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Zai Lab’s Optune Approved by China’s NMPA, Offering New Hope for Glioblastoma Patients
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Zai Lab Ltd (NASDAQ: ZLAB), a biopharmaceutical company based in China, has received approval from the National Medical Products Administration (NMPA) for its innovative therapeutic device, Optune. This tumor treating fields (TTFields) product is now cleared for use in newly diagnosed glioblastoma in combination with temozolomide, and as a monotherapy…
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Enhancing Clinical Trial Success: CDE’s New Adaptive Design Framework Opens for Comment
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The newly proposed guidelines are designed to be applicable across a spectrum of confirmatory clinical studies, encompassing chemical drugs, biological products, and traditional Chinese medicine (TCM). They also hold significant value for exploratory research endeavors. Adopting an adaptive design should be predicated on considerations of rationality, integrity, and feasibility. The…
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Thermo Fisher Scientific Develops Serology Test to Detect COVID-19 Antibodies in Collaboration with WuXi Diagnostics and Mayo Clinic
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Thermo Fisher Scientific Inc., a titan in the US device industry and listed on the NYSE under the ticker (TMO), has unveiled the development of a serology test designed to detect the SARS-CoV-2 coronavirus. This collaborative effort with China’s WuXi Diagnostics and the prestigious US medical institution, Mayo Clinic, is…
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Cuban-Chinese Pharma Synergy: Joint R&D and Sales Initiative Targets USD 24.53 Billion in Sales
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In a significant move to bolster its innovation pipeline, Guangzhou Pharmaceutical Holdings Ltd. has entered into a letter of intent with BioCubaFarma, Cuba’s leading state-owned pharmaceutical company. This strategic alliance is aimed at joint research and development (R&D), manufacturing, and sales of cutting-edge pharmaceutical products in China, with a particular…
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Guangzhou Pharma and BioCubaFarma Chart New Course with Joint Biologics R&D and Exchange Deal
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Guangzhou Pharmaceutical Holdings Ltd., a prominent player in China’s pharmaceutical sector, has inked a strategic letter of intent with BioCubaFarma, Cuba’s foremost state-owned pharmaceutical juggernaut, to embark on a joint venture in research and development (R&D), manufacturing, and commercialization of avant-garde pharmaceutical products within the Chinese market, with a spotlight…
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Hanx Biopharmaceuticals’ HX009 Receives NMPA Clinical Trial Approval for PD-1/CD47 Bispecific Antibody
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China-based Hanx Biopharmaceuticals Co., Ltd has announced that its self-developed anti PD-1/CD47 bispecific antibody drug, HX009, has received a clinical trial notice from the National Medical Products Administration (NMPA) on October 30, 2019 (Acceptance Number: CXSL1900098). This follows the drug’s ethical review approval in Australia in July, where Phase I…
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LanssonPharm Secures Series A Funding to Accelerate CNS Drug Development
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LanssonPharm, a company dedicated to the development of central nervous system (CNS) drugs, has announced the completion of a Series A funding round worth tens of millions of yuan. The financing was led by Yipu Capital, with follow-on investments from Qianrong Capital and existing shareholder Northern Light Venture Capital. This…
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China’s Ministry of Health Tightens Organ Transplant Regulations with Expert Conference
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Shi Bingyi, a distinguished Member of the National Committee of the CPPCC (Chinese People’s Political Consultative Conference) and Director of the Organ Transplantation Center of the People’s Liberation Army (PLA), has disclosed that China’s Ministry of Health has convened a panel of 70 experts to rigorously assess hospitals involved in…
