Singapore’s Agency for Science, Technology and Research (A*STAR) and US biotech incubator Flagship Pioneering have agree to collaborate on advancing health and sustainability outcomes in Singapore and the broader Asia Pacific region. 4 October 2024
PeptiDream says that its wholly-owned PDRadiopharma subsidiary has entered into a strategic partnership with French nuclear medicines firm Curium. 3 October 2024
Nxera Pharma has entered a new commercial partnership agreement with fellow Japanese drugmaker Shionogi regarding the distribution and sales for Quviviq (daridorexant 25 and 50mg) in Japan. 1 October 2024
Sino-American biotech Regor Pharmaceuticals has entered into a definitive purchase agreement whereby Swiss pharma major Roche (ROG: SIX) subsidiary Genentech will acquire a portfolio of next-generation CDK inhibitors from Regor for the treatment of breast cancer. 30 September 2024
China-based Asieris Pharmaceuticals announced that the international multicenter Phase III clinical study data of its non-surgical treatment for cervical high-grade squamous intraepithelial lesion (HSIL) product Cevira (APL-1702) will be published at the 27th Chinese Society of Clinical Oncology. 30 September 2024
The National Medical Products Administration (NMPA), China's top drug regulator, says it will redouble efforts to facilitate research and market registration of homegrown innovative drugs, while speeding up the introduction of novel foreign drugs to the domestic market to meet public demand. 30 September 2024
Shionogi said today that it has submitted a New Drug Application (NDA) in Japan for zuranolone, a treatment in development for major depressive disorder (MDD). 27 September 2024
China’s National Medical Products Administration (NMPA) has approved Dupixent (dupilumab) as an add-on maintenance treatment for adults with uncontrolled chronic obstructive pulmonary disease (COPD). 27 September 2024
Antibody-drug conjugates (ADCs) represent a significant advancement in cancer treatment, particularly within China's burgeoning oncology sector. 27 September 2024
Asklepios BioPharmaceutical (AskBio), a gene therapy company wholly-owned and independently operated as a subsidiary of Bayer, has announced a new strategic collaboration with Belief BioMed (BBM) to explore the potential for new gene therapies. 25 September 2024
Amgen yesterday revealed that Tepezza (teprotumumab [genetical recombination]) has been approved for the treatment of active or high clinical activity score (CAS) thyroid eye disease (TED) in Japan. 25 September 2024
Eli Lilly's Kisunla has been approved in Japan for early symptomatic Alzheimer's disease, following its US approval in July 2024. Administered via IV infusion, it targets patients with mild cognitive impairment and dementia linked to amyloid pathology. Kisunla aims to slow cognitive and functional decline in AD patients 25 September 2024
The Japanese Ministry of Health, Labor, and Welfare (MHLW) has approved Otsuka’s (TYO: 4578) Lupkynis (voclosporin) for the treatment of lupus nephritis (LN), an inflammation of the kidneys caused by systemic lupus erythematosus (SLE), an autoimmune disease 24 September 2024
CSL Vifor today announced that Japan’s Ministry of Health and Labor Welfare (MHLW) has granted its partner, Zeria Pharmaceutical marketing authorization approval for Veltassa (patiromer). 24 September 2024
Japan’s Daiichi Sankyo and Anglo-Swedish pharma major AstraZeneca were trading lower on Tuesday after announcing topline results from the TROPION-Breast01 study. 24 September 2024
Takeda has announced the Japanese approval of Fruzaqla (fruquintinib) capsules 1mg/5mg, a selective oral inhibitor of vascular endothelial growth factor receptor (VEGFR) -1, -2 and -3, to treat advanced or recurrent colorectal cancer (CRC) that is neither curable nor resectable and that has progressed after chemotherapy. 24 September 2024
Japan’s Ministry of Health, Labor and Welfare of Japan (MHLW) has approved New Drug Application (NDA) for Quviviq (daridorexant; ACT-541468) 25mg and 50mg for the treatment of adult patients with insomnia, submitted by Nxera Pharma. 24 September 2024
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
South Korea has recently decided to provide practical support to innovative pharmaceutical companies by revising the existing health insurance benefits system. 8 September 2021
Blockbuster anti-PD-1 therapy Keytruda (pembrolizumab) has been approved by China’s National Medical Products Administration (NMPA) in combination with platinum- and fluoropyrimidine-based chemotherapy for the first-line treatment of patients with locally advanced unresectable or metastatic carcinoma of the esophagus or gastroesophageal junction (GEJ). 7 September 2021
Shanghai, China headquartered Zai Lab has announced that the Taiwan Food and Drug Administration has approved its New Drug Application (NDA) for Qinlock (ripretinib) for the treatment of adult patients with advanced gastrointestinal stromal tumors (GIST). 6 September 2021
Chinese drug developer JW Therapeutics saw its shares rocket 28% to HK$22.80 today, as it announced that China’s National Medical Products Administration (NMPA) has approved the New Drug Application (NDA)... 6 September 2021
Japan’s largest drugmaker Takeda Pharmaceutical today revealed that the Phase III PANTHER (Pevonedistat-3001) study did not achieve pre-defined statistical significance for the primary endpoint of event-free survival (EFS). 2 September 2021
Brukinsa (zanubrutinib) has received approval from the US Food and Drug Administration (FDA) for the treatment of adult patients with Waldenström’s macroglobulinemia (WM). 2 September 2021
Chinese biopharma firm Innovent Biologics and US biotech Bolt Biotherapeutics have announced a drug research and development collaboration to develop three new anti-cancer therapeutic immune-stimulating antibody conjugate (ISAC) candidates. 31 August 2021
Japanese pharma major Eisai has concluded a license agreement concerning dotinurad, a treatment for hyperuricemia and gout discovered by Fuji Yakuhin, for development and distribution in five ASEAN (Association of Southeast Asian Nations) member states: Indonesia, Malaysia, Myanmar, the Philippines, and Thailand. 31 August 2021
Daiichi Sankyo has concluded an agreement on commercialization collaboration in Japan with the local subsidiary of US pharma major Eli Lilly for the 5-HT1F receptor agonist lasmiditan succinate, for which Eli Lilly Japan has submitted a new drug application for the treatment of migraines. 31 August 2021
Approval has been granted for the combination of Opdivo (nivolumab) intravenous infusion and Cabometyx (cabozantinib s-malate) tablets in Japan for the treatment of unresectable or metastatic renal cell carcinoma (RCC), for a partial change in approved items of the manufacturing and marketing approval. 25 August 2021
Sino-America biotech firm BeiGene today said that the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has accepted a supplemental Biologics License Application (sBLA) for its anti-PD-1 antibody tislelizumab in combination with chemotherapy as a first-line treatment for patients with recurrent or metastatic nasopharyngeal cancer (NPC). 23 August 2021
Japanese drugmaker Ono Pharmaceutical closed up 1% today, after it announced that its Ono Pharma Korea Co unit has received marketing approval for Braftovi (encorafenib) Capsule 75mg, a BRAF inhibitor, from the Ministry of Food and Drug Safety (MFDS) in South Korea. 20 August 2021
Japanese drug major Takeda Pharmaceutical’s TAK-994 has recently received Breakthrough Therapy designation (BTD) from the US Food and Drug Administration for the treatment of excessive daytime sleepiness (EDS) in patients with narcolepsy type 1 (NT1). 20 August 2021
A pre-clinical stage biopharmaceutical group developing new medicines and treatments to treat blood and autoimmune disease and to bring the curative power of bone marrow transplantation to a greater number of patients suffering from otherwise incurable life-threatening diseases.