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NMPA Announces Pathway for Developing Generic Drugs Without Reference Preparation
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The National Medical Products Administration (NMPA) has issued an announcement regarding the development of generic drugs without a reference preparation, titled “Announcement on the Development of Generic Drugs with No Reference Preparation (No. 130 of 2023).” This new guideline addresses the process for drugs lacking a reference for generic quality…
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Novo Nordisk Reports 33% YOY Sales Increase, Boosts GLP-1 Drug Sales Forecast
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Denmark-headquartered pharmaceutical giant Novo Nordisk (NYSE: NVO) provided a financial update last week, revealing a robust 33% year-on-year (YOY) increase in sales at constant exchange rates (CER) from Q1 to Q3 this year. Notably, Q3 alone saw a significant 38% YOY jump, indicating a strong market reception for the company’s…
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Pfizer’s Velsipity Approved by FDA for Ulcerative Colitis Treatment
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China-based pharmaceutical company Everest Medicines (HKG: 1952) announced that its licensing partner, Pfizer Inc. (NYSE: PFE), has secured market approval from the US FDA for Velsipity (etrasimod). This oral, once-daily, selective sphingosine-1-phosphate (S1P) receptor modulator is indicated for adults with moderately to severely active ulcerative colitis (UC), marking a significant…
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China’s New Drug Quality Management Measures to Take Effect in 2024
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The State Administration for Market Regulation (SAMR) has released the “Drug Operation and Use Quality Administration and Management Measures,” set to take effect from January 1, 2024. These measures will apply to the quality management and supervision of drug operation, use, and management activities within China, ensuring stringent standards for…
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Pfizer Adjusts 2023 Revenue Projections Amidst Decreased COVID-19 Solution Demand
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Pharmaceutical giant Pfizer Inc. (NYSE: PFE) has revised its projected 2023 revenues downward, reflecting a decrease in demand for COVID-19 solutions. The new revenue projection falls between USD 58.0 billion and 61.0 billion, a significant adjustment from the previously anticipated range of USD 67.0 billion to 70.0 billion as reported…
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Fujian’s Fourth Round VBP Seeks Public Feedback on Drug Procurement List
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The Fujian drug and device joint procurement center has published the “Fujian Fourth Round Drug Volume-Based Procurement (VBP) Document (draft proposal),” inviting public feedback until October 20, 2023. This initiative encompasses 50 chemical drugs and 24 Chinese patent drugs, with the procurement period set to last until December 31, 2025.…
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FDA Approves Pfizer’s Braftovi + Mektovi Combo for BRAF V600E Metastatic NSCLC
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The US Food and Drug Administration (FDA) has granted Pfizer (NYSE: PFE) regulatory approval for the combination therapy of Braftovi (encorafenib) and Mektovi (binimetinib) for the treatment of metastatic non-small cell lung cancer (NSCLC) with a BRAF V600E mutation. This decision is supported by interim results from an ongoing Phase…
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