GxP News presents a digest of the main news of February 2024 in the pharmaceutical and healthcare industries.
Market regulation
Russian President Vladimir Putin delivered a message to the Federal Assembly. In particular, he announced the launch of new national projects. Several of them are relevant for the pharmaceutical industry – these are the national projects “Personnel” and “Long and active life”.
In 2023, Russia managed to launch the production of several types of medical equipment, which had not previously been produced in the country. Russian President Vladimir Putin said this at the Forum of Future Technologies.
In the first reading, the State Duma adopted a bill that allows district hospitals in small towns where there is no pharmacy to sell medicines. As stated in the explanatory note to the document, in half of the Russian regions there are at least 125 such villages and villages, and the ability to buy medicines in any separate unit of a medical organization, rather than in a neighboring locality, would increase the availability of medicines for residents.
Deputies belonging to various factions The State Duma proposed to allow Russians to spend maternity capital on paid medical services for a child or purchase medicines prescribed by a doctor for him. The list of services and medicines available for such payment should be determined by the Government. The relevant bill has been submitted to the State Duma.
The Government of the Russian Federation did not support the bill of a group of deputies from the Liberal Democratic Party, which prescribed the mandatory use of an “easy-to-read” font in the instructions for medicines with a size (size) of at least 12 points (about 4 mm in height). It was assumed that this measure should make it easier for consumers to read the leaflet.
Russian Prime Minister Mikhail Mishustin ordered to allocate 440 million rubles from the federal budget for the development of bone marrow and hematopoietic stem cell donation. The funds will be spent on taking measures to increase the availability of high-tech medical care for patients.
The Ministry of Health of the Russian Federation has developed a draft government decree, which assumes an increase in the standard of financial costs per month for one Russian citizen receiving preferential medicines, medical devices, as well as therapeutic nutrition. According to the document, from February 1, 2024, the standard should be increased by 83.5 rubles to 1211.3 rubles.
The Ministry of Labor of the Russian Federation has developed a bill proposing to expand the list of professions for alternative civil service instead of conscription military service. The list may include a pharmacist, an epidemiologist, a trainee doctor, a statistician, a forensic psychiatric expert, a massage nurse, a general practitioner’s nurse, an anesthesiologist nurse.
The EAEU
On February 1, he assumed the post of Chairman of the Board of the Eurasian Economic Commission Bakytzhan Abdirovich Sagintayev. The corresponding decision was made by the heads of the member states of the Eurasian Economic Union at a meeting of the Supreme Eurasian Economic Council on December 25, 2023 in St. Petersburg. Also, on February 1, the new composition of the Board of the Eurasian Economic Commission, approved by the heads of the EAEU states, began work.
VED
Commission The Ministry of Health of the Russian Federation on the formation of lists of VED and VZN held a meeting for the first time since February 2023, during which it considered several applications, including from Biocad. As a result, both of the company’s new drugs against multiple sclerosis are recommended for inclusion in the lists.
The Ministry of Health has proposed changes to the draft resolution on the regulation of prices for medicines from the list of VED. It is planned to reduce the registration period for manufacturers’ maximum selling prices from 60 to 40 working days, as well as reduce the volume of necessary documents from 12 to 6. The proposed document provides for the provision of services in electronic form, including the use of the public services portal. It is planned to introduce changes from September 1, 2024.
Pharmaceutical market in Russia
In the Russian Federation, a biocenter of laboratory animals can be created for the development of medicines and testing.
Russian scientists have developed a test system that can detect about 2,500 hereditary diseases in newborns in the first days of life.
The Russian Ministry of Health has approved the new drug Afatinib (afatinib), developed by Axelpharm. The drug is recommended for patients suffering from locally advanced or metastatic non-small cell lung cancer (NSCLC) with an EGFR mutation.
Russian Biocad has submitted documents to the Ministry of Health of the Russian Federation for registration of the drug BCD-180 against axial spondyloarthritis – Bekhterev’s disease. This became known from the words of the chairman of the Board of directors of the company Dmitry Morozov. Biocad notes that this is the first in its class original drug based on monoclonal antibodies that can stop the development of the disease.
The Ministry of Health of the Russian Federation has faced difficulties in purchasing some drugs for the treatment of HIV due to the lack of applications from suppliers. The ZdravResurs expert group reported that out of 61 announced auctions at the beginning of 2024, 17 did not take place due to the lack of interested suppliers. This led to the fact that the Ministry of Health was unable to purchase 107 thousand annual courses of drugs for a total amount of about 1 billion rubles. The Ministry of Health assured that the accumulated stocks of HIV drugs in Russia will last for three months, new purchases are underway, and the situation is “under constant control.”
In January 2024 The Ministry of Health of the Russian Federation issued only 30 permits for conducting clinical trials (CI), which is 34 less than in December 2023 (more than twice). The decrease in the total number of CI at the junction of 2023-2024 turned out to be even more noticeable (more than twice) than last year, when the number of approved CI in January 2023 decreased only 1.2 times compared to December 2022. This is reported in the Sciencefiles review.
18 companies joined the experiment on traceability of the origin of pharmaceutical substances, launched in December 2023. Of these, 11 have a license to manufacture pharmaceutical substances, 10 import raw materials, 5 supply ready-made pharmaceutical substances, 3 introduce raw materials into circulation.
