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The FDA issued I3 Pharmaceuticals a Form 483 for multiple quality deficiencies observed during an inspection of its Warminster, Pa., facility from Feb. 7 to Feb. 22. Read More
The pharmaceutical industry spends more on lobbying than any other industry, having shelled out $314 million across about 1,600 lobbyists in 2021, spending almost three times the amount of the next biggest spender in the health sector, hospitals, which spent $116 million on federal lobbying in 2021. Read More
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 percent increased risk of death compared to standard treatment in patients with leukemia and lymphoma. Read More
The FDA’s Office of New Drugs (OND) provides a look into its work with stakeholders to support innovative trial designs in 2021, in its latest yearly report. Read More
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. Read More
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. Read More
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. Read More
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. Read More