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 Singapore Health Sciences Authority (HSA) has approved its 20-valent pneumococcal conjugate vaccine (PCV20) that protects against invasive pneumococcal disease and pneumonia caused by 20 Streptococcus pneumoniae (pneumococcus) serotypes. 18 March 2023
China’s National Medical Products Administration (NMPA) has approved its New Drug Application (NDA) for Xerava (eravacycline) for the treatment of complicated intra-abdominal infections (cIAI) in adult patients. 17 March 2023
Esperion Therapeutics’ shares plunged by over 60% to $1.64 on Thursday, after it stated in a company filing with Securities and Exchange Commission (SEC) that Daiichi Sankyo Europe has disputed Esperion’s right to receive milestone payments following a clinical trial. 17 March 2023
The Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has accepted the Biologics License Application (BLA) for enfortumab vedotin for the treatment of patients with locally advanced or metastatic urothelial cancer (la/mUC). 10 March 2023
The US subsidiary of Japanese drug major Astellas Pharma today announced disappointing top-line results from the Phase III MORPHO clinical trial evaluating gilteritinib as a maintenance therapy following allogeneic hematopoietic stem cell transplantation (HSCT) for patients with FMS-like tyrosine kinase 3 (FLT3)-internal tandem duplication (ITD) mutated acute myeloid leukemia (AML). 9 March 2023
Biotech companies in the Asia-Pacific (APAC) region are trailing Western rivals in terms of venture capital financing, according to a report from GlobalData. 9 March 2023
Japanese biotech Carna Biosciences has terminated a licensing deal with its Chinese partner BioNova Pharmaceuticals and regained all China rights of the asset AS1763, a BTK inhibitor treating chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), and B-cell non-Hodgkin lymphoma (B-cell NHL). 8 March 2023
Eisai and Biogen have announced that the US Food and Drug Administration (FDA) has accepted the supplemental Biologics License Application (sBLA) for Leqembi (lecanemab-irmb) 100 mg/mL injection for intravenous use. 6 March 2023
Japanese drugmakers Kyorin Pharmaceutical and Sumitomo Pharma have entered into a license agreement for the development, manufacturing, and commercialization of vibegron, a therapeutic agent for overactive bladder (OAB), in Taiwan, Hong Kong, Singapore, Indonesia, and Vietnam. 6 March 2023
Japan’s Teijin Parma has entered into an exclusive global license agreement with Swiss pharma giant Novartis to research, develop, manufacture and commercialize an investigational pre-clinical candidate for proteinuric kidney diseases. 6 March 2023
South Korea’s Celltrion Healthcare saw its shares gain more than 7% to 57,700 Korean won on Friday, after it presented new data for its novel subcutaneous infliximab treatment, CT-P13 SC, also known as Remsima, at the European Crohn’s and Colitis Organization congress last week. 6 March 2023
Taiwan generics drugmaker Lotus Pharmaceuticals has received approval in Vietnam for its cancer drug vinorelbine soft gel in two varieties - 20mg and 80mg- to compete with the branded version Navelbine, originated by French drugmaker Pierre Fabre. 3 March 2023
USA-based Ambrx Biopharma and partner NovoCodex Biopharmaceuticals have announced an update on ACE-Breast-02, a Phase III breast cancer trial. 2 March 2023
Florida, USA-based Avenue Therapeutics, which was founded by Fortress Biotech, today announced that it has entered into an exclusive license agreement with AnnJi Pharmaceutical, a Taiwanese clinical-stage drug company. 2 March 2023
Shanghai Junshi Biosciences had more positive news, this time on its monoclonal antibody (MAb) candidate ongericimab, adding to the successful trials results for its toripalimab in breast cancer last week. 1 March 2023
Sino-American biotech BeiGene yesterday reported financial results, showing that revenues for the fourth quarter and full year 2022 was $380.1 million, missing consensus estimates of $345 million by 2%, and $1.4 billion, respectively, compared to $214.0 million and $1.2 billion in the prior-year periods. 28 February 2023
The Biologics License Application (BLA) for Leqembi (lecanemab), an investigational anti-amyloid beta (Aβ) protofibril antibody, has been designated for Priority Review by the National Medical Products Administration (NMPA) in China. 28 February 2023
Japan’s Ministry of Health, Labor and Welfare (MHLW) has approved the oral androgen receptor inhibitor (ARi) darolutamide plus ADT in combination with docetaxel in the indication of metastatic prostate cancer. 27 February 2023
The spread of the COVID-19 epidemic has basically ended in China, though it is not completely over, according to a senior health expert, quoted on the website of the country’s National Medical Products Administration (NMPA). 27 February 2023