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Biogen Gains FDA Breakthrough Status for Felzartamab in Kidney Transplant Rejection Treatment
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Biogen Inc. (NASDAQ: BIIB) has secured breakthrough therapy designation (BTD) from the U.S. Food and Drug Administration (FDA) for felzartamab, an investigational anti-CD38 monoclonal antibody aimed at treating late antibody-mediated rejection (AMR) without T-cell mediated rejection in kidney transplant patients. This designation is pivotal as AMR is a leading cause…
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Johnson & Johnson’s Xarelto Demonstrates Reduced Bleeding Risk in Atrial Fibrillation Patients Post-PCI
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Healthcare conglomerate Johnson & Johnson (J&J; NYSE: JNJ) has announced positive results from a Phase III trial, highlighting the efficacy of its anticoagulant Xarelto (rivaroxaban) in reducing the risk of clinically significant bleeding (CSB) and net adverse clinical events (NACE) or rehospitalization in adult patients with nonvalvular atrial fibrillation (AF)…
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Hengrui Medicine Advances Clinical Trial for PD-L1 Inhibitor Combo in CLDN18.2 Positive Tumors
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Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276), a leading pharmaceutical company, has received approval from China’s National Medical Products Administration (NMPA) to initiate a Phase Ib/III clinical study. The study will evaluate the combination of Hengrui’s PD-L1 monoclonal antibody, adebrelimab (SHR-1316), with the antibody-drug conjugate (ADC) SHR-A1904 in patients with…
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Celltrion’s Infliximab Biosimilar Shows Promising Long-Term Efficacy and Safety in CD and UC
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South Korean biopharmaceutical company Celltrion (KRX: 068270) has presented positive long-term efficacy and safety data for its infliximab biosimilar in the treatment of Crohn’s disease (CD) and ulcerative colitis (UC). The biosimilar offers the advantage of subcutaneous administration, providing a more convenient alternative to Johnson & Johnson’s (J&J; NYSE: JNJ)…
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Blue Sail Medical Secures RMB 900 Million Investment for R&D and Capacity Expansion
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Blue Sail Medical Co., Ltd (SHE: 002382) has announced that its wholly owned subsidiary, Blue Sail Biosensors Medical Technology, has secured strategic investments totaling RMB 900 million from Capital Health Industry (Beijing) Fund and two other investors. The funds will be allocated to enhance product research and development as well…
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Huadong Medicine Ends Collaboration on vTv’s TTP273 for Diabetes Treatment
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US-based vTv Therapeutics LLC has received a cancellation notice from China’s Huadong Medicine Co., Ltd., (SHE: 000963) regarding their joint development of the type 2 diabetes drug TTP273. Huadong, confirming the cancellation, stated that TTP273 was found to be inferior to its own drug candidate, HDM1002. TTP273, a first-in-class, non-peptide,…
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Fosun Pharmaceutical Gets FDA Green Light for HLX42 ADC Clinical Study
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Fosun Pharmaceutical (Group) Co., Ltd (HKG: 2196; SHA: 600196) has received approval from the US Food and Drug Administration (FDA) to initiate a Phase I clinical study for HLX42, an antibody drug conjugate (ADC) co-developed with Shanghai Henlius Biotech Inc. (HKG: 2696) and Suzhou-based Medilink Therapeutics. The study targets advanced/metastatic…
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Merck Reports 9% Global Sales Growth in Q3 2023, Boosted by Keytruda and Gardasil
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US-based pharmaceutical giant Merck, Sharp & Dohme (MSD, NYSE: MRK) has reported a robust 9% year-on-year (YOY) increase in global sales for Q3 2023, reaching USD 15.9 billion. This strong performance has led the firm to raise its full-year sales forecast to a range of USD 59.7 billion to USD…
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Medytox Shifts Strategy for China Market Entry with Next-Generation Botulinum Toxin
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Korea-based biopharmaceutical company Medytox has reportedly revamped its strategy for entering the Chinese market, according to Koreabiomed.com. After withdrawing a drug registration filing for its Meditoxin/Neuronox (Botulinum toxin type A; BTX) with the National Medical Products Administration (NMPA) in 2018, Medytox is now setting its sights on introducing Newlux, a…
