One month after posting positive Phase II data, Novartis and Molecular Partners are seeking Emergency Use Authorization from the U.S. Food and Drug Administration for ensovibep, a DARPin antiviral therapeutic candidate developed to treat COVID-19.
Pharmaceutical products developed in China could have a steep hill to climb to be approved for use within the United States, impacting the plans of several large companies who hoped to capitalize on clinical data accumulated in that country.
Rivus Pharmaceuticals, a biopharma company focused on therapies for cardiometabolic health, announced positive data from a Phase IIa clinical trial.
Novavax Inc. delivered just a small fraction of the 2 billion COVID-19 shots the company plans to send around the world in 2022 and has delayed first-quarter shipments in Europe and lower income countries such as the Philippines, public officials involved in their government’s vaccine rollouts told Reuters.
The U.S. Food and Drug Administration is investigating a possible death risk for TG Therapeutics’ Ukoniq (umbralisib), which is indicated for two types of lymphoma.
A new variant of HIV was recently discovered in Europe that is more contagious and more deadly – the virus degrades the immune system into AIDS twice as fast as previous strains.
Specialty vaccine company Valneva, along with Pfizer, reported positive Phase II data from their clinical trial evaluating a Lyme disease vaccine candidate.
Belgium-based UCB hit the mark in the company’s Phase III clinical trial assessing zilucoplan as a potential treatment for adults with generalized myasthenia gravis, a rare autoimmune disease. Vanda Pharmaceuticals’ late-stage study of tradipitant as a treatment for the symptoms of gastroparesis, a digestive disorder, failed to meet the trial’s primary endpoint.
AbbVie reported the company’s fourth-quarter 2021 and full-year financial results on Feb. 2, with worldwide net reviews up 7.4% to $14.89 billion for the quarter. Total revenues for 2021 were $56 billion. The company’s anchor product remains Humira, which will begin to lose exclusivity in 2023.
New York-based Anavex Life Sciences announced positive topline results from the company’s Phase III AVATAR trial of Anavex 2-73 (blarcamesione) in adult female patients with Rett syndrome.
