Astellas Launches Phase 3 Trials of Fezolinetant for Menopausal Symptom Relief in Japan
Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) has initiated dosing for the first patient in the STARLIGHT™ 2 Phase 3 pivotal study for fezolinetant, an investigational…
Xolair Reduces Allergic Reactions to Multiple Foods: NEJM Study
Roche (SIX: RO, ROG; OTCQX: RHHBY) has revealed the findings from Stage 1 of the National Institutes of Health (NIH)-sponsored pivotal Phase III OUtMATCH study, assessing the effectiveness and safety…
AbbVie and OSE Immunotherapeutics Collaborate to Advance Novel Monoclonal Antibody for Chronic Inflammation Treatment
AbbVie Inc. (NYSE: ABBV) and OSE Immunotherapeutics SA (ISIN: FR0012127173; Mnemo: OSE), a clinical-stage immunotherapy company, have announced a strategic partnership aimed at developing OSE-230, a monoclonal antibody designed to…
FDA Prioritizes Review of EPKINLY® for Tough Follicular Lymphoma Cases
AbbVie (NYSE: ABBV) announces today that the U.S. Food and Drug Administration (FDA) has granted Priority Review for the supplemental Biologics License Application (sBLA) concerning epcoritamab-bysp, a subcutaneously administered T-cell…
CHMP Grants Positive Opinion to Vertex for KALYDECO® in Treating Cystic Fibrosis in Infants Aged 1 Month and Above
Vertex Pharmaceuticals (Nasdaq: VRTX) announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a favorable opinion regarding the expansion…
Bristol Myers Squibb’s Reblozyl® (luspatercept) Receives Positive CHMP Opinion for Anemia Treatment in Low- to Intermediate-Risk MDS Adults
Bristol Myers Squibb (NYSE: BMY) has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval of Reblozyl® (luspatercept) for…
Celltrion Reveals New Two-Year Results of Subcutaneous Infliximab (CT-P13 SC) for Treating Inflammatory Bowel Disease (IBD) at 19th ECCO Congress
Celltrion presented encouraging findings from the extensive LIBERTY studies, including LIBERTY-CD 1 and LIBERTY-UC 2, focusing on patients with Alzheimer’s disease, Crohn’s disease (CD), or moderately to severely active ulcerative…
Ironwood Pharmaceuticals to Showcase Four Abstracts at ASPEN’s 2024 Nutrition Science & Practice Conference
Ironwood Pharmaceuticals, Inc. (Nasdaq: IRWD), a company specializing in gastrointestinal healthcare, has revealed plans to present findings from four studies examining apraglutide in adults diagnosed with short bowel syndrome with…
Bristol Myers Squibb Reports Conclusion of RayzeBio Tender Offer Period
Bristol Myers Squibb (NYSE: BMY) has confirmed the conclusion of its tender offer, initially announced, to acquire all outstanding shares of RayzeBio, Inc. (Nasdaq: RYZB) common stock at a price…
FDA Prioritizes Review of Dupixent® sable for COPD Treatment Targeting Type 2 Inflammation
The U.S. Food and Drug Administration (FDA) has given priority review status to the supplemental Biologics License Application (sBLA) for Dupixent® (dupilumab), marking its sixth potential indication. This review targets…
Sanofi’s Board of Directors Recommends Clotilde Delbos, Anne-Françoise Nesmes, and John Sundy as Independent Directors
Sanofi’s Board of Directors has announced its intentions for the upcoming General Shareholder Meeting on April 30, 2024. The board proposes the renewal of Rachel Duan and Lise Kingo’s terms,…
Acquisition of Gracell completed
AstraZeneca Completes Acquisition of Gracell Biotechnologies Inc., Expanding Cell Therapy Portfolio AstraZeneca has successfully finalized the acquisition of Gracell Biotechnologies Inc. (Gracell, NASDAQ: GRCL), a prominent global biopharmaceutical company specializing…