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    Russian Medical Development: News

    flamming_python
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    Post  flamming_python Fri Jun 14, 2024 8:41 pm

    Ginzburg and the Gamaleya Center are on their way to becoming the superstars of medical science if this thing works in even 1/4th of cases

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    Hole
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    Post  Hole Fri Jun 14, 2024 11:21 pm

    Western companies and the medical sector make a lot of money with cancer.
    For them the "Evil Russians" are trying to put them out of business.
    The stuff will propably get sanctioned by western countries.

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    GarryB
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    Post  GarryB Sat Jun 15, 2024 12:22 pm

    The stuff will propably get sanctioned by western countries.

    That is a good thing and that is what you would expect... the west does not share or cooperate... it steals and suppresses.

    For clinics in Mexico treating cancer being able to use Russian technology will make them a must go destination for western cancer sufferers as their success rate increases massively.

    Of course one of the issues with cancer is that you can beat it, but it can also come back later for another go...

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    Post  flamming_python Sat Jun 15, 2024 2:30 pm

    Cancer tries to make an appearance all the time even in young and healthy people

    It ultimately comes about through imperfections of the DNA and RNA replication process. or through radiation and other things that damage DNA.. i.e. cancer comes from mutations. And such mutations occur in everybody.

    However for most of us our immune systems keep it bay, until such time as our immune systems weaken and can't do that job as well anymore, which can happen at different ages or not at all.

    So yes after it makes its debut appearance it's always going to be at risk of coming back, for the rest of your life. But if there exists a universal medicine to neutralize it then that's not going to be any more of a concern than the common Cold coming back again and again

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    Kiko
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    Post  Kiko Wed Jun 19, 2024 9:36 pm

    Ginzburg said that a new vaccine against tuberculosis will be tested in 2025., 06.19.2024.

    Ginzburg: a new vaccine against tuberculosis will be tested on volunteers at the end of 2025.

    The new tuberculosis vaccine will be tested on volunteers at the end of 2025, and it is planned to submit documents for its registration to the Ministry of Health in 2026, said the director of the National Research Center for Epidemiology and Microbiology. N.F. Gamaleya Alexander Ginzburg.

    “At the end of 2025, if everything goes according to plan, so far everything is going according to plan, then several thousand subjects will be vaccinated with this new vaccine, which prevents infection with tuberculosis,” TASS quotes Ginzburg .

    According to him, the new GamTBvac vaccine “should, in principle, change the epidemiology of this disease.” It is planned to be used for repeated vaccination of adolescents and adults against tuberculosis. The Ministry of Health issued permission to conduct the study in 2021.

    According to the director of the research center, the new drug may eventually replace the classic BCG, a vaccine against tuberculosis prepared from a strain of weakened live tuberculosis bacillus. This is the only available vaccine against tuberculosis and is over 100 years old.

    https://www.rbc.ru/rbcfreenews/667281009a79476231932c37

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    Post  Kiko Thu Jun 20, 2024 10:14 pm

    Murashko announced the development of a new drug for botulism in Russia, 06.20.2024.

    Murashko: Russia has developed a new medicine for botulism.

    Russia has developed a new drug for the treatment of botulism and is awaiting clinical trials, said Health Minister Mikhail Murashko.

    “Over the last year we have been developing a new drug to treat this type of infection, this is a new modern drug. Preclinical studies have now been completed, and we will begin clinical studies in the coming days,” he said (quoted by RIA Novosti ).

    In Russia, an outbreak of botulism has been observed since June 14. The first cases of poisoning were recorded in Moscow; a few days later in Kazan, the Nizhny Novgorod region and other regions more than 150 people were hospitalized with the infection.

    https://www.rbc.ru/rbcfreenews/66742dd19a7947180e5e6970

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    Post  Kiko Sat Jun 22, 2024 6:36 am

    Cancer Vaccine Trials on Volunteers to Begin by Mid-2025 - Microbiology Centre Director, 06.22.2024.

    MOSCOW (Sputnik) - Clinical trials of a cancer vaccine on patients with cancer are scheduled to begin by mid-2025, Alexander Ginzburg, the director of the Moscow-based Gamaleya National Research Centre for Epidemiology and Microbiology, told Sputnik.

