Japanese pharma major Takeda has announced that the US Food and Drug Administration (FDA) has approved Eohilia (budesonide oral suspension), the first and only FDA-approved oral therapy for people 11 years and older with eosinophilic esophagitis (EoE). 13 February 2024
Shares of Japanese drugmaker Otsuka Pharmaceutical fell more than 5% to 5,359 yen today, as it released top line results of the Phase III clinical trial of AVP-786 in the treatment of agitation associated with dementia due to Alzheimer's disease. 13 February 2024
Rare diseases specialist Swedish Orphan Biovitrum (also known as Sobi) has set up a joint venture with South Korean firm Handok to commercialize its drugs in the latter’s home market. 13 February 2024
Japan’s largest drugmaker Takeda Pharma has announced positive top-line results from a randomized, double-blind, placebo-controlled, multiple dose Phase IIb trial evaluating TAK-861, an oral orexin receptor 2 (OX2R) agonist, in patients with narcolepsy type 1. 9 February 2024
Vicor Pharma has entered into an exclusive licensing agreement with Japan’s Nippon Shinyaku, for the commercialization and development of its C21 idiopathic pulmonary fibrosis (IPF) drug candidate in Japan. 9 February 2024
Crovalimab, a humanized complement inhibitor C5 monoclonal antibody discovered by Japan’s Chugai Pharmaceutical (TYO: 4519), has been approved by China’s National Medical Products Administration (NMPA) for treatment of PNH. 8 February 2024
Immuno-oncology firm I-Mab saw its shares slip 4.5% to $1.91 pre-market today, as it announced that, as part of its strategy to become a USA-based biotech, it is divesting its Chinese subsidiaries. 8 February 2024
China-based Hutchmed has reported data from FRUTIGA, its Phase III trial of fruquintinib alongside paclitaxel for the treatment of second-line advanced gastric cancer in China, at the American Society of Clinical Oncology (ASCO) Plenary Series Session. 8 February 2024
Shares of French ophthalmology biotech Nicox shot up 16.8% to 0.48 euros this morning, after it announced a deal with privately-held Japanese firm Kowa Company. 8 February 2024
Hong Kong-listed biotech BeiGene has received Health Canada authorization for Brukinsa (zanubrutinib) in combination with obinutuzumab for the treatment of adult patients with relapsed or refractory grade 1, 2 or 3a follicular lymphoma (FL). 8 February 2024
California, USA-based biotech BridgeBio Pharma today announced a partnership wherein its affiliate, QED Therapeutics, grants Japan’s Kyowa Kirin an exclusive license for infigratinib. 7 February 2024
Japan’s largest drugmaker Takeda Pharma has appointed Dr Phuong Khanh (PK) Morrow as head of the Oncology Therapeutic Area Unit, effective as of January 29. 3 February 2024
Positive high-level results from the Japan Phase III trial of acoramidis in transthyretin-mediated amyloid cardiomyopathy (ATTR-CM) showed consistency to those in the global BridgeBio Pharma ATTRibute-CM Phase III trial, including survival, cardiac-related hospitalizations and other measures of improved functions and quality of life, at 30 months. 2 February 2024
Chinese biopharma Hutchmed today announced that Hong Kong-based Inmagene Biopharmaceuticals has exercised options to license two drug candidates discovered by Hutchmed. 2 February 2024
Clinical-stage US pharma company Protagonist Therapeutics' shares rose 6% to $26.5O in early trading, on news of a licensing deal for its blood disorder candidate rusfertide. 1 February 2024
Japan has recently approved Dutch immunology specialist argenx’ (Euronext: ARGX) Vyvdura (efgartigimod alfa and hyaluronidase-qvfc) subcutaneous (SC) injection for the treatment of adult patients with generalized myasthenia gravis (gMG), who do not have sufficient response to steroids or non-steroidal immunosuppressive therapies (ISTs). 31 January 2024
A division of Indian generics drugmaker Glenmark Pharmaceuticals has agreed terms for a licensing deal with Chinese firms Alphamab Biopharmaceuticals and 3D Medicines. 30 January 2024
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has approved Fruzaqla (fruquintinib) to treat adults with metastatic colorectal cancer (CRC)—to be used when other treatments have not worked. 20 September 2024
The Israeli Ministry of Health (IL MOH) has approved Tevimbra (tislelizumab) as monotherapy for the treatment of adult patients with unresectable or metastatic oesophageal squamous cell carcinoma (OESCC). 20 September 2024
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