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FDA Grants Accelerated Approval for Takeda’s Iclusig in Newly Diagnosed Ph+ ALL
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The U.S. Food and Drug Administration (FDA) has granted accelerated indication extension approval to Japan’s Takeda Pharmaceutical Company (TYO: 4502) for its tyrosine kinase inhibitor (TKI) Iclusig (ponatinib) in combination with chemotherapy for the treatment of newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL). This follows the drug’s previous…
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China Unveils Action Plan to Boost Foreign Investment and Open Economy Further
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The State Council of China has unveiled an ambitious “Action Plan to Promote the High-Level Opening up of China to Global Markets and Attract and Apply Greater Levels of Foreign Investment.” This initiative aims to further integrate China’s economy with global markets and enhance foreign investment inflows. Key measures include…
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Simcere Pharmaceutical Reports 4.5% Revenue Growth in 2023 Amid Shifts in Profitability
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Simcere Pharmaceutical Group (HKG: 2096), based in China, has released its 2023 financial performance report, revealing revenues of RMB 6.6 billion (USD 920 million) for the year, marking a 4.5% increase year-on-year (YOY). Within this total, drug sales and promotion services contributed RMB 6.567 billion, while out-licensing and research and…
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Sinopharm and Fresenius Kabi Expand Partnership to Enhance Drug Distribution and Healthcare Services
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China’s state-owned Sinopharm Group Co., Ltd. (HKG: 1099) has announced a new partnership with Germany’s Fresenius Kabi, enhancing collaboration across various sectors including drug sales, warehousing and distribution, as well as big health, medical care, and wellness. Financial details of the agreement were not disclosed. This partnership marks a continuation…
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Bayer and Thermo Fisher Partner to Develop Rapid Companion Diagnostics for Precision Oncology
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Germany’s Bayer (NYSE: BAYE) has entered into a strategic partnership with U.S. life sciences leader Thermo Fisher Scientific (NYSE: TMO) to develop next-generation sequencing (NGS)-based companion diagnostic assays (CDx) aimed at enhancing precision cancer therapies. Financial terms of the collaboration remain undisclosed. According to the press release, the diagnostic tests…
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iRegene’s NouvSight001 Gains Orphan Drug Designation for Retinitis Pigmentosa Treatment
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Wuhan-based cell therapy innovator iRegene has secured Orphan Drug Designation (ODD) from the U.S. FDA for its ophthalmic product NouvSight001, aimed at treating retinitis pigmentosa (RP). NouvSight001 is heralded as the world’s first universal ophthalmic cell therapy derived from induced pluripotent stem cells (iPSCs), developed through an innovative “AI+chemical induction”…
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BMS Reports Positive Phase III Results for Opdivo and Yervoy in Advanced HCC
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Bristol Myers Squibb (BMS; NYSE: BMY) announced this week that its Phase III study evaluating the combination of anti-PD-1 drug Opdivo (nivolumab) and anti-CTLA-4 biologic Yervoy (ipilimumab) as a first-line treatment for advanced hepatocellular carcinoma (HCC) has yielded promising top-line results. According to data from a pre-specified interim analysis, the…
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China Resources Guangdong Pharmaceutical Partners with BD to Enhance Drug and Device Distribution in GBA
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China Resources Guangdong Pharmaceutical Co., Ltd has entered into a strategic partnership with U.S.-based Becton, Dickinson and Co. (BD) to develop a specialized channel for drugs and medical devices in the Guangdong-Hong Kong-Macao Greater Bay Area (GBA). Under this partnership, China Resources Guangdong Pharmaceutical will capitalize on its strengths to…