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Biotechnology
Privately-held Certa Therapeutics, a biotech developing precision therapies for fibrotic diseases, has acquired fellow Australian firm OccuRx. 19 December 2024
Pharmaceutical
Japanese firms Nxera Pharma- formerly known as Sosei Group or Sosei Heptares- and Shionogi have announced that Quviviq (daridorexant) 25mg and 50 mg has been launched and is now available in the Asian country as a new treatment for adults with insomnia. 19 December 2024
Pharmaceutical
US pharma giant Merck & Co and Chinese biopharma Hansoh Pharma have entered into an exclusive global license agreement for HS-10535, an investigational pre-clinical oral small molecule GLP-1 receptor agonist (RA). 18 December 2024
Biotechnology
Eli Lilly has announced that China’s National Medical Products Administration has approved Kisunla (donanemab-azbt) for certain adults with early Alzheimer’s disease. 18 December 2024
Biosimilars
The US Food and Drug Administration (FDA) has approved Steqeyma (ustekinumab-stba), a biosimilar to Johnson & Johnson’s Stelara, from South Korea’s Celltrion. 18 December 2024
Biosimilars
South Korea has emerged as a global leader in the biopharmaceutical industry, driven by its advanced clinical research infrastructure and government support. 18 December 2024
Biotechnology
China's drug regulator has approved clinical trials for an experimental mpox vaccine developed by Sinopharm, marking a significant step in the country’s efforts to offer an alternative jab. 17 December 2024
Biotechnology
Cell therapy specialist Candid Therapeutics has entered a strategic collaboration with Shanghai-based EpimAb Biotherapeutics to discover and develop new T-Cell engager (TCE) candidates. 17 December 2024
Pharmaceutical
Japanese drugmaker Kyorin Pharmaceutical has entered into a licensee agreement with Bayer for the novel obstructive sleep apnea (OSA) treatment BAY2925976 and its backup compound discovered by the German pharma major. 17 December 2024
Pharmaceutical
Eli Lilly and Innovent Biologics have announced a distribution and promotion agreement for Jaypirca in China. 16 December 2024
Pharmaceutical
Japan’s largest drugmaker, Takeda Pharmaceuticals, announced it is working with the European Medicines Agency (EMA) to voluntarily withdraw the marketing authorization of Alofisel (darvadstrocel), a treatment for complex perianal fistulas in patients with Crohn’s disease, in the European Union (EU). 16 December 2024
Biotechnology
Chinese biotech RemeGen has presented results from a Phase III trial of disitamab vedotin, a HER2-targeted antibody-drug conjugate (ADC), at the San Antonio Breast Cancer Symposium. 16 December 2024
Biosimilars
The HSE University BRICS Competition Law and Policy Centre has summarized the first results of its annual analytical study on bringing biologics to the BRICS market. 13 December 2024
Biotechnology
Sino-American biotech BeiGene has announced it has entered into a global licensing agreement with China’s CSPC Zhongqi Pharmaceutical Technology for SYH2039, a novel methionine adenosyltransferase 2A (MAT2A)-inhibitor being explored for solid tumors. 13 December 2024
Pharmaceutical
Italy-based CNS specialist Newron Pharmaceuticals has entered into a license agreement with EA Pharma, part of Japan’s Eisai to develop, manufacture and commercialize Newron’s innovative modulator of the excessive release of glutamate, evenamide, in Japan and other designated territories. 13 December 2024
Biotechnology
Daiichi Sankyo has announced plans to invest 1.1 billion renminbi ($150 million) to build a new manufacturing facility for antibody-drug conjugates (ADCs) in Shanghai's Zhangjiang area. 12 December 2024
Pharmaceutical
Chinese biopharma Hutchmed today announced that the Center for Drug Evaluation of China’s National Medical Products Administration (NMPA) has granted Breakthrough Therapy designation (BTD) for the combination of its Orpathys (savolitinib) and AstraZeneca’s Tagrisso (osimertinib). 12 December 2024
Pharmaceutical
Swiss specialty pharmaceutical company Santhera Pharmaceuticals has received approval from the National Medical Products Administration in China for Agamree (vamorolone). 11 December 2024
Pharmaceutical
South Korean biotech SK Biopharmaceuticals has unveiled the Phase III clinical trial results of Xcopri (cenobamate) in Northeast Asian epilepsy patients through a poster presentation at the 2024 American Epilepsy Society (AES) Annual Meeting in Los Angeles, USA. 10 December 2024
Biotechnology
The BIOSECURE Act—US legislation aimed at safeguarding the country’s interests against potential security threats from China—is facing further delay. 10 December 2024
