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Regulatory

Latest Headlines

Latest Headlines

Merck sets $54K list price for hep C combo as it preps for battle with Gilead, AbbVie

Industry watchers have long been speculating on how Merck would take on heavyweights Gilead and AbbVie when it priced its new hep C regimen. And now, they have their answer: Undercut them. Big-time.

Canadian micro-cap Spectral nabs $7.1M to finalize PMA for septic shock device-Dx combo

Toronto-based Spectral Medical has raised CA$10 million ($7.1 million) in an offering to back its effort to earn FDA approval for its septic shock treatment device-diagnostic combination. The company said earlier this month that it expects to submit its final PMA module to the FDA in the second half of 2016; it added that it submitted the first three modules to the agency last year.

Struggling Eisai gets FDA approval for cancer drug Halaven for liposarcoma

Japan's Eisai got a much-needed boost on Thursday when the FDA approved its cancer drug, Halaven, for treatment of liposarcoma for patients in which the cancer has advanced to the point where surgery is not an option.

Allergan's depression drug bags a 'breakthrough' tag on the way to Phase III

The star of Allergan's pipeline, a ketamine-like drug for depression, secured the FDA's coveted breakthrough therapy designation, guaranteeing the company access to top agency officials as it moves toward late-stage development.

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.
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