Topic:

Regulatory

Latest Headlines

Latest Headlines

NIH launches crowdsourcing challenge to commercialize its neurological medical devices

Taking innovations from the clinic to the commercial market is one of medicine's biggest challenges. This is especially true for government scientists, who face rules and regulations that make it difficult for them to spinout their inventions to startups. But the National Institutes of Health is launching The Neuro Startup Challenge, a crowdsourcing competition featuring 72 teams from 80 hospitals and universities, with a goal of commercializing 16 of its neuroscience inventions, including enhancements to MRI machines. 

Arrowhead submits IND for its RNAi-based hep B candidate

Arrowhead Research Corporation is looking to add another entrant into the clinical trial-based race to commercialize the first  RNAi-based  compound, a market category that could become a new class of drugs akin to monoclonal antibodies and produce revenues exceeding $1 billion by 2020 according to one projection.  The company recently announced that it has submitted its Investigational New Drug application for its  RNAi  candidate, ARC-520, for the treatment of the chronic hepatitis B virus.

UPDATED: AbbVie wins blockbuster hep C approval, starts wheeling and dealing 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.