Chinese biotech DualityBio has shown that it means business in a filing to the Hong Kong stock exchange that reveals its plans for an initial public offering (IPO). 28 August 2024
Japanese pharma major Astellas Pharma today revealed that the European Commission has granted Marketing Authorization for Padcev (enfortumab vedotin, an antibody-drug conjugate [ADC]) in combination with Keytruda (pembrolizumab). 28 August 2024
Chugai Pharmaceutical has announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved an additional indication for Alecensa (alectinib). 28 August 2024
South Korea’s Celltrion yesterday announced the European Commission (EC) approval for the use of SteQeyma (CT-P43), an ustekinumab biosimilar referencing Stelara, for the treatment of multiple chronic inflammatory diseases. 27 August 2024
China's National Medical Products Administration (NMPA) has approved domestic biopharma firm Innovent Biologics’ Dupert (fulzerasib) for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) harboring KRAS G12C mutation who have received at least one systemic therapy. 22 August 2024
Germany's pharmaceutical sector is on high alert for potential drug shortages, following China’s recent intensification of its espionage laws. 21 August 2024
AstraZeneca (LSE: AZN) has announced that Fasenra (benralizumab) has picked up a new approval from China's National Medical Products Administration (NMPA). 20 August 2024
The Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has approved Padcev (enfortumab vedotin) for the treatment of adult patients with locally advanced or metastatic urothelial cancer. 20 August 2024
Japanese drugmaker Ono Pharmaceutical (TYO: 4528) has announced that the US medicines regulator will consider vimseltinib under the Priority Review scheme. 16 August 2024
Shanghai-based OcuMension Therapeutics (HKSE: 1477) has reached an agreement with Alcon (NYSE: ALC) to acquire commercialization rights in China for several of its dry eye products. 15 August 2024
Japanese drugmaker Chugai Pharmaceutical has filed a regulatory application with the Ministry of Health, Labor and Welfare (MHLW) for gene therapy delandistrogene moxeparvovec, for the treatment of Duchenne muscular dystrophy (DMD). 15 August 2024
Daiichi Sankyo’s shares rose 5.5% to 5,758 yen this morning, after it announced a third approval in China for Enhertu (trastuzumab deruxtecan). 13 August 2024
US pharma giant Merck & Co is to buy CN201, an investigational clinical-stage bispecific antibody for the treatment of B-cell associated diseases, from privately-held Chinese biotech Curon Biopharmaceutical. 9 August 2024
Germany-based Medigene’s shares were down 3.7% at 1.04 euros in late afternoon trading, after it revealed a collaboration with China’s WuXi Biologics. 8 August 2024
Takeda announced that the European Commission (EC) has approved Adzynma (apadamtase alfa/cinaxadamtase alfa; code name TAK-755) for the treatment of ADAMTS13 deficiency in children and adult patients with congenital thrombotic thrombocytopenic purpura (cTTP). 8 August 2024
US clinical-stage biotech Equillium saw its shares rise 8% to $0.68 as it revealed progress with its first-in-class anti-CD6 monoclonal antibody. 6 August 2024
Daiichi Sankyo (and US pharma giant Merck & Co have expanded their existing global co-development and co-commercialization agreement to include Merck’s MK-6070. 6 August 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
Japanese drugmaker Chugai Pharmaceutical says it will transfer the business of the secondary hyperparathyroidism drug Oxarol for Injection (maxacalcitol) to LTL Pharma in Japan. 29 August 2024