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FDA Panel Weighs in on Narrowing Use of PD-1 Inhibitors in Stomach and Esophageal Cancers
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The U.S. FDA’s Oncologic Drugs Advisory Committee (ODAC) convened on September 26 to scrutinize the application of PD-1 inhibitors in oncology, particularly focusing on Bristol Myers Squibb’s (NYSE: BMY) Opdivo (nivolumab) and Merck, Sharp & Dohme’s (NYSE: MRK) Keytruda (pembrolizumab). The committee evaluated the risk-benefit profile of these drugs for…
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2seventy bio and BMS Discontinue Phase III Trial for Multiple Myeloma Therapy Abecma
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2seventy bio Inc. (NASDAQ: TSVT), a U.S.-based biotechnology company partnered with Bristol-Myers Squibb (BMS, NYSE: BMY) on the development of the chimeric antigen receptor (CAR) T-cell therapy Abecma (idecabtagene vicleucel; ide-cel), has announced the discontinuation of enrollment in a Phase III clinical trial. The trial, known as KarMMa-9, was investigating…
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Zelgen Biopharmaceuticals Receives NMPA Approval for ZG005 Clinical Trial in Advanced Solid Tumors
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Suzhou Zelgen Biopharmaceuticals Co., Ltd (SHA: 688266), a biopharmaceutical company based in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to proceed with a Phase I/II clinical study for its pipeline drug candidate, ZG005, aimed at treating advanced solid tumors. ZG005 is an…
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Johnson & Johnson Reportedly Winding Down Cardiovascular and Metabolic Pharma Unit
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Johnson & Johnson (J&J; NYSE: JNJ), a healthcare giant in the U.S., is reportedly winding down its cardiovascular and metabolic pharmaceutical unit, as reported by Endpoints News. Insiders have indicated that J&J has issued notices to its sales, marketing, and medical affairs teams this week. The company has acknowledged the…
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Jiangsu Hengrui Medicine Gets NMPA Green Light for Generic Vizamyl Clinical Trial
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Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276), a leading pharmaceutical company based in China, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its generic version of GE Healthcare’s Vizamyl (flutemetamol F-18). This trial aims to evaluate the positron emission tomography (PET)…
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Sansure Biotech’s HPV Detection Kit Receives NMPA Approval for Comprehensive Screening
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Sansure Biotech Inc., a molecular diagnostics specialist based in China and listed on the Shanghai Stock Exchange (SHA: 688289), has announced that it has received marketing approval from the National Medical Products Administration for its human papillomavirus (HPV) nucleic acid detection kit. This kit, which uses the PCR fluorescent probe…
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ClouDr Receives NMPA Green Light for ClouDT-01, a Groundbreaking Digital Diabetes Treatment
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Hangzhou Kang Ming Information Technology Co., Ltd, trading under the banner of “ClouDr” on the Hong Kong stock exchange (HKG: 9955), has announced that it has secured marketing approval from the National Medical Products Administration (NMPA) for its innovative digital medicine product, ClouDT-01, designed for the treatment of diabetes. Leveraging…
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Sino Biopharmaceutical Receives NMPA Approval for Rivastigmine Patch for Mild-to-Moderate Alzheimer’s
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Sino Biopharmaceutical Ltd (HKG: 1177), a leading biopharmaceutical company based in China, has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its rivastigmine transdermal patch. This new treatment is intended for the management of symptoms associated with mild-to-moderate Alzheimer’s disease (AD). Rivastigmine, classified…
