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
With its potential to revolutionize type 2 diabetes (T2D) treatment, Chinese firm Innovent Biologics’ (HKG: 1801) mazdutide's success could reshape the landscape of diabetes therapeutics in China. 25 May 2024
Indian biotech major Biocon has signed an exclusive licensing and supply agreement with South Korea’s Handok, for the commercialization of its vertically integrated, complex drug product, synthetic liraglutide. 24 May 2024
The European Commission (EC) has approved the label update of both Nilemdo (bempedoic acid) and Nustendi (bempedoic acid / ezetimibe fixed-dose combination (FDC)), as treatments for hypercholesterolaemia (high levels of cholesterol) and to reduce the risk of adverse cardiovascular events. 24 May 2024
Privately-held Chinese developer of molecular glue degraders for cancer treatment Degron Therapeutics has entered into a collaboration and exclusive license agreement with Japan’s largest drugmaker Takeda Pharma. 23 May 2024
Roche’s Japan-based majority-owned company Chugai has launched PiaSky for injection 340 mg (crovalimab), a pH-dependent binding humanized anti-complement (C5) monoclonal antibody for the treatment of paroxysmal nocturnal hemoglobinuria (PNH), in the Asian country. 23 May 2024
Japanese drugmaker Daiichi Sankyo has established two research institutes: DS Research Institute Boston and DS Research Institute Munich, in Cambridge, Massachusetts, USA and Munich, Germany, respectively. 23 May 2024
Japanese drugmaker Otsuka Pharmaceutical and its US subsidiary have decided to terminate the development of the novel compound AVP-786, which was being studied as a potential treatment for patients with agitation associated with dementia due to Alzheimer's disease. 23 May 2024
Given that the USA’s House Committee on Oversight and Accountability held a markup meeting last week on the legislation, it is likely that the USA will pass the BIOSECURE Act (the Act) in December this year. 21 May 2024
UK pharma major AstraZeneca today revealed it intends to build a $1.5 billion manufacturing facility in Singapore for antibody-drug conjugates (ADCs), enhancing global supply of its ADC portfolio. 20 May 2024
Japanese drugmaker Otsuka has announced that the primary endpoint was achieved in the Phase III trial in Japan of bempedoic acid as a potential treatment for patients with hypercholesterolemia. 20 May 2024
Shares of HLB Pharma plunged almost 30% to 67,100 won on Friday to their daily price floors, as the US Food and Drug Administration (FDA) rejected a new drug approval for rivoceranib, the Korean firm’s liver cancer treatment, according to a Korea Times report. 18 May 2024
Japanese drugmaker Ono Pharmaceutical has received supplemental approvals for the BRAF inhibitor Braftovi (encorafenib), and the MEK inhibitor Mektovi (binimetinib), when used in combination, in Japan for two new indications. 17 May 2024
The USA’s House Committee on Oversight and Accountability held a markup meeting yesterday to consider a series of bills that address federal agency procurement of biotechnology equipment, safeguarding taxpayer dollars, improving federal cybersecurity, and more. 16 May 2024
Chinese biopharma company Everest Medicines announced that Nefecon, a delayed release capsule of budesonide, has been successfully launched in China with the first prescription issued. 14 May 2024
The Phase III study (SCORPIO-HR) with ensitrelvir did not meet its primary endpoint of a statistically-significant reduction in time to sustained resolution of 15 common COVID-19 related symptoms, said Japanese drugmaker Shionogi. 13 May 2024
The US unit of South Korea’s Celltrion announced that adalimumab-aaty, the company's high-concentration (100 mg/mL) and citrate-free formulation biosimilar to Humira (adalimumab), is now available at a low wholesale acquisition cost (WAC). 13 May 2024
A new version of a congressional bill, dubbed the BIOSECURE Act, that would restrict US business with certain Chinese biotechnology companies would give US companies until 2032 to end work with the firms, extending the amount of time to find new partners. 11 May 2024