In a move that may bode ill for the entire class of phosphatidylinositol 3-kinase (PI3K) inhibitors, the FDA has issued a warning against Secura Bio’s Copiktra (duvelisib), citing a 9…
Pfizer is jockeying for full FDA approval of its oral antiviral COVID-19 treatment, Paxlovid, which would allow the company to sell the drug commercially. Source: Drug Industry Daily
Netherlands-based Fagron drew a warning letter from the FDA for its facility in St. Paul, Minn., for inadequate equipment cleaning that could lead to cross-contamination of its drug products. Source:…
Novartis said it has resumed operations at its Millburn, N.J., and Ivrea, Italy, plants after recently halting production over quality lapses related to the manufacture of radioligand therapy medicines. Source:…
Phase 3 studies of Sanofi’s tolebrutinib in both multiple sclerosis (MS) and myasthenia gravis have been placed on partial clinical hold following reports of drug-induced liver injury in trial participants.…
In a letter to HHS Secretary Xavier Becerra, 100 members of Congress called for the use of several controversial federal authorities — including compulsory licensing, “march-in rights” and royalty-free rights…
Sanofi will begin offering 30-day supplies of its insulin products to uninsured patients in the U.S. for $35 on July 1, the company announced Wednesday. Source: Drug Industry Daily
The FDA outlined its latest thinking for sponsors of adjuvant therapies for renal cell and bladder cancer in two guidances released yesterday. Source: Drug Industry Daily
In its latest guidance on patient-focused drug development, released yesterday, the FDA calls for high-quality clinical outcome assessments (COAs) for drug trials. Source: Drug Industry Daily
The FDA’s Vaccines and Related Biological Products Advisory Committee voted 19 to 2 yesterday in favor of including a SARS-CoV-2 Omicron component in COVID-19 booster shots. Source: Drug Industry Daily