Novavax Covid-19 Vaccine demonstrates 90,4% Effective in Late-stage Trial
Biotech company Novavax said that its COVID-19vaccine is 90.4% effective in a late-stage trial of nearly 30,000 people in the U.S. and Mexico, possibly offering the United States another weapon against the deadly virus. Additionally, it said the two-dose vaccine was found to be 100% effective in preventing moderate and severe disease and 93% effective against some variants.
Today, Novavax is one step closer to addressing the critical and persistent global public health need for additional COVID-19 vaccines. These clinical results reinforce that NVX-CoV2373 is extremely effective and offers complete protection against both moderate and severe COVID-19 infection, – said Stanley C. Erck, President and Chief Executive Officer, Novavax. – Novavax continues to work with a sense of urgency to complete our regulatory submissions and deliver this vaccine, built on a well understood and proven platform, to a world that is still in great need of vaccines.
The company intends to file for regulatory authorizations in the third quarter, upon completion of the final phases of process qualification and assay validation needed to meet chemistry, manufacturing and controls (CMC) requirements. Upon regulatory approvals, Novavax remains on track to reach manufacturing capacity of 100 million doses per month by the end of the third quarter and 150 million doses per month by the end of the fourth quarter of 2021.
PREVENT-19 confirms that NVX-CoV2373 offers a reassuring tolerability and safety profile, – said Gregory M. Glenn, M.D., President of Research and Development, Novavax. – These data show consistent, high levels of efficacy and reaffirm the ability of the vaccine to prevent COVID-19 amid ongoing genetic evolution of the virus. Our vaccine will be a critical part of the solution to COVID-19 and we are grateful to the study participants and trial staff who made this study possible, as well as our supporters, including the U.S. Government.
Cuba will supply large quantities of its home-grown COVID-19 vaccine, Abdala, to Vietnam and also transfer the production technology to the Southeast Asian country by the end of the year, the Vietnamese health ministry said on Tuesday.
Joint-stock company “Grindeks” has invested 800 thousand euros in the site of production of active pharmaceutical ingredients (APIs) and installed new, state-of-the-art laboratories and technological equipment for industrial production, which has allowed the unit to become multifunctional. After the investments, the facility will be used for the development and production of active pharmaceutical ingredients. They will be used for production of Grindeks finished dosage forms or medicines, as well as for export. The department has the opportunity to work with equipment with a volume of 100ml to 20l, which allows the production of various of active substances from milligrams to kilograms. To ensure the safety of workers and the protection of the environment, a reduced-pressure insulator with filtration systems has been installed for production to prevent highly effective API contact with humans and the environment. This is the first device of its kind in the Grindeks API factory. The site is also equipped with a modern monitoring and communication system for rapid response in case of non-standard situations. Chairman of the Council of JSC Grindeks Kirovs Lipmans: “For the Grindeks Group to be able to grow rapidly, investments are necessary for the development of production. Every year we invest at […]
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 […]
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 […]
Human Vaccine LLC, a wholly owned subsidiary of the Russian Direct Investment Fund (RDIF, Russia’s sovereign wealth fund) announces the signing of an agreement for the supply of 220 million doses of two-dose Sputnik V Russian COVID-19 vaccine with the United Nations International Children’s Emergency Fund (UNICEF). This amount is sufficient to vaccinate 110 million people. The supply agreement with UNICEF for Sputnik V vaccine will broaden access to help meet vaccine demand around the world. Procurement and delivery of the vaccine by UNICEF is subject to the vaccine receiving WHO Emergency Use Listing. The decision is expected soon on the Sputnik V application for WHO Emergency Use Listing that was submitted in October 2020. Concurrently, RDIF will be holding a separate discussion with Gavi, the Vaccine Alliance to see the Sputnik V vaccine considered for inclusion in the COVAX Facility’s Portfolio of COVID-19 vaccines. The COVAX Facility (co-led by Gavi, the Coalition for Epidemic Preparedness Innovations (CEPI) and WHO) together with UNICEF aims to help end the acute phase of the global pandemic by the end of 2021 by providing rapid, fair and equitable access to safe and effective vaccines to all participating countries and territories regardless of income level, thus enabling […]
Bayer is building a new pharmaceutical facility in Turku and at the same time modernizing its existing production plant. The new production facility will use the latest technology and utilize automation and robotics extensively. The value of the total investment is €250 million, which is one of the largest investments in Finland in recent years. The investment will further strengthen Bayer’s footprint in Finland and Turku’s position as the contraceptive capital of the world. This investment is significant for both Bayer and Finland. It secures long-term supply, which is required to meet Bayer’s global sustainability goals. One of these goals is to provide 100 million women in low-and middle-income countries with access to family planning and modern contraception by the end of 2030. Turku plays a significant role in Bayer’s global sustainability strategy which is in line with the UN Sustainable Development Goals. The investment will further promote the measures that our Turku plant has already taken over the past 30 years, to achieve gender equality and support women and their families. This way we can make an impact on women’s health and social status, education and family size, – says Miriam Holstein, CEO of Bayer Nordic Bayer’s global sustainability […]
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 […]
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 […]
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.
