NANOLEK will invest 5 billion rubles in the full production cycle
By its 10th anniversary, Nanolek, a biopharmaceutical company, announces a plan to invest 5 billion rubles over 3 years in its full-cycle vaccine production facility in the Kirov region and an R&D Center for Biotech Medicines in Moscow. These steps are to be taken to triple the current vaccine portfolio by 2025 and to make us the leading vaccine manufacturer in the Russian market.
In 2020, Nanolek accounted for 20% of government vaccine purchases on the NPVC, the National Pediatric Vaccine Calendar. The state spent a total of 26.6 billion rubles on vaccines for the calendar, of which about 5.4 billion rubles on Nanolek’s vaccines. The company currently supplies two vaccines to the NPVC: Polymilex, against polio, and Pentaxim (jointly with Sanofi), a five-component combination vaccine to prevent diphtheria, tetanus, pertussis, polio, and diseases caused by Haemophilus influenzae.
The current vaccine portfolio must be tripled to significantly increase the volume of state purchases for the national vaccine calendar in 2025 and to take the lead among vaccine manufacturers. For this reason, Nanolek can no longer do without full-cycle production of vaccines and its proprietary R&D of Biotech Medicines. Over 5 billion rubles will be channeled into these areas in the next three years.
Now we have our proprietary R&D and a full cycle only for solid dosage forms, – comments Vladimir Khristenko, President of Nanolek. – As for the full vaccine production cycle, we are only starting now. This year, we also began creating our proprietary centers for the early development of immunobiological medicines, the R&Ds in the area of biotech medicines. We organize them in partnership with the Institute of Biological Instrumentation with Experimental Production of the Russian Academy of Sciences (IBP RAS) in Pushchino and Sechenov MSMU in Moscow. The plan is to have four or five proprietary developed medicines in our portfolio in a few years. This is the only way for us to become the leader in the Russian vaccine market and to get a head start on global markets. We continue to evolve as part of our mission to protect lives and health by making the world’s best technologies available.”
Now, for Nanolek, the goal of tripling the vaccine portfolio means adding at least four more vaccinations.
HPV vaccine. This year, Nanolek plans to begin Phase I clinical trials of an HPV vaccine, a human papillomavirus vaccine. A high HPV titer increases the risk of cervical cancer in women and laryngeal cancer in men dramatically. This front-line vaccination is a joint project with Combiotech, a research and production company. In Europe, Israel, and the United States, even adults are now receiving HPV vaccines once every five years, although the basic WHO recommendation is to vaccinate adolescents before they become sexually active. The HPV vaccination is expected to appear on the national immunization calendar in 2024.
Pneumococcal vaccine. Clinical trials have been completed, and a 13-valent pneumococcal vaccine is scheduled to hit the market next year.
Meningococcal vaccine. A joint project with Sanofi to transfer the production of a meningococcal vaccine is underway. From a five-year perspective, the two partner companies plan to deepen production of the vaccine against this life-threatening infection step-by-step.
4 proprietary vaccines. Several immunobiological medicines are in the early stages of development at the new R&D center (based at IBP RAS in Pushchino and Sechenov MSMU in Moscow). This is a proprietary covid vaccine and has been in preclinical trials. In the early development stage is a vaccine molecule for the prevention of shingles caused by the herpes zoster virus; this vaccine should be given to people aged 50+. The company has not yet disclosed two other new vaccines it has started working on. The first proprietary vaccine will not hit the market until 2024.
Facts about Nanolek
Nanolek has seen 10 billion rubles invested in it in the last 10 years. The company’s plant in the Kirov region that opened in 2014 was built with an eye on the best international practices and technologies. A total of 25 medicines are now in the Nanolek’s portfolio, and 20 more are at various stages of preparation for release and will hit the market in the next five years.
In 10 years, the company has produced 140 million packages of pills: they can pave the road from Kirov to New Zealand. Nanolek vaccines have also immunized 10 million children in Russia in the first ten years, making the company the country’s sole manufacturer of polio vaccines now.
The plant is not only GMP (good manufacturing practice) certified, but also has regular quality audits by major international pharmaceutical corporations: the Nanolek plant produces medicines in cooperation with Sanofi, Janssen, Merck, Aspen, and other companies.
Nanolek has paid 0.5 billion rubles in taxes to the Kirov region treasury for 10 years and plans to pay another 0.4 billion in taxes in 2021 to all levels of the regional budgets.
