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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 from a median price of $2,115 per year in 2008 to $180,007 per year in 2021. Read More
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 it reduced the risk of progression to severe disease or death by 50 percent in a group of unvaccinated patients at high risk of poor outcomes. Read More
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 user fee programs. Read More
In a new procedural document released on Wednesday, the FDA directs its Office of Generic Drugs (OGD) to request additional data from sponsors of generic combination products if the generic product’s user interface is substantially different from the original product. Read More
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, S.C., that unveiled numerous quality lapses. Read More
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). Read More
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 care visits for weeks after treatment ended, researchers reported in the Annals of Internal Medicine. Read More
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. Read More