TriRx Pharmaceutical Services Inc., a leading international CDMO, today announced an agreement to acquire two facilities from Elanco Animal Health Incorporated. Elanco is a global animal health leader dedicated to innovating and delivering products and services to prevent and treat disease in farm animals and pets. The sites are located in Shawnee, Kansas and Speke, United Kingdom, and will expand the manufacturing footprint of TriRx, adding to its existing pharmaceutical facilities in Huntsville, Alabama, and Segré, France. The sale of the Shawnee and Speke sites includes the physical assets at both locations and the transfer of approximately 600 employees. The two companies have also entered into long-term supply agreements for both facilities to continue to manufacture existing Elanco products. We are excited about this opportunity, taking us into a long-term partnership with Elanco, and welcome the employees at both Speke and Shawnee into our organization, – said Tim Tyson, Chairman and CEO at TriRx. – We have been impressed with the high caliber of people and capabilities at both sites and we look forward to acquiring additional customers at the sites to increase efficiency and utilization and to assure a long-term success. Jeff Simmons, President and CEO at Elanco Animal […]
Servier, a global independent pharmaceutical Group, and PRISM BioLab, a Japan based biotechnology company with proprietary small molecule drug discovery platform, “PepMetics™Technology”, today announced that they have entered into a Collaboration and Exclusive License Option Agreement. Under the collaboration agreement, PepMetics™ technology provided by PRISM BioLab are utilized to identify from their library or synthetize, characterize, and optimize small molecule compounds capable of binding and stimulating the activity of the target specified by Servier. Wesley Blackaby, Ph.D, Head of Chemistry at Servier says: “We look forward to working with PRISM BioLab in this collaboration. The PRISM BioLab technology has the potential to help with the identification and optimization of novel compounds against hard to drug targets, in particular in cancer, which is one of the Group’s priority R&D areas.” Upon finding the lead compounds, Servier has the option to license the lead compounds for further optimization and clinical development. PRISM BioLab will receive collaboration fee and option fees payments under the Option Agreement, and further milestones and royalty payments under the License Agreement. Specific financial terms are not disclosed. Dai Takehara, President and CEO, PRISM BioLab, says: “We are delighted to partner with Servier who is committed to delivering therapy […]
This article provides information on French manufacturers of veterinary medicines and the French Agency for Veterinary Medicinal Products (ANMV). In addition, the article summarizes the results of an inspection of French manufacturers for compliance with the requirements of the Good Manufacturing Practice (GMP), which were conducted in 2017-2020 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. French manufacturers of medicines for animals According to the French Association for Animal Health Industry (SIMV), France is the European leader in research and manufacture of veterinary medicines and reagents, with over 6,700 employees, and the largest therapeutic arsenal in Europe (2,700 marketing authorizations). Furthermore, two in every three medicines produced in France are exported . France offers products and services for the prevention and treatment of diseases affecting farm animals (cattle, pigs, sheep, poultry), pets (dogs, cats, horses), and wildlife (foxes, raccoons). In addition, veterinary autogenous vaccines are produced in France. Autogenous vaccine is a vaccine prepared using microorganisms which have been isolated from the same infected animal to which it is then administered. Autogenous vaccines regulation is defined in the Public Health Code and […]
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 […]
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 […]
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 […]
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, […]
Etten-Leur, Tokyo, Moscow, June 9, 2021. R-Pharm Group announces the signing of a distribution agreement with PHC Europe B.V., one of the largest suppliers of biopharmaceutical and medical equipment, formerly known as Panasonic Biomedical Sales Europe B.V.. The agreement provides for R-Pharm to register and promote in Russia, Azerbaijan, Armenia, Belarus, Georgia, Kazakhstan, Kyrgyzstan, Moldova, Tajikistan, Uzbekistan and Ukraine its high-tech refrigeration equipment, biotech incubators, climate chambers and an entire line of equipment for laboratories, biotech facilities, and medical institutions. PHCbi refrigeration equipment covers a temperature range from +23 to -150 ℃, making it possible to store all known types of vaccines and biologics, as well as blood and its components. It is important to note that the PHC refrigeration equipment is designed not only for medical institutions, but also for research laboratories and biopharmaceutical production. As of today, R-Pharm’s production sites have already purchased more than 20 units of equipment to support the vaccine project. Denis Cherednichenko, Vice-President for Medical Systems at R-Pharm Group: We welcome the agreement between R-Pharm and PHC Europe B.V. coming into force. It represents an important milestone in the development of the strategic partnership between Russia and Japan. Regarding the organization of this cooperation, […]
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.