Last year, Nanolek showed a multiple of turnover growth: 12 billion rubles in 2020 up from 7.5 billion rubles in 2019.
In early 2021, the Board of Directors approved a new business strategy for five years: the main focus is still the production of pediatric vaccines and medicines to treat severe diseases, as well as full-cycle import substitution in line with the objectives of the Pharma 2030 state program. The company’s structure has evolved to have three divisions now: the first, the flagship division for vaccines, the second for specialized medicines (drugs for the treatment of orphan diseases and cancer), and the third for contract manufacturing.
In March 2021, the company joined the coronavirus prevention task: during a live line with Russian President Vladimir Putin, Minister of Industry and Trade Denis Manturov announced that Nanolek had been selected as an industrial partner for the production of the CoviVac vaccine (developed by the Chumakov Research Institute). In mid-summer, the company’s high-tech, modern plant in the Kirov region plans to start producing CoviVac so that it can produce 5 million doses by the year-end, cooperating with the Chumakov Institute.
Scientists claim the nanoparticles obtained can carry an increased antibiotic “load” and easily penetrate tissues from the bloodstream and back, ensuring continuous drug delivery to the site of infection.
Vietnamese Prime Minister Pham Minh Chin has requested accelerating the transfer of vaccine production technology and the testing and production of home-grown vaccine for COVID-19, so that Vietnam will be able to produce COVID-19 vaccines no later than June 2022. The Company for Vaccine and Biological Production No.1 (Vabiotech) – the biggest vaccine manufacturer and supplier for the EPI in Vietnam is in talks with Russia to produce Sputnik V vaccine in the country. He made the order during working sessions with several producers of vaccines, biological products and medical supplies in Hanoi on June 24. At the Vaccine and Biological Production Company No. 1 under the National Institute of Hygiene and Epidemiology, the PM also reiterated the need to carry out the vaccination campaign in the quickest, most effective and safest manner. (VietnamPlus, Vietnam News Agency) During a working session with Medicon company which specialises in producing test kits for medical needs, the PM asked the company to keep up its creative spirit in research and production of medical products, including medical supplies for COVID-19 prevention and control. Successful realization of the vaccine strategy is the top solution to prevent and push back the COVID-19 pandemic as Vietnam, one […]
The Russian Direct Investment Fund (RDIF, Russia’s sovereign wealth fund) and Panacea Biotec, one of the leading vaccine and pharmaceutical producers in India, today announced the launch of production of the Russian Sputnik V vaccine against coronavirus. The first batch produced at Panacea Biotec’s facilities at Baddi will be shipped to the Gamaleya Center for quality control. Full-scale production of the vaccine is due to start this summer. Company’s facilities comply with GMP standards and are prequalified by WHO. Sputnik V was registered in India under the emergency use authorization procedure on April 12, 2021 and vaccination against coronavirus with the Russian vaccine started on May 14. As announced in April, RDIF and Panacea have agreed to produce 100 million doses per year of Sputnik V. To date Sputnik V has been registered in 66 countries globally with total population of over 3.2 billion people. Efficacy of Sputnik V is 97.6% based on the analysis of data on coronavirus infection rate among those in Russia vaccinated with both components of Sputnik V from December 5, 2020 to March 31, 2021. The vaccine is based on a proven and well-studied platform of human adenoviral vectors and uses two different vectors for […]
American Gene Technologies (AGT), a clinical-stage biotechnology company, announced treatment of the first participant in its Phase I clinical trial to evaluate safety of the cell and gene therapy product AGT103-T. Designated as the RePAIR trial (Restore Potent Antiviral Immune Responses, NCT04561258), participants are infused once with their own CD4 T cells that were enriched, for cells capable of reacting to HIV, and genetically modified to resist infection. The first infusion took place at Washington Health Institute, Washington, D.C. on May 19. This is a first-in-human study for AGT103-T. The primary endpoint is safety; testing related to secondary endpoints evaluates responses to treatment including changes in the immune response to HIV. Participants treated with AGT103-T will be followed for 6 months in this safety study before enrolling in an FDA-mandated 15-year long-term follow up required for all gene therapy trials. Enrollment, product manufacturing, and treatments are ongoing at AGT’s clinical trial sites. “Treating the first person with our product is an important step forward and the culmination of design, development, manufacturing, and approval of the product for human testing. We believe this therapy is capable of changing the body’s ability to fight HIV and the first-in-man study signals the first […]
