News Digest 03.04.2024 — 05.04.2024

Regulators

The Ministry of Health presented a list of clinical trials for 2024

The Ministry of Health published a list of clinical studies as part of the immunization strategy as part of the state task for 2024 and the planned period from 2025 to 2026. These data were shared in the response to the Russian Union of Industrialists and Entrepreneurs to proposals within the framework of the implementation of the “Strategy for the development of immunoprevention of infectious diseases for the period until 2035.”

Over the next three years, medical institutions subordinate to the Ministry of Health will conduct 21 clinical studies aimed at developing means of diagnosis, prevention and treatment of the following infectious diseases:

1. Completion of preclinical studies of the universal anti-influenza vaccine “Griflavak”, Federal State Budgetary Institution “Influenza Research Institute named after. A.A. Smorodintsev" (implementation period 2023-2024);
2. Mucosal influenza vaccine with a wide spectrum of protective effectiveness against seasonal and potentially pandemic influenza viruses, Federal State Budgetary Institution Research Institute of Influenza named after. A.A. Smorodintsev" (2023-2025);
3. Study of the effectiveness and safety of the recombinant subunit vaccine "GamTBvac" for the prevention of tuberculosis in a double-blind, placebo-controlled study, Federal State Budgetary Institution "National Center for Epidemiology and Medicine named after. N.F. Gamaleya" (2023-2024);
4. Development of technology for controlling the potential of memory B cells to create vaccines that induce neutralizing antibodies with broad specificity against highly variable viruses that cause human infectious diseases, using the SARS-CoV-2 model, Federal State Budgetary Institution “National Center for Epidemiology and Epidemiology” named after. N.F. Gamaleya" (2024-2026);
5. Development of a candidate vaccine for the prevention of tick-borne encephalitis with an adapted antigenic composition based on the mRNA platform, Federal State Budgetary Institution "National Center for Epidemiology and Epidemiology" named after. N.F. Gamaleya" (2024-2026);
6. Clinical trials of a vaccine based on virus-like particles (VLP) for the prevention of rotavirus infection (phase II), Federal State Budgetary Institution "National Center for Epidemiology and Epidemiology" named after. N.F. Gamaleya" (2024-2025);
7. Clinical trials of a vaccine based on VLP for the prevention of COVID-19 (phase III), Federal State Budgetary Institution "National Center for Epidemiology and Epidemiology" named after. N.F. Gamaleya" (2024-2025);
8. Development of a composition and technology for producing a new lipid nanocarrier using ionizable lipids for targeted delivery of mRNA vaccines aimed at preserving health and improving the quality of life of the population, Federal State Budgetary Educational Institution of Higher Education, St. Petersburg Polytechnic University (2024-2026);
9. Development of a test system for determining the antibiotic resistance of mycobacteriosis pathogens, Federal State Budgetary Institution "National Medical Research Center for Physical Research" (2023-2025);
10. Development of a test system based on polymerase chain reaction for the early diagnosis of mycobacterial infection caused by Mycobacterium avium complex in patients with immunodeficiency, including HIV infection, Federal State Budgetary Institution "National Medical Research Center for Physics and Pediatrics" (2024-2026);
11. Development, improvement and practical application of virological methods, enzyme-linked immunosorbent and molecular genetic test systems and technologies for monitoring the circulation of dangerous zoonotic viruses and the infections they cause in Russia, Federal State Budgetary Institution “NICEM named after. N.F. Gamaleya" (2024-2025);
12. Development of a test system for rapid determination of antibiotic resistance of pathogenic bacteria based on in situ analysis of bacterial cell motility, Federal State Budgetary Institution “National Center for Microbiology and Microbiology named after. N.F. Gamaleya" (2022-2024);
13. Creation of a panel of standard samples (clinical, viral, bacterial) for validation and updating of test systems used in diagnosis, prognosis of the course of the disease and assessment of the effectiveness of treatment and prevention of SARS-CoV-2, influenza and other acute respiratory infections, Federal State Budgetary Institution "National Center for Epidemiology and Epidemiology" named after. N.F. Gamaleya" (2022-2024);
14. Monitoring study of fever caused by a new variant of rickettsia, common in the regions of the Russian Federation: determination of antibiotic resistance of the pathogen; development of a diagnostic test system; study of ecological and genetic patterns of pathogen circulation, Federal State Budgetary Institution “National Center for Epidemiology and Mathematics named after. N.F. Gamaleya" (2024-2026);
15. Development of test systems for screening PCR diagnostics, monitoring the course of mycobacteriosis and species PCR identification of mycobacteria, Federal State Budgetary Educational Institution of Higher Education “Astrakhan State Medical University” (2024—2026);
16. Creation of a panel of standard samples (clinical, viral, bacterial) for validation and updating of test systems used in diagnosis, prognosis of the course of the disease and assessment of the effectiveness 4 of treatment and prevention of SARS-CoV-2, influenza and other acute respiratory infections, Federal State Budgetary Institution "NICEM . N.F. Gamaleya" (2024-2025);
17. Development of methods for treating various forms of urological infection with bacteriophage preparations, Federal State Budgetary Institution "National Medical Research Center of Radiology" (2022-2024);
18. Development of technology for the treatment of patients with infectious spondylitis based on a comprehensive study of the support ability and biomechanics of the spinal column using virtual modeling and artificial intelligence algorithms, Federal State Budgetary Institution "National Medical Research Center for Physical Education" (2021-2023);
19. Development of a comprehensive immunobiological technology for differentiating active and latent tuberculosis infection, Federal State Budgetary Institution "National Medical Research Center for Physical Research" (2021-2023);
20. Increasing the efficiency of microbiological diagnosis of mycobacteriosis in patients with HIV infection, Federal State Budgetary Institution "National Medical Research Center for Physical Research" (2021-2023);
21. Development of a prototype of a modular automatic device for differential express diagnostics of tuberculosis and non-tuberculous mycobacteriosis and determination of their antibiotic resistance, Federal State Budgetary Institution "National Medical Research Center for Physical Research" (2023-2025).

