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  • The microbiological laboratory of LLC “BioJet” successfully passed the inspection by Rospotrebnadzor experts

    The microbiological laboratory of LLC “BioJet” successfully passed the inspection by Rospotrebnadzor experts

    As a result of the inspection, the laboratory received a positive Sanitary and Epidemiological Conclusion and a license from Rospotrebnadzor for working with microorganisms of III-IV pathogenicity groups.

  • Russian spending on antidepressants reached nearly 3 billion rubles since the beginning of the year

    Russian spending on antidepressants reached nearly 3 billion rubles since the beginning of the year

    Pharmacy 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…

  • The State Duma rejected the bill on accelerated market entry for generics

    The State Duma rejected the bill on accelerated market entry for generics

    On 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,…

  • Russia to increase production of infliximab-based medicines

    Russia to increase production of infliximab-based medicines

    The 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…

  • A unified database for veterinary drugs will be launched in EAEU countries

    A unified database for veterinary drugs will be launched in EAEU countries

    The 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…

  • MSD will pay up to $2 billion for Chinese heart medication

    MSD will pay up to $2 billion for Chinese heart medication

    One 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…

  • FDA Introduces Draft Guidance on Accelerated Drug Approval Program

    FDA Introduces Draft Guidance on Accelerated Drug Approval Program

    The 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…

  • 18 Medical Organizations Granted Rights to Manufacture and Use Biotechnological Medicines

    18 Medical Organizations Granted Rights to Manufacture and Use Biotechnological Medicines

    Russian 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…

  • Expert Explains the Features of Building a Pharmacovigilance System

    Expert Explains the Features of Building a Pharmacovigilance System

    Occasionally, 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…

  • Hedge Funds Seek Insights into Pharma

    Hedge Funds Seek Insights into Pharma

    The sharp rises and falls in pharmaceutical company stocks are prompting major hedge funds to hire doctors, scientists, and analysts to gain expert assessments of market prospects, Reuters reports, citing its sources. The year 2024 was marked by significant stock price fluctuations in pharma companies, driven by financial performance announcements and updates on various stages…