China has provided more than 480 million doses of COVID-19 vaccines to the world, a Chinese Foreign Ministry spokesperson said here Friday. Wang Wenbin said China is a firm believer in making COVID-19 vaccines a public good, and has provided the most vaccines to the world. He said China so far has provided vaccines to nearly 100 countries, and announced that it has pledged to provide the first batch of 10 million doses of vaccines to COVAX. Chinese vaccines are the first batch of vaccines obtained by many developing countries. China has carried out joint research and development and cooperative production with many developing countries, and supported relevant companies to cooperate with foreign parties in conducting the phase III clinical trials, Wang said. He said the Chinese vaccines have gained a good reputation in the international community, adding that the safety and effectiveness of Chinese vaccines have been widely recognized. “At present, more than 100 countries have approved the use of Chinese vaccines. The WHO has included China’s Sinopharm and Sinovac vaccines in the emergency use list,” Wang said, adding that more than 30 foreign leaders took the lead in taking Chinese vaccines. Pledging that China will continue to contribute […]
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 […]
The 67,000-square-foot facility, located on Thermo Fisher’s Carlsbad campus, is part of an investment strategy to ensure customers can reliably meet growing global demand for cell and gene therapies and vaccines.
The World Health Organization (WHO) and its COVAX partners are working with a South African consortium comprising Biovac, Afrigen Biologics and Vaccines, a network of universities and the Africa Centres for Disease Control and Prevention (CDC) to establish its first COVID mRNA vaccine technology transfer hub. The move follows WHO’s global call for Expression of Interest (EOI) on 16 April 2021 to establish COVID mRNA vaccine technology transfer hubs to scale up production and access to COVID vaccines. Over the coming weeks, the partners will negotiate details with the Government of South Africa and public and private partners inside the country and from around the world. South African President Cyril Ramaphosa said: “The COVID-19 pandemic has revealed the full extent of the vaccine gap between developed and developing economies, and how that gap can severely undermine global health security. This landmark initiative is a major advance in the international effort to build vaccine development and manufacturing capacity that will put Africa on a path to self determination. South Africa welcomes the opportunity to host a vaccine technology transfer hub and to build on the capacity and expertise that already exists on the continent to contribute to this effort.” This is great news, particularly for […]
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.
A COVID-19 vaccine developed by a unit of China’s Chongqing Zhifei Biological Products (Zhifei) showed an 81.76% efficacy rate against COVID-19 cases of any degree of severity in a large, late-stage trial, Zhifei said on Friday.
