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FDA Introduces Draft Guidance on Accelerated Drug Approval Program
Read more: FDA Introduces Draft Guidance on Accelerated Drug Approval ProgramThe U.S. Food and Drug Administration (FDA) has published a draft guidance document for its Accelerated Approval Program, designed to expedite the approval process for new drugs.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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New requirements in the field of digital product labeling (“Chestny ZNAK”) come into force on September 1
Read more: New requirements in the field of digital product labeling (“Chestny ZNAK”) come into force on September 1Market participants in children’s toys, sports nutrition, instant beverages (tea, coffee, cocoa), confectionery, building materials, and razors are now required to be registered in the national digital product labeling system. Mandatory labeling for these categories will be introduced gradually starting October 1, 2025. The technical solutions for labeling have already been tested, and many companies…
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Vertex invested 190 million rubles in equipping its pharmaceutical complex
Read more: Vertex invested 190 million rubles in equipping its pharmaceutical complexSince the beginning of 2025, the pharmaceutical company Vertex has invested more than 194 million rubles into its innovative production complex located in the special economic zone “Saint Petersburg.” The main part of the funds has been allocated to equipping production lines for solid dosage forms, including cardiological and hormonal drugs. The key expenses are…
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Pharmstandard Leads Ranking of Russian Pharmaceutical Companies by Number of New Drug Registrations
Read more: Pharmstandard Leads Ranking of Russian Pharmaceutical Companies by Number of New Drug RegistrationsMoscow Region–based Pharmstandard has topped the ranking of pharmaceutical companies that obtained the highest number of marketing authorizations for medicinal products in 2024–2025, according to an analytical report by IT company Kursor. The ranking was compiled based on data from the State Register of Medicinal Products (GRLS) and Kursor’s proprietary database. During the reporting period,…
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Russian Retail Pharmaceutical Market Reaches ₽1.05 Trillion in January–July 2025
Read more: Russian Retail Pharmaceutical Market Reaches ₽1.05 Trillion in January–July 2025Retail sales of pharmaceuticals in Russia totaled ₽1.05 trillion in the period from January to July 2025, marking a 16.4% year-on-year increase, according to a report by analytics company RNC Pharma. Prescription drugs accounted for the majority of sales, making up 60.5% of the market. The top three pharmaceutical manufacturers by retail sales share were:…
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Antibiotic-Resistant Bacteria Discovered in Taganrog Bay Sediments
Read more: Antibiotic-Resistant Bacteria Discovered in Taganrog Bay SedimentsScientists from Southern Federal University (SFedU) have discovered bacteria carrying antibiotic resistance genes (ARGs) in bottom sediments of Taganrog Bay. These microorganisms may pose a potential public health risk by increasing human resistance to antibiotics, the university’s press service reported. “SFedU researchers conducted a comprehensive analysis of Taganrog Bay sediments and found elevated levels of…
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Moscow Endocrine Plant to Begin Deliveries of Domestically Produced Analgesic This Fall
Read more: Moscow Endocrine Plant to Begin Deliveries of Domestically Produced Analgesic This FallBy the end of the year, 25,000 vials of the drug will be released. The domestically produced opioid analgesic Remifentanil will become available in September, with 25,000 vials (2 mg each) expected to be manufactured by the end of the year, Denis Protsenko, Director of the Moscow Multidisciplinary Clinical Center “Kommunarka,” announced on his Telegram…
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MIPT Launches Platform for the Development and Scaling of Pharmaceutical Production
Read more: MIPT Launches Platform for the Development and Scaling of Pharmaceutical ProductionAs part of the “TsEH” (Chemical Engineering Hub) initiative, partners will focus their efforts on transforming laboratory research into ready, well-documented, and reproducible industrial technologies. The Moscow Institute of Physics and Technology (MIPT) has launched a specialized “TsEH” platform for experimental chemical production, which will provide a full cycle of development and scaling of active…
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RDIF Becomes Partner of Vietnamese and Russian Companies Supplying Pharmaceuticals and Medical Equipment
Read more: RDIF Becomes Partner of Vietnamese and Russian Companies Supplying Pharmaceuticals and Medical EquipmentThe Russian Direct Investment Fund (RDIF) announced a partnership during the SPIEF-2025 with Vietnamese pharmaceutical company EOC Vietnam Pharmaceutical Co. (EOC) and Russian distributor Good Distribution Partners (GDP) to establish a center for promoting Russian and Vietnamese companies in the pharmaceutical sector, including the supply of innovative drugs and medical equipment to the markets of…
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Amended Drug Registration Rules Come into Force in the EAEU
Read more: Amended Drug Registration Rules Come into Force in the EAEUAs of June 21, the updated Rules for the Registration and Examination of Medicinal Products for Human Use in the Eurasian Economic Union (EAEU), approved by the Council of the Eurasian Economic Commission (EEC), have come into effect, the EEC press service reported. “The new provisions are aimed at harmonizing the registration processes across EAEU…