Topic:

Regulatory

Latest Headlines

Latest Headlines

FDA expands indication of the only sublingual second-gen antipsychotic

The FDA has expanded the indication of Actavis's Saphris tablet, the only sublingual atypical, or second-generation, antipsychotic to include pediatric patients aged 10 to 17 with bipolar I disorder.

China's drug approval backlog swells as it gets nearly 9,000 applications in 2014

China had a backlog of more than 18,500 drugs awaiting approval by the end of 2014, up 33% from the previous year, according to the China FDA's Center for Drug Evaluation.

Study: Few clinical trial results posted on federal website as required by law

Only 13% of clinical trials registered at ClinicalTrials.gov posted their results within one year of data collection, as required by federal law, according to a study in The New England Journal of Medicine.

Cancer Drug Fund has failed, ex-health minister says: PMLive

England's Cancer Drugs Fund has been getting it from both sides lately, as both drugmakers and cancer patients are upset over its deletion of coverage for a couple of dozen drugs, and officials and researchers say it is not living up to its promise.

Takeda gets thumbs-up from U.K. cost gatekeeper for discounted Entyvio

Takeda got a positive recommendation from the U.K.'s cost gatekeeper for its inflammatory bowel disease drug Entyvio, but the National Institute for Health and Care Excellence tacked on a condition to its approval.

St. Jude's Portico TAVR gets CE mark reinstated after 'false alarm'

St. Jude Medical's transcatheter aortic valve replacement, or TAVR, cardiology device is now commercially available in Europe once again, after its CE mark was suspended following safety concerns about reduced valve leaflet mobility arising from the company's U.S. clinical trials.

Bristol-Myers heads back to the FDA with its long-delayed hep C drug

Bristol-Myers Squibb is finally in line for FDA approval for its once-rejected hepatitis C daclatasvir, angling to take third place among companies with next-generation cures for the virus.

China says backlog of drug approvals soared 33% last year as new applications jumped

China had a backlog of more than 18,500 drugs awaiting approval by the end of 2014, an increase of 33% from the previous year, according to the China FDA's Center for Drug Evaluation.

India considers standalone pharmaceutical ministry

Government officials in India are reportedly giving serious consideration to creating a standalone pharmaceuticals ministry, bringing all of the regulatory bodies under one tent.

China guidelines on stem cell research, treatments possible by summer

China could have guidelines governing stem cell and similar research and treatments by midsummer, the China FDA said in a meeting with local experts in the field.