New York-based Nuvation Bio, a biopharma tackling some of the greatest unmet needs in oncology by developing differentiated and novel therapeutic candidates, is to buy AnHeart Therapeutics. 26 March 2024
Japanese drug major Astellas Pharma today announced that Japan’s Ministry of Health, Labor and Welfare (MHLW) has approved Vyloy (zolbetuximab). 26 March 2024
Japanese drugmaker Otsuka Pharmaceutical and the US unit of Denmark’s Lundbeck have presented new post hoc pooled analyses of two pivotal Phase III trials evaluating the safety and efficacy of Rexulti (brexpiprazole) in patients with agitation associated with dementia due to Alzheimer's disease. 22 March 2024
Japanese drugmaker Chugai Pharmaceuticals today announced mixed results from the Phase III LUMINESCE study of Enspryng (satralizumab [genetical recombination]), created by Chugai, as an investigational treatment for generalized myasthenia gravis (gMG). 21 March 2024
German pharma and life sciences major Merck KGaA today revealed it plans to invests more than 300 million euros ($32.7 million) into a new Bioprocessing Production Center in Daejeon, South Korea. 20 March 2024
Following the US Food and Drug Administration approval last Friday of its Lenmeldy (atidarsagene autotemcel), Orchard Therapeutics today announced launch plans for the gene therapy. 20 March 2024
Capping a series of investments designed to increase its manufacturing footprint, Novo Nordisk has said it will spend around $550 million to up output in China. 20 March 2024
The US Food and Drug Administration (FDA) has granted accelerated approved the supplemental new drug application (sNDA) for Iclusig (ponatinib). 20 March 2024
Shanghai-based KeChow Pharma has secured approval in its home country for tunlametinib, a MEK blocker which was discovered and developed by the firm in-house. 19 March 2024
Mitsubishi Tanabe Pharma America has announced the publication of results in The Lancet Neurology from the pivotal, Phase III BouNDless trial. 18 March 2024
The US unit of South Korea’s Celltrion today announced the availability of Zymfentra (infliximab-dyyb), a subcutaneous (SC) formulation of infliximab. 18 March 2024
A new chief medical officer will take the reins at Shanghai-based biotech Everest Medicines, as the drug and vaccine firm undertakes a minor reshuffle at the top. 18 March 2024
Clinical-stage biotech Biotheus has entered into a collaboration with fellow China-based Hansoh Pharmaceutical following their current partnership since 2022. 18 March 2024
Japanese drugmaker Sumitomo Pharma and its US subsidiary Sumitomo Pharma America have amended a collaboration with Otsuka Pharmaceuticals. 18 March 2024
Cartesian Therapeutics has revealed in a stock exchange filing that it has received notice from Japanese pharma major Astellas’ subsidiary Audentes Therapeutic that it is terminating their license and development agreement. 15 March 2024
More than a year later than expected, Sino-American oncology specialist BeiGene has finally secured US approval for its novel checkpoint inhibitor, tislelizumab-jsgr. 15 March 2024
New real-world data show a positive safety profile for Xcopri (cenobamate), an anti-seizure medication which is offered in a tablet formulation. 14 March 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