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
Japanese pharma major Astellas Pharma has announced a strategic investment to support the advancement of Texas, USA-based Taysha Gene Therapies’ adeno-associated virus (AAV) gene therapy development programs for the treatment of Rett syndrome and giant axonal neuropathy (GAN). 25 October 2022
Sino-American biotech BeiGene shot up on Wednesday, after the company's chronic lymphocytic leukemia (CLL) treatment was shown to beat out a blockbuster drug from Johnson & Johnson. 13 October 2022
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
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
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
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
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
The European Medicines Agency (EMA) has accepted the marketing authorization application (MAA) for Japanese drugmaker Astellas Pharma’s fezolinetant. 30 September 2022
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
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
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
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
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
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