Archives: <span>Press Releases</span>

JUPITER-02 Phase III Global Study of Toripalimab at the Interim

Email Print Friendly Share September 28, 2020 22:35 ET | Source: Junshi Biosciences SHANGHAI, China, Sept. 28, 2020 (GLOBE NEWSWIRE) — Junshi Biosciences (HKEX: 1877; SSE: 688180), a leading innovation-driven biopharmaceutical company dedicated to the discovery, development and commercialization of novel therapies, announced today that an Independent Monitoring Committee (IDMC) determined that the randomized, double-blind, placebo-controlled, international multi-center Phase III […]Read More

Health Canada Approves REBLOZYL (luspatercept), New Class of Treatment for

  REBLOZYL® is the first and only erythroid maturation agent approved for use in Canada MONTREAL, Sept. 29, 2020 /CNW/ – Bristol Myers Squibb Canada (BMS) and Acceleron Pharma Inc. announced today that Health Canada has approved REBLOZYL® (luspatercept) for the treatment of adult patients with red blood cell (RBC) transfusion-dependent anemia associated with beta(β)-thalassemia.1 REBLOZYL® is the first and only erythroid maturation […]Read More

REGENERON’S REGN-COV2 ANTIBODY COCKTAIL REDUCED VIRAL LEVELS AND IMPROVED SYMPTOMS

TARRYTOWN, N.Y., Sept. 29, 2020 /PRNewswire/ — Greatest improvements in patients who had not mounted their own effective immune response prior to treatment Plan rapidly to discuss results with regulatory authorities Regeneron to host investor and media webcast to discuss results at 4:30 pm ET today Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced the first data from a descriptive analysis […]Read More

INOVIO Reports FDA Partial Clinical Hold for Planned Phase 2

PLYMOUTH MEETING, Pa., Sept. 28, 2020 /PRNewswire/ — INOVIO (NASDAQ:INO), a biotechnology company focused on bringing to market precisely designed DNA medicines to treat and protect people from infectious diseases and cancer, announced that the U.S. Food and Drug Administration (FDA) has notified the company it has additional questions about the company’s planned Phase 2/3 trial of […]Read More

Boston Scientific Launches ACURATE neo2 Aortic Valve System in Europe

Next-generation Valve Designed to Reduce Paravalvular Leaking, Improve Procedural Efficiency and Treat More Patients with Expanded Indication over Prior Version MARLBOROUGH, Mass., Sept. 28, 2020 /PRNewswire/ — Boston Scientific Corporation (NYSE: BSX) today announced it has initiated a controlled launch of the ACURATE neo2™ Aortic Valve System in Europe. This next-generation transcatheter aortic valve implantation (TAVI) technology is a new platform […]Read More

U.S. Food and Drug Administration Approves HAEGARDA (C1 Esterase Inhibitor

  KING OF PRUSSIA, Pa., Sept. 28, 2020 /PRNewswire/ — CSL Behring, a global biotherapeutics leader, announced today that the U.S. Food and Drug Administration (FDA) has approved an expanded indication for HAEGARDA® (C1 Esterase Inhibitor Subcutaneous [Human]) for routine prophylaxis to prevent hereditary angioedema (HAE) attacks in patients 6 years of age and older. A rare, genetic and potentially […]Read More

U.S. FDA APPROVES PFIZER’S XELJANZ (TOFACITINIB) FOR THE TREATMENT OF

September 28, 2020 NEW YORK–(BUSINESS WIRE)– Pfizer Inc. (NYSE: PFE) announced today that the United States (U.S.) Food and Drug Administration (FDA) approved XELJANZ® (tofacitinib) for the treatment of children and adolescents 2 years and older with active polyarticular course juvenile idiopathic arthritis (pcJIA). Two formulations were approved, a tablet and an oral solution, and are […]Read More

AbbVie Receives Orphan Drug and Fast Track Designations from the

– Elezanumab (ABT-555) is an investigational treatment being evaluated in neurological disorders, including treatment following spinal cord injury– Orphan Drug Designation is given to a drug or biologic for the treatment, diagnosis or prevention of a rare disease or condition¹– Fast Track Designation facilitates the development and expedites the review of drugs to treat serious […]Read More

Sarepta Therapeutics Reports Sustained Functional Improvement Two Years After Treatment

09/28/20 8:55 AM EDT –Results demonstrate continued safety and tolerability of SRP-9001 in four participants with Duchenne — –All four participants demonstrated improvements in NSAA scores compared to baseline and showed a durable response two years after administration of SRP-9001 — CAMBRIDGE, Mass., Sept. 28, 2020 (GLOBE NEWSWIRE) — Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today announced two-year follow up results from four Duchenne […]Read More

Sosei Heptares announces that a second novel drug candidate from

– Dosing of first subject in clinical trial by Pfizer triggers $5 million payment to Sosei Heptares – Clinical development candidate is an oral, small molecule modulator of an undisclosed G protein-coupled receptor (GPCR) target – Eighth GPCR-targeted drug candidate to enter clinical development originating from Sosei Heptares’ StaR® technology/SBDD platform NEWS PROVIDED BY Sosei […]Read More