    “I think that by the middle of next year we will begin clinical trials of the vaccine with the participation of patients with cancer,” Ginzburg said.

    He noted that now the vaccine is being tested in preclinical studies on mice, and the technology is being developed to not just extend the life of animals with melanoma by 2-3 times, but to create such drugs that would allow for guaranteed destruction of both the tumor and metastases.

    According to Ginzburg, if it is possible to work out this technology, the vaccine will help patients with non-small cell lung cancer, pancreatic cancer, certain types of kidney cancer, melanomas. Moreover, in these diseases metastases appear at early stages, so this vaccine will be very relevant for these patients, the specialist explained.

    https://sputnikglobe.com/20240622/cancer-vaccine-trials-on-volunteers-to-begin-by-mid-2025---microbiology-centre-director-1119056165.html

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    Kiko
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    Post  Kiko Sat Jun 22, 2024 9:23 am

    Further details:

    Gunzburg spoke about the development of a cancer vaccine, 06.22.2024.

    Director of the Gamaleya Research Center Gunzburg: the cancer vaccine will be personalized.

    The cancer vaccine will be personalized, that is, made for each patient individually, artificial intelligence will help in its development, which will analyze the parameters of the tumor and produce a “blueprint” of the future drug, and specialists will use it to make a vaccine within a week, the director of the Research Center told RIA Novosti epidemiology and microbiology named after Gamaleya Alexander Guinzburg.

    Earlier, Guinzburg told RIA Novosti that clinical trials of a cancer vaccine involving patients with cancer are planned to begin by mid-2025.

    “Now we have attracted a whole laboratory, and they are making software for us at a high professional, international level. That is, artificial intelligence, a neural network will help in creating a vaccine. Vaccines are made individually for each patient, this program analyzes information about the tumor and, accordingly, issues I actually have a plan, a blueprint for a future vaccine,” Guinzburg said.

    He noted that thanks to this mode of working with the neural network, the development of a vaccine, which is created for each specific patient, will take a maximum of a week from the start of tumor research.

    https://ria.ru/20240622/gintsburg-1954670130.html

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    Kiko
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    Post  Kiko Mon Jun 24, 2024 10:56 am

    The Russian vaccine will change the epidemiology of tuberculosis, predicts Guinzburg, 06.24.2024.

    Guinzburg: new Russian tuberculosis vaccine can change epidemiology.

    MOSCOW, June 24 - RIA Novosti. The tuberculosis vaccine being developed by specialists from the Gamaleya Research Center for Epidemiology and Microbiology will protect against infection; in the future, it may change the epidemiology of this disease, that is, tuberculosis will no longer be a “natural companion” of the human population, Alexander Guinzburg, director of the Gamaleya Research Center for Epidemiology and Microbiology, told RIA Novosti.

    “Our vaccine will protect against infection. If everything works out, it will be intended not only for children, but also for adults. This will, in principle, change the epidemiology of tuberculosis, that is, we can say that with mass vaccination, tuberculosis will no longer be a natural companion of the human body , the human population," Guinzburg said.

    He clarified that the vaccine requires a single injection. Clinical studies of the drug have been going on for a long time, 40-50% of the participants have already received it and are now being monitored by specialists, Guinzburg explained.

    https://ria.ru/20240624/vaktsina-1954944699.html

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    kvs
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    Post  kvs Mon Jun 24, 2024 1:49 pm

    Unlike in various other contexts, the "AI" in this case is a functional tool. "AI" is a fancy type of regression analysis. But that is what you need to fit a curve or solution to a set
    of data point and parameters. You are not asking it to have self-awareness.

    I hope the cancer vaccine pans out. If it could be effective against metastatic stage cancer, then that would be amazing. It is obvious they need custom vaccines for recipients.

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    Kiko
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    Post  Kiko Wed Jun 26, 2024 9:41 pm

    The manufacturer of the [Russian] Ozempic analogue has decided on the timing of the IPO on the Moscow Exchange, 06.26.2024.

    The group plans to raise up to ₽10 billion during the IPO. Experts call the pharmaceutical segment interesting for investors, and the industry players themselves are beneficiaries of import substitution.

