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.
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.
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.
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.
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.
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.
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.
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.
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.
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.