Topic:

Regulatory

Latest Headlines

Latest Headlines

Medtronic reveals cyberattack and patient data loss

Medtronic revealed that it was the target of a cyberattack in 2013 and that it lost patient records on a separate occasion, hearkening back to hacking rumors that circulated earlier this year.

Teva settles with Catalent, Perrigo in inhaler patent suit

Catalent and Perrigo will be able to sell generic versions of Teva's ProAir HFA inhaler starting in late 2016, resolving a patent dispute between the two parties.

The FTC launches new pay-for-delay probes, hoping to win some

In the wake of a Supreme Court ruling that affirmed its anti-pay-to-delay powers, the Federal Trade Commission has launched several new investigations this year, the agency's healthcare chief told Bloomberg. The enforcers are hoping to hit some unlucky pharma company with a $1 billion settlement this year, an FTC official said earlier this year.

FDA to stop regulating some medical device software

FDA will exercise "enforcement discretion" in its regulation (or lack thereof) of medical device data systems by opting not to enforce the general controls, such as product registration and Quality System Regulation, that normally apply to Class I devices, the agency said in a June 20 draft guidance.

Cubist's Trius buyout pays off with FDA nod on high-powered antibiotic Sivextro

Less than a year after Cubist scooped up Trius for $707 million in a bid to boost its presence in antibiotics, it can boast an FDA approval out of the deal. On Friday, the agency approved Sivextro, an antibacterial drug to treat a range of skin infections, including methicillin-resistant Staphylococcus aureus (MRSA).

Japan OKs Bayer's Nexavar for thyroid cancer

Building on approvals in the U.S. and EU, Bayer Healthcare said Japan has approved  Nexavar  to treat patients with unresectable differentiated thyroid carcinoma.

EU looks toward new medical device legislation in 2015

In 2012, an immediate action plan as well as new medical device legislation were proposed in the European Union. This week, the Employment, Social Policy, Health and Consumer Affairs Council of the European Commission declared the action plan a success and issued its vision for upcoming legislative changes.

FDA moves for more warnings on testosterone products

The FDA has dealt a blow to the $1.6 billion testosterone supplement market, which includes the top-selling AndroGel, made by AbbVie. The drug labels must now include a general warning about the risk of blood clots in veins.

Why does Sovaldi cost $84,000? Gilead Sciences being pressed hard for an answer

Payers, politicians and some regulators have been balking at the $84,000 price tag on Gilead's hepatitis C treatment Sovaldi ever since it hit the market in January. Now two top member of Congress are demanding that the company appear at a congressional hearing to explain the product's high price.

EU keeps rolling out pay-for-delay penalties with plan to fine Servier, Teva

European antitrust regulators may have been a little late to the party when it comes to pay-for-delay actions but are making up for lost time. Sources are saying they will levy fines against French drugmaker Servier and Teva Pharmaceutical Industries next month for delaying the launch of generic blood pressure meds.