Topic:

Regulatory

Latest Headlines

Latest Headlines

AZ's Onglyza has most to lose at FDA safety confab, analysts say

FDA experts will grill a couple of diabetes meds next Tuesday, and the outcome of that debate could put a damper on sales. The drugs: AstraZeneca's Onglyza and Takeda's Nesina, both DPP-4 blood sugar-fighters. The questions: Do they really increase the risk of heart failure? And if so, what's to be done about it?

Aethlon Medical eyes full marketing approval for Ebola biofiltration device

Aethlon Medical has submitted a Humanitarian Use Device application to the FDA for its Ebola biofiltration device, a steppingstone toward full marketing clearance for the product.

China's Sihuan marks first U.S. patient enrollment of PhI oncology candidate

Sihuan Pharmaceutical said it has successfully enrolled the first patient in the United States for its Phase I clinical trial of Pirotinib developed by Shandong XuanZhu Pharma, a wholly owned subsidiary, working with Covance on preparation and initiation.

India drug price chief sacked as essential drug prices rise

The head of India's National Pharmaceutical Pricing Authority was removed from the job just a week after his agency allowed the prices of 509 essential drugs to increase by 3.8%.

U.S. unit of Glenmark settles Medicaid charges for $25M

Glenmark Generics, the U.S. unit of Glenmark Pharmaceuticals, has signed a settlement agreement to pay $25 million to be split by the federal government and the state of Texas for alleged Medicaid fraud.

Roche nabs EU approval for Avastin for cervical cancer

Roche's Avastin has been on the market for more than a decade and boasts a long list of valuable approvals. But Roche is not sitting back the status quo, and continues to submit the drug for new uses. Now, the company racked up yet another OK for Avastin, scoring European approval for the drug in combination with chemotherapy to treat women with advanced cervical cancer months after the company got a similar decision from stateside regulators.

FDA recalls fall more than 50% in Q1 2015 after reaching record high in 2014

There were 426 medical device recalls in the first quarter of this year, according to FDA's recall database, down from a record high of 968 in Q4 2014.

FDA accepts Novo Nordisk's request for a re-do on once-rejected insulin

Novo Nordisk's comeback plan for the long-acting insulin Tresiba took another step forward, as the FDA accepted the Danish drugmaker's resubmitted application and cleared the way for a potential approval this year.

FDA approves breath test for stomach disorder, highlights its ease of use over standard of care

The FDA just approved a diagnostic for a troublesome stomach disorder that is easy to perform and does not use radioactive materials.

South Korea names first woman to head food and drug safety ministry

Seunghee Kim, a veteran member of South Korea's Ministry of Food and Drug Safety, has been named to become its first female minister. Kim has a pharmacology degree from Seoul National University and a doctorate in biochemistry from Notre Dame.