The U.S. Food and Drug Administration extended the Prescription Drug User Fee Act date for Merck’s supplemental Biologics License Application (sBLA) for Vaxneuvance, a pneumococcal conjugate vaccine intended for preventative use in infants and children.
Roche said ongoing trials of the company’s Alzheimer’s disease drug candidate gantenerumab are designed to provide unequivocal results on efficacy as controversy continues in the United States over the benefits of a rival’s approved drug.
Novo Nordisk on Feb. 2 rejected allegations by a U.S. congressional investigative committee that the company has engaged in maneuvers to increase net prices on life-saving insulin in tandem with its competitors on the U.S. insulin market.
Eli Lilly said on Jan. 28 the company expects the U.S. Food and Drug Administration to decline the approval of expanded use of the rheumatoid arthritis drug Olumiant as a treatment for adults with moderate-to-severe eczema.
GlaxoSmithKline and U.S. partner Vir Biotechnology will boost production of their antibody-based COVID-19 treatment by adding a second manufacturing plant to help meet soaring demand in the United States.
GlaxoSmithKline is lining up a potential new treatment for patients with anemia due to chronic kidney disease following positive results in a Phase III study that showed the investigational candidate daprodustat improved or maintained hemoglobin levels without an increase in cardiovascular risk.
GlaxoSmithKline said the company’s anemia pill for patients with kidney disease was shown to have about the same side effect risk as the current standard treatment in two important patient groups, a key advantage in a tight race with rival drug developers.
Moderna Inc. said on Oct. 25 the company’s Covid-19 vaccine generated a strong immune response in children aged 6 to 11 years and plans to submit the data to global regulators soon.
As Merck & Co. and Pfizer Inc. prepare to report clinical trial results for experimental Covid-19 antiviral pills, rivals are lining up with what they hope will prove to be more potent and convenient oral treatments of their own.
Pfizer Inc. started a large study testing the company’s investigational oral antiviral drug for the prevention of Covid-19 infection among those who have been exposed to the virus.
