Topic:

Regulatory

Latest Headlines

Latest Headlines

FDA proposes fast-track program for medical devices

The FDA is proposing expedited premarketing approval of devices that meet an unmet medical need for severe conditions.

Pfizer to plunk down $190M to wrap up Neurontin class action

In the latest settlement of a Big Pharma-delays-generics case, Pfizer has agreed to pay $190 million to wrap up a class-action suit over its seizure drug Neurontin. More than a decade old, the lawsuit claimed that Pfizer did some fast tap-dancing to prolong its Neurontin monopoly.

Teleflex hit with FDA warning letter over respiratory devices

The FDA has handed a warning letter to Teleflex, citing manufacturing issues at an Illinois plant that produces nebulizers, humidifiers and other respiratory technologies.

AbbVie heads to the FDA with its hep C combo in a race with Gilead, Merck

AbbVie has submitted an FDA application for its promising all-oral hepatitis C treatment, expecting approval this year as it prepares for a three-way race with perceived leaders Gilead Sciences and Merck.

FDA issued import alert after importer tried to ship saline not approved in U.S.

The FDA says the recent import alert imposed on 0.9% sodium chloride made at a Baxter International plant in Canada was issued because an "importer/consignee" tried to ship some into the U.S. The problem is, the saline made at that plant is not approved for sale in the U.S.

UPDATED: Federal court postpones Edwards' block of Medtronic's CoreValve

The Federal Circuit Court of Appeals delayed an injunction against Medtronic's CoreValve transcatheter aortic valve replacement sought by Edwards Lifesciences.

FDA OKs Lilly's blockbuster hopeful ramucirumab for stomach cancer

The bull case for Eli Lilly and its long-stunted R&D operation rests largely on a potential string of FDA approvals for the much-hyped ramucirumab, and the Indiana drugmaker picked up its first, clearing the treatment to treat stomach cancer.

Medtronic, Edwards need heart-to-heart over post-injunction access

Heart patients' lives are on the line in negotiations between Medtronic and Edwards Lifesciences over access to former's CoreValve after a federal court granted an injunction that will severely limit the device's use.

EndoStim bags a CE mark for MRI-safe reflux device

The Netherlands' EndoStim convinced European regulators that MRI scans won't harm patients using its LES system, an implant designed to to stimulate the esophagus and relieve acid reflux symptoms.

AbbVie careful about gay rights in its discussion of a new trial

AbbVie has asked a federal appeals panel to decide whether a new trial is really warranted in its case with GlaxoSmithKline over the price of an HIV drug. But the drugmaker was very careful to point out that it is not asking the court to disrupt any rights that gays and lesbians have achieved through a recent Supreme Court ruling.