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Countries need to shore up logistical and medical resources on the ground to facilitate vaccinating their citizens once the supply arrives, Hatchett said. Read More
Bristol Myers Squibb (BMS) subsidiary Juno Therapeutics has lost a bid to persuade a U.S. appeals court to overturn its own decision tossing out a $1.2 billion patent verdict that Juno won against Gilead Sciences subsidiary Kite Pharma. Read More
In its continuing effort to hire highly skilled senior executives from the private sector, the FDA took advantage of provisions in the 21st Century Cures Act to offer higher salaries than it could under traditional federal hiring authorities, but it still needs an overall workforce strategy for drugs and devices, the Government Accountability Office (GAO) said in a new report. Read More
All is well between Eli Lilly and the FDA after the agency’s Office of Prescription Drug Promotion (OPDP) admonished the drugmaker for not submitting two direct-to-consumer TV advertisements for its migraine drug Emgality (galcanezumab) to FDA for consideration before the ads aired. Read More
The European Commission has laid out its regulations for selecting EU member states to evaluate suspected unexpected serious adverse reactions (SUSARs) that occur in clinical trials. Read More
The FDA has submitted its user fee reauthorization letters covering prescription drugs, generics and biosimilars to lawmakers — enabling Congress to begin crafting legislation authorizing the programs for fiscal years 2023 to 2027. Read More
Could Biogen sidestep the Centers for Medicare and Medicaid Services (CMS) coverage decision that threatens to topple its longed-for Alzheimer’s treatment franchise? Read More
In a 13-to-8 vote yesterday, the Senate Health and Education, Labor and Pensions (HELP) Committee signed off on Robert Califf as the next FDA commissioner, paving the way for a full chamber vote on his nomination. Read More