Having won accelerated approval in January this year, Alzheimer’s drug Leqembi (lecanemab) now looks set to get full approval from the US Food and Drug Administration (FDA) as early as next month. 10 June 2023
South Korean contract development and manufacturing organization (CDMO) Samsung Biologics today revealed it has entered another strategic partnership with US pharma giant Pfizer (NYSE: PFE). 8 June 2023
GLP1 receptor agonists (GLP1RA) are known as diabetes treatments, but recently they have also doubled as the new generation drugs for overweight/obesity. 5 June 2023
Japanese drugmaker Chugai Pharmaceuticals has decided to invest over 50 billion yen ($356 million) in total for two new manufacturing facilities at the Utsunomiya plant. 31 May 2023
Ultomiris (ravulizumab) has been approved in Japan as the first and only long-acting C5 complement inhibitor for the treatment of adults with anti-aquaporin-4 (AQP4) antibody-positive (Ab+) neuromyelitis optica spectrum disorder (NMOSD). 26 May 2023
Hefei Tianhui Biotechnology (HTIT) has recently submitted a marketing authorization application (MAA) in China for the world’s first oral insulin for type 2 diabetes (T2D). 26 May 2023
The US Food and Drug Administration (FDA) has approved Yuflyma (adalimumab-aaty), a high-concentration (100mg/mL) and citrate-free formulation of AbbVie’s (NYSE: ABBV) mega-blockbuster drug Humira (adalimumab) biosimilar, the US subsidiary of South Korean biosimilars developer Celltrion Healthcare. 26 May 2023
Japanese drugmaker Daiichi Sankyo today announced that Vanflyta (quizartinib) has been approved in Japan for the treatment of acute myeloid leukemia (AML) that is FLT3-ITD mutation positive, with the news surprisingly pushing the firm’s shares down 4.4% to 4,582 yen 25 May 2023
Prime Minister Fumio Kishida has announced the government of Japan's pledge to contribute $200 million to the Global Health Innovative Technology Fund (GHIT Fund). 25 May 2023
South Korea’s HanAll Biopharma dipped more than 3% to 21,850 won yesterday, after it announced mixed results from the Phase III VELOS-3 trial evaluating the safety and efficacy of tanfanercept. 20 May 2023
The US Food and Drug Administration (FDA) has accepted Japanese pharma major Takeda’s Biologics License Application (BLA) for TAK-755, an enzyme replacement therapy for the treatment of congenital thrombotic thrombocytopenic purpura (cTTP), an ADAMTS13 deficiency disorder, for priority review. 17 May 2023
Chinese biotech start-up LaNova Medicines revealed it has entered into an exclusive license agreement with UK pharma major AstraZeneca, for LM-305, a pre-clinical stage antibody drug conjugate (ADC) targeting G protein-coupled receptor, class C, group 5, member D (GPRC5D). 15 May 2023
Following a regulatory update, Japanese speciality pharma company Kyowa Kirin has announced it will pull the plug on its small molecule bardoxolone methyl. 12 May 2023
Following a positive vote last month from the Joint Meeting of the Psychopharmacologic Drugs Advisory Committee, the US Food and Drug Administration (FDA) has now approved the supplemental New Drug Application (sNDA) of Rexulti (brexpiprazole) for use in the treatment of agitation associated with dementia due to Alzheimer’s disease. 11 May 2023
Privately-held Chinese biotech Zion Pharma revealed that Swiss pharms giant Roche has acquired the global rights to Zion’s lead program, ZN-A-1041, an orally administered selective tyrosine kinase inhibitor targeting the human epidermal growth factor receptor 2 (HER2). 10 May 2023
Risk control was a major topic at the DJSeedin innovation partnering event held on last month in Shanghai as Chinese biotechs are seeking more licensing deals and partnerships to survive in tmpetition in China. 4 May 2023
Privately-held Australian biotech Cartherics has granted Shunxi Holding Group a license to develop, manufacture and commercialize its autologous CAR-T cell product, CTH-004, for multiple solid tumors including ovarian cancer in Greater China. 28 April 2023
When it comes to getting a novel foreign-made treatment into China as quickly as possible, companies should also look into the local policies in some high-profile special zones. 27 April 2023
When it comes to expensive treatments such as cell therapy, companies usually do not wish to cut price heavily to join China’s national drug procurement scheme (NDPS). Rather, they have been actively looking for some intriguing, alternative opportunities, said speakers at DJSeedin innovation partnering conference held on April 20 in Shanghai. 24 April 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