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Pharmaceutical
Japanese pharma major Astellas today released positive 52-week results from the Phase III SKYLIGHT 4 clinical study evaluating the safety and tolerability of fezolinetant, an investigational oral, nonhormonal compound being studied for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause. 12 October 2022
Biotechnology
Shares of Belgian cell therapy developer Bone Therapeutics jumped 11% to 0.19 euros in early trading, after it announced it has extricated itself from a complicated licensing deal for its allogenic off-the-shelf, bone cell therapy platform ALLOB in certain Asian countries and was regaining rights to the product. 7 October 2022
Biotechnology
Japanese biotech Kyowa Kirin today announced it has launched its corporate venture capital (CVC) fund and invested in its first biotech start-up. 5 October 2022
Biotechnology
Shares of Japanese drugmaker Astellas Pharma rose 2.2% to 1,965 yen yesterday, after it announced a research deal with Germany’s Pantherna Therapeutics, which aims to generate mRNA-based regenerative medicine programs using direct reprogramming (transdifferentiation). 5 October 2022
Biotechnology
The Japanese business of Swiss biotech company Idorsia can boast positive top-line results from a Phase III trial of daridorexant. 3 October 2022
Biotechnology
The latest in a series of Industry Leader pieces from biological reagent supplier and service provider Sino Biological. 3 October 2022
Biotechnology
The US Food and Drug Administration (FDA) has approved Lytgobi (futibatinib) for the treatment of adult patients with previously treated, unresectable, locally advanced or metastatic intrahepatic cholangiocarcinoma (iCCA) harboring fibroblast growth factor receptor 2 (FGFR2) gene fusions or other rearrangements. 3 October 2022
Pharmaceutical
The European Medicines Agency (EMA) has accepted the marketing authorization application (MAA) for Japanese drugmaker Astellas Pharma’s fezolinetant. 30 September 2022
Pharmaceutical
Merck & Co and the China National Pharmaceutical Group - known as Sinopharm - have signed a cooperation framework agreement. 29 September 2022
Biotechnology
Spanish dermatology specialist Almirall and Simcere Pharmaceutical Group have signed an exclusive licensing agreement for the Chinese firm’s IL-2 mutant fusion protein (IL-2 mu-Fc) autoimmune drug candidate, SIM0278. 29 September 2022
Pharmaceutical
Japanese drug major Sumitomo Pharma has filed an appeal with the US Court of Appeals for the Federal Circuit (CAFC) seeking revocation of the decision of the US Patent and Trademark Office (USPTO) relating to the proprietary atypical antipsychotic agent Latuda (lurasidone HCl tablets). 29 September 2022
Pharmaceutical
Japanese drugmaker Shionogi closed 1% higher after Tokyo trading on Wednesday after reporting progress with its COVID-19 antiviral. 28 September 2022
Biotechnology
Japanese drugmaker Eisai’s shares gained more than 17% to 6,784 yen today, after it released top-line results from the Clarity AD Phase III clinical trial for lecanemab, an investigational anti-amyloid beta (Aβ) protofibril antibody for the potential treatment of early Alzheimer’s disease. 28 September 2022
Biotechnology
Japan’s Ministry of Health, Labor and Welfare (MHLW )has granted approval of the manufacturing and marketing application for Berinert SC Injection 2000 submitted by CSL Behring KK, a subsidiary of Australia’s CSL Limited. 28 September 2022
Biotechnology
Merck & Co has announced that its anti-PD-1 therapy Keytruda (pembrolizumab) has received four new approvals from Japan’s Ministry of Health, Labor and Welfare (MHLW). 27 September 2022
Biotechnology
KiOmed Pharma, a Belgian biotech developing medical devices based on a highly pure natural chitosan-derivative, has announced a deal with China’s Hansoh Pharmaceutical Group. 27 September 2022
Pharmaceutical
The US business of Japanese ophthalmology firm Santen Pharmaceutical has secured approval for Omlonti (omidenepag isopropyl). 27 September 2022
Biotechnology
In a busy day for the Japanese regulator, the Japanese Ministry of Health, Labor and Welfare (MHLW) has cleared three new medicines from European drugmakers for marketing in the country. 27 September 2022
Pharmaceutical
China-based Contract Research Development and Manufacturing Organization (CRDMO) WuXi STA has opened its first high potency (HP) oral drug product manufacturing facility at its Wuxi city campus. 27 September 2022
Pharmaceutical
There was a tepid market reaction to news that Japan’s Daiichi Sankyo had secured its first regulatory approval for Ezharmia (valemetostat tosilate), in a disease area where there is a severe lack of effective treatments. 26 September 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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