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Otsuka Files FDA Application for Sibeprenlimab in IgAN Treatment
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Japan-based Otsuka Pharmaceutical Co., Ltd. announced the filing of a Biologics License Application (BLA) with the U.S. Food and Drug Administration (FDA) for sibeprenlimab, an investigational monoclonal antibody for adults with immunoglobulin A nephropathy (IgAN). This marks a significant step toward making the therapy available in the US. Drug MechanismSibeprenlimab…
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Otsuka and Lundbeck Win EU Approval for Rxulti in Adolescent Schizophrenia
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Japan-based Otsuka Pharmaceutical Co., Ltd and its Danish partner Lundbeck A/S (OTCMKTS: HLUBF) jointly announced receiving marketing approval from the European Commission (EC) for Rxulti (brexpiprazole). The atypical oral antipsychotic can now be used to treat schizophrenia in adolescents aged 13 years and older in the European Union (EU). Background…
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Otsuka Holdings Weighs Sale of Stake in Medical Device Maker MicroPort Scientific
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Otsuka Holdings Co., a Japanese pharmaceutical and healthcare company, is reportedly considering the sale of its shares in Shanghai-based medical device giant MicroPort Scientific Corp. (HKG: 0853), according to a Bloomberg report. The company is said to be working with financial advisors to assess its minority stake in MicroPort after…
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Otsuka Pharmaceutical to Acquire US Biotech Jnana Therapeutics in $1.1 Billion Deal
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Otsuka Pharmaceutical Co., Ltd, a leading Japanese pharmaceutical company, has announced the signing of a definitive merger agreement to acquire US-based biotechnology firm Jnana Therapeutics Inc. Upon completion of the deal, Jnana will become a wholly owned subsidiary of Otsuka, with the transaction valued at $800 million in upfront payment…
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Pharmaceutical Giants Face UK Industry Code Breach Allegations, Including Novartis and Pfizer
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Several multinational pharmaceutical corporations have been reprimanded for violating the UK’s Prescription Medicines Code, a set of voluntary industry standards established by the Association of the British Pharmaceutical Industry (ABPI) and overseen by the Prescription Medicines Code of Practice Authority (PMCPA). The PMCPA has called out Novartis (NYSE: NVS), Pfizer…
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Otsuka and Shape Therapeutics Partner on Ophthalmology Gene Therapies Development
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Japan drug maker Otsuka (OTCMKTS: OTSKY) and US firm Shape Therapeutics have announced a strategic partnership aimed at developing a range of ophthalmology gene therapies. The collaboration will leverage Shape’s machine learning-backed capsid discovery platform to create viral vectors with high target precision, enabling lower doses, and its transgene engineering…
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Sumitomo Pharma and Otsuka’s Ulotaront Fails to Meet Primary Endpoint in Schizophrenia Trials
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Japan-based Sumitomo Pharma Co., Ltd (TYO: 4506) and Otsuka Pharmaceutical Co., Ltd (FRA: OS1) have revealed a setback in late-stage clinical trials for the potential first-in-class trace amine-associated receptor 1 (TAAR1) agonist, ulotaront, as a treatment for schizophrenia. Topline data from the Phase III DIAMOND 1 and DIAMOND 2 studies…