    The biopharmaceutical group of companies Promomed planned to hold an IPO in July, two sources close to the deal told RBC Investments. The placement will take place on the Moscow Exchange, the company plans to raise up to ₽10 billion. A source in the financial market said that the company’s valuation has not yet been finalized, but the issuer “would like” to be valued at no less than ₽100 billion. The financier called this figure ambitious, but realistic given favorable market conditions.

    https://quote.ru/news/article/667c37cb9a79477fefd188aa

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    Kiko
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    Post  Kiko Thu Jul 18, 2024 6:44 pm

    Mishustin Increases Payments to Medical Workers Who Move to New Regions, 07.18.2024.

    Prime Minister Mishustin: Payments to doctors who have moved to new regions will be increased.

    The government will increase payments to medical workers who have moved to new Russian regions, Prime Minister Mikhail Mishustin announced at a government meeting.

    Medical workers receive one-time payments under the Zemsky Doctor and Zemsky Paramedic programs.

    “Up to 2 million rubles for doctors and up to 1 million rubles for paramedics, nurses and other mid-level medical specialists,” Mishustin said.

    In total, more than 1 billion rubles will be allocated from the budget to increase payments, of which more than 350 million rubles have been reserved for 2024, the prime minister noted. Mishustin also signed a corresponding resolution.

    In addition, both programs will be supplemented with a new mechanism. It will allow a medical worker to change jobs within the region once during the term of the contract, the prime minister added.

    https://www.rbc.ru/rbcfreenews/669920a39a79476255f3ceb9

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    Post  Kiko Wed Jul 24, 2024 5:32 pm

    Ginzburg told when a vaccine against tuberculosis will appear in Russia, 07.24.2024.

    Ginzburg: Tuberculosis vaccine may appear in Russia in mid-2025.

    RIA News
    GINZBURG: TUBERCULOSIS VACCINE THAT PROTECTS FROM INFECTION MAY APPEAR IN RUSSIA IN MID-2025.

    https://ria.ru/20240724/vaktsina-1961767608.html

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    Post  Kiko Wed Jul 24, 2024 8:16 pm

    Further details:

    Ginzburg named the time frame for the appearance of a new tuberculosis vaccine in Russia, 07.24.2024.

    Ginzburg: New tuberculosis vaccine to appear in Russia in mid-2025.

    "GamTBvac", which could potentially replace BCG, will probably be used in mid-June 2025, the director of the Gamaleya Center said. The vaccine has passed the third phase of clinical trials.

    The booster (used for revaccination. — RBC ) vaccine "GamTBvac", which protects against tuberculosis infection, may appear in Russia in mid-2025, said Alexander Ginzburg, director of the N.F. Gamaleya Center for Epidemiology and Microbiology (NITsEM), at the "Healthy Society" forum, TASS reports .

    The vaccine was developed by the center's specialists, it has already passed the third stage of clinical trials and can begin to be used in mid-June 2025, he said. According to Ginzburg, about 2 thousand patients took part in the third phase of testing.

    “Statistical processing is currently underway; if everything goes as planned, then by mid-2025 the country will have its own booster vaccine that will protect people from tuberculosis infection,” said the centre's director.

    Tuberculosis vaccines already exist in Russia. In particular, vaccination is carried out using BCG  — most newborns are vaccinated in countries where this vaccine is included in the vaccination calendar. This only available tuberculosis vaccine is more than 100 years old.

    BCG vaccination only partially protects young children from tuberculosis and does not protect adolescents and adults from the disease. To reduce tuberculosis mortality by 90% worldwide by 2035, the World Health Organization has developed a strategy that outlines the need for a new vaccine that is effective for all ages and can curb the spread of multidrug-resistant tuberculosis.

    The development of GamTBvac began several years ago . Ginzburg predicted that it could replace BCG in the future. He previously said that the vaccine was planned to be tested on thousands of volunteers at the end of 2025. In 2026, the developers were going to submit documents for its registration to the Ministry of Health.

