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Novavax Initiates Phase 1/2 Clinical Trial of Combination Vaccine for COVID-19 and Seasonal Influenza
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 […]
The launch of R&D centre at BratskChemSyntez LLC
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.
EMA evaluating data on booster dose of COVID-19 vaccine Comirnaty
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 […]
Russian scientists developed intestinal soluble capsules
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 […]
Grindeks invests 800 thousand euros in the creation of a multifunctional site
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 […]
The single-component Sputnik Light vaccine authorized in Armenia
The Russian Direct Investment Fund (RDIF, Russia’s sovereign wealth fund) today announced the Russian single-component Sputnik Light vaccine against coronavirus has been approved by the Ministry of Health of the Republic of Armenia. Sputnik Light vaccine based on human adenovirus serotype 26 is the first component of the Sputnik V vaccine. Immunization with Sputnik Light will help Armenia to significantly reduce the infection rate in the country and create herd immunity in a short time frame. In February 2021 the two-dose Sputnik V vaccine was also approved in Armenia. Sputnik Light is safe and highly effective as demonstrated by the real-world vaccination data in a number countries. In particular, the data from the Ministry of Health of the Buenos Aires province (Argentina) shows 78.6-83.7% efficacy among the elderly. In Paraguay Sputnik Light is 93.5% effective during the ongoing vaccination campaign according to the country’s Ministry of Health. Thanks to its safety and efficacy, single-component Sputnik Light vaccine is now both used on standalone basis and also studied in combination with vaccines from other producers in a number of countries. The heterogeneous boosting approach (“vaccine cocktail” using human adenovirus serotype 26 as the first component and human adenovirus serotype 5 as […]
EpiVacCorona-N vaccine to be released for use in near future
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.
Sputnik V demonstrates 94.8% efficacy against COVID during the vaccination in San Marino
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 […]
R-Pharm earned runner-up in BRICS Solutions Awards 2021
R-Pharm`s project on the development of olokizumab has been declared as the Runner-up in the category “Good Health and Well Being” of the BRICS Solutions for SDG Awards 2021. The awarded project was launched by R-Pharm in 2016. The Phase 3 clinical trial of olokizumab, a novel treatment to manage RA was designed in cooperation with FDA and EMA and enrolled 2,444 patients from 19 countries. It is one of the largest projects in Russian pharma: R-Pharm invested over 300 million dollars in its development since the launch of the project. The 2021 contest was held under the Indian BRICS Chairmanship and brought together participants from five BRICS countries: Russia, India, Brazil, China, and South Africa. This year all projects were focused on solutions meeting United Nation’s Sustainable Development Goals (SDGs): zero hunger, good health and well-being, quality education, gender equality, affordable and clean energy and clean water and sanitation. The nominations were put through a rigorous evaluation by an esteemed jury comprising experts from all the BRICS member nations. The international jury evaluated the application with reference to the project`s relevance, approach, efficiency, sustainability, collaboration, uniqueness and scalability. The awarding ceremony to honor the finalists and winners will be […]
Flu Research Institute finishes pre-clinical tests of its COVID-19 vaccine
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.
Vladimir Rusinov: the Virus is Rapidly Mutating
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 […]
China’s Zhifei says unit’s COVID shot shows 81.76% efficacy in late-stage trial
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.
Chumakov Center plans to double CoviVac production in October, says director general
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 […]
Moderna vaccine production continues in EU amid contamination probe
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.
STADA continues to outpace the market in H1 and strengthens basis for further growth
STADA again demonstrated its resilience amid challenging conditions due to the pandemic by outperforming industry trends in the first half of 2021.
Vietnam says Cuba to supply COVID-19 vaccine, transfer technology
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.
The COVID-19 vaccine QazVac is firstly registrated abroad
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.
COVID-19 convalescent plasma did not prevent the progression of the disease
The trial was conducted by the SIREN clinical trials network and enrolled more than 500 participants.
Russian Chumakov Center discusses CoviVac vaccine’s approval in Asia and US
“We have just launched the third phase of clinical trials, therefore, it is too early to talk about the drug’s registration abroad,” the Russian expert said.
Do I still need the vaccine if I have COVID-19?
Even if you’ve had COVID infection, that you should go ahead and take the vaccination when it’s available to you.
Global Intranasal Drug Delivery Market to Reach $59.2 Billion by 2027
In the global Gel segment, USA, Canada, Japan, China and Europe will drive the 3.2% CAGR estimated for this segment.
Sai Life Sciences opens new Discovery Biology facility in Hyderabad, India
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 […]
A combination between AstraZeneca and Sputnik Light demonstrates high immunogenicity profile
Clinical trials in Azerbaijan began in February 2021. To date 64 volunteers have been vaccinated, the enrollment of volunteers is ongoing.
