News
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TOKYO ― FUJIFILM Corporation (President and CEO, Representative Director: Teiichi Goto) today announced that it has begun implementation of a phase 2a study in the U.S. to evaluate safety, tolerability, and preliminary efficacy of FF-10832, a liposomal drug candidate, in combination therapy with Merck & Co., Inc., Rahway, N.J., U.S.A.’s anti-PD-1 therapy KEYTRUDA® (pembrolizumab) for […]
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TOKYO —FUJIFILM Toyama Chemical Co., Ltd. (President: Junji Okada) has announced that the company has partnered with Chinese pharmaceutical company Carelink Pharmaceutical Co., Ltd. (hereinafter “Carelink”) in deploying anti-influenza drug Avigan® Tablets (generic name: favipiravir,“Avigan”) in China. Going forward, through a future application and approval of Avigan for imported drug registration, to be submitted by […]
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TOKYO —FUJIFILM Toyama Chemical Co., Ltd. (President: Junji Okada; hereinafter “FUJIFILM Toyama Chemical”) has announced that the company filed an Application for Partial Changes to manufacturing and marketing approval matters of its anti-influenza drug Avigan® Tablet (generic name: favipiravir,”Avigan”) to the Ministry of Health, Labour and Welfare in Japan. The filing seeks to add an […]
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TOKYO — FUJIFILM Corporation (President: Kenji Sukeno) announces the conclusion of a manufacturing contract agreement with biotechnology company, VLP Therapeutics Japan LLC (Representative Executor: Wataru Akahata, hereinafter “VLP Therapeutics”) regarding COVID-19 vaccine formulation developed by VLP Therapeutics. VLP Therapeutics’ COVID-19 vaccine is self-amplifying (replicon) RNA*1 vaccine and uses a formulation (lipid nanoparticle)*2, which is a […]
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LONDON and TOKYO ― Centus Biotherapeutics Ltd., a joint venture between Fujifilm Kyowa Kirin Biologics Co., Ltd. and AstraZeneca, today announced that the European Commission (EC) has granted the marketing authorization for Equidacent® (Product Code: FKB238), the company’s biosimilar to Avastin® (bevacizumab). The authorization follows the adoption of a positive opinion by the Committee for […]
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TOKYO — FUJIFILM Toyama Chemical Co., Ltd. (President: Junji Okada; hereinafter “FUJIFILM Toyama Chemical”) has announced today that primary endpoint has been met in phase III clinical trial of “Avigan Tablet” (generic name: favipiravir, “Avigan”) conducted in Japan for patients with novel coronavirus infections (hereinafter “COVID-19”). The efficacy primary endpoint is time to negative conversion […]
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TOKYO — FUJIFILM Toyama Chemical Co., Ltd. (Head Office: Chuo-ku, Tokyo; President: Junji Okada; hereinafter “FUJIFILM Toyama Chemical”) today filed an application to the Ministry of Health, Labour and Welfare for marketing authorization approval its new radiopharmaceutical compound F-1515 (INN: lutetium [177Lu] oxodotreotide) for the treatment of pancreatic, gastrointestinal, and pulmonary neuroendocrine tumors. F-1515 is […]
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At Fujifilm, our dedication to science and innovation has never been more important than it is today. We are collaborating across the globe and working together and finding ways to fight COVID-19 by leveraging our talents, experience and resources. But perhaps nothing is more inspiring than the way several FUJIFILM Group companies came together recently […]
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Centus Biotherapeutics Announces Positive CHMP Opinion for FKB238, Biosimilar Bevacizumab
LONDON and TOKYO ― Centus Biotherapeutics Ltd., a joint venture between Fujifilm Kyowa Kirin Biologics Co., Ltd. and AstraZeneca PLC (LSE/STO/NYSE: AZN), today announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for the Marketing Authorization Application of EquidacentTM (Product Code: FKB238), the company’s biosimilar […]
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Mylan and Fujifilm Kyowa Kirin Biologics Announce U.S. FDA Approval of Hulio® (adalimumab-fkjp)
HERTFORDSHIRE, England, PITTSBURGH and TOKYO – Mylan N.V. (NASDAQ: MYL) and Fujifilm Kyowa Kirin Biologics Co., Ltd. today announced that the U.S. Food and Drug Administration (FDA) has approved Hulio® (adalimumab-fkjp), a biosimilar to AbbVie’s Humira® (adalimumab), for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis (4 years and older), psoriatic arthritis, ankylosing spondylitis, adult […]
