Roche just can't win with the U.K.'s drug price watchdog, the National Institute for Health and Care Excellence (NICE). In August, the agency decided the company's heralded breast cancer drug Kadcyla was too expensive for the country's health system to cover. Now NICE has slapped Roche with a preliminary thumbs-down on Gazyvaro, its new drug to treat chronic lymphocytic leukemia (CLL).
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 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.
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 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.
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.
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.
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.
Breast cancer detection may soon leave 2-D mammography in the dust, embracing instead a more comprehensive diagnostic tool: 3-D technology.
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.