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
The China National Medical Products Administration (NMPA) has approved Sylvant (siltuximab for injection) for the treatment of adult patients with multicentric Castleman disease (MCD) who are human immunodeficiency virus (HIV) negative and human herpes virus-8 (HHV-8) negative, also known as idiopathic MCD (iMCD). 3 December 2021
Japanese pharma major Astellas Pharma and US artificial intelligence (AI) to gene therapy-focussed biotech Dyno Therapeutics have entered into an option and license agreement to develop next-generation adeno-associated virus (AAV) vectors for gene therapy directed to skeletal and cardiac muscle using Dyno’s CapsidMap platform. 2 December 2021
Japanese contract development and manufacturing organization (CDMO) FUJIFILM Diosynth Biotechnologies has confirmed a £400 million ($529 million) planned investment package at its UK facility in Billingham, Teesside. 2 December 2021
A subsidiary of WuXi AppTec and fellow Chinese firm Coherent Biopharma have announced the signing of a strategic partnership agreement, building on a successful previously-signed collaboration. 1 December 2021
Chinese biotechs used to prefer late-clinical stage assets when seeking in-licensing targets for a quick launch in China, but this is no longer the case. 1 December 2021
Shares of Chinese biotech Zai Lab Limited closed down 7% at HK$562 yesterday, even though the company announced that the Phase III PRIME study of Zejula (niraparib) as maintenance therapy met its primary endpoint. 1 December 2021
Canada and USA-based biotech Chinook Therapeutics today announced the formation of SanReno Therapeutics, a joint venture with an investor syndicate led by Frazier Healthcare Partners and Pivotal bioVenture Partners China, to develop, manufacture and commercialize kidney disease therapies in China, Hong Kong, Macau, Taiwan and Singapore (the Territory). 30 November 2021
Shares of Belgian cell therapy developer Bone Therapeutics jumped by a quarter over the weekend, following news of a deal with Link Health Pharma. 29 November 2021
Japanese drug majors Takeda Pharmaceutical and Sumitomo Dainippon Pharma announced today that Takeda will succeed the manufacturing and marketing approval and the marketing rights of Replagal (agalsidase alfa) for Fabry disease, an α-galactosidase enzyme intravenous (IV) infusion, as of February 15, 2022. 26 November 2021
Japanese mid-size drugmaker Mochida Pharmaceutical and Ayumi Pharmaceutical announced that Adalimumab BS MA (adalimumab biosimilar, code: LBAL) has now been launched in Japan as the NHI (National Health Insurance) drug price has been listed today. 25 November 2021
Japanese drugmaker Ono Pharmaceutical and its partner Bristol Myers Squibb have announced the approval for the use of Opdivo (nivolumab) in two new indications in Japan. 25 November 2021
The European Commission (EC) has approved Brukinsa (zanubrutinib) for the treatment of adult patients with Waldenström’s macroglobulinemia (WM) who have received at least one prior therapy or for the first-line treatment of patients unsuitable for chemo-immunotherapy, says Chinese biotech BeiGene. 24 November 2021
Multinationals corporations (MNCs) have been actively adding China to their multicenter global clinical studies in recent years, it was made clear at a recent meeting. 24 November 2021
French pharma major Sanofi has inked an agreement with Chinese tech giant Baidu, aimed at improving the company’s product design processes. 23 November 2021
Neurocrine Biosciences and Japanese firm Sosei Heptares have agreed a strategic collaboration and licensing deal to develop muscarinic receptor agonists which the US company will study in schizophrenia, dementia and other neuropsychiatric disorders. 22 November 2021
SCG Cell Therapy plans to establish Singapore as its international hub for cell therapy research, manufacturing and clinical development to deliver products across Asia Pacific, the USA, Europe and the world. 19 November 2021
Japanese drugmaker Daiichi Sankyo today announced positive top-line results from the global pivotal QuANTUMFirst Phase III trial evaluating quizartinib, a highly potent and selective FLT3 inhibitor, in patients with newly diagnosed FLT3-ITD positive acute myeloid leukemia (AML). 19 November 2021
China’s biotech industry enjoyed significant growth in the past several years, but major bottlenecks are looming as Chinese biotechs aims for a global expansion, said speakers at the two-day event Chinatrials on November 11 in Shanghai. 17 November 2021
The neuromyelitis optica spectrum disorder (NMOSD) therapeutics market is highly genericized, with corticosteroids and immunosuppressants currently accounting for the highest portion of prescribed drugs in China. 16 November 2021