The U.S. Food and Drug Administration issued a Complete Response Letter to UCB regarding the Belgium-based company’s Biologics License Application for bimekizumab for adults with moderate to severe plaque psoriasis.
AstraZeneca’s Phase III Provent trial results showed a statistically significant 77 percent decrease in a patient’s likelihood of developing symptomatic COVID-19 when proactively treated with Evusheld. Additionally, results were announced by Clover Biopharmaceuticals for the Phase II/III Spectra global study investigating the efficacy of the SCB-2019 (CpG 1018/Alum) vaccine booster in patients that have previously developed a COVID-19 infection.
Approval based on Phase 3 data showing Dupixent significantly reduced severe asthma attacks and also improved lung function and health-related quality of life for children Data reinforce well-established safety profile of Dupixent TARRYTOWN, N.Y. and PARIS, April 7, 2022 /PRNewswire/ — Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the European Commission (EC) has […]
Y-mAbs Therapeutics Inc. announced that the company completed the resubmission of its Biologics License Application (BLA) for 131I-omburtamab to the U.S. FDA.
The U.S. Food and Drug Administration revised the emergency use authorization (EUA) for AstraZeneca’s Evusheld to a higher dose to be effective in the prevention of COVID-19.
Belgium’s UCB is acquiring California-based Zogenix, a company focused on rare diseases, in a deal valued up to €1.7 billion ($1.9 billion).
Newly announced data from Eli Lilly’s Phase III BLAZE-1 clinical trial show a combination of two of the company’s monoclonal antibodies, bamlanivimab (LY-CoV555) and etesevimab (LY-CoV016), significantly reduced the risk of hospitalization and death in high-risk patients with newly diagnosed coronavirus disease 2019.
Two weeks after AstraZeneca announced the company was withdrawing the use of Imfinzi as a treatment for bladder cancer in the United States, Swiss pharma giant Roche followed suit with the checkpoint inhibitor Tecentriq (atezolizumab).
Patients are asking to join clinical trials of antibody-based Covid-19 drugs after U.S. President Donald Trump was treated with an experimental therapy from Regeneron Pharmaceuticals Inc.
Vir Biotechnology and GlaxoSmithKline dosed the first patient in a Phase II/III clinical trial of VIR-7831, a fully human monoclonal antibody against Covid-19.