The Russian Direct Investment Fund (RDIF) announces the real world data of the Ministry of Health of San Marino on the Russian Sputnik V coronavirus vaccine confirming its high efficacy during the vaccination campaign in the country including against new variants of COVID. The efficacy of Sputnik V was measured based on the monitoring of COVID cases between 25 February and 23 August, 2021. Overall efficacy over 21 days after administering the first dose was estimated at 94.8% while efficacy against hospitalizations estimated at 95.9%. Sputnik V is the most efficient vaccine against hospitalizations with COVID-19 in the country. San Marino was the first country in Europe to defeat COVID and lift restrictions thanks to inclusion of Sputnik V in the national portfolio. Over 70% of the adult population has been vaccinated with Sputnik V. The Russian vaccine is demonstrating high safety profile with data published in EClinicalMedicine (an open access clinical journal published by The Lancet, one of the world’s most respected medical journals). In particular, Sputnik V shows high tolerability profile in ≥60 age group with nearly all reported adverse events following immunization being mild or moderate and lasting less than 2 days. Sputnik V has a number […]
Novavax, Inc., a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced enrollment of the first participants in a Phase 1/2 study to evaluate the safety and immunogenicity of a combination vaccine using Novavax’ seasonal influenza and COVID-19 vaccines. The clinical trial combines Novavax’ recombinant protein-based NVX-CoV2373 and NanoFlu™ vaccine candidates and patented saponin-based Matrix-M™ adjuvant in a single formulation (COVID-NanoFlu Combination Vaccine). Both NVX-CoV2373 and NanoFlu have previously demonstrated strong results as standalone vaccines in Phase 3 clinical trials. “This study is the first-of-its-kind to evaluate the vaccine’s potential to induce a robust immune response, augmented by our Matrix-M adjuvant, against two life-threatening diseases simultaneously,” said Gregory M. Glenn, M.D., President of Research and Development, Novavax. “The combination of these two vaccines, which have individually delivered outstanding results with favorable safety and tolerability profiles, may lead to greater efficiencies for the healthcare system and achieve high levels of protection against COVID-19 and influenza with a single regimen.” The trial will evaluate the safety, tolerability and immune response to NanoFlu formulated together with NVX-CoV2373 and Matrix-M adjuvant in 640 healthy adults 50 to 70 years of age. Participants will have been either previously infected with the […]
EMA’s safety committee (PRAC) has concluded that people who have previously had capillary leak syndrome must not be vaccinated with Vaxzevria (formerly COVID-19 Vaccine AstraZeneca). The Committee also concluded that capillary leak syndrome should be added to the product information as a new side effect of the vaccine, together with a warning to raise awareness among healthcare professionals and patients of this risk. The Committee carried out an in-depth review of 6 cases of capillary leak syndrome in people who had received Vaxzevria.1 Most of the cases occurred in women and within 4 days of vaccination. Three of those affected had a history of capillary leak syndrome and one of them subsequently died. As of 27 May 2021, more than 78 million doses of Vaxzevria had been administered in the EU/EEA and the UK.2 Healthcare professionals should be aware of the signs and symptoms of capillary leak syndrome and of its risk of recurrence in people who have previously been diagnosed with the condition. People who have been vaccinated with Vaxzevria should seek immediate medical assistance if they experience rapid swelling of the arms and legs or sudden weight gain in the days following vaccination. These symptoms are often associated […]
Parliament wants to strengthen the transparency of both the Agency and all actors in the supply chain, and give a more active role to healthcare professionals, as well as encouraging synergies between EU agencies.
