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Innovent Biologics Initiates Phase III Neoshot Study for MSI-H/dMMR Colon Cancer Treatment
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Innovent Biologics, Inc. (HKG: 1801), a leading biopharmaceutical company based in China, has announced the first subject dosing in the randomized, multi-center Phase III Neoshot study for its anti-CTLA-4 monoclonal antibody IBI310. The study combines IBI310 with the PD-1 inhibitor sintilimab as a neoadjuvant treatment for patients with resectable MSI-H/dMMR…
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Alexion’s Ultomiris Secures FDA Approval for Anti-AQP4 Positive NMOSD Treatment
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AstraZeneca’s (AZ; NASDAQ: AZN) rare disease unit, Alexion, has registered its biologic Ultomiris (ravulizumab) with the US Food and Drug Administration (FDA) for the treatment of anti-AQP4 antibody-positive (Ab+) neuromyelitis optica spectrum disorder (NMOSD) in adults. This registration follows an initial rejection by the FDA last year and positions Ultomiris…
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NMPA Mandates Electronic Permits for Anesthetic Drugs and Psychotropic Substances
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The National Medical Products Administration (NMPA) has issued a new notification aimed at enhancing the management of import and export licenses for anesthetic drugs and psychotropic substances. Effective immediately, applicants for such permits are required to submit their application materials and supplementary materials in electronic form, eliminating the need for…
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Shanghai Fosun Pharma Reports 2023 Revenues, Highlights Innovation and R&D Progress
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Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196), a leading pharmaceutical company based in China, has released its financial report for 2023, recording RMB 41.4 billion (USD 5.73 billion) in revenues, marking a -5.81% year-on-year (YOY) decrease. However, excluding the loss of COVID-19 product sales, the figure shows…
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AbbVie Acquires Landos Biopharma to Boost Autoimmune Disease Pipeline
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AbbVie (NYSE: ABBV) has announced its acquisition of Landos Biopharma (NASDAQ: LABP), a biopharmaceutical company specializing in autoimmune diseases. The deal includes an upfront payment of USD 137.5 million plus a potential clinical milestone payment of USD 75 million, with the transaction expected to close in the second quarter of…
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National Drug Sampling Inspection Report Reveals High Compliance Rates in 2023
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The National Institute for Food and Drug Control (NIFDC) has released its “National Drug Sampling Inspection Annual Report (2023),” providing a comprehensive overview of the drug quality surveillance conducted in the past year. The report details the testing of 132 drug varieties, comprising 74 chemical drugs, 43 patented traditional Chinese…
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MSD’s Winrevair Approved by FDA as First Activin Signaling Inhibitor for Pulmonary Arterial Hypertension
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The US Food and Drug Administration (FDA) has granted Merck, Sharp & Dohme (MSD; NYSE: MRK) regulatory approval for Winrevair (sotatercept), marking it as the first activin signaling inhibitor for the treatment of pulmonary arterial hypertension (PAH) in adults. This milestone concludes a review process under the breakthrough therapy designation…
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China’s National Adverse Drug Reaction Report for 2023 Highlights Stability in Reporting Trends
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The National Center for ADR Monitoring has released its “National Adverse Drug Reaction Monitoring Annual Report (2023),” providing a comprehensive overview of the adverse drug reaction (ADR) landscape in China for the year. The National Adverse Drug Reaction Monitoring Network received a total of 2,419,000 ADR/Event Report Forms, with an…
