Tags : Japan

Chugai Reports NDA Submission of Risdiplam to the MHLW as

Shots: The NDA submission is based on FIREFISH study assessing Risdiplam in infants with symptomatic SMA Type 1 & SUNFISH study in children and young adults with SMA Type 2 or 3 FIRESISH study results: improvement in survival and motor milestones in infants. SUNFISH study results: improvement in motor function in people aged 2-25 with […]Read More

Chugai and Takeda Collaborate to Evaluate the Combination Therapy for

Shots: Following a joint clinical research agreement between Roche and Exelixis and in conjunction with certain rights granted in Japan, Chugai and Takeda will study Tecentriq (atezolizumab) and Cabometyx (cabozantinib) as a combination therapy in Japan The three global P- III CONTACT studies are ongoing to investigate the combination of atezolizumab and cabozantinib as a […]Read More

World’s First App-Based Nicotine Addiction Treatment Receives the MHLW’s Approval

Shots: On Aug 21, 2020, CureApp receives MHLW’s approval for the manufacturing and sale of Asia’s first therapeutics app, the “CureApp SC Nicotine Addiction Treatment App and CO Checker’’. The company plans to receive insurance reimbursement and release CureApp SC in FY2020 CureApp SC is a prescription medical device designed to aid patients receiving outpatient […]Read More

Takeda to Divest its Consumer Health Unit to Blackstone for

Shots: Takeda and Blackstone sign an agreement to divest it consumer health care business unit for $2.3B. The transaction expected to be closed by Mar 31, 2021 The portfolio to be divested includes OTC medicines and health products along with its lead product in the region, Alinamin. Blackstone plans to develop the business together with […]Read More

Solasia Signs a License Agreement with Isofol to Develop and

Shots: Isofol to receive $100M as up front, development, regulatory and commercial milestones, and clinical development cost and is eligible to receive royalties on sales of the therapy and retain its right to the therapy in ROW Solasia will lead clinical development activities in Japan and will be responsible for registrational filing and approval in […]Read More

Otsuka Signs a Development and Commercialization Agreement with Esperion for

Shots: Esperion to receive $60M up front, $450M as development & commercial milestone and is eligible to receive 15-30% royalties in the sale of products in Japan. Otsuka will get exclusive rights to Nexletol and Nexlizet and will fund Japan-specific development costs associated with the products The collaboration leverages Esperion’s expertise in lipid management and […]Read More

Dr. Reddy’s and GRA Collaborate with Fujifilm for Avigan (favipiravir)

Shots: Fujifilm to receive upfront, license fee along with royalties on sales of the therapy. Dr. Reddy’s and GRA to get the exclusive right to develop & commercialize Avigan globally (Ex- Japan). Additionally, Dr. Reddy’s would have exclusive rights for the therapy in India Fujifilm will provide pre/ clinical data of Avigan to Dr. Reddy’s […]Read More

Kyowa Kirin’s FKB327 (biosimilar, adalimumab) Receives the MMA Approval in

Shots: FKB327 (biosimilar, adalimumab) is an injectable medication that involves inhibition of Tumor Necrosis Factor (TNF) blocks the inhibition of activity, thereby reducing inflammation and other disease symptoms including RA, plaque psoriasis, Crohn’s disease, and ulcerative colitis In 2018, Fujifilm signed an agreement with Mylan to commercialize biosimilar adalimumab in EU and will expand it […]Read More