Following discussions with the US Food and Drug Administration (FDA), Japanese pharm major Takeda said it will be working with the agency towards a voluntary withdrawal of Exkivity (mobocertinib) in the USA. 3 October 2023
Information from research group GlobalData suggests there is a pressing need for innovation and collaboration in China to address an unmet medical need in Fabry disease. 29 September 2023
California, USA-based biotech AcuraStem has entered into a license agreement with Japan’s largest pharma company Takeda to develop and commercialize AcuraStem's PIKFYVE targeted therapeutics including AS-202, an innovative antisense oligonucleotide (ASO) for the treatment of amyotrophic lateral sclerosis (ALS). 26 September 2023
Japan’s Ministry of Health, Labor and Welfare (MHLW) ha approved Phesgo, a fixed-dose combination of Perjeta (pertuzumab) and Herceptin (trastuzumab) with hyaluronidase. 26 September 2023
The Japanese Ministry of Health, Labor and Welfare (MHLW) has granted approval for Rystiggo (rozanolixizumab) and for Zilbrysq (zilucoplan). 26 September 2023
The Japanese Ministry of Health, Labor and Welfare (MHLW) has approved the use of Cuvitru (immune globulin subcutaneous [human], 20% solution). 25 September 2023
China’s tension between the US-led West, its down-sliding economy and the increasingly wayward policy making all added to the factors that made investors seek different ways to grow their businesses in the country, said speakers at ChinaBio partnering forum held on September 20 in Shanghai. 25 September 2023
China-based immuno-oncology-focussed biotech I-Mab Biopharma revealed in a Securities and Exchange Commission (SEC) filing that US pharma major AbbVie had totally terminated their September 2020 collaboration, relating to certain CD47 antibody compounds and products. 25 September 2023
Having gained US and Taiwan regulatory approval for its hematology drug Altuviiio (efanesoctocog alfa) earlier this year, French pharma major Sanofi has now bagged marketing clearance in Japan. 25 September 2023
French biopharma company Inventiva saw its US traded shares jump 11.1% to $4.19 yesterday, after it announced a deal with Japan-based Hepalys Pharma, a company incubated by Catalys Pacific. 22 September 2023
A new collaboration will see Californian biotech Kezar Life Sciences and China’s Everest Medicines working together on an immunoproteasome blocker, zetomipzomib. 21 September 2023
According to a statement from China’s National Health Commission (NHC), mpox will now be treated under a higher level of threat protocol, after hundreds of new cases were detected in the country. 20 September 2023
Japanese biopharma firm PeptiDream saw its share rise almost 5% to 1,714 yen, after it revealed a potentially lucrative licensing deal with US biotech Genentech. 20 September 2023
Japanese drug major Astellas Pharma announced positive 24-month top-line results from the Phase III GATHER2 clinical trial evaluating the efficacy and safety of Izervay (avacincaptad pegol intravitreal solution), a complement C5 inhibitor for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD). 19 September 2023
Sino-American biotech BeiGene today announced that it has entered into an agreement with Novartis to regain worldwide rights to develop, manufacture, and commercialize Tevimbra (tislelizumab). 19 September 2023
Korean biotech 1ST Biotherapeutics has announced a clinical trial collaboration and supply agreement with US pharma giant Merck & Co. 19 September 2023
South Korean contract development and manufacturing organization (CDMO) Samsung Biologics has announced a new agreement with Bristol Myers Squibb for large-scale manufacturing of the US pharma major’s commercial antibody cancer drug substance. 18 September 2023
Taiwan-based BRIM Biotechnology today announced that 22,500 shares have been issued at a premium of NT$65 (~US$2.03), raising a total of NT$1.4625 billion (~US$45.8 million). 13 September 2023
Daiichi Sankyo’s today revealed that its Vanflyta (quizartinib) has been recommended by the National Institute for Health and Care Excellence (NICE) for routine National Health Service (NHS) commissioning in England and Wales. 19 September 2024
Gene therapy research in Japan has gained significant momentum due to the SAKIGAKE designation system and government-led initiatives like the “Project for Regenerative/Cellular Medicine and Gene Therapies” to accelerate research and development (R&D) to create new technologies for gene/cell therapy. 18 September 2024
The HERTHENA-Lung02 Phase III trial of patritumab deruxtecan, in patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC) who received prior EGFR tyrosine kinase inhibitor (TKI) treatment, has met its primary endpoint. 17 September 2024
US biotech Capricor Therapeutics has entered into a binding term sheet with Japanese drugmaker Nippon Shinyaku for the commercialization and distribution in Europe of Capricor’s lead asset, deramiocel. 17 September 2024
Women’s health focussed company Organon China today revealed that it has entered into license and supply agreements with Shanghai Bao Pharmaceutical, acquiring the exclusive commercialization rights to its investigational asset, SJ02, in China Mainland. 13 September 2024
On Thursday, the US Food and Drug Administration released a Drug Safety Communication warning that Veozah (fezolinetant), which is used to treat hot flashes due to menopause, can cause rare but serious liver injury. 13 September 2024
NewCo, a relatively new business model that involves a joint venture (JV) between a biotech and a group of investors to bring the biotech’s promising assets to the global market, is gaining popularity among Chinese biotechs, who traditionally rely on out-licensing deals to capitalize assets, s 11 September 2024
Detailed results were released from the TROPION-Lung01 Phase III trial, which showed a clinically meaningful trend toward improving overall survival (OS) with datopotamab deruxtecan (Dato-DXd) compared to docetaxe. 10 September 2024
Chinese companies Innovent Biologics and GenFleet have recently secured approval from China’s National Medical Products Administration (NMPA) for Dupert (fulzerasib). 9 September 2024
Summit Therapeutics on Sunday announced data from the primary analysis of the Phase III HARMONi-2 trial featuring the novel, potential first-in-class investigational bispecific antibody, ivonescimab compared to Merck & Co’s) mega blockbuster drug Keytruda (pembrolizumab). 9 September 2024
Organon KK, a Japan subsidiary of Organon & Co, announced that the primary endpoint was achieved in a domestic Phase III clinical trial evaluating the efficacy and safety of OG-8276A 6 September 2024
Targeted alpha therapy (TAT), or radioligand therapy, is a recent hot area that attracted big pharmas like Bristol Myers Squibb and Novartis. 5 September 2024
Biosimilar-focused biopharmaceutical company and contract development and manufacturing organization (CDMO) Tanvex BioPharma has named Stephen Lam its new chief executive (CEO). 5 September 2024
Privately-held Chinese biotech EpimAb Biotherapeutics and Vignette Bio have entered into a license agreement for EpimAb’s BCMA-targeting T-cell engager (TCE) EMB-06. 5 September 2024
Rigel Pharmaceutical’s shares dipped 4.4% to $12 .85 by late morning, despite announcing what could be a lucrative deal for the company. 3 September 2024
Chinese gene therapy specialist YolTech Therapeutics has entered into an exclusive licensing agreement with Salubris Pharmaceuticals (SHE: 002294). 3 September 2024
Japan’s Nxera Pharma today announced that it will receive a $35 million payment from Neurocrine Biosciences, triggered by the successful completion of the Phase II trial with NBI-1117568 (NBI-‘568) in adults with schizophrenia. 2 September 2024
Chinese biopharma Hutchmed on Friday announced that it has voluntarily withdrawn its supplemental New Drug Application (NDA) in China for fruquintinib. 2 September 2024
Jacobio Pharma announced that it has granted the China rights to KRAS G12C inhibitor glecirasib and SHP2 inhibitor JAB-3312 to Shanghai Allist Pharmaceuticals. 2 September 2024