Topic:

Regulatory

Latest Headlines

Latest Headlines

Teva growth hormone for children recalled after oil leaks into product

Israel-based Teva Pharmaceutical Industries, in the midst of restructuring its manufacturing network, has faced a number of recalls of late. Now a New Jersey company is recalling nearly 130,000 cartons of Teva's human growth hormone for children because there is a chance that oil leaked into it.

FDA clears 3D virtual reality device for surgical procedures

Surgical Theater scored FDA clearance for its 3D, augmented reality surgical navigation advanced platform (SNAP) for operating room procedures.

In obesity device race, ReShape lines up with FDA

There has been no new medical device to treat obesity approved by the FDA in more than a decade. A series of companies are hoping to be the first, including ReShape Medical, which has filed a PMA with FDA for its ReShape Integrated Dual Balloon System aimed at weight loss for the obese with a body mass index from 30 to 40.

Manufacturing questions lead to another CRL for Allergan migraine drug

Allergan is mired in a fight to remain independent from serial acquirer Valeant, so having to tell investors it received a complete response letter (CRL) is not what it wants to do. But the FDA has again delayed approval of an inhaled migraine treatment because of uncertainties about the production process with the canisters used to administer it.

Angling for early OK, Amgen wins 'breakthrough' title for leukemia drug

Amgen has scored boasting rights to a breakthrough drug designation from the FDA for its promising mid-stage leukemia drug blinatumomab.

India's IPA hires consulting firm to help it overcome bad publicity

Thinking it needs to change the spin on the story, an industry group in India has hired a Washington, D.C., consulting firm which is launching a campaign it hopes can do that.

Prevnar use in seniors is cost-effective now, CDC says. But will it last?

After meeting to discuss the use of Pfizer's Prevnar 13 in adults 65 and older late last week, a CDC advisory committee isn't planning to vote on recommendation of the shot just yet. But when it does, it will have a few things to consider--including Prevnar's long-term cost effectiveness in that population--before giving it a nod.

Merck takes to Europe with its promising PD-1 cancer drug

Merck is racing to be first on the market among contenders in the PD-1 field of cancer therapy, and the European Medicines Agency has agreed to review its pembrolizumab as a treatment for advanced melanoma.

FDA hands out its third rejection for Allergan's migraine drug Semprana

The FDA has handed out its third rejection of a new, inhalable migraine therapy Allergan had hoped could be used to help fend off Valeant's buyout bid. The big biotech did get some good news, though, announcing that the agency approved Ozurdex for diabetic macular degeneration.

Novartis pulls EMA app for new Tasigna use, but wins new NICE nod for Gleevec

As blood cancer wonder-drug Gleevec ages, Novartis is trying to build out indications for follow-up Tasigna. After an up-and-down week for the pair, the Swiss pharma is now short a potential Tasigna label expansion, thanks to a snag in Europe. But a change of heart for the U.K.'s cost watchdog on Gleevec may give the franchise a boost.