Launch Price of New Drugs Rising by 20 Percent Annually, Says Study
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…
FDA Form 483 Cites Nephron Pharmaceuticals for Unsanitary Practices, Lack of Recordkeeping
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,…
OPDP Raps Althera’s Promotional Pamphlet for Cholesterol Drug
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 Cuts Risk of Death and Hastens Recovery
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…
Genentech Files Suit Against Tanvex BioPharma for Alleged Infringement of Herceptin Patents
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
Amid Controversy, FTC Votes to Investigate Large PBMs
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…
J&J to Drop Emergent After Mutual Claims of Contract Breach
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
Novartis’ Chemo Combo Pulls Impressive Numbers in Tough-to-Treat Pediatric Brain Tumors
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…
Former Eli Lilly Employee Files Lawsuit Alleging Manufacturing Problems at N.J. Facility
A former Eli Lilly employee is suing the drugmaker over allegations she was fired after identifying numerous production issues at Lilly’s Branchburg, N.J., plant, including in the manufacture of the…
FDA Advisory Committee Recommends Novavax’s COVID-19 Vaccine
The FDA’s Vaccines and Related Biological Products Advisory Committee voted almost unanimously yesterday for Emergency Use Authorization (EUA) of a two-dose primary series of the Novavax COVID-19 vaccine. Source: Drug…
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