Topic:

Regulatory

Latest Headlines

Latest Headlines

Health Diagnostic CEO resigns as feds start doctor payment investigation

Health Diagnostic Laboratory CEO Tonya Mallory resigned from her position at the same time a federal investigation was launched to look into the company's blood-sample practices.

FDA to weigh in on cybersecurity concerns

Amid growing concern over the cybersecurity of medical devices, the FDA is weighing in on the issue and addressing product safety at an upcoming conference.

Hamburg called on to resign for FDA's approval of Zohydro

The FDA approved opioid painkiller Zohydro nearly a year ago as a med to provide relief for those with chronic pain. But the drug has been nothing but 11 months of aggravation for the agency and its leader, Commissioner Margaret Hamburg, who is now being called on to resign by organized anti-addiction groups who say the FDA has contributed to an epidemic of abuse in the country.

Celgene's Otezla nabs psoriasis approval, launching next-gen showdown

Celgene's anti-inflammatory newcomer Otezla just took another step toward the powerhouse. The drug won FDA approval in a big market important to its sales: psoriasis, the most common autoimmune disease in the U.S. It's the first in a new generation of psoriasis meds to nab that indication.

J&J 'disappointed' U.K. watchdogs nixed Olysio-Sovaldi hep C combo. What next?

Johnson & Johnson pessimists are already worried that Olysio will end up like a mayfly, with a short, happy, busy life and an all-too-sudden end. If the U.K.'s cost-effectiveness gatekeepers offer any indication, they may be correct.

Fast-tracked Ebola studies put Tekmira, Mapp and Sarepta in the spotlight

On Monday Tekmira noted that the FDA had cleared the regulatory path needed to allow the use of its experimental Ebola treatment on a compassionate use basis. And then today the Vancouver-based biotech followed up with the news that it is collaborating with health officials on a fast-tracked study of Ebola therapies in Africa, a one-two punch that helped bolster its stock price as investors gambled on a successful outcome forged out of a lethal outbreak.

T2 Biosystems wins FDA approval for sepsis diagnostic system

T2 Biosystems won FDA approval to market its diagnostic system for sepsis, riding on the tailwinds of last month's IPO and moving the company forward on its path toward full commercialization of the product.

Treasury's crackdown on inversion could scupper Medtronic-Covidien deal

Treasury Secretary Jacob Lew yesterday unveiled a plethora reforms to make tax inversion more difficult and less attractive, potentially killing a plethora of pending mergers with foreign companies, including Medtronic's $43 billion tie-up with Ireland's Covidien. 

Recall of Mylan nitroglycerin revised to avoid shortage

Mylan and Health Canada have rethought a recall of Mylan-Nitro Spray that it hopes will not deprive users of the meds they need for angina. The effort comes as the FDA has been fighting a shortage of nitroglycerin in the U.S.

Who loses in biopharma as Treasury moves to block tax inversions?

As promised, the U.S. Treasury has changed the tax rules related to tax inversions in a move aimed at throwing up a roadblock on the road to lower tax rates abroad. And the move doused shares of AstraZeneca, Shire and others which had either been in the crosshairs of a potential inversion gambit or were waiting to complete the paperwork.