Astellas Shares Update on IZERVAY™ Supplemental New Drug Application
Astellas Pharma Inc. (TSE: 4503) announced that the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) on November 15, 2024, regarding the supplemental New Drug Application…
Dapirolizumab Pegol Phase 3 Data Highlights SLE Disease Activity Reduction
UCB and Biogen have unveiled detailed Phase 3 results for dapirolizumab pegol (DZP), a novel Fc-free anti-CD40L drug candidate, demonstrating significant improvements in managing moderate-to-severe systemic lupus erythematosus (SLE). Findings…
WHO Investment Round: A Defining Moment at G20 Summit with Leaders’ Pledges
The World Health Organization’s (WHO) first-ever Investment Round reached a pivotal milestone at the G20 Leaders’ Summit in Rio de Janeiro. Chaired by Brazilian President H.E. Luiz Inácio Lula da…
CVS Health Announces New Board Appointments
CVS Health® (NYSE: CVS) announced the addition of four new members to its Board of Directors: Leslie Norwalk, Larry Robbins, Guy Sansone, and Doug Shulman. These appointments follow collaborative discussions…
Lilly’s Muvalaplin Reduces Lipoprotein(a) by Up to 85% in High-Risk Adults
Eli Lilly and Company (NYSE: LLY) has revealed encouraging Phase 2 results for muvalaplin, an investigational once-daily oral inhibitor targeting lipoprotein(a) [Lp(a)], a hereditary risk factor for cardiovascular disease. The…
Celltrion Shares Phase III Data on Denosumab and Tocilizumab Biosimilars at ACR 2024
Celltrion presented new findings from Phase III randomized controlled trials (RCTs) for its biosimilar candidates CT-P41 (referencing PROLIA®/XGEVA® for postmenopausal osteoporosis) and CT-P47 (referencing ACTEMRA® for moderate-to-severe rheumatoid arthritis) at…
Astellas Updates on IZERVAY™ (Avacincaptad Pegol) Supplemental NDA
Astellas Pharma Inc. (TSE: 4503) announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) regarding the supplemental New Drug Application (sNDA) for IZERVAY™…
Inebilizumab Earns FDA Breakthrough Designation for IgG4-RD; New Data at ACR 2024
Hansoh Pharmaceutical Group Co., Ltd. (03692.HK) announced that the U.S. FDA has granted Breakthrough Therapy Designation (BTD) to Inebilizumab for the treatment of Immunoglobulin G4-related disease (IgG4-RD). This designation follows…
Bylvay® Data Shows Continued Improvement in Itch and Bile Acid Levels in PFIC and ALGS
Ipsen (Euronext: IPN; ADR: IPSEY) presented new data at the American Association for the Study of Liver Diseases (AASLD) from two Phase III open-label extension studies, evaluating the long-term efficacy…
Hospital Data Reveals New Insights on Maternal and Newborn Health in Nigeria
A team of Nigerian researchers and clinicians, led by Aminu Kano Teaching Hospital, has made significant progress in understanding maternal and newborn health through a groundbreaking data initiative. In collaboration…
Baku COP29 Strengthens Health-Climate Initiatives with Launch of New Coalition
The United Nations Climate Change Conference (COP29) in Baku achieved a pivotal advancement in aligning health and climate agendas. Building on commitments from previous COPs, this year’s conference emphasized tangible…
Halozyme Shares Update on Potential Merger Proposal with Evotec
Halozyme Therapeutics, Inc. (NASDAQ: HALO) has provided an update regarding its non-binding proposal to acquire Evotec SE (NASDAQ: EVO) for €11.00 per share in cash, valuing the transaction at approximately…