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Generics
Hong Kong-based Uni-Bio Science has secured approval from the China National Medical Products Administration (NMPA) for Bogutai (teriparatide), a treatment for osteoporosis. 22 January 2024
Pharmaceutical
Voydeya (danicopan) has been approved in Japan for the treatment of paroxysmal nocturnal hemoglobinuria (PNH). 19 January 2024
Pharmaceutical
USA–based heart disease specialist Windtree Therapeutics has entered into a license agreement with Lee's Pharmaceutical, related to its candidate istaroxime. 18 January 2024
Biotechnology
Dutch immunology specialist argenx has announced that Japan’s Ministry of Health, Labor and Welfare (MHLW) approved Vyvdura (efgartigimod alfa and hyaluronidase-qvfc; also marketed under the Vyvgart brand name) injection subcutaneous (SC). 18 January 2024
Biotechnology
Japanese drugmaker Daiichi Sankyo yesterday announced that the US Patent and Trademark Office (US PTO) rendered a Final Written Decision invalidating all claims of Seagen’s US patent 10,808,039 (the ’039 patent) that were challenged by Daiichi Sankyo in a post-grant review proceeding (PGR). 18 January 2024
Generics
Taiwan’s Bora Pharmaceuticals is to acquire Upsher-Smith Laboratories, a US generics manufacturer. 17 January 2024
Pharmaceutical
After first approving the drug in 2014 for the treatment of primary immunodeficiency (PI) in adults, the US Food and Drug Administration (FDA) has now approved a new indication for HyQvia [immune globulin Infusion 10% (Human) with recombinant human hyaluronidase]. 17 January 2024
Biosimilars
Samsung Bioepis, a business of South Korea-based Samsung BioLogics has released a biosimilar market report. 17 January 2024
Pharmaceutical
British pharma major AstraZeneca is to invest around $25 million in a new manufacturing facility in Taizhou, Zhejiang province. 16 January 2024
Biotechnology
In potentially the biggest pharma licensing deal ever, Japanese pharma major Daiichi Sankyo and US drug giant Merck & Co announced a collaboration in October. 16 January 2024
Biotechnology
Food and healthcare company Orion Group has made a bold step to expand its biotech interests, buying around a quarter of LegoChem Biosciences (Kosdaq: 141080) for $420 million. 16 January 2024
Biosimilars
South Korea’s Celltrion has announced the next phase of its strategic transformation from a developer of the world's first monoclonal antibody (MAb) biosimilar to an innovative company focused on new drug development at the 42nd Annual JP Morgan Healthcare Conference in San Francisco, California. 15 January 2024
Biotechnology
Shanghai-headquartered JiXing Pharmaceuticals has announced the acquisition of US biotech major Biogen’s (Nasdaq: BIIB) BIIB131 for global clinical development. 15 January 2024
Biotechnology
HilleVax (Nasdaq: HLVX) has agreed terms for a licensing deal with Chengdu-based Kanghua Biological, a Chinese biotech also known as Kangh. 12 January 2024
Biotechnology
Beijing-based Biocytogen Pharmaceuticals has entered into an option and license deal with Radiance Biopharma, related to next-gen antibody-drug conjugates (ADC). 12 January 2024
Biotechnology
China-based contract research, development and manufacturing organization (CRDMO) WuXi Biologics saw its shares jump nearly 9% to HK$30.45 by close of trading today, after it announced a new collaboration. 11 January 2024
Biotechnology
The New Drug Application (NDA) for China-based Hutchmed’s sovleplenib as a treatment of adult patients with primary immune thrombocytopenia (ITP) has been accepted for review and granted priority review by the China National Medical Products Administration (NMPA). 11 January 2024
Pharmaceutical
China’s Shanghai Henlius Biotech today announced a strategic collaboration with USA-based Sermonix Pharmaceuticals for exclusive rights to develop, manufacture and commercialize Sermonix’ lead investigational drug, lasofoxifene, in China. 11 January 2024
Biotechnology
Coherus Biosciences has notified the US markets authority that it will terminate a collaboration with Shanghai-based Junshi Biosciences related to an anti-TIGIT candidate. 11 January 2024
Biotechnology
Japanese drugmaker Eisai announced today that the Scientific Advisory Group (SAG) will convene to discuss the marketing authorization application (MAA) of its Alzheimer’s disease drug Leqembi (lecanemab) which is currently under review by the European Medicines Agency (EMA). 11 January 2024
Biotechnology
