Topic:

Regulatory

Latest Headlines

Latest Headlines

UPDATED: AbbVie wins blockbuster hep C approval, but shuns a deep discount on price

AbbVie won an expected FDA approval for its next-generation treatment for hepatitis C, kicking off a race with Gilead Sciences for dominance in a blockbuster field.

Myriad scores FDA approval for ovarian cancer companion Dx

Myriad Genetics won FDA approval for its companion diagnostic test for AstraZeneca's ovarian cancer drug Lynparza, giving the company a boost as it recoups from its latest patent battle loss and helping it gain ground in a fast-growing market.

AstraZeneca grabs a surprise early approval for its $2B cancer contender

Despite loud objections from its advisers, the FDA granted an accelerated approval to AstraZeneca's ovarian cancer treatment, clearing an oral therapy the U.K. drugmaker believes will bring in blockbuster sales.

Novo Nordisk gets EU recommendation for Tresiba use in kids

Novo Nordisk has a while yet to wait for another shot at FDA approval for Tresiba, a drug on which it has pinned its future, but it continues win support for it in Europe.

Private equity firm backs Sonoma Orthopedic with $12M to get ankle implant to market

Chicago-based private equity group First Analysis expects its $12 million cash infusion into Sonoma Orthopedic Products will be sufficient for the startup to gain FDA clearance for a new ankle implant--as well as to launch it and start to scale up sales.

Orexigen's weight-loss drug gets thumbs-up from CHMP

Orexigen has scored another big boost for its weight-loss drug, with a European drug advisory group giving it a recommendation for approval. The favorable review comes three months after the FDA approved it in the U.S., where it is already seeing some significant demand.

Sorin says newly cleared Memo 3D ReChord will improve mitral valve repair

Italy's Sorin Group says its just-cleared Memo 3D ReChord semirigid annuloplasty ring for mitral valve repair will simplify the procedure and enable surgeons to achieve reproducible results.

Small cap Cerus spikes on back-to-back Intercept approvals by FDA

Small cap Cerus has gained some serious ground on Wall Street after the FDA approved its Intercept Blood System for platelets just a few days after the agency approved it for plasma use. Investors are betting that with the risk of Ebola in the forefront of public consciousness that processors of blood products will use any technology they can to improve the safety of their supply. These approvals mark the first time the FDA has approved a system to inactivate pathogens in platelets or plasma.

Putney continues winning streak with launch of generic chewable Rimadyl

Putney was founded in Portland, ME, in 2006 with the goal of developing a pipeline of 20 generic drugs for the veterinary market, and it's well on the way to moving those products to market.

China promises faster drug approvals, equal treatment for U.S. companies

U.S. and Chinese trade officials announced on Thursday that China will streamline drug approvals and promised equal treatment of U.S. and Chinese companies in pricing probes.