Topic:

Regulatory

Latest Headlines

Latest Headlines

FDA to allow midstream changes to device trials as part of effort to speed up approvals

The FDA issued draft guidance this week on adaptive designs for medical device clinical studies. Similar to a prior guidance on the incorporation of patient preference data in clinical trials, the latest guidance should help companies perform trials faster, and signals greater flexibility on the behalf of the FDA.

Merck's Keytruda, BMS' Opdivo score European nods to keep immuno-oncology race blazing

Merck's Keytruda gained some regulatory ground in Europe on Friday, nabbing a melanoma recommendation that Opdivo snagged last month. But Opdivo continued to charge ahead, too, winning a nod in lung cancer to help preserve its lead.

England's Cancer Drugs Fund keeps Bayer's Stivarga, axes Eisai and Lilly meds

England's Cancer Drugs Fund has drawn a hard line when it comes to its list of covered meds, axing cancer treatments despite pushback from drugmakers. But Bayer scored a victory for its cancer med Stivarga, getting the fund to reverse its decision and keep the drug on its list even as rival companies lose similar battles.

Want the U.K.'s NHS to quickly adopt new products, drugmakers? There's an office for that

Drugmakers want market access and reimbursement for their new products as fast as possible, and now, the U.K.'s National Institute for Health and Care Excellence is setting up an office with the same goal.

Australia zeroes in on pharma in transfer-pricing probe

Australia has singled out the pharmaceutical industry for special scrutiny in its examination of corporations moving money offshore to avoid local taxes.

Cipla, Wockhardt among FDA recalls as India manufacturing woes continue

Cipla and Wockhardt each announced drug recalls from the U.S. market, the former because of failure to meet specifications, the latter because of U.S. FDA concerns about two of its India plants. A Japan devicemaker also announced a U.S. recall.

Is uniQure's gene therapy worth $1.4M?

The Federal Joint Committee is assessing uniQure's Glybera, the first-ever gene therapy approved in Europe, and now the world's most expensive drug at €1.1 million ($1.4 million). And the questions raised in Germany offer a preview of reimbursement conversations in other countries, about this and other uber-pricey gene therapies.

Novo, Baxter spar over hemophilia patent amid ITC probe

Baxter said back in March that Novo Nordisk's recently launched hemophilia med infringed some of its patents, spurring an investigation from the U.S. International Trade Commission. But the Danish drugmaker doesn't see what all the fuss is about.

China academy plans clinical trials on artemisinin derivative aimed at lupus

The Chinese Academy of Sciences says it is set to begin clinical trials on a drug it invented, SM934, a derivative of artemisinin for treating lupus. The only other drug developed specifically for the disease has been an antibody-based drug.

Japan eyes higher target for generics despite missing earlier aims

Although it has not even reached its goal of generics comprising 60% of drugs prescribed in Japan, the government is about to raise it to 80% or 90%, according to reports.