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.
The U.S. Food and Drug Administration approved Sanofi’s Dupixent (dupilumab) 300 mg weekly to treat patients with eosinophilic esophagitis (EoE) aged 12 years and older, weighing at least 40 kg. With this approval, Dupixent is the first and only medicine specifically indicated to treat EoE in the United States.
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.
Regeneron is acquiring Checkmate Pharmaceuticals and entered a clinical trial collaboration with SpringWorks Therapeutics to evaluate REGN5458 in multiple myeloma in combination with nirogacestat.
The U.S. Food and Drug Administration extended by three months the regulator agency’s review of Regeneron Pharmaceuticals Inc.’s application for full approval of the COVID-19 antibody therapy combination of casirivimab and imdevimab, the U.S. drugmaker said on April 14.
U.S. FDA extends review of Biologics License Application for REGEN-COV (casirivimab and imdevimab) for treatment and prophylaxis of COVID-19Biologics License Application (BLA), Coronavirus Disease (COVID-19) Pandemic, COVID-19 Therapeutic, COVID-19 Therapeutics, COVID-19 Therapies, FDA, Pandemics, Regeneron Pharmaceuticals, Therapeutics
The U.S. Food and Drug Administration extended by three months the regulatory agency’s review of the Biologics License Application (BLA) for Regeneron Pharmaceuticals Inc.’s REGEN-COV (casirivimab and imdevimab) to treat COVID-19 in non-hospitalized patients and as prophylaxis in certain individuals.
Dupixent® (dupilumab) Approved by European Commission for Children Aged 6 to 11 Years with Severe Asthma with Type 2 InflammationApprovals, Asthma, EMA, European Commission, Expanded Approval, Marketing Authorization Application (MAA), Monoclonal Antibodies, Pediatric Asthma, Regeneron Pharmaceuticals, Sanofi, Severe Asthma, Severe Pediatric Asthma, Therapeutics
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 […]
Lexicon, BridgeBio, Esperion, Pfizer, More Celebrate Wins at 71st ACC MeetingAstraZeneca, BioSpace, Cholesterol, Clinical Data, Clinical Trial Endpoints, Elevated Low-Density Lipoprotein Cholesterol (LDL-C), Heart Attacks, Heart Failure with Reduced Ejection Fraction (HFrEF), Pfizer, Primary Endpoints, R&D, Regeneron Pharmaceuticals, Sanofi, Small-Interfering RNA (siRNA) Class, Strokes, TTR Amyloidosis (ATTR)
The 71st annual American College of Cardiology’s Scientific Session saw several wins – and some “mehs” led by some of biopharma’s largest companies, according to BioSpace.
FDA Accepts Dupixent® (dupilumab) for Priority Review in Patients Aged 12 Years and Older with Eosinophilic EsophagitisBlockbusters, Eosinophilic Cells, Eosinophilic Esophagitis, Inflammatory Diseases, Regeneron Pharmaceuticals, Research & Development, Sanofi, Spplemental Biologics License Application (sBLA), Therapeutics
The U.S. Food and Drug Administration accepted for Priority Review the supplemental Biologics License Application for Dupixent (dupilumab) 300 mg weekly to treat adult and pediatric patients aged 12 years and older with eosinophilic esophagitis (EoE), a chronic and progressive type 2 inflammatory disease that damages the esophagus and impairs the ability to swallow.
BioNTech announced an expansion of a collaboration with Regeneron Pharmaceuticals to continue advancing mRNA technology and develop the FixVac candidate BNT116 in combination with Regeneron and Sanofi’s shared pharmaceutical product Libtayo (cemiplimab) for non-small cell lung cancer.