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…
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. Source: Drug Industry Daily
GlaxoSmithKline (GSK) and Vir Biotechnology have developed an intramuscular version of their investigational monoclonal antibody infusion, sotrovimab, for the early treatment of COVID-19 and are asking the FDA to expand…
As the Omicron variant rages, Peter Marks, the FDA’s top vaccine regulator, said that getting a booster dose earlier than six months after initial doses may be the best way…
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…
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…
Could Biogen sidestep the Centers for Medicare and Medicaid Services (CMS) coverage decision that threatens to topple its longed-for Alzheimer’s treatment franchise? Source: Drug Industry Daily
AstraZeneca has signed a collaboration deal with Scorpion Therapeutics to discover, develop and commercialize precision medicines against previously hard-to-target cancer proteins, the so-called “undruggable” targets. Source: Drug Industry Daily
Sanofi has agreed to buy exclusive global rights to develop Korean company ABL Bio’s preclinical antibody for the treatment of neurodegenerative conditions, including Parkinson’s disease. Purchase price: $75 million upfront,…
The FDA has issued a warning about the potential for serious dental problems associated with buprenorphine medicines dissolved in the mouth to treat opioid use disorder (OUD) and pain. Source:…