Topic:

Regulatory

Latest Headlines

Latest Headlines

Sinovac Biotech gets GMP stamp from CFDA for hand, foot and mouth vaccine

Beijing-based Sinovac Biotech has secured its good manufacturing certificate from the China FDA, placing it on track to sell the Enterovirus 71 (EV71) vaccine to prevent hand, foot and mouth disease.

India's Wockhardt knocked again by U.S. FDA

Mumbai-based drugmaker Wockhardt is once again in the crosshairs of the U.S. Food and Drug Administration (FDA) after the American regulator found the pharma giant was hiding the results from failed tests on drugs and deleting the resulting data from computer systems at a plant in western India, according to a report by Reuters.

Merck goes toe-to-toe with Gilead's hep C goliath, flags discount with blockbuster OK

Two years after Gilead Sciences triggered a market quake with a groundbreaking approval for Sovaldi, Merck is making a late entrance into the hep C market.

Neos wins FDA approval for a melts-in-your-mouth take on Adderall for ADHD

Neos Therapeutics, at work on extended-release versions of old drugs, won FDA approval for a long-acting ADHD pill that dissolves in patients' mouths.

Roche/AbbVie's venetoclax grabs third FDA 'breakthrough' for blood cancer

AbbVie and Roche's venetoclax has received yet another accelerated review from the FDA--this time in patients with the most common type of acute leukemia.

Sino Biopharma's asset management deal drawing negative reviews

Investors in Hong Kong-listed Sino Biopharma are raising questions about the company's plan to spend HK$6 billion ($770 million) to buy 5% of China Cinda Asset Management and the company's shares have dropped by 20% since the deal was signed this month.

India's Supreme Court allows Cipla move in Roche patent case

The Supreme Court of India will allow a scientist to join the patent case involving Indian drug giant Cipla which had earlier been found to have violated the Roche patent on its Tarceva (erlotinib) cancer drug.

CMS draws blood, says Theranos poses 'immediate jeopardy to patient health'

The Centers for Medicare & Medicaid Services has published a letter to Theranos director Dr. Sunil Dhawan saying that the diagnostics company's Newark, CA, laboratory is not in compliance with the agency's CLIA regulations, and "based on the Condition-level requirement at C.F.R. § 493.125, Hematology, it was determined that the deficient practices of the laboratory pose immediate jeopardy to patient health and safety."

Lilly, BI approach CV-benefit label change for SGLT2 med Jardiance

Eli Lilly and Boehringer Ingelheim are one step closer to an important label change for SGLT2 contender Jardiance.

Merck lines up for a quick approval with its C. diff therapy

Merck is nearing FDA approval for its Clostridium difficile-fighting antibody, picking up the agency's priority review designation with the promise of a shortened vetting process.