Pharmaceuticals, Biotechnology and Life Sciences
OSAKA, Japan–(BUSINESS WIRE)–Shionogi & Co., Ltd. (hereafter “Shionogi”) today announced new results from two late-breaking presentations of S-217622 at the…
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.
Takeda today announced that it has received manufacturing and marketing approval from the Japan Ministry of Health, Labour and Welfare (MHLW) for Nuvaxovid® Intramuscular Injection (Nuvaxovid), a novel recombinant protein-based COVID-19 vaccine, for primary and booster immunization in individuals aged 18 and older.
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 launch marks MediCane’s entry into the pharmaceutical sector of a major European market. For Dr. Reddy’s, the launch reinforces its presence in Germany’s growing medical cannabis market
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.
Ignis Therapeutics and STADA’s Britannia Pharmaceuticals Ltd. affiliate have jointly announced that two companies have signed an exclusive licensing agreement under which Ignis Therapeutics will develop and commercialize subcutaneous apomorphine for Parkinson’s disease in mainland China, Hong Kong and Macau.