We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Brand-name drugmakers will have to pay the UK government nearly $4.1 billion this year, a sharp increase from approximately $2.2 billion in 2022. Read More
Marcus Research Laboratory of St. Louis, Mo., was slapped with a nine-observation Form 483 for deficiencies ranging from walls and floors so covered in the facility’s active pharmaceutical ingredient (API) that one investigator’s feet got stuck to the floor, to batch production records missing several key steps. Read More
After a potential carcinogen, Nitroso-STG-19 (NTTP), was found in samples of Merck’s sitagliptin-containing diabetes drugs, the New Jersey drugmaker says it has identified the root cause of the nitrosamine impurity and hopes to fix the issue this year. Read More
Moderna is claiming a phase 3 win based on interim trial data for its investigational mRNA-1345 vaccine targeting respiratory syncytial virus (RSV). Read More
In the ongoing battle of pro-life groups vs. the government on access to the so-called abortion pill, the FDA is pressing a Texas judge to reject a request by anti-abortion groups for a court order withdrawing federal approval for the drug. Read More
AbbVie and Eli Lilly have pulled out of a voluntary UK drug pricing agreement for the National Health Service (NHS) — a move that could leave NHS patients with curtailed access to their therapies. Read More
Last year’s decision by HHS to limit payment for Biogen’s controversial Alzheimer’s drug Aduhelm to patients in a clinical trial could have a long-term negative effect on the entire accelerated approval (AA) pathway, said former FDA Commissioner Scott Gottlieb. Read More