A new discovery and development collaboration has been agreed between Boston, USA-based Verastem Oncology and Shanghai's GenFleet Therapeutics. 29 August 2023
Japanese drugmaker Otsuka Holdings subsidiary Taiho Pharmaceutical has entered into an option and license agreement with French biotech firm Phost’in Therapeutics, through which Taiho will gain option rights to in-license PhOx430, a first-in-class small molecule targeting GnT-V (nacetylglucosaminyltransferase-V). 29 August 2023
An update on the Phase III LEAP-010 trial evaluating Eisai Lenvima (lenvatinib) plus Merck & Co’s Keytruda (pembrolizumab), as a first-line treatment for patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) whose tumors express PD-L1, was announced today. 25 August 2023
Japanese mid-size drugmaker Kyowa Kirin says it has received approval from the Ministry of Health, Labor and Welfare (MHLW) for partial change of approved indication of Lumicef (brodalumab [genetical recombination]) for the treatment of palmoplantar pustulosis (PPP) that respond inadequately to existing therapies. 24 August 2023
US mRNA specialist Moderna saw its shares close up 9.3% at $111.08 on Monday after the announcement of a collaboration agreement to investigate Shanghai, China-based CARsgen Therapeutics’ investigational Claudin18.2 CAR T-cell product candidate (CT041) in combination with Moderna’s investigational Claudin18.2 mRNA cancer vaccine. 22 August 2023
Chinese biopharma Hutchmed has announced that the pivotal Phase III trial ESLIM-01 evaluating the investigational use of sovleplenib met its primary endpoint of durable response rate in adults with primary immune thrombocytopenia (ITP) in China. 21 August 2023
Daewoong Pharmaceutical has already won approvals for its indigenous therapies—sodium–glucose linked transporter-2 (SGLT-2) inhibitor Envlo (enavogliflozin) and its metformin combination drug Envlomet—in South Korea. 18 August 2023
Forxiga (dapagliflozin) has been approved in China to reduce the risk of cardiovascular death, hospitalization for heart failure (HF), or urgent HF visits in adults with symptomatic chronic HF, UK Pharma major AstraZeneca announced this morning. 18 August 2023
Singapore-listed healthcare company Medi Lifestyle has announced a collaboration involving its subsidiaries, HealthPro Pharma and Healthpro Marketing, with FIOR Bioscience and Shine Bioscience. 16 August 2023
According to the official website of the China State Drug Administration the application for marketing authorization of Feisumei (benaglutide) injection for obesity or overweight indications declared by Benemae Pharmaceuticals/Renhui Biotech was approved for weight management of adults. 16 August 2023
US CNS specialist Corium and Taiwan-based Lotus Pharmaceutical have entered into an exclusive collaboration and license deal for Adlarity (donepezil transdermal system), an innovative Alzheimer’s dementia treatment, in 10 markets across Asia. 11 August 2023
Following the approval of toripalimab, the drug is expected to get a first-mover advantage in the first-line treatment setting within the PD-1 market in RCC for China, says data and analytics company GlobalData. 11 August 2023
Anglo-Swedish pharma major AstraZeneca’s research into mRNA vaccines is to be aided by the use of Chinese biotech firm CanSino Biologics' manufacturing platform. 10 August 2023
Japanese drug major Astellas Pharma has announced a strategic investment to support the advancement of Poseida Therapeutics’ commitment to redefining cancer cell therapy. The news pushed Poseida’s shares up as much as 24% to $2.69. 9 August 2023
South Korean vaccine developer SK bioscience’s shares were up 4.6% at 84,500 won, after it announced its decision to make an equity investment of around $85 million in US biotech Novavax. 9 August 2023
Sino-American biotech Terns Pharmaceuticals yesterday revealed positive top-line results from the Phase IIa DUET clinical trial of TERN-501, both alone and in combination with TERN-101, for the treatment of non-alcoholic steatohepatitis (NASH). 9 August 2023
The US Food and Drug Administration (FDA) approved Japanese drug major Astellas Pharma’s Izervay (avacincaptad pegol intravitreal solution) for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD) late Friday, 7 August 2023
Sino-American biotech specializing in liver disease and cancer Terns Pharmaceuticals has announced that Senthil Sundaram has resigned from his position as Terns’ chief executive for health reasons previously disclosed in January 2022. 5 August 2023
The US Food and Drug Administration (FDA) has approved Lonsurf (trifluridine/tipiracil), developed by Taiho Oncology Inc and Taiho Pharmaceutical, subsidiaries of Japanese drugmaker Otsuka Holdings, with the decision coming ahead of the August 13 expected date. 3 August 2023
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