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MSD’s Welireg Meets Primary Endpoint in Phase III RCC Study but Misses OS Milestone
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Merck, Sharp & Dohme (MSD; NYSE: MRK) has revealed that the ongoing Phase III study evaluating the first-in-class HIF-2α inhibitor Welireg (belzutifan) in previously treated advanced renal cell carcinoma (RCC) has shown statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared to everolimus, meeting its primary endpoint. However,…
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MSD’s Q2 2023 Earnings: Keytruda and Gardasil Drive Growth Amid COVID-19 Sales Decline
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US-based major Merck, Sharp & Dohme Inc., (MSD; NYSE: MRK) has released its financial results for the second quarter of 2023, showing a 7% year-on-year (YOY) growth in worldwide sales, reaching USD 15 billion in constant exchange rates. The pharmaceuticals business reached USD 13.457 billion, up 8% YOY, while Animal…
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MSD’s V116 Vaccine Shows Superior Immune Response in Phase III Trials
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Merck, Sharp & Dohme (MSD; NYSE: MRK) has revealed positive topline results from two Phase III trials assessing the company’s 21-valent pneumococcal conjugate vaccine candidate, V116. This vaccine, the first of its kind designed for use in adults, is being evaluated in a comprehensive clinical trial program involving 2,600 patients.…
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Johnson & Johnson Files Lawsuit Against US Government’s Drug Pricing Negotiation Authority
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United States-based Johnson & Johnson (J&J, NYSE: JNJ) has filed a lawsuit this week, challenging the US government’s authority to negotiate the price of selected drugs for the 2026 period onwards through the elderly health insurance program, Medicare. The company argues that such a project would damage innovation and potentially…
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Sichuan Kelun-Biotech Biopharmaceutical Prices IPO at HKD 60.6 to 72.8 per Share
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Sichuan Kelun Pharmaceutical Co., Ltd’s (SHE: 002422) innovative drug development subsidiary, Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (HKG: 6990), has priced its initial public offering (IPO) filing to the Hong Kong Stock Exchange at a range of HKD 60.6 to 72.8 per share. At an assumed offering price of HKD 60.60…
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Sichuan Kelun’s SKB264 Earns Breakthrough Therapy Designation for Breast Cancer Treatment
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The Center for Drug Evaluation (CDE) website has indicated that China-based Sichuan Kelun Pharmaceutical Co., Ltd’s (SHE: 002422) antibody-drug conjugate (ADC) SKB264, targeting trophoblast cell-surface antigen 2 (TROP2), has obtained breakthrough therapy designation (BTD) status. This designation is for use in locally advanced or metastatic hormone receptor positive and HER2…
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BioNTech’s DB-1303 ADC Shows Promising Results in Solid Tumor Phase I/IIa Trial
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Germany’s BioNTech (NASDAQ: BNTX) has released preliminary data from a Phase I/IIa trial for DB-1303, a DNA topoisomerase I-inhibiting antibody-drug conjugate (ADC) licensed from China-based Duality Biologics. The trial focused on patients with solid tumors, and the results indicated that 44.2% of patients exhibited an objective partial tumor response. Notably,…
