Topic:

Regulatory

Latest Headlines

Latest Headlines

New FDA report finds banned antibiotics still showing up in dairy cow tests

According to a new report by the FDA, some farmers continue to use antibiotics that routine tests don't detect, especially in dairy cows, because those drugs are banned.

USDA to launch national equine study this spring

The U.S. Department of Agriculture is launching a new study in May that focuses on the country's equine industry. Dubbed "Equine 2015," the study is a follow-up to the agency's National Animal Health Monitoring Systems' previous reports on the industry conducted in 1998 and 2005.

Samsung Bioepis JV with Biogen Idec moves on Remicade biosimilar in Europe

South Korea's Samsung Bioepis has submitted a marketing authorization application to the European Medicines Agency for SB2, a biosimilar of autoimmune drug Remicade (infliximab) for moderate to severe rheumatoid arthritis.

Merck can't get the sugammadex curse lifted, faces 3rd FDA rejection

Merck's anesthesia drug sugammadex has been cited repeatedly over the years as one of the top experimental meds in the pharma giant's pipeline, a trophy obtained in its megamerger with Schering. But the treatment has racked up a painful series of setbacks over the years, starting with its first rejection at the hands of the FDA 7 years ago and continuing now with a third looming rejection over unresolved questions surrounding a hypersensitivity study performed for its pitch to the agency.

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.