Privately-held Swiss firm Helsinn Group has today announced today the signing of exclusive license and distribution agreements with a subsidiary of China’s Fosun Pharma effective from October 1, 2021 in the territory of Mainland China for Aloxi (palonosetron hydrochloride), Akynzeo (netupitant and palonosetron hydrochloride) and anamorelin. 12 October 2021
Japanese drugmaker Chugai Pharmaceutical, which is majority-owned by Roche, has filed an application with the Ministry of Health, Labor and Welfare (MHLW) for approval of additional indications for the anti-SARS-CoV-2 monoclonal antibody cocktail Ronapreve (casirivimab/imdevimab) for the prophylaxis of COVID-19 and treatment of asymptomatic COVID-19 infected patients. 12 October 2021
Launching Tavulus (tiotropium bromide) in Spain, Mumbai’s Glenmark Pharmaceuticals has become one of the first companies to offer a generic version of the dry powder inhaler,. 11 October 2021
The US Food and Drug Administration’s Antimicrobial Drugs Advisory Committee (AMDAC) voted unanimously to recommend use of maribavir (TAK-620) for the treatment of refractory cytomegalovirus (CMV) infection and disease with genotypic resistance to ganciclovir, valganciclovir, foscarnet or cidofovir in transplant recipients. 8 October 2021
South Korean contract development and manufacturing organization (CDMO) Samsung Biologics and US drug developer Enzolytics have signed a strategic CDMO partnership agreement. 7 October 2021
The Japanese Ministry of Health, Labor and Welfare (MHLW) has approved Cibinqo (abrocitinib), an oral, once-daily, Janus kinase 1 (JAK1) inhibitor, for the treatment of moderate to severe atopic dermatitis (AD) in adults and adolescents aged 12 years and older with inadequate response to existing therapies. 7 October 2021
Japan’s largest drugmaker Takeda Pharmaceutical saw its shares fall 6.4% to 3,340 yen this morning, after it revealed that a safety signal has emerged in Phase II studies of TAK-994, an investigational oral orexin agonist. 6 October 2021
Saphnelo (anifrolumab) has been approved in Japan for the treatment of adult patients with systemic lupus erythematosus (SLE), a serious autoimmune disease, who show insufficient response to currently available treatment. 28 September 2021
China’s Sihuan Pharmaceutical, through its subsidiary Xuanzhu Biopharmaceutical, has entered into an exclusive collaboration and licensing agreement with Canada-based SignalChem Lifesciences for the clinical development and commercialization of SLC-391, a potent and selective AXL targeting inhibitor, in the Greater China region. 28 September 2021
Switzerland’s Vifor Pharma Group has announced that Japan’s Ministry of Health and Labor Welfare has granted its partner, Kissei Pharmaceutical, marketing authorization approval for Tavneos (avacopan). 27 September 2021
Japan’s Ministry of Health, Labor and Welfare (MHLW) has granted approval for the manufacture and marketing of Alofisel (darvadstrocel: code: Cx601) for the treatment of complex perianal fistulas in patients with non-active or mildly active luminal Crohn’s disease (CD). 27 September 2021
Japan’ Astellas Pharma has secured a nod from the country’s medicines regulator, the Ministry of Health, Labour and Welfare (MHLW), for Padcev (enfortumab vedotin). 27 September 2021
The results from a clinical study called DREAM show that dorzagliatin, a glucokinase activator and a first-in-class investigational drug of China’s Hua Medicine may make progress in diabetes remission. 27 September 2021
Spanish drugmaker PharmaMar has announced its licensing partner, Specialised Therapeutics Asia (STA), has received provisional marketing approval for Zepzelca (lurbinectedin) by the Singapore Health Sciences Authority (HSA) for the treatment of adult patients with metastatic small cell lung cancer (SCLC) who have progressed after prior platinum-containing chemotherapy. 24 September 2021
China’s Worg Pharmaceuticals (Hangzhou) has entered into an asset purchase agreement to acquire Belgian biotech’s Apitope International’s proprietary platform and therapeutic pipeline. 23 September 2021
South Korea’s Celltrion Healthcare saw its shares gain more than 3% to 275,500 won today, after it revealed over the weekend that the Korean Ministry of Food and Drug Safety (MFDS) approved its regdanvimab (CT-P59), a monoclonal antibody treatment for COVID-19. 20 September 2021
The US Food and Drug Administration has granted accelerated approval for Brukinsa (zanubrutinib) for the treatment of adult patients with relapsed or refractory (R/R) marginal zone lymphoma (MZL) who have received at least one anti-CD20-based regimen. 16 September 2021
The Center for Drug Evaluation of China’s National Medical Products Administration (NMPA) has granted Breakthrough Therapy designation (BTD) to amdizalisib (HMPL-689), a highly selective and potent PI3Kδ inhibitor, for the treatment of relapsed or refractory follicular lymphoma (FL), a subtype of non-Hodgkin’s lymphoma (NHL). 13 September 2021
Sumitomo Dainippon Pharma has launched Twymeeg (imeglimin hydrochloride) in Japan, the first launch of the diabetes drug anywhere in the world. 10 September 2021
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