Falsified COVISHIELD vaccine identified in the WHO regions of Africa and South- East Asia
WHO requests increased vigilance within the supply chains of countries and regions likely to be affected by these falsified products.
South Korea aims to make vaccine industry more competitive with emphasis on COVID-19
South Korea has recently unveiled a US$2bn plan to emerge as a global COVID-19 vaccine production hub and become one of the top five manufacturing bases by 2025.
One shot Sputnik Light has high safety and 93.5% efficacy against COVID
The heterogeneous boosting approach was at the core of Sputnik V, the world’s first registered vaccine against coronavirus.
Grindeks has reached record high turnover and profit in the first half of 2021
The sales of final dosage forms in the first half of 2021 totaled 109,5 million euros and compared to the first half of 2020 increased by 21.9 million euros.
Hanmi Science has completed the development of six types of raw materials for mRNA vaccines
Hanmi Science has formed a consortium with ST Pharm and GC Green Cross to secure and commercialize domestic mRNA vaccine technology by 2022.
Artificial intelligence in medicine regulation
Regulators may need to apply a risk-based approach to assessing and regulating AI, which could be informed through exchange and collaboration in ICMRA.
Over 38 tonnes of medicines from Russia arrive to Cuba
This assistance is of great importance for countering the consequences of the pandemic, as well as at a time when the U.S. is tightening the blockade against country.
No deaths linked to EpiVacCorona vaccine registered in Russia
EpiVacCorona is a single-dose synthetic peptide vaccine against COVID-19 developed by the Vector State Research Center of Virology and Biotechnology.
Russia sends files to register coronavirus vaccine for animals to 4 countries
Carnivak-Cov was developed by the Federal Center for Animal Health. It is the first in the world and currently the only registered vaccine against the coronavirus for animals.
Top biopharma companies could be affected by Brazilian drug patent suspension
GlaxoSmithKline will be the most affected, as it represents 26% of the potentially impacted drugs. This is followed by Novartis at 14%, Sanofi at 11%, and both Pfizer and Bayer with 8%.
Falsified Remdesivir identified in WHO region of the Americas
WHO requests increased vigilance within the supply chains of countries and regions likely to be affected by these falsified products.
FDA Authorizes Additional COVID-19 Vaccine Dose for Certain Immunocompromised Individuals
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.
Moderna and Canada Announce Collaboration to Bring mRNA Manufacturing
The collaboration aims to provide Canadians with access to a domestically manufactured portfolio of mRNA vaccines against respiratory viruses, including COVID-19, seasonal influenza…
WHO’s Solidarity clinical trial enters a new phase with three new candidate drugs
The Solidarity PLUS trial is a platform trial that represents the largest global collaboration among WHO Member States.
Laboratorios Richmond delivers the first batch of over 1M doses of the Sputnik V produced in Argentina
Locally produced Sputnik V was supervised and verified by the National Administration of Drugs, Foods and Medical Devices of Argentina (ANMAT).
Official data from leading countries confirms the Sputnik V vaccine’s high safety and efficacy profile
To date Sputnik V has been approved in 69 countries with total population exceeding 3.7 billion people – nearly half of the global population.
Pre-clinical trials of intranasal version of Sputnik V completed
The vaccine helps to develop a local immunity, therefore it will be most likely recommended to those who have contraindications to injections.
Recommendations on common technical denominators for track and trace systems
The extensive and helpful feedback was carefully analysed and reviewed in order to refine and finalise the recommendations on common technical denominators for track and trace systems.
WHO revises guidance on GMPs for investigational products and R&D facilities
WHO said the objective of the update is to align the guidance with “current expectations and trends in good manufacturing practices”.
Russian ministers visit Pharmasintez production site
In 2020 the share of the Pharmasyntez Group of Companies in the hospital procurements segment reached 7.3% in terms of volume.
Bayer strengthens drug discovery platform through acquisition of Vividion Therapeutics
Following closing of the acquisition, Bayer will own full rights to Vividion’s proprietary discovery platform, which comprises three integrated, synergistic components.
Petrovax to manufacture up to 10 mln doses of China’s Convidencia a month
The company said earlier that it planned to commission its Convidencia full cycle production line by the end of 2021.
Combination of the Sputnik Light with others vaccines demonstrates high safety profile
Sputnik Light is the first component (recombinant human adenovirus serotype number 26 (rAd26)) of Sputnik V – the world’s first registered vaccine against coronavirus.
EC approves contract for a potential COVID-19 vaccine with Novavax
Under this contract, Member States will be able to purchase up to 100 million doses of the Novavax vaccine, with an option for 100 million additional doses.