The global active pharmaceutical ingredient market stood at around $190 billion in 2020, and it is expected to reach approximately $300 billion by 2030. This can be attributed to the widening of the application area of drugs, expiration of patented biologics, increase in the incidence of chronic and lifestyle-associated diseases, such as cancer, diabetes, and cardiovascular diseases, rise in the geriatric population, government initiatives to promote generic drugs, investments in biosimilars, increasing healthcare expenditure, and surging awareness about diseases. Due to the COVID-19 pandemic, lockdowns were imposed by the government in several countries across the world, which disrupted the supply chain and economic activity during the first half of 2020. However, established pharmaceutical and biotech companies, as well as research institutes, stepped forward to develop a treatment against the coronavirus, which had a positive impact on the API market. Due to High Investments by Major Players, Captive Category Held Larger Share The captive category held the larger share in the active pharmaceutical ingredient market during 2015–2020, and it is expected to retain its position in the upcoming years, based on the type of manufacturer. This can be attributed to the easy availability of raw materials and surging investments by the […]
For the first quarter of 2021 NPO Microgen, managed by the Nacimbio holding of the Rostec State Corporation, has increased the export of medicinal products to Uzbekistan by more than one and a half times compared to the same period last year. By volume, about 500 thousand packages of medicines have been exported to the republic. The medicines of the pharmacological group of bacteriophages, registered in the country in 2019, turned to be the key sales driver. Their ratio was about 40% of total sales. Sextafag, supplied to Uzbekistan since 2018, was in the highest demand. In the first quarter of this year alone, its sales to the republic exceeded the total annual sales volume of the drug in 2020 by 60%. Sextafag has a broad spectrum of antimicrobial action and is designed for the treatment and prevention of pyoinflammatory and enteric diseases caused by staphylococci, streptococci, Proteus mirabilis, Klebsiella, Pseudomonas, and E. coli. Moreover, wholesale supplies to the republic of two types of bacteriophages (Intesti and Staphylococcus bacteriophage) were arranged for the first time. For the Staphylococcus bacteriophage a new, more convenient dosage form of 20 ml was registered in Uzbekistan last year. The Republic of Uzbekistan is Microgen’s […]
The Heads of the World Bank Group, International Monetary Fund, World Health Organization, and World Trade Organization today convened for the first meeting of the Task Force on COVID-19 Vaccines, Therapeutics and Diagnostics for Developing Countries. They issued the following joint statement: “As many countries are struggling with new variants and a third wave of COVID-19 infections, accelerating access to vaccines becomes even more critical to ending the pandemic everywhere and achieving broad-based growth. We are deeply concerned about the limited vaccines, therapeutics, diagnostics, and support for deliveries available to developing countries. Urgent action is needed now to arrest the rising human toll due to the pandemic, and to halt further divergence in the economic recovery between advanced economies and the rest. We have formed a Task Force, as a “war room” to help track, coordinate and advance delivery of COVID-19 health tools to developing countries and to mobilize relevant stakeholders and national leaders to remove critical roadblocks—in support of the priorities set out by World Bank Group, IMF, WHO, and WTO including in the joint statements of June 1 and June 3, and in the IMF staff’s $50 billion proposal. At today’s first meeting, we discussed the urgency of increasing supplies of vaccines, […]
ISPE announced the release of its latest Guide, ISPE Good Practice Guide: Knowledge Management in the Pharmaceutical Industry. The Guide focuses on how Knowledge Management (KM) can enable a more effective Pharmaceutical Quality System (PQS).
The R&D centre is tasked to optimise its substance manufacturing process and develop new unique molecules. The complex has modern and high-precision equipment that allows to: optimise technologies for synthesising generic drugs, develop synthesis methods and produce substance samples for clinical and preclinical studies, validate analytical procedures to control the quality of active pharmaceutical ingredients. The laboratory is also unique since it is in touch with production, which allows transferring laboratory scale developments faster to the industrial level. It is also possible to carry out advanced multi-stage syntheses, which helps reduce substance prices and import dependence. More than 20 synthetic chemists, analytical chemists and operators work in the laboratory that is in active search for personnel and recruitment.
It is envisaged to implement the project in three stages from 2021 to 2024, the amount of investment from the company “SOLYPHAR” will be more than 20 million US dollars, in accordance to the international GMP standards.
This review contains the latest information related to inspection of manufacturers of veterinary medicinal products manufactured outside the Russian Federation for compliance with the requirements of the Good Manufacturing Practice (GMP). These inspections are conducted by specialists of the Federal State Budgetary Institution “The All-Russian State Center for Quality and Standardization of Veterinary Drugs and Feed” (FSBI “VGNKI”) subordinated to Rosselkhoznadzor. GMP rules Since January 2021, the GMP Rules of the Eurasian Economic Union (EAEU GMP Rules), approved by the Resolution of the EEC Council No. 77 of November 3, 2016, entered into force with respect to medicinal products for veterinary use . In January 2021, on the Official Internet Portal of Legal Information publication.pravo.gov.ru the Order of Rosselkhoznadzor No. 1231 of November 17, 2020 “On approval of the application form for issuing a conclusion on the compliance for a manufacturer (foreign manufacturer) of veterinary medicinal products with the GMP Rules requirements, the form of the inspection report based on the results of the inspection of the manufacturer (foreign manufacturer) of veterinary medicinal products for compliance with the GMP Rules requirements and the form of the conclusion on the compliance of the manufacturer (foreign manufacturer) of veterinary medicinal products with […]
The FDA evaluated information on the use of a third dose of the Pfizer-BioNTech or Moderna Vaccines and determined that the administration of third vaccine doses may increase protection in this population.
