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Biotechnology
Shares of Japanese drugmaker Eisai were lifted by more than 3% to 8,327 yen this morning, after it revealed it has filed for domestic approval of its Alzheimer’s drug Leqembi (lecanemab), which was granted accelerated approval in the USA earlier this month. 16 January 2023
Biotechnology
Japanese companies have been late to progress COVID-19 vaccines, so news that Daiichi Sankyo had now filed for regulatory approval of its vaccine candidate sent the company’s shares up 2.2% to 4,134 yen on Friday. 16 January 2023
Pharmaceutical
China’s National Medical Products Administration (NMPA) has approved Japanese pharma giant Takeda’s Exkivity (mobocertinib) for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) Exon20 insertion mutations, whose disease has progressed on or after platinum-based chemotherapy. 12 January 2023
Pharmaceutical
Research from industry analyst GlobalData finds that western companies are likely to play an important role in providing new cardiovascular disease (CVD) management options in China. 12 January 2023
Biotechnology
Massachusetts, USA-based biotech Selecta Biosciences’ shares were up 11% at $1.37, after it announced an exclusive licensing and development agreement with Japan’s Astellas Pharma for IdeXork (Xork). 10 January 2023
Biotechnology
Today, US biotech Arrowhead Pharmaceuticals announced positive top-line data from a Phase II placebo-controlled study evaluating an investigational RNAi therapeutic, fazirsiran (TAK-999/ARO-AAT), for the treatment of alpha-1 antitrypsin (AATD) liver disease. 9 January 2023
Pharmaceutical
The US Food and Drug Administration (FDA) has determined that the supplementary New Drug Application (sNDA) for brexpiprazole for the use in the treatment of agitation associated with Alzheimer’s dementia (AAD) is sufficiently complete to permit a substantive review. 9 January 2023
Biotechnology
Having controversially approved the first new Alzheimer’s disease drug Aduhelm (aducanumab) in decades in 2021, dead on schedule, the US Food and Drug Administration on Friday announced its decision on a follow-on product. 7 January 2023
Biotechnology
BioRay Pharmaceutical's claim to be China’s leading autoimmune-focused biopharmaceutical firm looks substantially more robust after the company announced a $218 million strategic financing. 6 January 2023
Biotechnology
Chinese contract research, development and manufacturing organization WuXi Biologics has announced a license agreement with UK pharma major GSK. 6 January 2023
Biotechnology
Armed with promising new data from the Phase III interim analysis, Japan’s largest drugmaker Takeda says it aims to seek marketing authorization for TAK-755 as the first recombinant ADAMTS13 (rADAMTS13) for a disorder with considerable unmet patient need. 6 January 2023
Biotechnology
Adding to a deal with a US pharma giant last year, Cambridge, USA-based biotech Orna Therapeutics has now entered into a collaboration with Shanghai Xianbo Biotech, also known as Simnova outside of China, to discover, develop and commercialize multiple potential therapeutics in the area of oncology in China. 6 January 2023
Pharmaceutical
Merck & Co’s Lagevrio (molnupiravir) has been granted emergency approval by China’s National Medical Products Administration. 5 January 2023
Biotechnology
USA-based Legend Biotech Corporation has announced that China’s National Medical Products Administration (NMPA) has formally accepted its New Drug Application (NDA) for ciltacabtagene autoleucel (cilta-cel). 3 January 2023
Biotechnology
AstraZeneca’s Calquence (acalabrutinib) has secured a new approval in Japan, for the treatment of adults with chronic lymphocytic leukemia (CLL), in the first-line setting. 28 December 2022
Biosimilars
South Korea’s Celltrion Healthcare has submitted a Biologics License Application (BLA) under the 351 (a) pathway of the Public Health Service Act for its lead product candidate, CT-P13 SC (also known as Remsima), which is the subcutaneous formulation of infliximab, to the US Food and Drug Administration (FDA). 28 December 2022
Biotechnology
Japanese biotech PeptiDream saw its shares gain more than 20% to 1,965 yen today, after it announced a new research collaboration and license agreement with US pharma major Eli Lilly focused on the discovery and development of novel peptide drug conjugates (PDCs). 27 December 2022
Biotechnology
Japan’s Ministry of Health, Labor and Welfare (MHLW) has approved anti-cancer agent/humanized anti-CD20 monoclonal antibody Gazyva (obinutuzumab [genetical recombination]) intravenous infusion for an additional indication of CD20-positive chronic lymphocytic leukemia (including small lymphocytic lymphoma). 27 December 2022
Biotechnology
Japan’s Ministry of Health, Labor and Welfare (MHLW) has approved Yescarta (axicabtagene ciloleucel), a chimeric antigen receptor (CAR) T-cell therapy, which was developed by Kite pharma, now a subsidiary of US biotech Gilead Sciences. 23 December 2022
Biotechnology
While the vast majority of M&A deals announced so far this year are in the hundreds of million dollars, licensing agreements have been getting ever bigger. 22 December 2022
Biotechnology
Japanese drugmaker Takeda has launched Fruzaqla (fruquintinib) in its home country. 22 November 2024
Biotechnology
Chinese biopharma CStone Pharmaceuticals has announced a strategic commercial collaboration with Pharmalink Store, a prominent pharmaceutical company based in the United Arab Emirates (UAE). 22 November 2024
Biotechnology
Zhongshan-based biopharma company Akeso will await the verdict of the Chinese medicines regulator on a penpulimab-based combo therapy. 22 November 2024
Pharmaceutical
Shanghai-based Zai Lab and New York’s Pfizer are to work together on the commercialization of Xacduro (sulbactam-durlobactam) in China. 22 November 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
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