Topic:

Regulatory

Latest Headlines

Latest Headlines

Pluristem snags spot on EMA's nascent fast-track scheme

Pluristem Therapeutics has bagged itself a spot on the European Medicines Agency's adaptive pathways pilot project. The EMA's decision gives Pluristem a shot at slashing the time it takes to bring its PLX cell program in critical limb ischemia to market in a subpopulation.

Gilead's Sovaldi faces renewed advocacy CL pressure, this time for China and Russia

China and Russia have become new targets for compulsory-licensing campaigns as an activist group widens its global challenge to Gilead's expensive Sovaldi (sofosbuvir) hepatitis C drug.

Chicken producer Sanderson says FDA's crackdown on antibiotics lacks 'reliable science'

Joe Sanderson, CEO of chicken producer Sanderson Farms, says he's telling his chicken farmers to continue using antibiotics to treat sick birds and prevent illnesses, because he believes FDA's concerns are overblown, according to the Wall Street Journal.

Hep C landscape shifts again as BMS combo nabs breakthrough tag

Gilead Sciences and AbbVie caught a break for their hepatitis C treatments when the FDA rescinded breakthrough designations earlier this year for potential competitors being developed by Merck and Bristol-Myers Squibb.

The root of Orexigen's Contrave data blunder: CEO's 'I have to see it' choice

A couple of years back--before Orexigen's recent data leak landed it in hot water with regulators, researchers and marketing partner Takeda--CEO Mike Narachi said he believed data from a large cardiovascular outcomes study should be kept among "a small team." But he also believed he should be on that team.

InVentiv invests in compliance as regulations shift for real-world studies

CRO inVentiv Health is amping up its capacity in regulatory compliance to prepare for changes in European trial rules, unveiling a global database it claims can help sponsors avoid costly confusion.

Roche snags FDA CLIA waiver for rapid Strep A test

Roche got an FDA CLIA waiver for its rapid Strep A test, opening the door to expanded use of the product months after the agency signed off on the test.

Australia launches clinical trials website to sharpen patient access for PhIII

Australia launched an online register of clinical trials so that patients can search for potential treatment opportunities as recruitment falls short for many Phase III efforts in the country, the Australian newspaper reported.

Takeda bolsters offerings of flu vaccines

Japan's Takeda Pharmaceutical has reached an agreement to distribute Kaketsuken's influenza vaccine domestically in the 2015-2016 season as the government makes a major push to cover the elderly population.

China plans for the long march in biomedical, device reforms

China, the country of 5-year plans, has inaugurated a longer one: 10 years for increased manufacturing, including biomedicine and high-end medical devices. The State Council calls it "Made in China 2025."