Topic:

Regulatory

Latest Headlines

Latest Headlines

Salix calls it quits on an inversion over mounting political pressure

Specialty drugmaker Salix Pharmaceuticals is backing out of a $2.7 billion deal that would have given it an Irish domicile--and thus a lower tax rate--in the first victory for U.S. leaders working to discourage such transactions.

Philips slapped with $466M verdict in Masimo patent battle

Philips was slapped with a $466 million verdict in its patent infringement battle with Masimo over technology used for its pulse oximeter devices, casting a pall over the company's recent restructuring and product development efforts.

Zogenix races to FDA with abuse-deterrent version of maligned pain pill Zohydro

Ever since the FDA approved Zogenix's all-hydrocodone painkiller Zohydro last year, both the agency and the company have faced a storm of criticism. The powerful pill, without tamper-resistant features, was destined to be abused, they claimed.

Philips gets apps FDA-cleared, launches psoriasis device after HealthTech refocus

Philips is getting serious about consumer health, staking the entire business on merging its healthcare and consumer units into one company focused on health tech. It will spin off the lighting business into a separate company next year.

FDA finalizes cybersecurity guidance in push to secure devices from hackers

The FDA announced that it has finalized its guidance on managing cybersecurity risks as it aims to protect patient privacy and prevent devices from malfunctioning due to computer viruses.

Judge won't toss dinner-party kickback claims against Novartis

Note to sales reps: You might think twice about inviting the same doctors to the same speaker events over and over. Particularly when those events involve pricey dinners at Nobu and Smith & Wollensky.

Warning to Gilead, AbbVie and BMS: France has a new tax for pricey hep C meds

European countries are known for wresting price cuts from drugmakers. Usually, it's a straightforward cost-effectiveness argument. But France has come up with a new strategy: Arm-twisting taxes.

FDA spotlights innovation in 3-D imaging

Breast cancer detection may soon leave 2-D mammography in the dust, embracing instead a more comprehensive diagnostic tool: 3-D technology.

India sending inspectors on facility visits with global peers

Over the past year India has begun to face up to the reality that its regulatory machinery is insufficient to enforce quality standards, leading authorities to commit to hiring more inspectors. Now those new inspectors are tagging along on inspections run by their international peers.

Novartis dinner-party kickback case must go on, judge says

In an order filed Tuesday, U.S. District Judge Paul Gardephe refused to dismiss claims that Novartis lavished entertainment on certain physicians in return for increased prescriptions.