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
China's National Medical Products Administration (NMPA) has approved Benlysta (belimumab) for the treatment of adult patients with active lupus nephritis (LN) who are receiving standard of care. 10 February 2022
Since the early days of the pandemic, a number of developers have pursued the concept of using a nasal spray to administer anti-virals for treatment and prevention of coronavirus. 9 February 2022
Japanese drug major Shionogi has completed its analysis of the Phase IIa part of a Phase II/III clinical trial of S-217622, an orally administered antiviral drug for COVID-19, and presented the results today. 7 February 2022
In the third Japanese financial quarter, Takeda Pharmaceutical delivered year-to-date revenues of 2,700 billion yen ($23.5 billion), an increase of 11% on the same period from last year. 3 February 2022
Tokyo-based drugmaker Kyowa Kirin has submitted for Japanese approval for Mitomycin-C (mitomycin) as a topical ophthalmic drug for use in glaucoma surgery. 31 January 2022
Japanese drug major Shionogi edged up 2.4% to 6,464 yen this morning, as it presented the results up to day six of the Phase IIa part of a Phase II/III clinical trial of S-217622, an orally administered antiviral drug for COVID-19. 31 January 2022
Trade group Medicines Australia has called for the country’s government to deliver a plan that shortens the time that patients wait for access to the latest innovative treatments and vaccines. 28 January 2022
UK drugmaker GlaxoSmithKline and its US partner Vir Biotechnology have taken action to boost production of their antibody-based COVID-19 faced with huge demand. 24 January 2022
Belgium biopharma UCB today announced that the Japanese Ministry of Health, Labor and Welfare (MHLW) has granted marketing authorization for Bimzelx (bimekizumab) for the treatment of plaque psoriasis, generalized pustular psoriasis and psoriatic erythroderma in patients who are not sufficiently responding to existing treatments. 24 January 2022
The Japanese subsidiary of New York’s Bristol Myers Squibb has secured approval for its CAR T-cell immunotherapy Abecma (idecabtagene vicleucel). 21 January 2022
The equity research team at US financial services firm Morningstar has published the Annual Drug Pipeline report, which looks at the large-cap biopharma groups and their position in the market. 20 January 2022
Japanese drug major Daiichi Sankyo edged up 1.6% to 2,608 yen after it revealed it has entered into an agreement with Cosette Pharmaceuticals, whereby it divested and Cosette acquired rights for manufacturing, commercialization, and certain other rights for the following products in the USA: 20 January 2022
The Japanese subsidiary of Swiss biotech Idorsia today announced that the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) has approved Pivlaz (clazosentan sodium) 150mg. 20 January 2022
Chinese biotech Hutchmed today announced that the Center for Drug Evaluation of China’s National Medical Products Administration (NMPA) has granted Breakthrough Therapy designation (BTD) to HMPL-523, a novel, investigational spleen tyrosine kinase (Syk) inhibitor, for the treatment of chronic adult primary immune thrombocytopenia (ITP) patients who have received at least one prior therapy. 12 January 2022
China’s Pharmaron Beijing has acquired Aesica Pharmaceuticals (the Cramlington Site) from Swedish Contract Development and Manufacturing Organization (CDMO) Recipharm group. 10 January 2022
Japanese pharma major Eisai has granting the exclusive rights for global research, development, manufacture and sale of the investigational anticancer agent H3B-8800 to a subsidiary of London-headquartered Roivant Sciences. 6 January 2022
Chinese biotech BeiGene has announced that the China National Medical Products Administration (NMPA) has approved its anti-PD-1 antibody tislelizumab as a second- or third-line treatment for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC). 6 January 2022
Shares of Swiss biotech Santhera Pharmaceuticals were up 15.4% at 1.50 Swiss francs by early afternoon, after it revealed an exclusive license agreement with China-based rare diseases specialist Sperogenix Therapeutics. 4 January 2022
South Korean Celltrion Group’s shares edged up 1.8% to 200,000 Korean won in early trading on Monday, after it released results for its COVID-19 cocktail therapy candidates including neutralization data against the Omicron variant. 4 January 2022