Production of Moderna COVID-19 vaccines at a plant in Spain can continue, the European Union drugs regulator said on Friday, while it carries out its investigation of a suspected metallic contamination incident.
Nanolek, a biopharmaceutical company, announces a plan to invest 5 billion rubles over 3 years in its full-cycle vaccine production facility in the Kirov region and an R&D Center for Biotech Medicines in Moscow.
Crohn’s disease and ulcerative colitis are severe chronic bowel diseases for which there are no effective drugs yet. The main approach in their therapy is to take drugs that reduce inflammation and restore the intestinal mucosa. At the same time, there are still no funds on the market that can gradually release an active substance inside the body, which could significantly increase the effectiveness of therapy. Under the leadership of the Federal State Budgetary Institution “CSP” of the FMBA of Russia, scientists from the N.N. DI Mendeleev developed a technology for obtaining such a dosage form: they created enteric capsules containing a biopolymer complex that releases an active substance at a controlled rate, which ensures a prolonged action and high bioavailability of the drug. Crohn’s disease and ulcerative colitis are severe chronic inflammatory bowel diseases of a non-infectious nature. According to statistics, they affect more than 23 million people around the world, while the frequency of detection of these diseases is increasing every year, and most often they are sick in developed countries and regions with a high level of urbanization. The exact figures for Russia are unknown, but according to various estimates, the prevalence of ulcerative colitis and Crohn’s […]
European Union approval of Russia’s Sputnik V coronavirus vaccine will be delayed because a June 10 deadline to submit data was missed, two people familiar with the matter told Reuters, diminishing the shot’s prospects in the EU’s pandemic response, – reports Reuters One of the sources, a German government official, said the failure to provide the necessary clinical trial data to the EU medicines watchdog would postpone any go-ahead in the bloc until at least September. “Approval of Sputnik will be delayed probably until September, maybe until the end of the year,” the official said, speaking on condition of anonymity. The European Medicines Agency (EMA) had previously been expected to conclude its review of the Russian vaccine and issue a decision in May or June. A second source said the June 10 cut-off date not been met and that EMA had given the vaccine’s developer, Russia’s Gamaleya Institute, another week to file the required data. The Russian Direct Investment Fund (RDIF), which markets the vaccine, said the EMA review was on track. “All of the information on the Sputnik V vaccine clinical trials has been provided and GCP (General Clinical Practice) review has been completed with positive feedback from the […]
Johnson & Johnson has shaken off another lingering liability claim in the US, agreeing a $263 million settlement with New York to resolve lawsuits focused on its role in the US opioid crisis. The last-ditch agreement over the weekend means that a jury trial due to start today will now go ahead without J&J, although other defendants will still be in the spotlight. J&J also said in a statement that it committed to exiting its opioid painkiller business altogether last year. While the company didn’t provide finished opioid drugs, J&J supplied raw materials used to make them, and has been accused by various US states of using deceptive marketing to say the drugs were effective for treating pain and were unlikely to cause addiction. The settlement relates to its marketing and promotion of Duragesic (fentanyl), Nucynta (tapentadol) and Nucynta ER products, which are no lomger on sale in the US. The opioid epidemic has wreaked havoc on countless communities across New York state and the rest of the nation, leaving millions still addicted to dangerous and deadly opioids, – said NY attorney general Letitia James, – Johnson & Johnson helped fuel this fire, but today they’re committing to leaving the opioid business […]
The factory, which will be located on a 42 hectare greenfield site is planned to be operational by 2023, will be run by Recipharm and will mirror the company’s new fill finish line at its facility in Monts, France on a larger scale.
An efficacy study was conducted in Bahrain in accordance with WHO guidelines involving more than 5,000 subjects. Overall efficacy beyond 14 days after administering the second dose was estimated at 94.3%.