By the end of 2023, the production of medicines and medical devices in Moscow increased 1.4 times (40.3% more than in 2022). For the effective development of the industry in the capital, a pharmaceutical cluster has been formed, including 11 companies, 8 of which are already operating. As planned, when reaching full capacity, all these enterprises will produce medicines (LP) for 128 INN.
During 2023, pharmaceutical companies with which Moscow has signed offset contracts supplied the city with over 830 thousand packages of medicines, the mayor of Moscow said Sergei Sobyanin.
St. Petersburg PJSC Pharmsintez has decided to sell the Estonian Kevelt plant. The buyer is Dmitry Genkin, Chairman of the Board of Directors of the company.
Group of Companies (GC) R-Pharm increased the production of drugs for the treatment of human immunodeficiency virus (HIV) by 31%. This result was achieved thanks to the national project “Labor Productivity”. Together with experts from the Moscow regional competence center, about 80 types of problems in the production of the drug were identified and eliminated.
By the autumn of 2024, the company “PSK Pharma” will reconstruct its production building in the Dubna SEZ near Moscow and create a laboratory for the analysis of pulmonological drugs on its basis. 250 million rubles will be required to achieve these goals.
The head of the Republic of Crimea, Sergey Aksenov, in his telegram channel, spoke about the increase in the number of complaints from residents about violations of the supply of medicines for privileged categories of citizens. First of all, according to him, these are people with cancer and diabetes mellitus.
The Kyrgyz authorities have announced plans to start purchasing Russian-made medicines directly at production sites.
The pharmaceutical market in the world
Up to $1 billion will be allocated to accelerate vaccine production in Africa under a new scheme announced by the GAVI Vaccine Alliance, WHO said. The project aims to solve the problem of inequality in access to preventive drugs, that is, not to repeat the scenario that unfolded during the COVID-19 pandemic. In addition, the use of proprietary vaccines to combat diseases that kill hundreds of thousands of Africans every year, such as cholera and malaria, would reduce the death rate on the mainland.
The U.S. Food and Drug Administration (FDA) has approved the drug Xolair (omalizumab) from Genentech, which is able to reduce food allergic reactions. The drug is taken by the course and is not intended for immediate emergency treatment of allergic reactions, including anaphylaxis.
The FDA has approved an injection of Aurlumyn (iloprost) from Eicos Sciences, which is used to reduce the risk of limb amputation in frostbite. As stated in the company itself, this is the first drug to combat the effects of severe frostbite with proven effectiveness.
The FDA has rejected Defender Pharmaceuticals’ application for approval of a gel with the active ingredient scopolamine, which is intended to prevent nausea and vomiting caused by movement. It was assumed that the nasal preparation DPI-386 would be especially in demand among astronauts and the military. The project was implemented with the support of NASA, and approval of the drug was expected in the US Navy.
Biogen has announced the termination of all Aduhelm (aducanumab)-related projects. It is a drug to combat Alzheimer’s disease, which in 2021 became the first to receive FDA approval for the treatment of this disease since 2003. Biogen will return the rights to Aduhelm to Neurimmune, from which it obtained a license for the drug in 2007.
The American Bristol-Myers Squibb (BMS) acquired the developer of radioactive cancer drugs RayzeBio for $4.1 billion ($62.5 per share). This will allow the company to expand its portfolio of anticancer drugs.
AbbVie has completed the acquisition of ImmunoGen for $10.1 billion. This step will significantly strengthen its oncology portfolio with drugs for the treatment of solid tumors and hematological malignancies. The companies signed a final agreement in November 2023.
AbbVie announced the upcoming personnel changes in the management. Richard Gonzalez, who has served as CEO since 2013, will give way to Robert Michael, who is currently the company’s chief operating officer. The changes will take effect on July 1, 2024.
European Medicines Agency (EMA) provided an expedited review of the Bavarian Nordic chikungunya vaccine. This means that the regulator will consider the application in 150 days, and not in 210, as usual.
CRISPR gene therapy Casgevy (exagamglogene autotemcel) from companies Vertex Pharmaceuticals and CRISPR Therapeutics are approved in Europe for the treatment of sickle cell disease and transfusion-dependent beta thalassemia. Previously, the method was approved in the UK and the USA to combat the same diseases. The decision of the European Commission followed the positive conclusion adopted by the European Medical Agency (EMA) in December 2023.
Health trends
More than half of the world’s countries will be at high or very high risk of measles outbreaks by the end of 2024 unless urgent preventive measures are taken, she warned The World Health Organization (WHO). The number of measles cases is increasing mainly due to the neglect of vaccination during the years of the massive spread of COVID-19, when countries’ health systems were already overloaded.
The U.S. Senate is criticizing the heads of pharmaceutical companies because of rising drug prices.
The British Medicines and Healthcare Products Regulatory Agency (MHRA) announced that Codeine Linctus cough medicine, containing codeine, will be transferred to the category of prescription-only medicines. The reason for this decision was reports of misuse of the drug. Pharmaceutical Company Roche is cutting 345 jobs in the product development department in response to the profit decline recorded in 2023 and a more cautious outlook for the coming year.
Source: gxpnews.net
