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The Department of Justice (DOJ) announced an $8.3 billion settlement deal with Purdue Pharma Wednesday to resolve criminal and civil probes into the OxyContin manufacturer, which some critics view as insufficient punishment for the company and its owners, the Sackler family. Read More
Moderna CEO Stéphane Bancel said that the drugmaker’s COVID-19 vaccine candidate could receive an Emergency Use Authorization (EUA) in December if all goes according to plan, with interim data expected out next month. Read More
The Government Accountability Office (GAO) on Monday agreed to begin looking into allegations that the Trump administration exerted political pressure on the FDA and Centers for Disease Control and Prevention (CDC) to influence pandemic-related policies, following a request by three Democrat senators. Read More
Catalyst Pharmaceuticals has filed a patent infringement lawsuit against competitor Jacobus Pharmaceutical over the latter’s Ruzurgi (amifampridine) tablets. Read More
The EMA’s Committee for Medicinal Products for Human Use (CHMP) has recommended ten medicines for authorization by the European agency, including two investigational cell therapies and two antiretrovirals. Read More
HHS Deputy Chief of Staff for Policy Paul Mango said that within 24 to 48 hours after an Emergency Use Authorization is granted for a COVID-19 vaccine, “we expect to be putting needles in people’s arms.” Read More
A reported settlement between the Justice Department and Purdue Pharma relating to the company’s alleged role in the opioid crisis has drawn more heat from 25 state attorneys general. Read More
The UK’s National Institute of Health and Care Excellence (NICE) has recommended Novartis’ Mayzent (siponimod) for treating secondary progressive multiple sclerosis (MS) after previously declining to support the drug. Read More
A highly anticipated meeting of the FDA’s COVID-19 vaccine advisory committee will take place Oct. 22 to discuss the emergency authorization and approval of vaccine candidates, including what is necessary for post-market studies. Read More
A group of Democrats led by Sen. Maggie Hassan (D-N.H.) have asked FDA Commissioner Stephen Hahn to detail what the agency is doing to ensure COVID-19 drugs and vaccines will be safe and effective in older patients. Read More