The European Investment Bank (EIB) and Univercells S.A (Univercells) have signed a €30 million loan agreement to enable the production of large volumes of prophylactic COVID-19 vaccines in a new facility and to co-develop a pipeline of COVID-19 vaccines. This facility will address the unprecedented global demand for vaccines brought on by the COVID-19 pandemic. The partnership backs Univercells’s Belgian hub, strengthening pandemic resilience in Europe and supporting global manufacturing autonomy through Univercells’ efforts to launching new production sites around the world based on the company’s innovative biomanufacturing technology. In collaboration with the European Commission, the EIB Group is on its way to mobilising billions for the COVID-19 response, which it kicked off as soon as the crisis hit to tackle the global health emergency and the economic consequences of the COVID-19 pandemic. The InnovFin Infectious Diseases Finance Facility (IDFF) was scaled up at the beginning of the outbreak to directly support highly innovative projects that work towards halting the spread of the virus. The programme helps biotech and medtech companies across Europe find solutions for vaccines, cures and diagnostics. The new venture debt to Univercells backed by the IDFF adds to a previous €20 million operation under the programme […]
The Russian health ministry’s Smorodintsev Flu Research Institute has finished pre-clinical tests of its own coronavirus vaccine and plans to begin trials on volunteers by the yearend, the institute’s director, Dmitry Lioznov, told a news conference on Monday. We have finished pre-clinical tests and are filing documents for the approval of the coronavirus vaccine’s clinical trials. We expect that this vaccine will protect against both the coronavirus infection and type A influenza. Such research is going on and I hope if everything is all right, we will begin clinical tests of this vaccine before the New Year, he said. The institute told TASS earlier that its specialists were working on a coronavirus vaccine on the basis of the flu virus. A weakened flu virus will be used as a vector to deliver coronavirus proteins and prompt an immune response. The conserved part of the virus will be used to enter cells. The vaccine will be in the form of nasal drops or a spray.
Philip Morris International Inc. announced it has entered into an agreement to acquire Fertin Pharma A/S (Fertin Pharma), a leading developer and manufacturer of innovative pharmaceutical and well-being products based on oral and intra-oral delivery systems, for an enterprise value of DKK 5.1 billion (approximately USD 820 million). “The acquisition of Fertin Pharma will be a significant step forward on our journey toward delivering a smoke-free future—enhancing our smoke-free portfolio, notably in modern oral, and accelerating our progress in beyond nicotine,” stated Jacek Olczak, Chief Executive Officer. “Both PMI and Fertin share a commitment to science and consumer-centric innovations for better living, and I am delighted we have reached this agreement. Fertin’s diverse portfolio of technologies, evolving business mix, and world-class expertise will enrich our innovation pipeline and capabilities, providing speed and scale in oral delivery to support our 2025 goals of generating more than 50% of our net revenues from smoke-free products and at least USD 1 billion from products beyond nicotine.” Fertin Pharma is a privately held company with more than 850 employees and operations in Denmark, Canada, and India. It is a leading contract development and manufacturing organization (CDMO), specializing in the research, development and production of […]
Walmart announced the launch of the first-ever private brand analog insulin, which will revolutionize the access and affordability to diabetes care by offering customers a significant price savings without compromising quality. Available exclusively through Walmart’s private ReliOn brand, the new offering includes analog insulin vials ($72.88) and FlexPen® ($85.88). These products will save customers1 between 58% to 75% off the cash price of branded analog insulin products, which translates to a savings of up to $101 per branded vial or $251 per package of branded FlexPens®. The new private label ReliOn™ NovoLog® Insulin (insulin aspart) injection, manufactured by Novo Nordisk, is available in Walmart pharmacies this week, and Sam’s Club pharmacies in mid-July across the United States. ReliOn™ NovoLog® is a rapid-acting insulin analog used to control high blood sugar in adults and children with diabetes. Customers will need a prescription in order to purchase the products and should always consult with their doctor regarding their diabetes management. “We know many people with diabetes struggle to manage the financial burden of this condition, and we are focused on helping by providing affordable solutions. We also know this is a condition that disproportionately impacts underserved populations. With ReliOn NovoLog® insulin, we’re […]
The Directors-General of the World Health Organization (WHO), the World Intellectual Property Organization (WIPO) and the WTO agreed to enhance their support to members battling COVID-19 by collaborating on a series of workshops to augment the flow of information on the pandemic and by implementing a joint platform for tripartite technical assistance to member governments relating to their needs for medical technologies. As a result of their meeting on 15 June, Dr Tedros Adhanom Ghebreyesus, Daren Tang and Dr Ngozi Okonjo-Iweala issued a joint statement. On June 15, 2021, we, the Directors General of WHO, WIPO and the WTO, met in a spirit of cooperation and solidarity to map out further collaboration to tackle the COVID-19 pandemic and the pressing global challenges at the intersection of public health, intellectual property and trade. Acutely conscious of our shared responsibility to communities across the world as they confront a health crisis of unprecedented severity and scale, we pledged to bring the full extent of the expertise and resources of our respective institutions to bear in ending the COVID-19 pandemic and improving the health and well-being of all people, everywhere around the globe. We underscored our commitment to universal, equitable access to COVID-19 […]
The minister also revealed that the Karaganda pharmaceutical plant will produce extra 1,7 million doses of Sputnik V vaccine. They will be distributed among regions of the country according to the approved schedule.