Laboratorios Richmond to provide with over 3 million doses of the second component of the Sputnik V vaccine
RDIF and partners facilitated the technology transfer to Laboratorios Richmond for the local production of the vaccine with the first batch manufactured in April 2021.
Antitrust watchdog sets maximum selling price for 50 doses of CoviVac vaccine at $297
FAS has agreed on the maximum selling price for a new package of the CoviVac vaccine. The new form of vaccine release contains 50 doses.
Kazakhstan’s Karaganda pharmaceutical plant ready to manufacture Sputnik Light vaccine
By now, the Karaganda plant has manufactured five million doses of the Sputnik V vaccine.
FAS initiated a case in the ALV supply market
The FAS Russia has initiated an antimonopoly case against Hamilton Medical AG on the grounds of coordinating the actions of the manufacturer’s official distributors.
Sanofi acquires biotech company Translate Bio for $3.2 billion
Sanofi and Translate Bio have a shared commitment to innovation in the mRNA space.
Betuvax coronavirus vaccine clinical trials to begin in September
The Betuvax-CoV-2 is a split recombinant vaccine of the basis of spherical particles with the coronavirus surface antigen (protein).
Coronavirus mutations only slightly reduce vaccines’ efficacy
The mutations of the novel coronavirus cause only a marginal decrease in the efficacy of vaccines certified in Russia.
The combination between the AstraZeneca vaccine and the Sputnik Light shows no serious adverse events
In August 2021, RDIF and partners will publish initial data on the immunogenicity of the combined use of the AstraZeneca vaccine and the Sputnik V vaccine in Azerbaijan.
Uzbekistan produces first batch of Sputnik V vaccine
At the first stage, the vaccine will be produced using raw materials from Russia, in the future a full cycle of production from local components.
Delta strain may become standard for coronavirus vaccines, expert says
When developing new vaccines in the future, the basis of vaccines registered in Russia will probably be replaced with the Delta variant.
Contract production of pharmaceutical ingredients by 2028 may reach $ 136 billion
The traditional active pharmaceutical ingredient dominated the market and accounted for the largest revenue share of 40.5% in 2020.
FDA warns of clinical trial results showing increased risk of death associated with Pepaxto
Due to the detrimental effect on overall survival in the OCEAN trial, FDA is requiring the manufacturer suspend enrollment in the trial.
ICH releases widely anticipated guidance on continuous manufacturing
Three different models of continuous manufacturing are described in the draft guideline. The guideline incorporates the ICH Q7 definition of a batch to continuous manufacturing.
Amgen To Acquire Privately Held Teneobio For $900 Million
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.
AstraZeneca and Regeneron to research, develop and commercialise new small molecule medicines for obesity
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 […]
STADA and Sanofi strike consumer healthcare distribution agreement in selected countries in Europe
The agreement covers approximately 50 well-established consumer healthcare brands currently marketed by Sanofi.
SINOVAC Announces Positive Data on Booster Dose of CoronaVac®
CoronaVac® generates good immune memory after the second dose. Third dose of CoronaVac® induces strong immune response. No serious adverse reactions reported
Russian Health Ministry permits Biocad to conduct clinical trials of new COVID vaccine
The state registry notes that the trials will last until late 2026 and will involve 360 patients. The vaccine will be administered via an intramuscular injection.
36 labs to be set up in Russia by 2030 to study bioagents
By 2024, it is planned to organize 240 border checkpoints with special equipment to carry out express diagnostic.
FAS fined Bayer for improper advertising
The FAS Russia imposed an administrative fine of 200 thousand rubles on Bayer JSC for improper advertising of the medicine Teraflex Hondrokrem Forte.
AI and big data will continue to disrupt pharmaceutical sector
AI and big data have been identified by healthcare industry professionals as the top technologies that will transform pharmaceutical drug discovery and development processes.
EC announces €120 million in Horizon Europe funding
The Horizon Europe program is part of broader steps the EU has taken to combat the pandemic and is congruent with the broader goals of the HERA incubator.
Russia calls on European politicians to rely on scientific publications about Sputnik V
Moscow calls on European politicians to rely on Western scientific publications rather than on political propaganda.
EMA: vaccine Moderna approved for children aged 12 to 17 in EU
The use of the Spikevax vaccine in children from 12 to 17 years of age will be the same as in people aged 18 and above.
Chemists Found an Effective Cure for Senile Brain Disease
The most effective compound was tested on living tissues of rats with secondary injuries after craniocerebral injuries.
GMP-Inspections of foreign veterinary manufacturers in the first half of 2021
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 […]
Russian medicine to be supplied to Slovakia under special approval for the prevention of COVID-19
Polyoxidonium® (INN: Azoximer bromide) is an original Russian medication, which has been widely used in Russian clinical practice and exported to foreign countries for over 20 years.