    According to Ginzburg, GamTBvac "should fundamentally change the epidemiology" of tuberculosis. It is planned to be used for revaccination of adolescents and adults against this infection.

    https://www.rbc.ru/society/24/07/2024/66a11b559a79477681138575

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    Post  Kiko Thu Aug 15, 2024 11:22 pm

    Ginzburg spoke about the development of a vaccine against monkeypox in Russia, 08.15.2024.

    In Russia, research into the development of a vaccine against monkeypox has been completed, Alexander Ginzburg, director of the N.F. Gamaleya National Research Center for Epidemiology and Microbiology, told RIA Novosti .

    “The R&D work is essentially finished, and we are waiting to see who will finance the ‘clinic’ (clinical trials – RBC ), since this is a lot of money,” the agency quotes the microbiologist as saying.

    The timing of preclinical trials is still unknown, but their duration will be up to six to seven months, Gintsburg specified. Vaccination will be administered to the entourage of a person who has contracted monkeypox, as well as to patients suspected of being infected, he added.

    Monkeypox is a viral disease that causes fever, muscle pain, a characteristic rash, and itching. Monkeypox usually goes away on its own, but people with weak immune systems, children, and pregnant women may have a harder time with it.

    The World Health Organization (WHO) declared monkeypox a public health emergency the day before , citing the virus's spread in the Democratic Republic of Congo. The Africa Centers for Disease Control and Prevention had previously declared a public health emergency over monkeypox.

    Against this backdrop, Rospotrebnadzor reported that there is no danger of the virus spreading in Russia . The agency clarified that it has prepared proposals for assistance for African countries where the epidemic has been recorded.

    https://www.rbc.ru/rbcfreenews/66be4acc9a794796671716bd

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    Post  PhSt Fri Aug 16, 2024 3:45 am


    Ginzburg spoke about the development of a vaccine against monkeypox in Russia

    Sounds promising, but such a vaccine will only benefit Russia, and perhaps some of its allies. Recall that during the height of the Covid pandemic, NATO used its influence to coerce the WHO to delay certification for Russia's Sputnik vaccines in an effort to sabotage the distribution of Russian vaccines and allow NATO companies to monopolize vaccine production and distribution worldwide.

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    Post  GarryB Fri Aug 16, 2024 2:24 pm

    They did, which reflects on the WHO and those that manipulate them.

    In the future would the global south put much credibility in western vaccines over Russian or Chinese or Cuban vaccines?

    Sounds like the west tried to stop a superior product reaching the market before they could secure sales... I think if they try to do that again... and of course they will, then fewer and fewer countries will be fooled and those countries that actually care about their own populations are more likely to ignore western interests and western influence and go with what is best for their own countries.

    That is the problem the west does not understand... they believe they wield all this power... and to an extent they do, but when they misuse that power they weaken their own position of trust and when trust is gone they have nothing.

    So I say... keep it up America... keep doing what you are doing.

    You left the path of truth and justice... even when it goes against your interests, and now you are left with the American way... which was truth and justice, but now it is lies and revenge.

    Who could look up to that?

    Which is why all your coalitions of the willing are just lynch mobs of has been colonial power hoping to get the scraps from your rampages around the world.

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    Post  Kiko Wed Aug 21, 2024 1:01 am

    Easy breathing: Russia creates world's first allergy vaccine, by Maria Frolova for Izvestia. 08.20.2024.

    ​​​​​​​Its clinical trials will begin in September.

    Scientists from the Institute of Immunology of the Federal Medical and Biological Agency have created the world's first allergy vaccine. It will help people with allergies to birch pollen, apples and some other products. Izvestia found out how the vaccine will work and when it will appear in hospitals.

    Russian allergy vaccine: when will it be

    The world's first allergy vaccine has been created in Russia. This was reported by the head of the Federal Medical and Biological Agency (FMBA) Veronika Skvortsova.

    The vaccine was developed by employees of the Institute of Immunology of the Federal Medical and Biological Agency under the leadership of Director Musa Khaitov together with Professor Rudolf Valenta from the Vienna Medical University. It will help people with allergies to birch pollen and products that cause cross-food allergies, such as apples. Scientists have promised that it will be possible to get rid of the disease in just three to five injections of the drug, while classical therapy usually takes three to five years.

