Topic:

Regulatory

Latest Headlines

Latest Headlines

St. Jude gains CE mark for first pacemaker with MultiPoint Pacing

St. Jude Medical has gained approval for a quadripolar cardiac resynchronization therapy pacemaker that for the first time incorporates its MultiPoint Pacing technology that's been shown to be better for patients who don't respond to traditional biventrical pacing.

FDA offers guidance as track-and-trace rules loom

With the deadline for new track and trace requirements kicking in January 1 for drugmakers and wholesalers, the FDA has issued new guidance to help them understand what they are up against. According to Regulatory Focus, the agency has issued draft guidance on what information companies are supposed to exchange under the Drug Quality and Security Act (DQSA), which Congress passed last year.

Amicus eyes a 2015 EU filing for its rare disease drug with FDA in sight

Amicus Therapeutics says it's on track to file its Fabry disease treatment for European approval next year, the next major step for a biotech in the midst of comeback.

Startup gains FDA clearance for breast surgery guidance system

Cianna Medical has received clearance from the FDA for its SAVI Scout surgical guidance system. This is Cianna's second marketed product in addition to its SAVI breast brachytherapy applicator.

Merck wins FDA approval for Gardasil follow-up

Merck's Gardasil follow-up is here, meaning blockbuster sales figures are likely on the way. But the bad news is that they'll come at the expense of the world's second-best-selling shot.

Ebola vaccine makers Merck, GSK, J&J get legal protections in U.S. thanks to HHS declaration

Ebola vaccine developers now have a little less to worry about thanks to a Tuesday announcement from the U.S. Department of Health and Human Services. HHS will provide liability protections for the companies scrambling to develop Ebola vaccines in response to the current outbreak in West Africa, it said.

Indian drugmakers lambast proposed PET packaging ban

Indian drugmakers are in a dogfight with Indian regulators who have proposed banning the use of PET plastic bottles for some drug packaging. If they have to move to glass, it will add up to 30% to their transportation cost per bottle, they have complained.

VertiFlex faces regulatory setback for spinal implant as FDA delays panel meeting

VertiFlex is facing a regulatory setback for its spine implant, as the FDA postponed a meeting slated to review the company's application for premarket approval of the device.

Mylan, Stada, Dr. Reddy's drugs suspended after contractor's trial failures

U.S. drugmaker Mylan, Germany's Stada, India's Dr. Reddy's Laboratories and Unichem Laboratories are among 16 drugmakers who have had dozens of generic meds sidelined by German regulators who raised questions about bioequivalence tests.

Insys collects gastric cancer orphan designation for liposome-trapped paclitaxel

Insys Therapeutics, a combination drug developer and delivery specialist, won an orphan designation from the FDA for a gastric cancer treatment that delivers paclitaxel trapped in liposomes to make the common cancer drug more soluble and less toxic.