Chugai Pharmaceutical says its Taiwan subsidiary (CPT) has obtained an import drug license from the Taiwan Food and Drug Administration (TFDA) for Alecensa (alectinib) 2 August 2024
UK health technology assessor the National Institute for Health and Care Excellence (NICE) has issued a final draft guidance (FDG) recommending Brukinsa for MZL. 1 August 2024
IDEAYA Biosciences has entered into an option and license agreement for a potential first-in-class B7H3/PTK7 BsADC program with Chinese biotech Biocytogen Pharmaceuticals. 1 August 2024
Tigermed (SZ: 300347), a global clinical research solution provider, has completed a move to boost capabilities in Japan and beyond, with the acquisition of the contract research organization (CRO) Medical Edge. 31 July 2024
EMA Committee for Medicinal Products for Human Use (CHMP) has adopted a negative opinion on the marketing authorization approval (MAA) for the humanized anti-soluble aggregated amyloid-beta (Aβ) monoclonal antibody Leqembi (lecanemab). 26 July 2024
Beijing, China-based Gan & Lee Pharmaceuticals announced that its independently developed long-acting GLP-1 receptor agonist (GLP-1 RA), GZR18 injection, has achieved positive results in a clinical trial for adults with obesity/overweight in China. 23 July 2024
Chugai today announced it will transfer to Maruishi Pharmaceuticals the business in Japan concerning the physiological intestinal function improving and hyperammonemia drug Monilac 22 July 2024
The US Food and Drug Administration (FDA) has approved the Biologics License Application (BLA) submitted by South Korea’s Samsung Bioepis for Epysqli (eculizumab-aagh) as a biosimilar to Soliris (eculizumab). 22 July 2024
SOTIO Biotech, a Czech biopharma owned by PPF Group, and Biocytogen, a Chinese firm focused on the discovery of novel antibody therapeutics, have announced a research collaboration and exclusive option and license agreement. 16 July 2024
Eisai has entered into a license agreement with fellow Japanese drugmaker Sato Pharmaceutical regarding the development and commercialization rights for the antifungal agent fosravuconazole in the Asia/Oceania region. 16 July 2024
Efforts to end US business deals with certain foreign biotechs considered threats are gaining traction again, with House Speaker Mike Johnson stating his intention to hold a vote on the BIOSECURE act this year. 11 July 2024
French drugmaker Ipsen has entered into an exclusive global licensing agreement for FS001, an antibody-drug conjugate (ADC) with first-in-class potential, from China-based Foreseen Biotechnology. 11 July 2024
US biotech Moderna and Japan’s Mitsubishi Tanabe Pharma have entered into a joint agreement regarding the co-promotion of Moderna's mRNA respiratory vaccine portfolio in Japan, including Moderna's COVID-19 vaccine, Spikevax. 9 July 2024
Ascentage Pharma yesterday announced that olverembatinib has been approved by the Pharmaceutical Administration Bureau (ISAF) of the Macau Special Administrative Region (SAR) of China. 8 July 2024
China’s National Medical Products Administration (NMPA) has approved Xpovio (selinexor), from Antengene Corp as a monotherapy for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (R/R DLBCL). 8 July 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