    Clinical trials of the vaccine will begin at the end of September. Therefore, there is hope that the first field season in April and May will allow "to fully confirm its effectiveness and safety." The allergy vaccine is a unique drug that is currently being widely discussed by the global scientific community.

    After conducting research, the vaccine should appear in Russian medical institutions.

    How does the birch allergy vaccine work?

    Scientists at the Institute of Immunology have been studying pollen allergens for several years and have finally obtained a purified recombinant vaccine to prevent and treat allergies. The drug consists of hypoallergenic peptides of major birch (Bet v 1) and apple (Mal d 1) allergens, as well as the PreS protein of the hepatitis virus as an immunogenic carrier, explained Musa Khaitov, director of the Institute of Immunology.

    — We mapped the birch allergen, that is, we identified the most significant sections in its structure, and they were included in the allergy vaccine. The fragments of the allergen that are responsible for its toxicity were excluded, and as a result, with the help of such recombination, we obtained a hypoallergenic vaccine, — the immunologist explained.

    As Izvestia was told at the Institute of Immunology, the mechanism of action of the drug itself is simple: when it is administered, the body produces IgG antibodies to birch pollen, which are characteristic of a normal immune response. At the same time, IgE antibodies, characteristic of an allergic reaction, are blocked, that is, they stop being produced.

    Preclinical studies have already shown that the vaccine is non-toxic and does not cause damage to vital organs, and even a strong overdose does not provoke negative consequences. Now the drug will have to undergo the final stage of research involving volunteers. Permission for their implementation was issued by the Russian Ministry of Health, and the Federal Medical and Biological Agency is currently recruiting patients.

    Who is the allergy vaccine for?

    First of all, the new vaccine is intended for people who suffer from allergies to birch pollen. In Russia, immunologists believe, there may be hundreds of thousands of such patients.

    According to official data, 20-30% of the population suffers from allergic rhinitis during the flowering period (and according to estimates, their number may be several times higher - up to 80%). And birch pollen is one of the most common allergens in this category.

    Today, the most effective way to treat allergies is considered to be allergen-specific immunotherapy (ASIT). Several months before the onset of the pollen season, the patient is periodically administered small doses of the allergen, gradually "accustoming" the body to it. As a result, after several years, a person may stop reacting to pollen.

    The new vaccine scheme created by Russian scientists is simpler and more effective. As explained by the FMBA, the entire treatment will consist of three to five injections before the start of the season during the first year of therapy and one or two more injections before the following seasons.

    Animal studies have shown that only one or two booster injections are needed to increase the level of protective allergen-specific IgG antibodies after the main course of immunization, enhancing the effect already achieved. This means that patients will need less time for treatment and fewer visits to the doctor.

    Important development
    As Lyubov Stankevich, a candidate of medical sciences and director of laboratory medicine and production at LabQuest and Q-Clinic, told Izvestia, the vaccine will open up new possibilities in the fight against allergic diseases. Unlike traditional treatment methods, it is aimed at preventing allergic reactions before they occur.

    — The essence of the development is to prepare the immune system to meet certain allergens, such as birch pollen or stone fruits. And these are the most common sources of allergies. Introducing the vaccine several weeks before the season allows the immune system to produce protective antibodies that will prevent the development of an unwanted reaction, — the expert explains.

    According to Stankevich, the vaccine is especially important for people at high risk of allergic diseases. This includes patients with a burdened family history or those who have already encountered allergies in the past. For such people, the vaccine can be an effective preventive measure that can protect them from seasonal exacerbations.

    The emergence of an allergy vaccine is of great importance. It not only simplifies the treatment process, but also makes it accessible to many patients. The ability to vaccinate shortly before the start of the allergen season significantly reduces risks and increases the chances of successfully preventing adverse reactions, notes the Izvestia interlocutor.

    In the future, the expert suggests, it is possible to improve this vaccine, for example, to create polyvalent versions that will protect against several allergens at once. This would further simplify the treatment and make it more effective for patients with multiple sensitization to several allergens. However, the primary task remains the mass introduction and testing of the effectiveness of existing vaccines against individual allergens.

