Topic:

Regulatory

Latest Headlines

Latest Headlines

J&J eyes long-acting boost for Invega franchise with quick FDA look at new formula

Johnson & Johnson's antipsychotic med Invega Sustenna is already bringing in blockbuster-plus sales for J&J, and if the company has its way, a new, even longer acting formula will give the franchise an even bigger boost.

UPDATED: Novartis scores the first victory in a blockbuster psoriasis race

Novartis picked up FDA and European approvals to sell its secukinumab as a treatment for psoriasis, the first steps in the company's plot to build a global anti-inflammatory contender and outpace its rivals.

Apple CEO's visit to Congress a sign of growing engagement with the feds

Apple has growing med tech ambitions, but those gnarly healthcare regulations have left a sour taste in its mouth. As a result, the Silicon Valley bigwig has stepped up its engagement with the feds, seeking not only to learn by meeting with the FDA but also to change the rules via a lobbying effort that cost nearly $3 million last year.

Gilead, AbbVie rack up new payer deals, but hep C obstacles loom across the Atlantic

The hepatitis C market is breaking new ground all over the place. As payers put the squeeze on Gilead Sciences and AbbVie for discounts in the U.S., England's National Health Service is delaying a broad rollout of Gilead's blockbuster Sovaldi till July, citing the drug's high cost--an unprecedented move on a treatment already blessed by the country's cost-effectiveness watchdogs.

FDA to avoid regulating most wearables, seeking to reduce device accessory regulation overall

The FDA said in a draft guidance issued last week that it does not intend to regulate general wellness products, which include an array of consumer-oriented wearables like Fitbit's exercise trackers.

CytRx surges after FDA lifts a partial hold on late-stage cancer drug

Shares of CytRx bounced up 10% this morning as investors responded to the news that the FDA had lifted its partial hold on its late-stage cancer drug aldoxorubicin.

FDA raises issues with another Apotex plant

An Apotex plant in Brantford, Ontario, was cited in a November inspection for equipment that was not properly cleaned and was found to be contaminated, according to a report in The Star. The plant was also cited for not having password-protected computers that could prevent employees from altering or deleting testing data.

India makes move to reduce reliance on Chinese APIs

Authorities in Himachal Pradesh have responded to calls to reduce restrictions on bulk drug manufacturers to help relieve India's reliance on Chinese APIs.

India opens medical device industry to foreign direct investment

India's medical device industry will officially open Jan. 21 to unlimited foreign direct investment as the government kicks off what is expected to be a year of vast changes in the way it regulates the products.

China bans import of U.S. poultry products on avian flu fear

This week, China joined a growing list of countries banning the import of U.S. poultry products following reports of the discovery of a highly contagious strain of avian influenza in three West Coast states.