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.
UCB psoriasis drug will need to wait for US approval
Autoimmune Diseases, Biologics License Application (BLA), Complete Response Letter, FDA, Generalized Myasthenia Gravis (gMG), Humanized IgG1 monoclonal antibody, Immune-Mediated Diseases, Immunotherapeutics, Immunotherapies, Inflammatory Diseases, Lesions, Monoclonal Antibodies, Plaque Psoriasis, Plaque Psoriasis, Plaque Psoriasis, Psoriasis, Psoriasis, Psoriasis, Psoriasis, Psoriasis, Psoriasis Lesions, Scalp plaque psoriasis, Scalp Psoriasis, Skin Diseases, Therapeutics, UCBThe 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.
Dupixent® (dupilumab) Approved by European Commission for Children Aged 6 to 11 Years with Severe Asthma with Type 2 Inflammation
Approvals, Asthma, EMA, European Commission, Expanded Approval, Marketing Authorization Application (MAA), Monoclonal Antibodies, Pediatric Asthma, Regeneron Pharmaceuticals, Sanofi, Severe Asthma, Severe Pediatric Asthma, TherapeuticsApproval 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.