Japanese drugmaker Takeda has signed an option agreement with China’s Ascentage Pharma to enter into an exclusive license agreement for olverembatinib. 14 June 2024
China’s Innovent Biologics recently presented Phase I study results of its first-in-class anti-CLDN18.2/CD3 bispecific antibody (IBI389) for the treatment of advanced pancreatic cancer. 14 June 2024
South Korea’s Samsung Bioepis today presented the post-hoc analysis of the Phase III clinical study results for Epysqli (SB12), a biosimilar to AstraZeneca’s Soliris (eculizumab), at the EHA Congress. 14 June 2024
US drugmaker AbbVie and China’s FutureGen Biopharmaceutical have announced a license agreement to develop FG-M701, a next generation TL1A antibody for the treatment of inflammatory bowel disease (IBD), currently in preclinical development. 13 June 2024
The Center for Drug Evaluations of the National Medical Products Administration (NMPA) in China has accepted the biologics license application (BLA) for zanidatamab for second-line treatment of HER2-positive biliary tract cancer (BTC). 11 June 2024
Japanese drugmaker Kyowa Kirin yesterday revealed it is establishing a new, state-of-the-art manufacturing facility in Sanford, North Carolina, in the USA. 11 June 2024
The Chinese National Medical Products Administration (NMPA) held a meeting recently to carry out the 2023 annual review of the vaccine regulatory quality management system (QMS). 10 June 2024
Japanese drugmaker Shionogi has entered into an option agreement with French firm Cilcare to acquire the exclusive license for the development, manufacturing, and commercialization of CIL001 and/or CIL003, a hearing loss treatment drug candidates worldwide. 8 June 2024
Singaporean speciality pharma company Hyphens Pharma International has entered into an exclusive license, development and commercialization agreement with Japanese drugmaker Maruho. 6 June 2024
USA-based ArriVent BioPharma has entered into a collaboration agreement with a unit of Chinese biotech Alphamab Oncology, to discover, develop and commercialize novel antibody-drug conjugates (ADCs) for the treatment of cancers. 6 June 2024
Japanese pharma major Shionogi says it is responding to the urgent global need for additional antimicrobial research and development by establishing its first discovery laboratory in San Diego, California, USA. 4 June 2024
Japan’s Nxera Pharma has expanded its strategic R&D partnership with UK-based computational biology company PrecisionLife into autoimmune disorders with the potential to identify new drug targets for the treatment of complex, chronic conditions. 30 May 2024
Globally, the devastating and widespread impact of neurological disorders like Alzheimer's disease, epilepsy, Parkinson’s disease and depression is only getting worse. 30 May 2024
Bio-Thera Solutions has partnered with STADA Arzneimittel for the commercialization of BAT2506, a biosimilar candidate to Simponi (golimumab). 30 May 2024
Shares of Swedish biotech Calliditas Therapeutics shot up more than 78% to 202.60 kronor by late afternoon, on news of a takeover bid from Asahi Kasei. 28 May 2024
Privately-held Swiss drug firm Ewopharma it has entered into a strategic commercial collaboration with China’s CStone Pharmaceuticals to gain rights for sugemalimab in Switzerland and 18 Central Eastern European countries (CEE). 28 May 2024
USA-based Nippon Shinyaku subsidiary NS Pharma has published a disappointing initial analysis from an important trial of Viltepso (viltolarsen). 28 May 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 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