Topic:

Regulatory

Latest Headlines

Latest Headlines

Guided Therapeutics reels from latest FDA rejection

The FDA dealt Guided Therapeutics its second "not approvable" letter in 18 months, asking more questions about a cervical scanning device the company submitted for review in 2010.

Remicade knockoff delivers pioneering antibody biosimilar OK for Hospira, Celltrion

Today the European Commission made healthcare history with its first approval of a biosimilar antibody--Inflectra (infliximab)--which was developed by Korea's Celltrion and will be sold by generics powerhouse Hospira. But the companies don't expect to file for U.S. approval until 2015 as they wait for the FDA to finalize its regulatory pathway.

J&J's troubled McNeil unit recalls more products

Manufacturing issues continue to plague Johnson & Johnson's McNeil Consumer Healthcare unit, this time related to problems with the active pharmaceutical ingredient in some Motrin for infants.

Celgene's Abraxane approved for first-line treatment of pancreatic cancer

The FDA today approved Celgene's Abraxane for pancreatic cancer, an approval that provides some hope for extending the lives of patients with the aggressive cancer. It should also significantly extend the earnings power of the drug, which is already approved for breast and lung cancers.

FDA staff plugs efficacy of projected COPD blockbuster from GSK and Theravance

GlaxoSmithKline and partner Theravance are closing in on an important advisory committee meeting for their experimental lung drug Anoro Ellipta next week. And FDA staff has noted in a briefing document that the combination therapy for COPD was effective at two doses, Bloomberg reported.

Another compounder recalls drugs because of lapse in outside testing

A third compounding pharmacy is recalling sterile injectable drugs nationwide because it can't rely on the results of an outside laboratory that tested them for sterility. The recall comes as the FDA is applying more heat to this niche of the drugmaking market despite the lack of its clear authority to do so.

India advances effort to modernize medical device regs

India's Parliament is considering a long-awaited bill that would modernize regulatory oversight for the medical device industry. The proposed bill would expand regulatory control over medical device quality and standards.

Germany's drug gatekeeper spurns Shire's new ADHD drug Elvanse

The German price watchdog has found yet another drug it can't warm up to. This time it's Shire's new ADHD drug Vyvanse, known as Elvanse in Germany.

Cepheid wins key 'moderate complexity' designation for combo TB test

Cepheid says it gained a key "moderate complexity" CLIA designation for its new combo TB test, helping to position the diagnostic to reach the broadest possible market.

Oramed submits pre-IND for oral exenatide Type 2 diabetes pill

Jerusalem-based Oramed submitted a pre-IND application to the FDA for another of its oral insulin capsules, this one containing exenatide, a hormone that stimulates the secretion of insulin by the pancreas.