VTB Capital has invested in the pharmaceutical holding company Binnopharm Group. Sistema’s wholly-owned subsidiary LLC Sistema Telecom Assets sold an 11.2% stake in Ristango Holding Limited, which owns 100% of the authorised capital of Binnopharm Group, to Nevsky Property Investments Limited (controlled by VTB Capital). The transaction totalled RUB 7 billion. As a result, Sistema’s effective stake in Binnopharm Group together with its financial partner (VTB Bank) stands at 75.3%; a consortium of investors consisting of the Russian Direct Investment Fund (RDIF), the Russia-China Investment Fund (co-founded by RDIF and China Investment Corporation) and leading Middle Eastern funds holds 12.5%; VTB Capital, represented by Nevsky Property Investments Limited, holds 11.2%. The remaining 1% of shares in Binnopharm Group are owned by a minority shareholder (an individual). Binnopharm Group is a full-cycle Russian pharmaceutical holding company that combines five production sites located in different regions of Russia: JSC Alium (formerly OBL Pharm in the Serpukhov district of the Moscow region), JSC Binnopharm (two sites: Zelenograd and Krasnogorsk), OJSC Sintez (Kurgan) and CJSC Biocom (Stavropol). The Binnopharm Group companies produce a wide range of drugs across therapeutic groups and have the largest portfolio of drugs among Russian manufacturers (more than 450 marketing […]
Sai Life Sciences, a leading global Contract Research, Development & Manufacturing Organization (CRO-CDMO), announced the opening of a new biology facility at its integrated R&D campus in Hyderabad, India. The facility marks an important milestone in the journey of positioning itself as a differentiated player in Discovery Biology. Making the announcement, CEO & Managing Director of Sai Life Sciences, Krishna Kanumuri said, The new facility marks the culmination of a journey we began two years ago, of creating differentiated value for our discovery clients through an integrated delivery model across Boston and Hyderabad. Continuing with the company’s aggressive growth in its biology services, the new state-of-the-art facility houses expanded in vitro and in vivo biology services, DMPK, toxicology and a vivarium. In this new facility Sai Life Sciences is augmenting both, its capabilities and capacity, to deploy cutting-edge platforms and technologies for accelerating integrated drug discovery programs. Boston-Hyderabad integrated delivery model Sai Life Sciences has been steadily growing its biology capabilities to complement its strong foundation in medicinal chemistry, DMPK and toxicology for supporting its customers across the entire drug discovery journey from target ID and validation to IND. In 2019, the company opened its first international R&D facility with […]
The EpiVacCorona-N coronavirus vaccine will be released into civil circulation in the near future, Tatiana Nepomnyashchikh, a deputy head of the Vector State Research Center of Virology and Biotechnology, told TASS on Thursday. EpiVacCorona-N has not yet been released into the stream of commerce because we received the authorization only on Thursday. As soon as our industrial partners manufacture the series, the health regulator will give authorization for the release into the civil circulation. It will be in the near future, she said on the sidelines of the Eastern Economic Forum (EEF). The EpiVacCorona-N coronavirus vaccine developed by the Vector Center was registered with the Russian health ministry last Thursday. The Center’s chief, Rinat Maksyutov, said earlier that were are no principal differences between the EpiVacCorona and EpiVacCorona-N vaccines. According to Maksyutov, the vaccines differ by technological specifics of the production process. However, new clinical tests were needed all the same.
The acquisition includes Teneobio’s proprietary bispecific and multispecific antibody technologies, which will enable significant acceleration and efficiency in the discovery and development of new molecules.
An application for the registration of the anti-COVID vaccine EpiVacCorona-N has been submitted to the Russian Health Ministry for registration, as follows from a post uploaded to the state register of medicines. Earlier, the CEO of the State Research Center of Virology and Biotechnology Vector, Rinat Maksyutov, said there were no fundamental distinctions between EpiVacCorona-N and the previous version EpiVacCorona. EpiVacCorona, developed at the State Research Center of Virology and Biotechnology Vector, was a second vaccine to have been registered in Russia. The registration certificate was issued on October 14, 2020. About a month later the vaccine’s developers were given permission to conduct post-registration research in different groups of patients, including elderly people.
