The Israeli Ministry of Health (IL MOH) has approved Tevimbra (tislelizumab) as monotherapy for the treatment of adult patients with unresectable or metastatic oesophageal squamous cell carcinoma (OESCC). 20 September 2024
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
A new drug application has been filed with the Japanese Ministry of Health, Labor and Welfare (MHLW) for satralizumab (development code: SA237), an anti-interleukin-6 (IL-6) receptor humanized recycling antibody, for the treatment of neuromyelitis optica spectrum disorder (NMOSD). 8 November 2019
Anglo-Swedish pharma major AstraZeneca’s love affair with China shows no sign of cooling off, with the company now announcing three new projects in the Asian country to advance its R&D efforts. 6 November 2019
India’s largest drugmaker Sun Pharmaceutical Industries has entered into a licensing agreement with UK pharma major AstraZeneca to introduce certain novel ready-to-use (RTU) infusion oncology products in China. 6 November 2019
In what could prove to be something of a landmark development, Shanghai-based Green Valley Pharmaceuticals says that China's National Medical Products Administration (NMPA) has granted conditional approval for oligomannate (GV-971) as new drug for the treatment of mild-to-moderate Alzheimer's disease (AD) and improving cognitive function." 4 November 2019
Ahead of the upcoming flu season, two Japanese healthcare professionals’ associations have updated their guidance on considerations for the prescribing of medicines and vaccines. 28 October 2019
There was good news today for Shanghai-based WuXi AppTec subsidiary WuXi STA Pharmaceutical, with the announcement that its Jinshan manufacturing facility in Shanghai, China, has successfully passed an inspection by the European Medicines Agency (EMA) with no critical and no major findings. 28 October 2019
Switzerland-based Tillotts Pharma AG, part of the Japanese Zeria Group, today announced an agreement with Italy’s Menarini and its Chinese subsidiary for the distribution and marketing of Tillotts’ Asacol (mesalazine) product range in the People’s Republic of China. 28 October 2019
The Amsterdam headquarters of the European Medicines Agency hosted an important meeting between European and Chinese medicines regulators on Friday. 25 October 2019
Privately-held US biotech Ambrx has announced a second collaboration with NovoCodex Biopharmaceuticals Ltd, a majority-owned company of Chinese group Zhejiang Medicine. 24 October 2019
Californian infectious disease specialist Qpex Biopharma has entered into a multi-product collaboration with Shanghai’s Brii Biosciences. 23 October 2019
Japanese drugmaker Shionogi has filed a supplemental New Drug Application (sNDA) for Xofluza (baloxavir marboxil) in its native country for the postexposure prophylaxis of influenza virus infection. 16 October 2019
Independent pharma company Specialised Therapeutics Asia (STA) has gained rights to market Yondelis (trabectedin) to patients in Australia, New Zealand and throughout south east Asia. 14 October 2019
China is currently the second largest pharmaceutical market in the world and is aiming to be a major innovator as well, as part of its ‘Made in China 2025’ program. 14 October 2019
US biotech major Gilead Sciences yesterday announced that the New Drug Application (NDA) for filgotinib, an investigational, oral, selective JAK1 inhibitor for the treatment of adults with rheumatoid arthritis (RA), has been submitted to the Japanese Ministry of Health, Labor and Welfare (MHLW). 8 October 2019
The Japanese Intellectual Property High Court has ruled in favor of the Roche majority-owned subsidiary Chugai in relation to allegations that its hemophilia A drug Hemlibra (emicizumab-kxwh) breached another company’s patent. 3 October 2019
The US Food and Drug Administration has published a letter warning a Chinese company about the potential impact of its refusal to undergo an inspection of its drug product testing facility. 2 October 2019
Keytruda (pembrolizumab) has been approved in China for first-line treatment of certain patients with advanced non-small cell lung cancer (NSCLC) whose tumors express PD-L1. 2 October 2019