Vladimir Rusinov, the Head of the Laboratory of Organic Synthesis of Ural Federal University, Corresponding Member of RAS, one of the creators of Triazavirin, told Rossiyskaya Gazeta why scientists have not yet invented a pill against coronavirus, how scientists managed to create vaccines against Covid pretty quickly and in what direction scientists are working now. The virus is mutating rapidly, right before our eyes: more than a dozen strains have already appeared since the pandemic began. It is incredibly difficult to catch up with it. Scientists can for a long time select a compound that will bind to the viral protein of a certain structure, but during mutation its structure may change, and the virus will become resistant to the drug, Vladimir Rusinov explained why scientists have not yet invented a cure for coronavirus. Moreover, the virus is not a cell, but an RNA particle covered with a protein shell, the chemist explains. The purpose of the virus is to penetrate into our cell at all costs, use it as an incubator for its own reproduction, and eventually kill the cell itself. Then break out and continue destroying other cells. Today, there are no drugs that specifically and invasively attack […]
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 […]
A Wuhan-based affiliate of China National Pharmaceutical Group (Sinopharm) said the start of operations at a new factory will raise the annual production capacity of its COVID-19 vaccine to at least 1 billion doses.
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 […]
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 […]
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 […]
The Chumakov Center plans to double the production of the CoviVac whole-virion vaccine against the coronavirus to 2.5 mln doses per month in October 2021, Director General Aidar Ishmukhametov said in an interview aired by the Rossiya-24 TV news channel on Tuesday, TASS reports. We spoke for three months about the technical upgrade we expected, and finally, we received reactors two weeks ago. Two reactors mean a breakthrough for us, a principal modernization. We managed to install them properly. Basically, we will use them for the first time since the creation of the vaccine as early as the end of this week. We suggest that we will be able to plan at least a doubling of the production to 2.5 mln [doses of CoviVac vaccine] per month starting October. It will be clear at the end of September. The inactivated whole-virion CoviVac vaccine was developed by the Chumakov Federal Scientific Center for Research and Development of Immune-and-Biological Products of Russian Academy of Sciences (known as the Chumakov Center) was registered with the Russian Health Ministry on February 19. Whole-virion vaccines are based either on artificially weakened viruses incapable of causing a disease or killed (inactivated) viruses. Four coronavirus vaccines have […]
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 […]
Yposkesi, a leading Contract Development and Manufacturing Organization (CDMO) specializing in cell and gene therapies, announces the launch of project SKY, the construction of Yposkesi’s second commercial cell and gene therapy facility and new global resource for drug developers of biologics, also called ATMPs (Advanced Therapy Medicinal Products). ATMPs treat patients living with rare and life-threatening diseases. To accelerate innovation, in March 2021 Yposkesi welcomed SK Pharmteco, a global CDMO player, as a new majority equity shareholder in its company. Backed by SK Pharmteco, Yposkesi is investing €58M (approx. $71M) in the new 5,000m² site, making it one of the largest ATMP facilities in Europe. Project SKY will create approximately 80 new jobs by 2023. With this new state-of-the-art facility, designed for European and American GMP compliance, Yposkesi will double its production surface to 10,000m². This new resource equips it to address the shortage in manufacturing capacity for drug developers seeking to advance clinical trials and commercialize new therapeutic drugs. Yposkesi is proud and excited to embark full speed on this new phase in our development. SKY is the culmination of our industrial strategy, guaranteeing clients a range of quality services from early clinical drug development through all phases to […]
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 […]
The Russian Direct Investment Fund (RDIF, Russia’s sovereign wealth fund) and Sanofi, one of the leading global pharmaceutical companies, agree to cooperate for joint implementation of digital healthcare projects in Russia. The corresponding announcement was made on June 4 on the sidelines of St. Petersburg International Economic Forum. Sanofi and RDIF are planning to engage in development, maintenance, management and commercialization of Virtual Healthcare products in Russia in four therapeutic areas, including hypertension and diabetes. The products include a range of Sanofi’s initiatives, such as combination of drug therapy and technology, standalone digital therapeutics and tech-enabled virtual healthcare (virtual clinics, telehealth and wearables). The agreement is part of RDIF’s strategy of promoting the leading healthcare technologies in Russia within the framework of RDIF.Healthcare division aiming to develop existing initiatives and launching new investment projects. Thanks to wide international network of partners and accumulated internal expertise, RDIF is implementing a number of leading anti-COVID projects in Russia and globally and is now joining efforts with Sanofi to develop new cutting-edge healthcare solutions in the future.
