AstraZeneca

AstraZeneca moved to bolster the company’s COVID-19 portfolio of antibodies on May 17 with a $157 million licensing deal for experimental therapies developed by newly launched biotech RQ Bio.

FDA, stop sign

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 […]

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.