Biotechnology
Privately-held Certa Therapeutics, a biotech developing precision therapies for fibrotic diseases, has acquired fellow Australian firm OccuRx. 19 December 2024
Pharmaceutical
Japanese firms Nxera Pharma- formerly known as Sosei Group or Sosei Heptares- and Shionogi have announced that Quviviq (daridorexant) 25mg and 50 mg has been launched and is now available in the Asian country as a new treatment for adults with insomnia. 19 December 2024
Pharmaceutical
US pharma giant Merck & Co and Chinese biopharma Hansoh Pharma have entered into an exclusive global license agreement for HS-10535, an investigational pre-clinical oral small molecule GLP-1 receptor agonist (RA). 18 December 2024
Biotechnology
Eli Lilly has announced that China’s National Medical Products Administration has approved Kisunla (donanemab-azbt) for certain adults with early Alzheimer’s disease. 18 December 2024
Biosimilars
The US Food and Drug Administration (FDA) has approved Steqeyma (ustekinumab-stba), a biosimilar to Johnson & Johnson’s Stelara, from South Korea’s Celltrion. 18 December 2024
Biosimilars
South Korea has emerged as a global leader in the biopharmaceutical industry, driven by its advanced clinical research infrastructure and government support. 18 December 2024
Biotechnology
China's drug regulator has approved clinical trials for an experimental mpox vaccine developed by Sinopharm, marking a significant step in the country’s efforts to offer an alternative jab. 17 December 2024
Biotechnology
Cell therapy specialist Candid Therapeutics has entered a strategic collaboration with Shanghai-based EpimAb Biotherapeutics to discover and develop new T-Cell engager (TCE) candidates. 17 December 2024
Pharmaceutical
Japanese drugmaker Kyorin Pharmaceutical has entered into a licensee agreement with Bayer for the novel obstructive sleep apnea (OSA) treatment BAY2925976 and its backup compound discovered by the German pharma major. 17 December 2024
Pharmaceutical
Eli Lilly and Innovent Biologics have announced a distribution and promotion agreement for Jaypirca in China. 16 December 2024
Pharmaceutical
Japan’s largest drugmaker, Takeda Pharmaceuticals, announced it is working with the European Medicines Agency (EMA) to voluntarily withdraw the marketing authorization of Alofisel (darvadstrocel), a treatment for complex perianal fistulas in patients with Crohn’s disease, in the European Union (EU). 16 December 2024
Biotechnology
Chinese biotech RemeGen has presented results from a Phase III trial of disitamab vedotin, a HER2-targeted antibody-drug conjugate (ADC), at the San Antonio Breast Cancer Symposium. 16 December 2024
Biosimilars
The HSE University BRICS Competition Law and Policy Centre has summarized the first results of its annual analytical study on bringing biologics to the BRICS market. 13 December 2024
Biotechnology
Sino-American biotech BeiGene has announced it has entered into a global licensing agreement with China’s CSPC Zhongqi Pharmaceutical Technology for SYH2039, a novel methionine adenosyltransferase 2A (MAT2A)-inhibitor being explored for solid tumors. 13 December 2024
Pharmaceutical
Italy-based CNS specialist Newron Pharmaceuticals has entered into a license agreement with EA Pharma, part of Japan’s Eisai to develop, manufacture and commercialize Newron’s innovative modulator of the excessive release of glutamate, evenamide, in Japan and other designated territories. 13 December 2024
Biotechnology
Daiichi Sankyo has announced plans to invest 1.1 billion renminbi ($150 million) to build a new manufacturing facility for antibody-drug conjugates (ADCs) in Shanghai's Zhangjiang area. 12 December 2024
Pharmaceutical
Chinese biopharma Hutchmed today announced that the Center for Drug Evaluation of China’s National Medical Products Administration (NMPA) has granted Breakthrough Therapy designation (BTD) for the combination of its Orpathys (savolitinib) and AstraZeneca’s Tagrisso (osimertinib). 12 December 2024
Pharmaceutical
Swiss specialty pharmaceutical company Santhera Pharmaceuticals has received approval from the National Medical Products Administration in China for Agamree (vamorolone). 11 December 2024
Pharmaceutical
South Korean biotech SK Biopharmaceuticals has unveiled the Phase III clinical trial results of Xcopri (cenobamate) in Northeast Asian epilepsy patients through a poster presentation at the 2024 American Epilepsy Society (AES) Annual Meeting in Los Angeles, USA. 10 December 2024
Biotechnology
The BIOSECURE Act—US legislation aimed at safeguarding the country’s interests against potential security threats from China—is facing further delay. 10 December 2024
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