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 […]
Russia should minimize its dependence on imports of ready-made medicines and pharmaceutical substances, Russian Deputy Prime Minister Tatyana Golikova said on Thursday. /TASS/ “In 2020, we updated the list of drugs strategically important for the country, the production of which should be in a full cycle [created within Russia — TASS]<…> The pace [of production] is important here. Of course, the production of cardiovascular and oncological drugs means long cycles of preclinical and clinical trials, but our work with vaccines has shown that we know how we can, and so we must. We must minimize our country’s dependence on imports <…> both on foreign pharmaceutical substances and on ready-made medicines,” she said at the final board of the Industry and Trade Ministry. Golikova recalled that in 2020, the government updated the list of 215 strategically important drugs, the production of which should be fully located in the country. By 2024-2025, a full production cycle in Russia should be provided for 65% of such drugs, by 2030 — for 80%, the Deputy Prime Minister emphasized. “These are mainly painkillers, cardiovascular and oncological drugs <…>”, Golikova specified.
Today, the domestic COVID-19 vaccine QazVac has been officially registered in the Kyrgyz Republic! The Ministry of Health and Social Development of the Kyrgyz Republic issued a registration certificate (KG.1.11159.08560-2021) on the state registration of the COVID-19 vaccine QazVac.
In October 2020, the Federal Service for Veterinary and Phytosanitary Surveillance (Rosselkhoznadzor) announced that from January 1, 2021, the Rules of Good Manufacturing Practice of the Eurasian Economic Union, approved by the Resolution of the Council of the Eurasian Economic Commission of November 3, 2016 No. 77, will come into force, in relation to medicinal products for veterinary use. Compliance with these Rules will be taken into account when issuing permits (licenses) to manufacturers of medicinal products for animals for these activities, as well as when inspecting them . In this short overview, we’ll look at some of the articles, presentations and documents that veterinary manufacturers may find useful. EAEU GMP rules The text of the Rules of Good Manufacturing Practice of the Eurasian Economic Union (the EAEU GMP Rules) is published on the website of the Eurasian Economic Commission (EEC) in the section “Resolutions of the Council of the Eurasian Economic Commission” . The EAEU GMP rules were approved in 2016. They entered into force in 2017, with the exception of the provisions of these Rules concerning the requirements for the production of veterinary medicinal products. The requirements of the EAEU GMP Rules for the manufacture of veterinary medicinal […]
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 […]
Young scientists from NUST MISIS have presented multilayer antibacterial coatings with a prolonged effect and a universal spectrum of action. The coating is based on modified titanium oxide and several antiseptic components. The coatings can be used in modern implantology as a protective layer for the prevention of concomitant complications – inflammation or implant rejection. The results of the work have been published in the international scientific journal Applied Surface Science. Antibacterial coatings are currently being actively researched, as the search for alternatives to traditional antibiotics is growing. They can be applied to implants, thereby preventing inflammation caused by nosocomial infections. Nevertheless, the creation of antibacterial, but at the same time biocompatible and bioactive surfaces is a problem that the scientific community has been solving for many years, and the “dream materials” have not been developed. Young scientists from the NUST MISIS Laboratory of Inorganic Nanomaterials have created an innovative multilayer coating that synthesizes the protective properties of nanoparticles, biopolymers, anticoagulants and antibiotics. The antibiotic and silver nanoparticles provide an antibacterial effect, while heparin prevents bacterial cells from sticking to the tissue surface, which reduces the amount of antibacterial agent required. The method of obtaining a multilayer coating is a […]
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.
EMA has started evaluating an application for the use of a booster dose of Comirnaty to be given 6 months after the second dose in people aged 16 years and older. Booster doses are given to vaccinated people (i.e. people who have completed their primary vaccination) to restore protection after it has waned. EMA’s human medicines committee (CHMP) will carry out an accelerated assessment of data submitted by the company that markets Comirnaty, including results from an ongoing clinical trial in which around 300 adults with healthy immune systems received a booster dose approximately 6 months after the second dose. The CHMP will recommend whether updates to the product information are appropriate. The outcome of this evaluation is expected within the next few weeks, unless supplementary information is needed, and will be communicated by EMA. Separately, EMA is also assessing data from the literature on the use of an additional, third dose of an mRNA vaccine (Comirnaty or SpikeVax) in severely immunocompromised people (i.e., with weakened immune systems). People with severely weakened immune systems who do not achieve an adequate level of protection from their standard primary vaccination may need an ‘additional’ dose as part of their primary vaccination. EMA […]