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FDA Introduces Draft Guidance on Accelerated Drug Approval Program
Read more: FDA Introduces Draft Guidance on Accelerated Drug Approval ProgramThe U.S. Food and Drug Administration (FDA) has published a draft guidance document for its Accelerated Approval Program, designed to expedite the approval process for new drugs. The guidance outlines criteria for two types of endpoints considered for accelerated approval: surrogate and clinical endpoints. Drugs approved under the Accelerated Approval Program must undergo additional confirmatory…
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A radio probe, food, and medicine: How scientific developments from Tomsk saved lives during the war
Read more: A radio probe, food, and medicine: How scientific developments from Tomsk saved lives during the warDuring the Great Patriotic War, a radio probe helped doctors in military hospitals extract shrapnel from the wounded, while a special cart was used to detect defects on railway tracks. In Siberia, several new deposits of useful minerals were discovered, and new medicinal herbs were identified and used to support the war effort—especially when traditional…
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Mishustin: The share of domestically produced essential medicines must increase to 90%
Read more: Mishustin: The share of domestically produced essential medicines must increase to 90%To ensure people receive quality medical care, effective domestic drugs are needed, the Prime Minister emphasized. The share of Russian essential medicines must grow to 90%. This objective was announced by Russian Prime Minister Mikhail Mishustin during a speech at the “Znanie” society marathon. “The share of domestic production of essential and vital drugs must…
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Russian spending on antidepressants reached nearly 3 billion rubles since the beginning of the year
Read more: Russian spending on antidepressants reached nearly 3 billion rubles since the beginning of the yearPharmacy chains earned 2.8 billion rubles from antidepressant sales in January-February 2025. A total of 3.2 million packages were sold since the start of the year, according to data from the analytical company DSM Group, as reported by Vedomosti. This figure is 30% higher in monetary terms and 15% higher in quantity compared to last…
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The State Duma rejected the bill on accelerated market entry for generics
Read more: The State Duma rejected the bill on accelerated market entry for genericsOn March 20, deputies of the State Duma rejected in the first reading a bill that proposed simplifying the market entry of generics produced by companies from “unfriendly” countries. The existing procedure for the market release of reproduced drugs will remain in place. This may result in patients continuing to pay higher prices for medications,…
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Russia to increase production of infliximab-based medicines
Read more: Russia to increase production of infliximab-based medicinesThe company “Pharmapark” plans to steadily increase its production volumes. Specifically, over 30,000 packages of infliximab-based medicines are expected to be introduced into civilian circulation in Russia by the end of 2025, according to TASS, citing the press service of the Ministry of Industry and Trade of Russia. Earlier, media reports highlighted a shortage of…
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A unified database for veterinary drugs will be launched in EAEU countries
Read more: A unified database for veterinary drugs will be launched in EAEU countriesThe Collegium of the Eurasian Economic Commission (EEC) has approved the creation of a unified database for animal drugs identified through state supervision. This database will include information about quality, substandard, counterfeit, and falsified veterinary drugs within the territory of the Eurasian Economic Union (EAEU) member states. New participants will join this process according to…
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MSD will pay up to $2 billion for Chinese heart medication
Read more: MSD will pay up to $2 billion for Chinese heart medicationOne of the world’s largest pharmaceutical companies, MSD, will pay up to $2 billion for the rights to the experimental drug HRS-5346 from China’s Jiangsu Hengrui Pharmaceuticals Co. for heart treatment. The deal is expected to be completed in the second quarter of 2025, pending the necessary approvals. This will be MSD’s second recent attempt…
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18 Medical Organizations Granted Rights to Manufacture and Use Biotechnological Medicines
Read more: 18 Medical Organizations Granted Rights to Manufacture and Use Biotechnological MedicinesRussian Prime Minister Mikhail Mishustin has signed a document designating medical institutions authorized to produce and utilize biotechnological medicinal products (BTMPs). These are personalized drugs developed based on the unique genetic characteristics of each patient, representing a modern approach in gene and cell therapy. The official registry includes 18 leading medical organizations from various regions…
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Expert Explains the Features of Building a Pharmacovigilance System
Read more: Expert Explains the Features of Building a Pharmacovigilance SystemOccasionally, authorized bodies announce the need to update drug instructions. But how is it determined that an update is necessary? Who manages these processes within pharmaceutical companies and at the state level? Evgeniya Shapiro, General Director of “PSK Pharma,” provided insights into these and other questions. Do pharmaceutical manufacturers need to monitor the use of…