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
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
South Korean contract development and manufacturing organization (CDMO) Samsung Biologics today provided an update on the deal it announced last month with US pharma major Pfizer. 4 July 2023
Political and health leaders have signed and adopted the Nagasaki Outcomes Statement, calling for accelerated R&D, access, and delivery for neglected tropical diseases (NTDs). 4 July 2023
For many years, Britain’s pharma largest company AstraZeneca has maintained a strong presence in China, and this approach looks set to pay off. 4 July 2023
Japanese drugmaker Maruho has entered into an exclusive license agreement to develop and commercialize Alchemedicine's aldehyde dehydrogenase 2 (ALDH2) activator following Maruho's exercise of the option right included in the exclusive negotiation and evaluation agreement that had already been executed between the companies. 4 July 2023
China's National Medical Products Administration (NMPA) has recently launched a nationwide drug safety consolidation and enhancement campaign to establish a solid foundation for drug safety. 30 June 2023
Adding to strong data released earlier this year form the SKYLIGHT 2 and SKYLIGHT 4 studies, Japanese drug major Astellas today announced positive top-line results from the Phase IIIb DAYLIGHT clinical trial for fezolinetant. 28 June 2023
Japanese drugmaker Otsuka Pharmaceutical has announced positive results from a Phase III trial in its home country for brexpiprazole in the treatment of agitation associated with Alzheimer's dementia. 28 June 2023
China’s National Medical Products Administration (NMPA) has approved Xigduo XR (dapagliflozin and metformin hydrochloride extended-release), a once-daily fixed-dose combination, for the treatment of adults with type-2 diabetes (T2D) as an adjunct to diet and exercise to improve glycemic control, from UK pharma major AstraZeneca. 27 June 2023
Based on analysis of available information and input from a MEDACorp patent attorney, SVB Securities Research believes US pharma major AbbVie’s allegations that Brukinsa infringes on a recently granted patent (#11,672,803) are substantiative and could potentially result in damages to China-headquartered biotech BeiGene. 26 June 2023
Japanese pharma major Shionogi has signed seven sublicence agreements with the Medicines Patent Pool (MPP), a United Nations-backed international public health organization, for generic version of Shionogi's ensitrelvir fumaric acid, a COVID antiviral, to be manufactured by generics companies. 26 June 2023
Japan’s largest drugmaker Takeda has released full results from the pivotal Phase III ADVANCE-CIDP 1 clinical trial investigating Hyqvia (immune globulin infusion 10% [human] with recombinant human hyaluronidase) as maintenance therapy in adult patients with chronic inflammatory demyelinating polyneuropathy (CIDP). 21 June 2023
The World Health Organization (WHO) has granted WHO Emergency Use Listing (EUL) for the COVID-19 vaccine, SKYCovione, from South Korean company SK bioscience. 19 June 2023
China-headquartered biotech BeiGene says it is aware that Pharmacyclics has filed a complaint against BeiGene and its US subsidiary alleging that its lead product Brukinsa (zanubrutinib) infringes a patent issued on June 13, 2023, to Pharmacyclics, a subsidiary of US pharma major AbbVie. 19 June 2023
Sir Mene Pangalos, executive vice president, BioPharmaceuticals R&D, AstraZeneca, has stressed the importance of a new collaboration and licensing agreement to the company. 16 June 2023
The European Medicines Agency (EMA) has validated and accepted for regulatory review the marketing authorization application (MAA) for fruquintinib. 16 June 2023
Japanese drug major Astellas Pharma has entered a research collaboration and exclusive option agreement with privately held clinical-stage US biotech firm Cullgen to discover multiple innovative protein degraders. 15 June 2023
Japanese drugmaker Chugai Pharmaceutical said today it has filed a regulatory application with the Ministry of Health, Labor and Welfare (MHLW) for the anti-C5 antibody crovalimab for the treatment of paroxysmal nocturnal hemoglobinuria (PNH). 14 June 2023
Spanish drugmaker PharmaMar and China-based Luye Pharma have revealed that the New Drug Application (NDA) submission of lurbinectedin has been accepted by the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA). 12 June 2023