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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
Vertex Pharmaceuticals has decided to give up on its experimental VX-814, a small molecule drug for the rare genetic disease Alpha-1 antitrypsin deficiency (AATD), canning the drug’s development after seeing lackluster results from an early phase 2 trial. Read More
Roche has partnered with Dyno Therapeutics to develop adeno-associated virus (AAV) vectors for gene therapies for nervous system diseases and liver-directed treatments, part of the Swiss drugmaker’s push to expand into gene therapies. 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
More than a month has passed since AstraZeneca’s phase 3 COVID-19 vaccine trial was paused due to a potential adverse event, but few solid details have emerged from ongoing safety reviews by the FDA and the UK drugmaker. Read More