In a marathon markup on Thursday, the House Energy & Commerce Committee advanced more than 30 bills to address the opioid crisis. Source: Drug Industry Daily

In an effort to curb the “gaming tactics” that delay generic drug competition, the FDA released a public list of companies found to be potentially restricting access to samples of…

The FDA’s guidance on developing Alzheimer’s drugs is overly rigid when it comes to enrollment of patients in clinical trials, drugmakers said in public comments. Source: Drug Industry Daily

The FDA took vendor IQVIA to task for a discrepancy in data regarding sales of opioid drug products that the agency said could undermine forecasts used in the fight against…

The Center for Medicare & Medicaid Services issued a long-awaited update to its online dashboard, increasing drug price transparency for consumers by adding year-over-year drug pricing changes and price-hiking manufacturers.…

Clinical trial sponsors must step up their efforts to address underrepresentation of women among trial subjects, said FDA Commissioner Scott Gottlieb Wednesday during a meeting in White Oak, Maryland to…

Vermont’s governor Phil Scott signed a bill Wednesday to allow wholesalers to import drugs across the Canadian border. Source: Drug Industry Daily

The increased use of fast track regulatory pathways has led to the FDA having the shortest median approval time for new active drug substances in 2017 compared to five other…

Against a backdrop of widespread scrutiny of drug prices, Pharmacyclics opted to scrap a plan to triple the price of its blood cancer drug, Imbruvica (ibrutinib). Source: Drug Industry Daily

West Virginia’s Supreme Court declined to expand the state’s product liability law to cover claims against branded drugs for harm caused by their generics. Source: Drug Industry Daily