to capitalize on a soon-to-come U.S. market for biosimilars that is expected to explode.

GSK submits world's first malaria vaccine for EMA approval

It's taken 30 years, but GlaxoSmithKline's experimental malaria vaccine is finally ready for regulatory review. Looking to bring the world's first shot for the mosquito-borne disease to market, the pharma giant said Thursday that it has submitted its candidate for approval.

UPDATED: Gilead picks up blockbuster FDA blood cancer approvals for idelalisib

Gilead said today that the FDA has approved its PI3k inhibitor idelalisib for three types of B-cell blood cancers following its early Phase III success last fall on impressive leukemia data. EvaluatePharma analysts estimate this drug could earn $1.2 billion a year by 2020, making it one of the top therapies in late-stage development.

Edwards Lifesciences CEO asks Congress for better device regulation

Edwards Lifesciences CEO Mike Mussallem advocated for a more efficient regulatory and reimbursement system for medical devices before the congressional House Committee on Energy and Commerce yesterday July 22, pointing out that the U.S. was the 42nd country to approve the Irvine, CA-based company's Sapien artificial heart valve for frail, high-risk patients.