South Korea’s Samsung Bioepis and USA-based Organon have announced the interchangeable result of its Humira (adalimumab) biosimilar, SB5, based on a recently conducted Phase IV study. 3 August 2023
Japanese companies have been slow to progress COVID-19 vaccines, but today Daiichi Sankyo announced that it has received approval for the manufacturing and marketing of Daichirona for Intramuscular Injection (DS-5670). 2 August 2023
German family-owned drugmaker Grünenthal and Japan’s Kyowa Kiron today announced the successful completion of a deal to enter into a joint venture collaboration for Kyowa Kirin International's established medicines portfolio. 2 August 2023
As the first obesity drug to be approved in Japan in the last three decades, Danish diabetes giant Novo Nordisk’s Wegovy (semaglutide) is expected to bring a substantial shift in the treatment approach. 28 July 2023
Japan’s largest pharma company Takeda today announced strong financial results for the first quarter of fiscal year 2023 (period ended June 30, 2023). The firm’s edged up 0.7% to 4,401 yen following the news. 27 July 2023
The Center for Drug Evaluation of China’s National Medical Products Administration (NMPA) has granted Breakthrough Therapy designation (BTD) for the combination of fruquintinib and sintilimab (a PD-1 antibody). 20 July 2023
Japan’s Ministry of Health, Labor, and Welfare approved FluMist Quadrivalent in March of this year, marking the first approval of an intranasal vaccine in the country’s history. 14 July 2023
Japan’s largest drugmaker Takeda announced that it has voluntarily withdrawn the US Biologics License Application (BLA) for its dengue vaccine candidate, TAK-003. 12 July 2023
The Swiss subsidiary of Sino-American biotech BeiGene and Swiss pharma giant Novartis on Tuesday entered into a mutual termination and release agreement to mutually terminate the option agreement, effective immediately. 12 July 2023
Yesterday after market close, US genetic medicines company 4D Molecular Therapeutics announced a license agreement with Japanese drug major Astellas Pharma. 11 July 2023
Sino-American biotech BeiGene has entered an agreement with Duality Biologic (DualityBio) to acquire an exclusive option for a global clinical and commercial license to an investigational, pre-clinical antibody-drug conjugate (ADC) therapy for patients with select solid tumors. 11 July 2023
China-based Brii Biosciences says that it has entered into license agreements with US firm VBI Vaccines, expanding the companies’ collaboration in the hepatitis B virus (HBV) field. 11 July 2023
The New Drug Application (NDA) submission for lurbinectedin has been accepted by China’s National Medical Products Administration (NMPA) for the treatment of adult patients with metastatic small cell lung cancer (SCLC) with disease progression on or after receiving platinum-based chemotherapy. 10 July 2023
Chinese biopharma firm Innovent Biologics and development partner IASO Biotherapies last week received approval from the China National Medical Product Administration (NMPA) for Fucaso (equecabtagene autoleucel) as a treatment for patients with relapsed or refractory multiple myeloma who have received ≥3 lines of prior therapies. 10 July 2023
The European Commission has granted conditional marketing authorization for Lytgobi (futibatinib) monotherapy for the treatment of adult patients with locally advanced or metastatic cholangiocarcinoma (CCA). 6 July 2023
UK and USA-based biotech F-star Therapeutics, an invoX company, has entered into another collaboration with Japan’s largest drugmaker Takeda. 5 July 2023
Chinese rare disease drug developer RareStone Group has received approval from the National Medical Products Administration (NMPA) for Wakix (pitolisant) for the treatment of excessive daytime sleepiness (EDS) or cataplexy in adult patients with narcolepsy. 5 July 2023
South Korean firm SK bioscience today revealed it has signed a Memorandum of Understanding (MOU) with the Government Pharmaceutical Organization (GPO), a state pharmaceutical enterprise in Thailand, to strengthen Thailand’s vaccine infrastructure. 5 July 2023
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