Topic:

Regulatory

Latest Headlines

Latest Headlines

Bristol-Myers bags a record-fast approval for its cancer blockbuster Opdivo

Bristol-Myers Squibb picked up FDA approval to use its new oncology treatment in lung cancer, significantly boosting the value of a therapy already expected to bring in billions each year.

Orexigen blabs results early, but wins analyst confidence in the process

The FDA isn't happy with Orexigen, which put out some early positive cardio data for obesity drug Contrave Tuesday. The way the FDA sees it, the data were too early. In fact, it had already asked Orexigen for a second outcomes study because it had shared the info with too many people.

McDonald's ditches antibiotics-raised chicken as legislators launch bill to curb use

Fast-food giant McDonald's announced Wednesday that it will phase out all chicken raised with antibiotics used in human healthcare within the next two years. The policy is part of the company's new Global Vision for Antimicrobial Stewardship in Food Animals, according to a statement from the company.

FDA shoots down Pacira's bid for expanding Exparel

Pacira's hopes of expanding the use of its surgical pain drug took a hit this week, as the FDA rejected its application to get Exparel approved through a new delivery pathway.

FDA calls for heart, stroke warnings on 'Low T' meds

The FDA threw another hurdle in the path of drugmakers selling "Low T" drugs, requiring manufacturers to update labels to warn that the meds could increase the risk of heart attacks and strokes and should not be prescribed to treat age-related symptoms.

Surprise: Obesity med Contrave might help CV outcomes. Too bad Orexigen blabbed it

The FDA isn't happy with Orexigen, which put out some early positive cardio data for obesity drug Contrave Tuesday. The way the FDA sees it, the data were too early, and it's now asking Orexigen for a second outcomes study. But meanwhile, the new stats have changed some analysts' minds about Contrave's safety profile--something that could give it a leg up in a crowded market going forward.

India's Sun Pharma research arm gets U.S. FDA nod for epilepsy therapy

Sun Pharma Advanced Research, the research arm of India's top drug firm Sun Pharmaceuticals, said Wednesday it received U.S. Food and Drug Administration approval to market its epilepsy drug.

Big pharma bodies ask China FDA to review comparability in biosimilar approval guidelines

U.S.-based Biotechnology Industry Organization (BIO) and the China-based R&D-based Pharmaceutical Association Committee (RDPAC) want changes in China FDA's most recent biosimilar approval guidelines.

Cima Labs wins a round in India on Fentora patent

Cima Labs, U.S.-based maker of Fentora (fentanyl), a painkiller for cancer patients, will get to keep its India patent for the oral version of the drug, at least for now.

Gilead's hep C combo Harvoni wins NICE blessing at $58K price

The U.K.'s cost-effectiveness watchdogs gave a thumbs up to Gilead Sciences' combo hepatitis C pill Harvoni, despite its £39,000 price, or about $58,000. The pill combines Gilead's new blockbuster hep C drug Sovaldi with another antiviral, ledipasvir, and has delivered impressive cure rates.