    Allergies can cause dangerous consequences, lead to disability and even death (more often in the case of insect bites). Pollen allergies can cause severe eye damage (keratitis) or severe manifestations of bronchial asthma. And the vaccine will help to exclude complications and save patients , — concludes candidate of medical sciences, allergist-immunologist of the Paracelsus Medical Center Sergey Ilyin.

    https://iz.ru/1745945/mariia-frolova/legkoe-dykhanie-v-rossii-sozdali-pervuiu-v-mire-vaktcinu-ot-allergii

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    Post  GarryB Wed Aug 21, 2024 5:03 am

    They should develop a vaccine for peanut allergies, and charge a fortune for them and use rich western peoples money to fund vaccines needed in the rest of the world...

    Certainly it will be a numbers thing first where the most common allergies get sorted first, though criteria should include the good it will do for the sufferers, and how achievable it is too.
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    Post  Kiko Wed Aug 21, 2024 7:15 pm

    Ginzburg shared details about the Russian vaccine against monkeypox, 08.21.2024.

    Ginzburg: Russian vaccine against monkeypox will help against all diseases of this group.

    The Russian vaccine against monkeypox will help protect against all current diseases of this group. This was reported to Izvestia on Wednesday, August 21, by Academician of the Russian Academy of Sciences and Director of the N.F. Gamaleya National Research Center for Epidemiology and Microbiology Alexander Ginzburg.

    “It will protect against everything that is relevant. <…> It will protect against smallpox, which does not exist [in Russia], but against which the entire country needs to have a vaccine just in case,” he said.

    Earlier, on August 14, the Director General of the Africa Centers for Disease Control and Prevention (AfricaCDC) Jean Caseya announced that a health emergency had been declared in Africa due to mpox . He said that about 200,000 doses of vaccines would be quickly purchased and distributed across Africa. On the same day, the head of the World Health Organization (WHO) Tedros Adhanom Ghebreyesus said that international measures must be taken to protect against the virus.

    On August 15, the Swedish Ministry of Health reported that a severe case of the virus, also known as mpox Clade 1, had been identified outside Africa for the first time . That day, Ginzburg told Izvestia that research and development work on a vaccine against monkeypox in Russia was essentially complete .

    Later, on August 19, the first case of monkeypox was registered in the Philippines . That day, Rospotrebnadzor head Anna Popova stated that the outbreak of the disease did not pose any danger to Russia.

    https://iz.ru/1746565/2024-08-21/gintcburg-rasskazal-podrobnosti-o-rossiiskoi-vaktcine-ot-ospy-obezian

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    Post  Kiko Thu Aug 22, 2024 9:31 am

    AstraZeneca challenges patent on analogue of its cancer drug Tagrisso, by Maria Kotova for RBC. 08.22.2024.

    AstraZeneca has challenged the patent for a Russian analogue of its cancer drug Tagrisso, which is protected by a patent until 2032. At the same time, its partners are challenging government procurement contracts for the analogue.

    The British-Swedish pharmaceutical company AstraZeneca has challenged the patent for an analogue of its cancer drug Tagrisso, registered by its Russian competitor Akselpharm. The relevant information is available on the Rospatent website.

    The corresponding decision was made by the Patent Disputes Chamber on August 14 this year, having considered an objection filed by a foreign company to the registration of a patent for "Osimertinib" from "Axelpharm". The objection was received back in September 2023, as follows from the text of the decision. RBC sent a request to "Axelpharm".

    "Tagrisso" is used to treat lung cancer. According to the state register of medicines, AstraZeneca registered this drug in Russia in 2017. The medicine, protected by a patent until 2032, is produced at the foreign company's plant in the Kaluga region. AstraZeneca emphasizes that the drug is produced in volumes that "fully satisfy the needs of Russian patients." "There has been and is no shortage of this drug," they added.

    The drug is in demand on the market. According to industry analytics company DSM Group, 21.9 thousand packages of Tagrisso were purchased in 2023 for 6.1 billion rubles. Year-on-year growth was 35.1% and 36.8%, respectively. In May 2023, Akselpharm registered its analogue. AstraZeneca unsuccessfully tried to challenge the registration of the generic in court.

