Topic:

Regulatory

Latest Headlines

Latest Headlines

Biotronik wins CE mark for new pacers that instantly broadcast patient problems to doctors

Biotronik has a CE mark in hand for its new Eluna pacemakers, made with MRI-compatible technology and other advances designed to help them stand out in an already-crowded, stagnant market.

Bayer keeps cheap Nexavar copy from being exported from India

Chalk up a win for Bayer KGaA in its running battle in India over a compulsory license granted to Natco to produce a cheap knock-off of its cancer drug Nexavar. The drug is being sold in India but a high court there says that is as far as the Indian drugmaker can go with it for now.

MannKind faces stiff skepticism in its third go at FDA approval

After two FDA rejections, MannKind has returned with more data on its long-delayed inhaled diabetes drug, but regulators see Afrezza as anything but a slam-dunk case, raising questions over the treatment's safety and efficacy before a scheduled review.

Exact Sciences wins unanimous FDA panel approval for its colon cancer Dx

Exact Sciences won unanimous FDA committee approval for its stool-based cancer diagnostic, moving the company one step closer to receiving full regulatory clearance for the test.

UPDATED: Hospira puts shareholder lawsuit behind it with $60M settlement

Hospira is getting past quality issues that for several years dominated its attention and undermined its revenues. Now it has unburdened itself of litigation that came along with it.

Roche nabs European approval for time-saving formulation of Rituxan

Pharma companies sometimes try to extend the lives of drugs by developing new formulations or follow-on products before their patent expires. Swiss pharma giant Roche scored a victory today when European regulators approved a subcutaneous version of its cancer drug Rituxan, known as MabThera overseas.

FDA panel throws dirt on Novartis' would-be cardio blockbuster serelaxin

After a daylong session heavy on scathing criticism, a panel of FDA advisers voted unanimously against approving Novartis' in-development heart drug serelaxin, casting serious doubts on the treatment's potential.

Japan's regulators OK Accuray's latest robotic radiosurgery system

California's Accuray snagged Japanese regulatory approval for a new iteration of its CyberKnife robotic full-body radiosurgery system--a market known for its robust demand for med tech products and services.

GlaxoSmithKline's diabetes contender albiglutide nabs EU approval

European officials gave a green light to GlaxoSmithKline's once-weekly diabetes drug Eperzan (albiglutide). The GLP-1 drug is awaiting FDA approval, with a decision expected next month.

New NICE evals could green-light more drugs, but only at 'the very best price'

The U.K.'s cost watchdog is changing up the way it evaluates drugs. The National Institute for Health and Care Excellence (NICE) will be zooming out to look at the bigger picture when assessing therapies, which could result in more positive recommendations--something drugmakers have been dreaming of for years.