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The FDA has revised the Emergency Use Authorization (EUA) for Pfizer’s Paxlovid (nirmatrelvir and ritonavir) to allow state-licensed pharmacists to prescribe the oral antiviral drug to COVID-19 patients. Read More
CureVac has filed a patent infringement lawsuit against BioNTech, claiming its messenger RNA (mRNA) technology was used without credit or compensation to create BioNTech’s and Pfizer’s Comirnaty, the world’s first approved COVID-19 vaccine and now the most widely used one. Read More
A Chicago jury has ruled that Endo Pharmaceuticals didn’t violate antitrust laws by paying Impax $112 million to delay the release of a generic that would compete against Opana ER, Endo’s extended-release version of the opioid painkiller oxymorphone. Read More
To help clear up confusion about the Drug Supply Chain Security Act (DSCSA) enhanced drug distribution security requirements that will go into effect on Nov. 27, 2023, the FDA has issued two draft guidances that detail matters related to trading partners and electronic reporting. Read More
Three big drug U.S. distributors accused of fueling the opioid crisis in West Virginia’s Cabell County and the city of Huntington were let off on Monday as a U.S. District judge ruled that they were not to blame. Read More
FDA approval alone does not ensure “the optimal administration” of novel treatments like immunotherapy for traditionally underserved populations, according to the authors of a study published in JAMA Network Open. 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