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Regulatory

Latest Headlines

Latest Headlines

iRhythm has CE mark in sight for arrhythmia Dx patch

After closing a $17 million Series E financing, iRhythm Technologies CEO Kevin King isn't slowing down. He has his eye on a CE mark in 2014 for the company's ZIO Service, a move that would greatly expand the market and revenue potential for the arrhythmia diagnostic device.

WHO's links to ICH under fire amid efforts to strengthen manufacturing regulations

To the casual observer, the International Conference on Harmonisation (ICH) could appear to be a fusty but uncontroversial group. Yet ICH's position in the highly charged debate over how quality standards affect the cost and availability of drugs--coupled with its links to the pharma industry--have made it a target of criticism.

Fresenius recalls hemodialysis liquid after bacteria discovery

German company Fresenius has had multiple runs with the FDA in recent years, with the agency hitting its plants in the U.S., Puerto Rico and India with warning letters. Fresenius' Montreal, Canada, plant has caused it fewer problems, but it too has now encountered quality-control failings.

Amgen's Vectibix scores first-line approval in wild-KRAS colorectal cancer

The FDA has OK'd the use of Amgen's Vectibix as a first-line treatment for wild-type KRAS metastatic colorectal cancer. The agency approved the frontline use of the drug in combination with Folfox chemotherapy.

Teva and Active Biotech not giving up on EU-spurned MS treatment

The EU's Committee for Medicinal Products for Human Use (CHMP) is sticking to its opinion to recommend against approval of Teva and Active Biotech's MS drug Nerventra. But the companies aren't giving up, announcing Friday that they remain committed to the clinical development program and plan to evaluate CHMP's feedback before they plot out their next steps.

Teva keeps the faith after another rebuke for Copaxone's heir

Teva's $4-billion-a-year multiple sclerosis treatment Copaxone is slated to lose patent protection next year, and the Israeli drugmaker is struggling to move the needle on its planned replacement, enduring another rejection from European reviewers.

FDA-nixed diabetes drug from Lilly, Boehringer could face rough path to stardom

The FDA may not have been so keen on Boehringer Ingelheim and Eli Lilly's Type 2 diabetes drug Jardiance when it issued a complete response letter in March for problems at its future production site. That didn't stop its across-the-pond counterpart from green-lighting the drug Friday--and it won't keep it from cracking the blockbuster barrier, analysts say. But that doesn't mean getting there will be easy.

eNeura receives 510(k) for second-generation migraine treatment device

Following the FDA's de novo approval of eNeura's device for the treatment of pain from migraine headaches with aura, the company announced May 23 that its second-generation SpringTMS received 510(k) clearance. 

The EU's not impressed with Novartis' 'breakthrough' cardio drug, either

After an FDA rejection and an earlier negative opinion, Novartis' cardio treatment serelaxin has again failed to sway European regulators, and the drugmaker has resigned that its breakthrough-designated therapy will not hit any market this year.

PTC soars as EU changes its tune on the DMD-treating ataluren

Reversing an earlier rejection, European regulators are recommending early approval for PTC Therapeutics' ataluren, a treatment for Duchenne muscular dystrophy, news that more than doubled the biotech's share value in premarket trading.