Allergan has agreed to pay $200 million to resolve New York-based claims that it helped facilitate the state’s opioid crisis through deceptive marketing. Source: Drug Industry Daily

An FDA advisory committee unanimously rejected recommending approval of Reata Pharmaceuticals’ bardoxolone methyl as a treatment for patients 12 years and up with chronic kidney disease caused by Alport syndrome…

Cutting prices for costly therapies approved under an accelerated pathway may not significantly reduce total prescription drug spending by Medicare, says a new study by researchers at Brigham and Women’s…

The FDA offered guidance for sponsors of individualized drugs developed for use against life-threatening genetic diseases in two draft guidances released yesterday. Source: Drug Industry Daily

Merck’s islatravir-based HIV antiretroviral program has hit another bump in the road, with the company pausing enrollment in two phase 3 studies that are key to advancing the once-a-month oral…

The world’s first plant-based COVID-19 vaccine just returned positive results in a late-stage study. Source: Drug Industry Daily

Gilead Sciences has recalled two lots of its blockbuster COVID-19 antiviral Veklury (remdesivir) for possible contamination with glass particulates. Source: Drug Industry Daily

The FDA’s Center for Drug Evaluation and Research (CDER) has issued two manuals for agency staff on user fees — one updated and one brand new. Source: Drug Industry Daily

Janus kinase (JAK) inhibitor anti-inflammatories made by Pfizer, AbbVie and Eli Lilly for inflammatory diseases, such as rheumatoid arthritis and ulcerative colitis, have all received the strictest warnings added to…

Aeglea BioTheraputics hopes to snag a first-in-class approval for its recombinant human enzyme pegzilarginase after finding that the molecule normalized plasma arginine levels in more than 90 percent of patients…