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Biosecure Act Faces Opposition from Senior House Democrat Jim McGovern
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The trajectory of the US Biosecure Act through the House of Representatives encountered unexpected turbulence this week, as opposition emerged from a prominent legislator. Democrat Jim McGovern, a senior congressman representing Massachusetts and the ranking member of the House Rules Committee, has voiced his dissent against the act, as reported…
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China’s CDE Releases 86th Batch of Reference Preparations for Generic Drug Evaluation
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China’s Center for Drug Evaluation (CDE) has unveiled its 86th roster of reference preparations for generic quality and consistency evaluation (GQCE), seeking public commentary until September 20, 2024. The latest draft opinion expands the list by incorporating 23 new drugs and 27 specifications, aiming to enhance the standardization and reliability…
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Akeso’s Ivonescimab Shows Promising Results in Phase III Clinical Trial for Hepatocellular Carcinoma
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Akeso Inc. (HKG: 9926), a biopharmaceutical company based in China, has announced that its first-in-class bispecific antibody, ivonescimab, in combination with lenvatinib and transcatheter arterial chemoembolization (TACE), has reached a significant milestone in its Phase III clinical trial for unresectable, non-metastatic hepatocellular carcinoma (HCC). The drug has demonstrated promising results…
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AstraZeneca Faces Investigation in China Over Data Privacy and Unapproved Drugs
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AstraZeneca (NASDAQ: AZN), a leading UK pharmaceutical company, is reportedly under the spotlight in Shenzhen, China, with an investigation involving five current and former employees, as per a report by Bloomberg. The probe is said to center on potential breaches of data privacy regulations and the unauthorized importation of drugs…
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U.S. House of Representatives to Review the Biosecure Act Amid Legislative Hurdles
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The U.S. House of Representatives is slated to take up the contentious Biosecure Act the week commencing September 9, as indicated on a website associated with the legislative body. Initially introduced in January, the bill’s trajectory has been marked by delays, raising questions about its potential progression through the House…
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Eli Lilly Partners with Genetic Leap for RNA-Targeted AI Drug Discovery
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Eli Lilly & Co. (NYSE: LLY), a leading pharmaceutical company based in the U.S., has entered into a research collaboration with Genetic Leap, a U.S. biotech firm specializing in artificial intelligence (AI) and RNA genetic medicine. This partnership expands on a previously successful pilot and will see Genetic Leap apply…
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Euroapi to Downsize API Production, Citing Asian Competition and Market Stagnation
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Euroapi (EPA: EAPI), a French company and a spinoff from Sanofi established in 2022, has announced plans to reduce production of 13 active pharmaceutical ingredients (APIs), as reported by Nikkei News. This strategic decision will lead to the divestment of its manufacturing facilities located in Brindisi, Italy, and Haverhill, UK,…
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Rigel Pharmaceuticals Strikes Deal with Kissei for Development and Commercialization of Rezlidhia in East Asia
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Rigel Pharmaceuticals Inc. (NASDAQ: RIGL), a biopharmaceutical company based in the U.S., has entered into a license and supply agreement with Japan’s Kissei Pharmaceutical Co., Ltd. The agreement grants Kissei the rights to develop and commercialize Rigel’s Rezlidhia (olutasidenib) across Japan, South Korea, and Taiwan. Rezlidhia is an oral isocitrate…
