Regeneron Pharmaceuticals shared positive results from the company’s Phase III trial of a candidate drug for children with homozygous familial hypercholesterolemia (HoFH), a rare, life-threatening condition characterized by elevated circulating levels of low-density lipoprotein cholesterol (LDL-C) and accelerated, premature atherosclerotic cardiovascular disease (ACVD.
UCB psoriasis drug will need to wait for US approvalAutoimmune 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, UCB
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.
Regeneron Overcomes Loss of COVID Antibody to Post Positive First QuarterAcquisitions, Biologics License Application (BLA), Blockbusters, Business, COVID-19 Antibodies, FDA, Monoclonal Antibodies, Quarterly results, REGEN-COV (casirivimab and imdevimab), Regeneron Pharmaceuticals, Sales, Sanofi, Therapeutics
Despite the loss of the company’s COVID-19 antibody REGEN-COV earlier in 2022, Regeneron posted a positive first quarter driven primarily by sales of Dupixent and Eylea.
The U.S. health regulator said on April 5 GlaxoSmithKline and Vir Biotechnology’s antibody therapy was no longer authorized as a COVID-19 treatment, with data suggesting it was unlikely to be effective against the dominant Omicron sub-variant in the country.
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.
FDA says current dose of GSK-Vir COVID therapy unlikely to work against BA.2 variantBebtelovimab (LY-CoV1404; LY3853113), CDC, Columbia University, COVID-19 Antibodies, COVID-19 treatment pill, FDA, GlaxoSmithKline, Molnupiravir, Omicron (B.1.1.529) (South Africa), Omicron BA.2, Paxlovid, Remdesivir, Sotrovimab, Vir Biotechnology
The U.S. health regulator said on March 25 the current authorized dose of GlaxoSmithKline and Vir Biotechnology’s COVID-19 antibody therapy is unlikely to be effective against the Omicron BA.2 variant.
The U.S. government will run out of supplies of COVID-19 treatments known as monoclonal antibodies as soon as late May and will have to scale back plans to get more unless Congress provides more funding, the White House said on March 15.
SAB Biotherapeutics Announces Update to the Phase 3 NIH ACTIV-2 Trial Design Evaluating SAB-185 for Treatment of COVID-19Biopharmaceutical, Clinical Trials, COVID-19 Infections, Covid-19 Variants, Hospitalized COVID-19 Patients, Immunotherapy, Monoclonal Antibodies, Omicron (B.1.1.529) (South Africa), Placebo, R&D
Clinical-stage biopharmaceutical company SAB Biotherapeutics announced an update to the design of the ongoing Phase 3 ACTIV-2 trial evaluating the clinical efficacy and safety of SAB-185 for the treatment of participants with mild-moderate COVID infections at higher risk for progression to hospitalization.
COVID-19 Update: Omicron BA.2 Raises Questions, FDA Limits GSK AntibodyBNT162b2 (Pfizer and BioNTech), CDC, Clinical Trials, Coronavirus Cases, Covid-19 Data, COVID-19 Studies, COVID-19 Vaccinations, FDA, GlaxoSmithKline, Monoclonal Antibodies, mRNA-1273/Moderna COVID-19 Vaccine (Moderna), Multisystem Inflammatory Syndrome in children (MIS-C), Omicron (B.1.1.529) (South Africa), Omicron BA.2, R&D, Sotrovimab, Teenagers, Vir Biotechnology
The BA.2 subvariant of Omicron, which appears to be even more transmissible than Omicron, is accounting for more than a third of global COVID-19 cases. In other news, the U.S. Food and Drug Administration placed limits on the use of GlaxoSmithKline and Vir Biotechnology’s COVID-19 antibody therapeutic, sotrovimab.
The U.S. Food and Drug Administration said on February 23 GlaxoSmithKline and Vir Biotech’s COVID-19 antibody treatment should not be used in places with circulation of variants that are not susceptible to the drug.