Topic:

Regulatory

Latest Headlines

Latest Headlines

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.

T2 Biosystems gains FDA signoff for time-saving Candida Dx

T2 Biosystems, a month after launching its IPO, won FDA approval to market a new kind of test to quickly identify Candida, a bloodstream infection that can cause sepsis.

Medtronic gains approval, launches Tyrx antibacterial envelope in Europe

Already cleared by the FDA last year, the Tyrx Absorbable Antibacterial Envelope has won a CE mark for use with cardiac devices, and Medtronic has launched it in Europe.

Amgen goes to FDA early with new leukemia drug

Amgen is hoping to redeem its drug development rep by going to the FDA with an application for its new leukemia drug blinatumomab based on promising Phase II data, FierceBiotech reports.

Why are so many companies failing to pay the device tax?

The 2.3% medical device excise tax raised $913 million in the first half of 2013, or about 75% of what was anticipated. A look at the number of filers reveals a large part of the problem. Out of estimates as high 15,000 only 5,107 medical device tax forms were filed.