AstraZeneca is aiming to expand the use of its dual-antibody COVID-19 treatment Evusheld (tixagevimab–cilgavimab) to nonhospitalized patients with mild-to-moderate COVID 19 based on data from a late-stage study that showed…
With 392 ayes and 28 nays, the U.S. House of Representatives passed a package of legislation late Wednesday to reauthorize the FDA’s prescription drug, generic drug, biosimilar and medical device…
As Congress continues to search for ways to rein in prescription drug costs, a new study published in JAMA this week showed that the price of new medicines has spiked…
Nephron Pharmaceuticals’ recall of approximately 2 million doses of 20 drug products last week followed a March 28 to April 20 inspection of the company’s outsourcing facility in West Columbia,…
The FDA’s Office of Prescription Drug Promotion (OPDP) sent Althera Pharmaceuticals an untitled letter for the company’s misleading promotional pamphlet for its cholesterol-lowering drug Roszet (rosuvastatin and ezetimibe). Source: Drug…
Merck’s COVID-19 pill Lagevrio (molnupiravir) not only reduced the risk of hospitalization or death in patients with mild-to-moderate COVID-19 by 32.1 percent, it also reduced the chance of needing acute…
Roche subsidiary Genentech has filed a federal lawsuit claiming that Tanvex BioPharma’s not-yet-on-the-market biosimilar of Genentech’s blockbuster chemotherapy drug Herceptin infringes three patents. Source: Drug Industry Daily
After getting deluged with more than 24,000 mostly negative comments about pharmacy benefit managers’ (PBM) effect on patients and payers, the U.S. Federal Trade Commission (FTC) has voted unanimously to…
Johnson & Johnson (J&J) is pulling out of its COVID-19 vaccine supply contract with the troubled drug manufacturing plant, Emergent BioSolutions. Source: Drug Industry Daily
Calling the results “a potential new standard-of-care” for pediatric brain tumors, Novartis said its chemotherapy combination of Tafinlar (dabrafenib) and Mekinist (trametinib) reduced the risk of disease progression or death…