Topic:

Regulatory

Latest Headlines

Latest Headlines

India's IPCA buys plant as it deals with FDA issues

Indian drugmaker IPCA, which has stopped shipping products to the U.S. and Canada from a plant in Bangalore, has acquired a high potency oral solid dosage facility from Alpa Laboratories.

Flowonix submits MRI-compatible implantable infusion pump for FDA approval

Pending FDA approval, the upgraded Prometra Implantable Pump System for targeted drug delivery of pain medication will feature MRI compatibility, Flowonix CEO Steve Adler told FierceDrugDelivery in an interview.

Attorney questions FDA's authority to regulate devices promoted on social media

An attorney whose practice is focused on medical device law has called into question the FDA's authority to regulate devices that are promoted on social media platforms like Facebook and Twitter.

Takeda back in court facing bladder cancer claims against Actos

Lawyers in another Actos failure-to-warn trial claimed the company put profits ahead of patient safety, by keeping mum on study data that flagged links between the diabetes drug and cancer.

Catalyst Pharma to join parade of huge price hikes on old, cheap drugs

Yet another drugmaker is taking a cheap drug and turning it into an FDA-approved brand--and adding an enormous premium along the way. Once again, the cost increase promises to be huge, The Street reports: Analysts figure on a list price of $60,000 to $80,000 per year.

NICE nixes Roche's new leukemia drug Gazyvaro despite discount offer

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).

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.