Topic:

Regulatory

Latest Headlines

Latest Headlines

Intercept files its 'breakthrough' liver drug for rare disease approval

Intercept Pharmaceuticals has submitted its top candidate to the FDA for approval in primary biliary cirrhosis, a rare disease that results in serious liver damage.

FDA, Gates Foundation call for improved global access to veterinary drugs

In late June, drug regulators from around the world gathered in Dar Es Salaam, Tanzania, to brainstorm solutions for solving a major problem in many African countries and other developing nations: a lack of access to veterinary care, and most importantly, to particular drugs and vaccines that could protect against livestock losses.

Startup gets CE mark for novel blood-draw tech after FDA clearance, Series A earlier this year

Velano Vascular is hoping that its device is adopted widely by hospitals seeking to reduce the need for patient needle sticks and the exposure of healthcare providers to needles. Its device has now gotten a CE mark, after being cleared by the FDA in February.

Waksal's post-prison startup runs into more fraud allegations

Sam Waksal, the once-jailed former CEO of ImClone, is again the subject of fraud accusations as a former associate says he bailed on an investment deal designed to circumvent his punishment and defaulted on a $15 million promise.

No artful tax dodging here, drug firms tell Australia transfer-price inquiry

We checked and everything is done correctly on our tax obligations, 9 drug companies said in separate submissions ahead of testimony on July 1 to an Australian Senate inquiry on tax avoidance.

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.