Merck Serono totes up the toll of its 1,250 Geneva job cuts

By Tracy Staton In a somewhat unusual move, Merck Serono has given a person-by-person accounting of its Geneva headquarters shutdown. Those 1,250 Swiss staff targeted in that cost-cutting ...

Sunshine Heart gets conditional approval for heart failure tech

By Damian Garde Sunshine Heart’s ($SSH) painless trip through the regulatory world continues, as the FDA conditionally approved its C-Pulse Heart Assist System, giving the company ...

Welch Allyn touts iPhone-based eye exam device

By Damian Garde Welch Allyn has taken its PanOptic Ophthalmoscope and fitted it with iPhone capabilities, and the resulting iExaminer allows physicians to capture, store, send ...

AutoGenomics gives IPO another go with $65M offering

By Damian Garde Diagnostics company AutoGenomics is again trying its hand at going public, filing for a $65 million IPO and planning to trade under AGMX. As Xconomy notes, AutoGenomics ...

FDA wants employee spying suit thrown out

By Mark Hollmer The FDA is trying to make lawsuits accusing it of spying on the personal Gmail accounts of current and former device center employees go away. It’s a big, messy ...

FDA cites Zimmer for hip replacement manufacturing shortfalls

Regulators warned the company for lacking quality testing for its Trilogy line at a Puerto Rico plant By Mark Hollmer Zimmer ($ZMH) is in trouble with the FDA over manufacturing shortfalls ...

Evan Bayh: ObamaCare’s Tax Raid on Medical Devices

The industry that gave us stents, replacement joints and defibrillators will get a dose of bad fiscal medicine. By EVAN BAYH The Supreme Court decision in June upholding the Affordable ...

FDA approves Boston Scientific’s market-first wire-free pacemaker

By MassDevice staff Medical device titan Boston Scientific lands FDA approval for the subcutaneous lead-free heart rhythm implant it acquired in the $1.35 billion deal for Cameron ...

Products Containing Sunland Peanut Butter Still Being Recalled

BY NEWS DESK The Sept. 24 peanut butter recall by Sunland Inc. of Portales, NM continues to have ramifications for other foods made with the recalled products. Sunland took the action ...

FDA chief says scarce funding hobbles sweeping food safety regulations

By David Morgan (Reuters) – The U.S. Food and Drug Administration said it is having difficulty implementing expansive new rules to improve food safety, nearly two years after ...

Hemispherx wants to sell genital warts drug Alferon in Argentina for hepatitis C

Philadelphia Business Journal by John George, Senior Reporter Hemispherx Biopharma filed an amended new drug application in Argentina seeking approval for its natural Alferon N Injection ...

Novo’s Tresiba approved in Japan, haemophilia drug dropped

KEVIN GROGAN Novo Nordisk has been granted a first approval for its ultra long-acting insulin degludec, in Japan, and has discontinued development of a Phase III haemophilia drug. The ...
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