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 drugmaker Chugai Pharmaceutical says it will transfer the business of the secondary hyperparathyroidism drug Oxarol for Injection (maxacalcitol) to LTL Pharma in Japan. 29 August 2024
Politics has entered the scientific realm in the form of new US legislation that has prompted the Biotechnology Innovation Organization (BIO) to come into line with Congress’s position on Chinese companies. 14 March 2024
Once dubbed as me-too copycats and fast followers, Chinese biotechs are flocking to innovation mix, or combinatorial innovation, hoping to discover a novel therapy based on a mixture of existing resources, according to the consulting firm Clarivate. 13 March 2024
Swiss drugmaker Basilea Pharmaceutica announced yesterday that the continued strong sales performance of the antifungal Cresemba (isavuconazole) by its license partner Pfizer in the Asia Pacific region and China exceeded the sales threshold triggering a $1.25 million milestone payment. 12 March 2024
The US Food and Drug Administration (FDA) has granted orphan drug and pediatric exclusivity to Cresemba (isavuconazonium sulfate) for the treatment of invasive aspergillosis (IA) and invasive mucormycosis (IM) in pediatric patients. 12 March 2024
Shanghai-based CARsgen Therapeutics has announced that zevorcabtagene autoleucel (CT053), or zevor-cel, its autologous CAR T-cell developed for multiple myeloma, has been approved by China’s National Medical Products Administration (NMPA). 11 March 2024
Privately-held German firm Boehringer Ingelheim and Japan’s Sosei Group Corporation have entered into a global collaboration and exclusive option-to-license agreement. 11 March 2024
Sino-American biotech BeiGene on March 8 disclosed in stock exchange announcement that it has filed patent infringement suits under the Hatch-Waxman Act against the US subsidiary of Swiss firm Sandoz and separately against Indian-owned companies MSN Pharmaceuticals and MSN Laboratories Private in the US District Court for the District of New Jersey. 9 March 2024
After the debacle surrounding Aduhelm (aducanumab), Leqembi (lecanemab) was supposed to be the Alzheimer’s amyloid beta-directed antibody that delivered results for patients and its manufacturers Eisai and Biogen. 8 March 2024
The US Food and Drug Administration granted accelerated approval for Brukinsa (zanubrutinib) with obinutuzumab for relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy. 8 March 2024
A key committee of the US Senate has given its stamp of approval for the BIOSECURE Act, which aims to prevent contracts with Chinese biotech companies. 7 March 2024
South Korean vaccine maker SK bioscience today announced that it has broken ground on a major expansion of its vaccine manufacturing plant, L HOUSE, located in Andong, Gyeongsangbuk-do. 7 March 2024
Marking a fourth deal this year, Japanese drugmaker Ono Pharmaceutical today announced that it has entered into a license agreement with pre-clinical stage Korean biotechnology NEX-I for NXI-101. 6 March 2024
The European Medicines Agency (EMA) has validated two marketing authorization applications (MAAs) for AstraZeneca and Daiichi Sankyo’s datopotamab deruxtecan (Dato-DXd) in two types of cancer. 4 March 2024
China-headquartered oncology specialist BeiGene has announced a new matching adjusted indirect comparison (MAIC) of the efficacy of Brukinsa (zanubrutinib) versus acalabrutinib in relapsed or refractory (R/R) chronic lymphocytic leukemia (CLL) based on data from the Phase III ALPINE and Phase III ASCEND trials. 1 March 2024
Japanese drugmaker Taiho Pharmaceutical, a subsidiary of Otsuka, is to collaborate with Shanghai-based Haihe Biopharma on a new cancer med. 1 March 2024
British pharma major AstraZeneca has chosen Shanghai as the location for what will become its fifth global strategic center for research and development. 29 February 2024
Japanese drugmaker Shionogi says it has submitted a marketing approval application for the digital therapeutic app SDT-001, for commercialization and sale in Japan. 27 February 2024
Teva Pharmaceutical Industries has formed a partnership with Jiangsu Nhwa Pharmaceutical for the marketing and distribution in China of Teva’s Austedo (deutetrabenazine). 26 February 2024