Topic:

Regulatory

Latest Headlines

Latest Headlines

Troubled India's Wockhardt sees third U.S. drug recall in as many months

India's Wockhardt has voluntarily recalled 85,000 cartons of over-the-counter heartburn treatment famotidine tablets, calling the state of its plans to recover from U.S. FDA import bans on two plants into further question, Business Line said.

UPenn study finds FDA regulates devices optimally, European regulators are 'too lax'

The FDA is putting increased focus on approving devices faster, as it races to catch up to its European Union counterpart. But University of Pennsylvania researchers were surprised to find that the agency is actually regulating devices appropriately, while European regulators are not.

Newly FDA-cleared device treats sleep apnea, tracks patient compliance

The inconvenience of sleep apnea devices makes patient compliance tough to achieve, particularly over the long term. But now a new oral device to treat mild and moderate sleep apnea incorporates a wireless microrecorder to track and transmit patient usage. The device, SomnoDent, is expected to help level the playing field for usage tracking between CPAP machines and oral devices.

More SCOTUS fallout: Appeals court revives Lamictal pay-for-delay fight against GSK, Teva

In the post- FTC v. Actavis  world, cash doesn't have to change hands for a pay-for-delay deal to fall afoul of antitrust law. That's becoming clear as court rulings pile up. And a new U.S. appeals court decision specifically addresses a branded drugmaker's agreement not to launch an authorized generic of its branded drug.

EU stands by crackdown on drug spending in Ireland

The European Commission is standing by its latest attempt to reduce spending on patented drugs in Ireland--and it's not buckling under Big Pharma pressure.

Out with the old, reimburse the new: Merck's Frazier wades into Australia drug debate

Wading into what has become an "argy-bargy" political issue, Merck CEO Ken Frazier gave his two cents on why Australians miss out on new drugs.

Blurred lines in Japan's vision for healthcare in next two decades

Japan's efforts to blend cost savings and innovation are so tied up in broader national goals to revive the deflation-hit economy that a plan had to be drawn up for the next two decades--but the documents and slides to describe the ideas seem to deftly avoid any look at the hard choices needed.

Taiwan's PharmaEngine racks up good news on MM-398

Taiwan's PharmaEngine had a host of good news last week as Merrimack Pharma, its U.S. license holder for pancreatic cancer candidate MM-398 was granted priority review by the U.S. FDA and a subsidiary of Baxter also had a filing accepted by the European Medicines Agency that sparked an $11 million payment.

Sarepta submits its DMD drug for FDA scrutiny, on the heels of BioMarin

Sarepta, ending a protracted process that may have cost its last CEO his job, submitted its treatment for Duchenne muscular dystrophy to the FDA, setting the stage for a possible approval early next year.

TCM-based oncology candidate wins U.S. FDA nod for PhIII, Xinhua says

A traditional Chinese medicine (TCM)-based candidate, Kanglaite, won U.S. FDA approval for a multiregion Phase III trial in pancreatic cancer treatment that uses a derivative of the coix seed, the state-run Xinhua news agency reports.