Hong Kong-based Sino Biopharm has signed an equity investment and strategic collaboration agreement with LaNova Medicines, advancing its oncology focus. 22 November 2024
Pharmaceutical
Japanese drugmaker Eisai has announced that the amyotrophic lateral sclerosis (ALS) treatment Rozebalamin for Injection (mecobalamin) has been launched in Japan as a treatment for slowing progression of functional impairment in amyotrophic lateral sclerosis. 21 November 2024
Biotechnology
San Diego-based Kura Oncology and Japan’s Kyowa Kirin have entered into a global strategic collaboration to develop and commercialize ziftomenib. 21 November 2024
Pharmaceutical
Shanghai-based Leading Tac Pharmaceutical has announced the successful completion of a series A financing round, raising over 100 million yuan ($14 million). 21 November 2024
Pharmaceutical
Ascentage Pharma will see its investigational BCL-2 selective inhibitor, lisaftoclax, assessed under China’s Priority Review scheme. 20 November 2024
Pharmaceutical
California, USA-based biotech Cytokinetics saw its shares fall as much as 4% to $9.67 yesterday, after it announced a deal with Germany’ Bayer. 20 November 2024
Biotechnology
Californian oncology-focused biotech Avenzo Therapeutics has announced a pair of important updates. 19 November 2024
Pharmaceutical
Big pharmas are not deterred by China’s increasingly complex business environment. Instead, they are changing strategies to minimize risks while continuing to benefit from China, said speakers at ChinaTrials held last week in Shanghai. 18 November 2024
Biosimilars
Following US approval in May this year, South Korea’s Samsung Bioepis and US biotech Biogen have now won approval from the European Commission (EC) for their Opuviz 40mg/mL solution for injection in a vial, a biosimilar referencing Regeneron and Bayer’s Eylea (aflibercept). 18 November 2024
Biotechnology
Shanghai-based Junshi Biosciences has received UK regulatory approval for Loqtorzi (toripalimab) in nasopharyngeal carcinoma (NPC) and esophageal squamous cell carcinoma (ESCC). 18 November 2024
Biotechnology
Chinese biotech Keymed Biosciences has entered an exclusive licensing agreement with Platina Medicines for its bispecific antibody candidate, CM336. 18 November 2024
Pharmaceutical
In yet another sign of the mounting interest in radiopharmaceuticals, Tongrui Biopharma, a Chinese innovator in this area, has announced the completion of a $100 million series A+ financing round. 18 November 2024
Biotechnology
Shanghai-based biopharma Zai Lab has announced the pricing of its underwritten public offering at $25.50 per share, aiming to raise around $200 million. 15 November 2024
Biosimilars
South Korean biosimilars company Celltrion today announced its acquisition of iQone Healthcare Switzerland a specialty pharmaceutical company focused on distribution, sales, and marketing in Switzerland. 15 November 2024
Biotechnology
Merck & Co has entered into an exclusive global license to develop, manufacture and commercialize LM-299 from China-based clinical-stage biotech LaNova Medicines, bringing the US pharma giant into the newly attractive PD-1/VEGF bispecific antibody space. 15 November 2024
Biotechnology
Japanese drugmaker Nippon Shinyaku and USA-based Atsena Therapeutics have entered into an exclusive license agreement for the commercialization of ATSN-101 in the USA and Japan for advancing Atsena’s first- in-class, investigational gene therapy ATSN-101 for Leber congenital amaurosis caused by biallelic mutations in GUCY2D (LCA1). 13 November 2024
Biotechnology
Anglo-American biotech Apollo Therapeutics and China-based Sunshine Lake Pharma have signed an exclusive license agreement to develop APL-18881, a bi-specific fusion protein aimed at treating metabolic diseases. 13 November 2024
Biotechnology
Dutch firm Argenx and China’s Zai Lab have received an approval from the National Medical Products Administration (NMPA) for Vyvgart Hytrulo (efgartigimod alfa). 13 November 2024
Biotechnology
Although it is seeing a downturn in sales and profits, German biotech BioNTech is continuing to acquire assets with the cash pile it made through the covid pandemic, notably iis Comirnaty vaccine that was developed with Pfizer (NYSE: PFE). 13 November 2024
Biotechnology
Sino-American oncology company BeiGene has announced third-quarter 2024 financials, showing the total revenues was $1,002 million, up 28% compared to $781 million in the same period of 2023. 13 November 2024
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