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
Australian CSL Limited’s recently-incorporated Swiss business CSL Vifor and its partner Fresenius Kabi today announced that China’s National Medical Products Administration (NMPA) has approved Ferinject (ferric carboxymaltose). 28 November 2022
The Medicines for Malaria Venture (MMV) and Shin Poong Pharm have welcomed the formal inclusion of Pyramax (pyronaridine-artesunate), developed by the South Korean company, in the World Health Organization’s (WHO) Guidelines for Malaria following an extensive review process. 25 November 2022
Japanese drugmaker Shionogi (TYO: 4507) said yesterday that its Xocova (ensitrelvir fumaric acid, Code No.: S-217622), a novel anti-SARS-CoV-2 drug for COVID-19 obtained emergency regulatory approval from the Ministry of Health, Labor and Welfare (MHLW) in Japan for the indication of SARS-CoV-2 infection. 23 November 2022
Investing in early-stage multicenter trials is imperative to achieve global commercialization for Chinese biotechs, but a US site may not be necessary, said speakers at the Chinatrials meeting held in Shanghai earlier this month. 21 November 2022
Japanese drug major Takeda today revealed that the Phase III PhALLCON trial of Iclusig (ponatinib) for adult patients with newly-diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) met its primary efficacy endpoint in the frontline setting. 17 November 2022
Japanese drug major Astellas Pharma today announced positive top-line results from the Phase III SPOTLIGHT clinical trial evaluating the efficacy and safety of zolbetuximab in combination with mFOLFOX6 (a combination regimen that includes oxaliplatin, leucovorin and fluorouracil). 17 November 2022
Swiss biotech Idorsia has entered into an exclusive licensing agreement with China’s Simcere Pharmaceutical for the commercialization of its dual orexin receptor antagonist daridorexant, a treatment for adult patients with insomnia, in China. 16 November 2022
Japanese drugmaker Daiichi Sankyo edged up 1.7% to 4,486 yen today, as it announced that a trial evaluating the efficacy and safety of booster vaccination with DS-5670, an mRNA vaccine against the novel coronavirus infectious disease (COVID-19), the primary endpoint was achieved. 15 November 2022
Israel-headquartered clinical-stage diabetes specialist Oramed Pharmaceuticals saw its shares rise as much as 3.3% to $7.82 in early trading, after it revealed signing an exclusive commercial distribution agreement for South Korea with Medicox Co. 14 November 2022
R-Pharm Group, one of Russia’s leading pharmaceutical producers, is expanding into the market Southeast Asia, according to the company, reports The Pharma Letter’s local correspondent. 10 November 2022
The entry of new treatments for atypical hemolytic uremic syndrome (aHUS) such as Swiss pharmaceutical giants Novartis and Roche that have strong digital experience can alter the aHUS digital landscape dynamics in Japan, says data and analytics company GlobalData. 10 November 2022
Shares of Sino-American biotech BeiGene rose as much as 3.8% to 133.97 renminbi when trading started this morning, as the company released third-quarter 2022 financial results that beat consensus forecasts. 10 November 2022
The growing US-China tension, a chilled market and a weakened China economy had Chinese biotechs re-think their strategies. However, most of them agreed that, despite all the challenges, going global is a must, said speakers at the DJSeedin innovation partnering conference held in Shanghai earlier this month. 9 November 2022
Japanese drug major Eisai today announced that it has entered into an agreement to divest its rights for muscle relaxant Myonal (eperisone hydrochloride) and vertigo and equilibrium disturbance treatment Merislon (betahistine mesilate) in Asia to a subsidiary of Switzerland-based DKSH Holding Ltd. 7 November 2022
Japanese drugmaker Kissei Pharmaceutical has entered into a license agreement with Synmosa Biopharma for the development and commercialization rights in Taiwan for the GnRH antagonist linzagolix that was discovered by Kissei. 4 November 2022
Sino-American biotech BeiGene claims significant progress in its efforts to unlock global opportunities for its Brukinsa (zanubrutinib) with recent regulatory approvals in six Latin American countries. 31 October 2022
There has been an update regarding an ongoing collaboration in neurology between Japanese pharma companies Takeda Pharmaceutical and Shionogi. 31 October 2022
Japanese drugmaker Kyowa Kirin revealed on Friday that is has submitted a New Drug Application (NDA) for tenapanor hydrochloride (KHK7791) to the Japanese Ministry of Health, Labor and Welfare. 31 October 2022
US immuno-oncology cell therapy company 2seventy bio’s shares gained 3.5% to $16.00 this morning, as it announced a strategic alliance with Chinese biotech JW Therapeutics. 27 October 2022