The European Medicines Agency (EMA) announced on June 11, 2021 that its committee for human medicines (CHMP) has approved a new manufacturing site for the production of Moderna COVID-19 vaccine finished product. The site, operated by Recipharm, is located in Monts, France. In addition to the new manufacturing facility for this vaccine, the CHMP has also given a positive opinion for the addition of several alternative sites responsible for batch control/testing. Already on 4 June 2021, two new sites for the manufacturing of active substance and finished product intermediates, located in the US (ModernaTX, Inc., Norwood, Massachusetts and Lonza Biologics, Inc., Portsmouth, New Hampshire), were approved by CHMP. Together, these changes are expected to allow the production of an additional one to two million vials of ready-to-use vaccine for the European Union market every month. This will increase the supply of the vaccine in the European Union. This recommendation does not require a European Commission decision and the site in Monts can become operational immediately. The changes described will be included in the publicly available information on this vaccine.
Sanofi and GSK started enrollment in their Phase 3 clinical study to assess the safety, efficacy, and immunogenicity of their adjuvanted recombinant-protein COVID-19 vaccine candidate. The global, randomized, double-blind placebo-controlled Phase 3 study will include more than 35,000 volunteers aged 18 and older from several countries, including sites in the US, Asia, Africa, and Latin America. The primary endpoint of the study is the prevention of symptomatic COVID-19 in SARS-CoV-2 naïve adults, with secondary endpoints being the prevention of severe COVID-19 disease and prevention of asymptomatic infection. In a two-stage approach, the study will initially investigate the efficacy of a vaccine formulation targeting the original D.614 virus (Wuhan), while a second stage will evaluate a second formulation targeting the B.1.351 (South African) variant. Recent scientific evidence1 shows that antibodies created against the B.1.351 variant may provide broad cross-protection against other more transmissible variants. The design of the Phase 3, conducted across a broad diversity of geographies, also allows evaluation of the efficacy of the candidate against a variety of circulating variants. Following encouraging interim results from the recent Phase 2 study, the companies will also begin clinical studies in the coming weeks to assess the ability of the adjuvanted recombinant-protein […]
Governments around the world struggle with the logistical challenges of procuring, deploying and administering vaccines at scale. To deliver the vaccines, pharmaceutical companies, logistical partners and governments have come together to create a “cold chain” that ensures vaccines are kept at precise temperatures—adding a major layer of complexity to the delivery of vaccines. The Role of Good Distribution Practices Clearly there’s still much that can be done from a logistical standpoint to ensure the various vaccines are able to reach the people who need them. Complexity and challenges can be found throughout the vaccine cold chain, but one major factor working in our favor is the emergence of new technology and infrastructure that will help ensure the integrity of the vaccine cold chain. Good Distribution Practices (GDP) that describe calibration of all temperature measurement instruments and storage devices are moving from recommendations to requirement—and the quicker they’re adopted and integrated into vaccine logistics globally, the sooner the promise of vaccine prevention could help end the pandemic. GDP was created in U.S. by the FDA, but at present they’re only recommendations and not requirements. Unfortunately, during the pandemic little progress has been made in implementing them more fully, but if they had […]
Interleukin-6 blocking drugs – tocilizumab and sarilumab – act to suppress this overreaction. WHO has launched an expression of interest for prequalification of manufacturers of interleukin-6 receptor blockers.
AstraZeneca has entered into a collaboration with Regeneron to research, develop and commercialise small molecule compounds directed against the GPR75 target with the potential to treat obesity and related co-morbidities. The companies will evenly split research and development costs and share equally in any future potential profits. As published in Science, the new target was found by sequencing nearly 650,000 people and identifying individuals with rare protective mutations. Individuals with at least one inactive copy of the GPR75 gene had lower body mass index (BMI) and, on average, tended to weigh about 12 pounds less and faced a 54% lower risk of obesity than those without the mutation.1 Strong associations were also seen with improvements in diabetes parameters, including glucose lowering.1 Obesity and insulin resistance are key drivers in the development of type-2 diabetes and often lead to cardiorenal complications, as well as liver disease. Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, AstraZeneca, said: We are pleased to announce this important collaboration with Regeneron to identify small molecule modulators against GPR75, a newly identified target with genetic validation in metabolic disorders. Obesity and insulin resistance remain key drivers in the development of type-2 diabetes and areas of significant unmet medical […]