Japanese drugmaker Kyowa Kirin has decided to build a new active pharmaceutical ingredient (API) manufacturing building (HB7 Building) at its Takasaki plant that is responsible for manufacturing biopharmaceuticals. 17 May 2022
Alzheimer’s disease (AD) is a progressive fatal neurological disorder and the most common cause of dementia primarily affecting the elderly population, with AD-associated dementia accounting for two-thirds of dementia cases in Japan. 17 May 2022
Anglo-Austrian firm F2G Ltd has entered a strategic collaboration with Japan’s Shionogi to develop and commercialize the new antifungal agent olorofim for invasive fungal infections in Europe and Asia. 16 May 2022
Japanese drugmaker Takeda has announced the Indian launch of Adynovate, an extended half-life recombinant Factor VIII (rFVIII) treatment, using established technology (controlled PEGylation), for hemophilia A patients. 16 May 2022
Japanese drugmaker Otsuka says it has decided to terminate its global license agreements with Akebia Therapeutics for vadadustat, under development as an oral treatment for anemia associated with chronic kidney disease (renal anemia). 16 May 2022
The US Food and Drug Administration has approved Radicava ORS (edaravone) oral suspension for the treatment of adults with amyotrophic lateral sclerosis (ALS). 13 May 2022
Japanese ophthalmology specialist Santen Pharmaceutical has received approval of Verkazia (ciclosporin eye drops) from the National Medical Products Administration (NMPA) in China through its Chinese legal entity for the treatment of severe vernal keratoconjunctivitis (VKC) in children and adolescents aged 4 years and above. 11 May 2022
Alzheimer’s drug developer Eisai has completed a rolling submission to the US Food and Drug Administration for its next-gen anti-amyloid beta candidate lecanemab. 10 May 2022
Sino-American biotech BeiGene has announced that the China National Medical Products Administration (NMPA) has granted conditional approval of Blincyto (blinatumomab) for injection for the treatment of pediatric patients with relapsed or refractory (R/R) CD19-positive B-cell precursor acute lymphoblastic leukemia (ALL). 6 May 2022
Ireland-headquartered drugmaker Jazz Pharmaceuticals and Japan’s Sumitomo Pharma have announced that the companies have entered into an exclusive licensing agreement. 5 May 2022
Singapore-based Juniper Biologics and privately-held Swiss drugmaker Helsinn Group have signed an exclusive license agreement to develop and commercialize infigratinib (INN) in Australia, New Zealand, Southeast Asia and certain markets in the Middle East and Africa . 4 May 2022
Biotechnology Innovation Organization (BIO) has hit out at the US Trade Representative’s (USTR) continued support for a waiver of IP protections for COVID-19 vaccines under the WTO (World Trade Organization) Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). 3 May 2022
Chinese biotech Hutchmed on Monday announced that the US Food and Drug Administration has issued a Complete Response Letter (CRL) regarding the New Drug Application (NDA) for surufatinib for the treatment of pancreatic (pNETs) and extra-pancreatic (non-pancreatic, epNETs) neuroendocrine tumors (NETs). 3 May 2022
Chinese start-up Xbiome, an AI-based microbiome drug development company, has acquired the clinical-stage M201 program from Californian firm Assembly Biosciences. 27 April 2022
The China National Medical Products Administration (NMPA) has recently granted breakthrough therapy (BTD) designation to China’s Innovent Biologic’s IBI310 in combination with Tyvyt (sintilimab) to treat patients with recurrent or metastatic cervical cancer. 27 April 2022
Japanese drugmaker Eisai today announced an article about long-term health outcomes of its investigational anti-amyloid-beta protofibril antibody lecanemab in people living with early Alzheimer’s disease (AD) using simulation modeling was published in a peer-reviewed journal Neurology and Therapy. 27 April 2022
The Malaysian business of Biocon subsidiary Biocon Biologics has agreed a deal to supply its recombinant human insulin brand Insugen to the country’s healthcare system. 26 April 2022
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