First batch of the Sputnik V vaccine produced in Vietnam
To date, Sputnik V has been registered in 68 countries with a total population of over 3.7 billion people, which is nearly half of the global population.
Catalent Plans Multi-Phase, $100 Million Expansion of Italian Facility
Catalent’s Anagni site is a world-class biologics and oral dose manufacturing facility that specializes in late-stage and commercial product launches.
Appeal supported FAS in case of orthopedic products cartel
The FAS Russia has sent the case materials to law enforcements for making a decision on initiating criminal cases against company officials.
Sputnik V vaccine approved for use in Chile
Thus Sputnik V is now approved in 69 countries with total population exceeding 3.7 billion people – nearly half of the global population.
EAEU GMP Certificate issued to Pharmasyntez
The Pharmasyntez Group of Companies also was one of the first in Russia to be granted a Marketing Authorization under the EAEU rules.
Thermo Fisher Scientific Opens cGMP Plasmid DNA Manufacturing Facility
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.
Sputnik V vaccine against coronavirus authorized in Nigeria
Total population of all countries where Sputnik V is approved for use now exceeds 3.7 billion people, which is nearly half of the global population.
Rapid growth characterizes production of china’s vaccines
More than 1.4 billion doses of vaccines have been administered in China, and the country has provided over 500 million doses of vaccines overseas to assist in the global fight against the pandemic.
Russia wants to take down barriers for global production, distribution of vaccines
Russia actively fosters localization of its vaccine production abroad, which is based on technology transfer, while agreements were inked with several foreign companies.
Single-dose Sputnik Light vaccine registered in Kazakhstan
Sputnik Light demonstrated 79.4% efficacy according to analyzed data taken from 28 days after the injection was administered. In February 2021, Kazakhstan approved the two-dose Sputnik V vaccine.
WTO issues joint indicative list of critical inputs for COVID-19 vaccines
The WTO Secretariat has published an indicative list compiling information on the critical inputs for the manufacturing, distributing and administering of COVID-19 vaccines.
RDIF and Serum Institute of India to start production of Sputnik vaccine in September
The first batch of Sputnik vaccine is expected to be produced at SII’s facilities in September. The parties intend to produce over 300 million doses of the vaccine in India per year.
R-Pharm and Frontier Biotech will provide Russia with a new drug for the treatment of HIV
Aikening™ is a new fusion inhibitor. It is the first and only long-acting injectable (as IV infusion QW) available as a dual therapy for treatment-experienced patients with HIV-1 replication.
Sputnik V vaccine effective against new variants of coronavirus
Sputnik V pioneered the vaccine cocktail approach with two shots. The tests conducted by the Gamaleya Center have demonstrated validity of this approach.
SINOVAC Enters Into Agreement to Supply CoronaVac® to COVAX
In total, up to 380 million doses of CoronaVac® will be available to both self-financing participants of the Facility as well as those supported by the Gavi COVAX AMC.
Media allegations on the rise in medicine prices are manipulative
To date, the FAS Russia has already set 61 new economically reasonable prices for 22 medicines, ensuring their presence in the market.
European Pharmacopoeia to put an end to the rabbit pyrogen test
There are currently 59 Ph. Eur. texts – covering a variety of topics including vaccines for human use, blood products, antibiotics, radiopharmaceuticals and containers – that refer to the RPT and will be affected.
Sputnik V demonstrates strong safety profile during vaccination campaign in San Marino
San Marino was the first country in Europe to defeat COVID and lift restrictions thanks to inclusion of Sputnik V vaccine in the national portfolio.
Comirnaty and Spikevax: possible link to very rare cases of myocarditis and pericarditis
At this point in time, no causal relationship with myocarditis or pericarditis could be established with two other COVID-19 vaccines authorised in the EEA, COVID-19 Vaccine Janssen and Vaxzevria.
The European Parliament proposed to expand the powers of the EMA
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.
Philip Morris Announces Firm Offer to Acquire Vectura Group
Vectura is a provider of innovative inhaled drug delivery solutions that enable partners to bring their medicines to patients.
Russia, EU to begin negotiations on mutually recognizing vaccination certificates
Electronic certificates are already in force in Europe, which allows EU citizens to move around the continent without hindrance.
Entry into Force of PIC/S Guidance on Good Practices for Data Management and Integrity
The guidance has been developed primarily for inspectors, but also serves as a valuable resource for industry to provide clarity on areas of greatest risk and regulatory expectations.
Recipharm signs Memorandum for the fill finish of vaccines and biotherapeutics in Morocco
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.
WHO recommends life-saving interleukin-6 receptor blockers for 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.