Pharmaceuticals, Biotechnology and Life Sciences
South Korean pharmaceutical manufacturers are rapidly expanding capacity to support manufacturing of long‑acting obesity shots, signalling deeper integration with global…
Italian Newron Pharmaceuticals S.p.A., a biopharmaceutical company focused on the development of novel therapies for patients with diseases of the central and peripheral nervous system, and Japanese EA Pharma, a subsidiary of Eisai Co., Ltd., have entered into a license agreement to develop, manufacture and commercialize Newron’s innovative modulator of the excessive release of glutamate, evenamide, in Japan and other designated Asian territories.
BEIJING, Dec. 12, 2024 (GLOBE NEWSWIRE) — LakeShore Biopharma Co., Ltd. (Nasdaq: LSB) (“LakeShore Biopharma” or the “Company”), a leading…
US$10 million milestone payment to HUTCHMED follows first national reimbursement in Europe — — Follows June 2024 European approval of FRUZAQLA® (fruquintinib), the first novel oral targeted therapy in the EU for metastatic colorectal cancer regardless of biomarker status in over a decade
Idorsia Ltd (SIX: IDIA) and Idorsia Pharmaceuticals Japan have announced that PIVLAZ (clazosentan) is now available to physicians in Japan to start treating aSAH patients. PIVLAZ is a potent, selective endothelin A (ETA) receptor antagonist which targets the root cause of cerebral vasospasm.
The Center of Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) approved Bayer’s larotrectinib, under the brand name Vitrakvi, for the treatment of adult and pediatric patients with advanced solid tumors that harbor a Neurotrophic Tyrosine Receptor Kinase (NTRK) gene fusion. NTRK gene fusions should be identified by a sufficiently validated test.
Shanghai Junshi Biosciences Co., Ltd (“Junshi Biosciences”, HKEX: 1877; SSE: 688180) and Coherus BioSciences, Inc. (“Coherus”) have announced the results of the prespecified final progression-free survival (“PFS”) analysis and the interim overall survival (“OS”) analysis of the JUPITER-02 study (NCT03581786), a pivotal Phase 3 trial in first-line treatment of recurrent or metastatic nasopharyngeal carcinoma (“NPC”).
Shanghai Junshi Biosciences Co., Ltd (“Junshi Biosciences,” HKEX: 1877; SSE: 688180), a innovation-driven biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies, has announced that the U.S. Food and Drug Administration (FDA) has approved its Investigational New Drug (IND) application for its anti-CD112R monoclonal antibody (TAB009/JS009) for the treatment of advanced solid tumors.
The Japanese Ministry of Health, Labor, and Welfare (MHLW) has granted marketing authorization for Xenpozyme (olipudase alfa) for the treatment of adult and pediatric patients with non-central nervous system (non-CNS) manifestations of acid sphingomyelinase deficiency (ASMD), a rare, progressive, and potentially life-threatening genetic disease.
Sobi has announced that the National Medical Products Administration of China (NMPA) has approved Gamifant (emapalumab) for use in China. The indication is for treatment of adult and paediatric (newborn and older) patients with primary haemophagocytic lymphohistiocytosis (HLH) with refractory, recurrent or progressive disease or intolerance to conventional HLH therapy.