    In July of this year, AstraZeneca filed a complaint against Akselpharm to the Prosecutor General's Office over the Tagrisso analogue. In its appeal, the foreign company indicated that at the end of June 2024, the Sverdlovsk Region Ministry of Health, the Novosibirsk Region State Budgetary Institution "Contract System Administration", and the Ryazan Region Ministry of Health signed contracts (for a total of 42 million rubles) for the supply of the drug Osimertinib from the Russian Akselpharm.

    AstraZeneca asked the Prosecutor General's Office to conduct an investigation into violations of the law by persons involved in state procurement of "Osimertinib", including signs of violations provided for in the Code of Administrative Offenses - circulation of counterfeit, falsified and poor-quality drugs, violation of procurement legislation. This complaint is still under consideration, the company clarified to RBC.

    What the Patent Dispute Means for Patients

    Despite the controversy surrounding the drug, the Tagrisso analogue has already entered circulation and is actively supplied through government procurement. According to Roszdravnadzor, the first batch of the analogue from Akselpharm entered circulation on July 4 of this year. A total of three batches were released, their volume is not disclosed. Regional government customers, including Moscow, have already signed 43 contracts with distributors supplying Osimertinib, AstraZeneca told RBC. RBC studied all these tenders, the total amount of contracts concluded under them is almost 450 million rubles, and the terms of contract execution in most cases are until the end of 2024.

    Ten purchases are currently being contested, AstraZeneca told RBK. "The legislation on public procurement limits the list of persons who can contest the results of tenders, so in terms of appeals, much depends on the participants, that is, the distributors," the company explained. They believe that government agencies - the FAS and regional customers - should play a "key role" in the current situation.

    One of AstraZeneca's partners, the distributor Pharmriva, has already managed to challenge the tender results . The supplier complained to the FAS that the State Unitary Enterprise of the Republic of Mordovia, Pharmacia, which carried out the procurement of Osimertinib, recognized the company Alkorpharm as the winner of the tender. It was going to supply an analogue of Tagrisso, which, according to Pharmriva, violated AstraZeneca's rights. The antimonopoly service agreed with this and demanded that the State Unitary Enterprise review the auction results.

    But DSM Group CEO Sergey Shulyak doubts that all the tenders concluded for Osimertinib can really be challenged. “This threatens a collapse in drug supplies, which the Ministry of Health would definitely not want,” the expert explains. The state customer is not obliged to monitor whether someone’s patent rights are violated during procurement; its task is to give preference to Russian drugs and also to purchase what is cheaper, Shulyak reminds.

    Patent attorney, managing partner of Zuykov and Partners Sergey Zuykov does not rule out that Akselpharm will try to challenge the patent cancellation in the Intellectual Property Court (IPC). In practice, the IPC cancels quite a lot of decisions on patents, since Rospatent's positions are not always well motivated, Zuykov notes.

    The lawyer recalls that Akselpharm tried to obtain a compulsory license from AstraZeneca to produce an analogue of Osimertinib through the court. Now, judging by the information in the arbitration case file, the proceedings on this case have been suspended. However, this does not automatically mean that Akselpharm will be prohibited from producing and selling the controversial drug, Zuikov notes. There are other mechanisms for using a patent, for example, with government permission, he recalls.

    In response to RBC's request, the FAS only reminded that they satisfied Pharmriv's complaint regarding the Mordovian tender, since the analogue proposed by the winning supplier violated AstraZeneca's exclusive rights. They were unable to promptly answer questions about whether another 10 tenders for the supply of osimertinib are really currently being contested, as well as about the prospects for a possible contestation of all purchases of the analogue.

    RBC sent a request to the Ministry of Health.

    https://www.rbc.ru/business/22/08/2024/66c4c0039a79473dc7893502

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    Post  Kiko Sat Aug 24, 2024 12:33 am

    A unique Russian drug for treating Bechterew's disease was presented to the international community, by Irina Nevinnaya for Rossiyskaia Gazeta. 08.23.2024.

    Russian drug for Bechterew's disease presented to the international community.

    The results of a clinical trial of the drug seniprutug, developed by scientists from the N.I. Pirogov Russian National Research Medical University, were presented at a major international congress APLAR 2024 in Singapore.

