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
UK pharma major AstraZeneca (LSE: AZN) saw its shares dip 1.2% after it announced an exclusive global license deal with KYM Biosciences. 23 February 2023
Ono Pharmaceutical’s shares closed down 2.3% at 2,784 yen today, after the Japanese drugmaker revealed it has signed a collaboration and option agreement with Boston, USA-based biotech Cue Biopharma (Nasdaq: CUE) for CUE-401. 22 February 2023
Drug regulators in China are focusing on approving homegrown antiviral therapies with the ability to tackle new COVID-19 variants, according to analysis from a data and analytics provider. 20 February 2023
Japanese firms Teijin and Axcelead have announced an agreement on a capital and business alliance to establish a joint venture company. 20 February 2023
US biotech Capricor Therapeutics has entered into a partnership with mid-sized Japanese drugmaker Nippon Shinyaku, for the exclusive commercialization and distribution in Japan of Capricor’s lead asset, CAP-1002, for the treatment of Duchenne muscular dystrophy (DMD), a rare neuromuscular disease with limited treatment options. 16 February 2023
China and USA-based Harbour BioMed saw its shares rise more than 7% to HK$3.17, after it announced an exclusive license agreement with US firm Cullinan Oncology for the development and commercial rights on HBM7008 (CLN-418) in the USA. 14 February 2023
Contract research organization (CRO) Novotech has published a new global report on Phase I trial activity including current metrics on fast growth regions and therapeutic areas. 13 February 2023
The US Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) to expand the use of Takhzyro (lanadelumab-flyo) for prophylaxis to prevent attacks of hereditary angioedema (HAE) in pediatric patients aged two to 6 February 2023
Shares of Denmark’s ALK-Abello were up 7.9% at 110.90 Danish kroner by early afternoon, as the allergy immunotherapy company announced 2022 financial results and acceptance of a regulatory filing in China. 3 February 2023
A rosy future is predicted for Sino-American biotech BeiGene oral Bruton tyrosine kinase inhibitor (BTKi) Brukinsa (zanubrutinib), which recently gained US Food and Drug Administration (FDA) approval for patients with chronic lymphocytic leukemia (CLL) or small lymphocytic leukemia (SLL). 31 January 2023
Exkivity (mobocertinib) is the first targeted therapy to be approved for locally-advanced or metastatic epidermal growth factor receptor (EGFR) exon 20 insertions (exon20ins)-positive non-small cell lung cancer (NSCLC) in China. 27 January 2023
The Chinese Center for Disease Control and Prevention has recorded that Omicron lineages BA.5.2 and BF.7 account for 97.5% of all local infections in the country. 25 January 2023
Sandoz, the generic and biosimilar medicines business of Swiss pharma giant Novartis, has signed an agreement to acquire worldwide product rights for leading systemic antifungal agent Mycamine (micafungin sodium, Funguard in Japan) from Astellas Pharma. 24 January 2023
The US medicines cost effectiveness watchdog the Institute for Clinical and Economic Review (ICER) today released a Final Evidence Report assessing the comparative clinical effectiveness and value of Japanese drug major Astellas Pharma’s fezolinetant for moderate-to-severe vasomotor symptoms (VMS) associated with menopause, finding that the evidence is not yet adequate to demonstrate a net health benefit to the drug when compared to no pharmacological treatment. 23 January 2023
Japan’s largest drugmaker Takeda has entered into an exclusive licensing agreement with Chinese biotech Hutched for the further development and commercialization of fruquintinib outside of mainland China, Hong Kong and Macau. 23 January 2023
Hematology specialist Disc Medicine has in-licensed certain antibodies from Mabwell Therapeutics, a division of Shanghai-based Mabwell Bioscience. 20 January 2023