Source: https://pharmvestnik.ru/content/news/Minzdrav-predstavil-spisok-klinicheskih-issledovanii-na-2024-god.html

Market news

The Moscow region will purchase medical equipment worth 1 billion rubles to re-equip maternity hospitals

The authorities of the Moscow region plan to purchase more than 700 ultrasound and ventilator machines in 2024 for the needs of perinatal centers and maternity hospitals in the region. The total purchase bill will be more than 1 billion rubles.

The equipment is planned to be supplied to 12 medical organizations, including city hospitals in Khimki and Klin, perinatal centers in Kolomna and Vidnoye, as well as other clinics.

Another 192 pieces of equipment, including mammographs with a biopsy attachment, ultrasound machines, endoscopic stands and laboratory equipment, are planned for purchase to equip the oncology departments of hospitals in the region. The amount of funds that will be allocated for the purchase of equipment is not disclosed.

In addition to equipping specialized departments, there is a program in the Moscow region to replace “heavy” medical equipment. Purchases are carried out under the program for upgrading analog equipment to digital equipment.

In 2024, the regional authorities plan to purchase 137 pieces of heavy medical equipment for a total amount of 4.6 billion rubles. The range of medical equipment includes X-ray machines, mammographs, fluorographs, computed tomography machines, MRI and angiographs.

The first 16 tenders for the supply of X-ray machines, computer and magnetic resonance imaging scanners, fluorographs, angiographs and mammographs totaling 2.935 billion rubles were announced in February-March 2024.

Source: https://vademec.ru/news/2024/04/04/moskovskaya-oblast-zakupit-medtekhniku-na-1-mlrd-rubley-dlya-pereosnashcheniya-roddomov/

Other

A portable device for diagnosing skin lesions was created in St. Petersburg

The St. Petersburg State University of Aerospace Instrumentation (SUAI) has developed a portable device for diagnosing the depth of human skin lesions due to burns, frostbite and dermatological diseases. The Ministry of Education and Science of the Russian Federation spoke about this.

The device operates on the principle of active infrared sensing - a method developed at the department of biotechnical systems and technologies of the university.

Now the students participating in the project are working on creating a startup that will use the device together with a neural network that independently classifies tumors into eight categories of lesions. This will make it possible to diagnose skin cancers, primarily melanoma.

Source: https://78.ru/news/2024-04-02/v-peterburge-razrabotali-pribor-dlya-diagnostiki-porazhenii-kozhi

Medical organizations in the Sverdlovsk region are equipped with modern and high-quality equipment for recovery and rehabilitation

As part of the implementation of the regional program “Optimal medical rehabilitation for restoring health,” a planned number of units of purchased medical equipment has been approved in 2024, with which it is planned to equip and re-equip medical organizations in the Sverdlovsk region that provide medical rehabilitation to adults and children.

According to the Territorial Authority of Roszdravnadzor for the Sverdlovsk Region, in 2024 the region plans to purchase 276 units of medical equipment, including verticalizers, bicycle ergometers, treadmills, mobile systems for lifting and moving patients, and pneumatic massagers.

New medical equipment will immediately go to 7 institutions in the region: City Hospital No. 4 of Nizhny Tagil, City Clinical Hospital No. 40 of Yekaterinburg, Irbit Central City Hospital, Obukhovsky Sanatorium, Sverdlovsk Regional Clinical Psychoneurological Hospital for War Veterans, Yekaterinburg Clinical Perinatal Center, Regional Children's clinical Hospital.

It is planned to put into operation medical equipment purchased under the regional program “Optimal medical rehabilitation for restoring health” in 2024 by July 1 of this year.

The federal project “Optimal Medical Rehabilitation for Health Restoration” was launched in 2022 and is designed to make treatment better and more effective, and rehabilitation more accessible to the population. Thus, patients who were previously forced to travel to large federal centers for rehabilitation will be able to undergo it in their own city.

In total, since 2022, more than 2 thousand units of medical equipment have been supplied to medical organizations in the Sverdlovsk region.

Source: https://t.me/roszdravnadzor_official/2404

New registered medical devices

We publish a list of new medical devices registered from 03/29/2024 to 04/05/2024

Link to the list: [see. table in attachment]