    "Rossiyskaya Gazeta" has already reported on this unique development . The discovery of a unique medicinal molecule capable of coping with axial spondylitis (Bechterew's disease) belongs to Russian scientists headed by Academician of the Russian Academy of Sciences, Rector of the Russian National Research Medical University named after N.I. Pirogov of the Russian Ministry of Health, Sergei Lukyanov.

    "Using the example of Bechterew's disease, we decided to propose a completely new principle of action of a drug for the treatment of autoimmune diseases - to create a drug that does not attack the communication molecules, does not suppress the immune system as a whole, but very specifically, in a targeted manner, destroys those cells of the immune system that cause the disease," explained Academician Lukyanov.

    Clinical studies conducted over 48 weeks confirmed that the drug acts directly on the cause of the disease, and many patients achieve complete remission with this therapy.

    "There is no immunosuppression or side effects associated with it, and in addition, there is no addiction effect. There are no analogues of the drug in the world today," emphasized Sergey Lukyanov.

    The drug is a monoclonal antibody capable of slowing down and even stopping the immune-inflammatory process that progresses in patients with Bechterew's disease, leading to profound disability. "The developed drug allows the destruction of pathological T-lymphocytes that attack the body's own cells. Initial clinical studies have confirmed that the development of the disease is stopped without reducing the activity of the body's immune system as a whole," this is how the Ministry of Health described the new drug, announcing its registration in April 2024.

    Now information about the achievement of Russian scientists has become available to the world community. The drugs used today for Bechterew's disease suppress the body's immune response, reducing overall immunity. Therefore, the unique Russian medicine may be in demand in other countries: according to WHO, more than 20 million people suffer from Bechterew's disease. In Russia, according to various estimates, there are from 150 to 250 thousand of them.

    Bechterew's disease is a chronic autoimmune disease in which the human immune system perceives cartilage and joints as foreign bodies and produces antibodies that "attack" the body's own musculoskeletal cells, gradually destroying them. Pain and stiffness in the spine lead to limited mobility and disability.

    https://rg.ru/2024/08/23/rossijskij-preparat-ot-bolezni-behtereva-predstavili-mezhdunarodnomu-soobshchestvu.html

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    Post  Kiko Fri Sep 06, 2024 9:56 pm

    The Russian Academy of Sciences reported the completion of preclinical trials of a cancer vaccine, 09.06.2024.

    Academician of the Russian Academy of Sciences Kaprin: Preclinical studies of a cancer vaccine have been completed.

    The Russian cancer vaccine has passed preclinical trials. This was announced on September 6 by the chief academician of the Russian Academy of Sciences, oncologist of the Russian Ministry of Health, and general director of the National Medical Research Center of Radiology Andrey Kaprin at a press conference at the international multimedia press center "Russia Today".

    "We have completed the pre-clinical phase. Now a letter has been sent to the Ministry of Health so that they will allow us to start the first phase of testing," Kaprin said, as quoted by RIA Novosti.

    He noted that the recruitment of volunteers will be announced as soon as permission for research is received. The decision on the possibility of participating in testing will be made by specialists.

    The Herzen Oncology Institute, the Blokhin National Oncology Center, and the Gamaleya National Research Center for Epidemiology and Microbiology are participating in the development of the cancer vaccine.

    Earlier, on February 16, the Ministry of Health spoke about the principle of the cancer vaccine. It was reported that it works on a deep analysis of the genetic characteristics of a specific patient's tumor. Kaprin then emphasized that this is not cancer prevention, but rather treatment.

    https://iz.ru/1755187/2024-09-06/v-ran-rasskazali-o-zavershenii-doklinicheskikh-ispytanii-vaktciny-ot-raka

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    Post  GarryB Yesterday at 8:54 am

    Bechterew's disease is a chronic autoimmune disease in which the human immune system perceives cartilage and joints as foreign bodies and produces antibodies that "attack" the body's own musculoskeletal cells, gradually destroying them. Pain and stiffness in the spine lead to limited mobility and disability.

    This sounds rather similar to what Vladimir79 had.

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