TriRx Enters Agreement for the Acquisition of Elanco Animal Health Facilities
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 Health stated – Following our acquisition of Bayer Animal Health, we completed an evaluation of our newly combined manufacturing network, and it became clear that creating the greatest opportunity for full capacity was best for the future of Shawnee, Speke and the respective staff. TriRx shares this vision and is well positioned to improve site utilization and create opportunity for the employees, while becoming an important long-term manufacturing partner for Elanco.
The sale of the Shawnee facility is expected to close in the second half of 2021, while the Speke facility sale is expected to close by early 2022.
These transactions are part of our long-term strategy to deliver integrated capabilities in the Animal and Human Health markets to serve the rapidly growing market need. We are passionate about delivering on our commitments to our customers, – said Tyson.
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 […]
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 […]
CureVac shares fell by as much as 52% on Thursday after the German biotech’s COVID-19 vaccine proved only 47% effective in an initial trial, denting investor confidence in its ability to take on established rivals, reports Reuters . The disappointing efficacy of the shot known as CVnCoV emerged from an interim analysis in a study of about 40,000 volunteers in Europe and Latin America, with CureVac saying on Wednesday that new variants had proved a headwind. Late-stage trials of BioNTech/Pfizer and Moderna vaccines, which like CureVac’s are based on mRNA technology, had efficacy rates of well above 90% but took place when the original version of the coronavirus was dominant. Data on their products have, however, so far suggested only somewhat weaker protection against new variants. “This could cast doubt on competitiveness of its mRNA platform,” Jefferies said in a research note on CureVac’s study. CureVac shares were down 44% at 1005 GMT in Germany, trading at their lowest in more than seven months and wiping more than 6 billion euros off the company’s market value. Public health representatives across the globe are pushing for a fast deployment of available vaccines to counter highly contagious mutations of COVID-19 such as […]
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 […]
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.
Presidential Decree UP-No. 6221 of 5 May 2021 has introduced a registration recognition procedure for medical devices from June 1, 2021. Medical devices that have been registered with the following foreign organizations shall be subject to the recognition procedure: Food and Drug Administration (FDA), USA. Bodies authorized to issue the European Certificate of Conformity (CE), European Union. European Medicines Agency (EMA), European Union. Pharmaceuticals and Medical Devices Agency (PMDA), Japan. Ministry of Food and Drug Safety (MFDS), Republic of Korea. Medicine and Healthcare Products Regulatory Agency (MHRA), United Kingdom. Medical devices certified under the requirements of the above organizations during the state registration in the Republic of Uzbekistan, shall not be tested in vitro and shall be duly registered no later than fifteen working days. Also, the State Customs Committee (Azimov M. B.), together with the Pharmaceutics Development Agency, the Uzstandard Agency, the Commissioner for the Protection of the Rights and Legitimate Interests of Business Entities and the Chamber of Commerce and Industry, shall establish permanent control over the import of medical devices and their components provided for in this paragraph, without allowing unnecessary barriers.
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 […]
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 […]
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, […]
When an epidemic of smallpox came to the English village of Yetminster in 1774, Benjamin Jesty vaccinated his family with cowpox, and later Peter Plett repeated this experiment. The first known vaccines were developed in 1796, when Edward Jenner after finding a case of cowpox in a dairy maid collected matter from her pustules and inoculated an 8-year-old boy. In the 1870-80s, Louis Pasteur developed the first vaccines for anthrax and rabies. Autogenous vaccine (prepared from the bacteria harbored by the patient) was first introduced by Sir Almroth Edward Wright in 1903. In the following years, several case reports were published regarding the preparation and indications of autogenous vaccines. This article is dedicated to veterinary autogenous vaccines used to treat various animal infections. Important role of veterinary autogenous vaccines Today, autogenous vaccines play a much more important role than simply “filling the gap” where there are no commercial products currently available. They play a vital role in preventative health management programs, allowing veterinarians to stay close to the farm, better understand the existing disease status and as a result reduce the need for emergency treatments. This is particularly vital to ensure that antibiotics remain effective and available for use when […]
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 […]
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 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.
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 […]
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 […]
This Combination Vaccine May Simplify Execution and Reduce Shots Needed to Complete CDC’s Recommended Child and Adolescent Immunization Schedule VAXELIS™ (Diphtheria and Tetanus Toxoids and Acellular Pertussis, Inactivated Poliovirus, Haemophilus b Conjugate and Hepatitis B Vaccine), developed as part of a U.S.-based partnership between Merck, known as MSD outside the United States and Canada, and Sanofi Pasteur, the global vaccines business unit of Sanofi, is now available in the U.S. VAXELIS is the first and only hexavalent (six-in-one) combination vaccine available in the U.S. indicated for active immunization to help prevent diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, and invasive disease due to Haemophilus influenzae type b. VAXELIS is approved for use as a 3-dose series in children 6 weeks through 4 years of age (prior to the 5th birthday). Given the potential to reduce the number of shots by as many as three in the first six months of life, as compared to pentavalent vaccines plus hepatitis B or Haemophilus influenzae type b vaccines, VAXELIS represents an important option for healthcare professionals and parents, – said Joanne Monahan, senior vice president, U.S. Vaccines, Merck. – Merck and Sanofi have been in contact with the major insurers and the appropriate pricing […]
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.
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, […]
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 […]
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 […]
A Russian military research unit that was involved in the development of Sputnik V is working on a new coronavirus vaccine in the form of chewing gum, the RBC news website reported Friday. The Defense Ministry’s 48th Central Research Institute collaborated with the state-run Gamaleya Research Institute in Moscow to develop and trial Sputnik V last year. Russia, facing accusations of rushing human trials, touted the adenoviral vector vaccine as the world’s first to be approved for widespread use. Citing an unnamed Defense Ministry source and confirmation from the 48th Central Research Institute’s director, RBC said “work is underway” toward developing a mucosal Covid-19 vaccine in the form of chewable tablets and pastilles. “After testing, the drug will be included in various treatment and prevention regimens for coronavirus,” the source was quoted as saying. Col. Sergei Borisevich, who heads the 48th Central Research Institute, confirmed work on the new vaccine but did not specify what stage it was at. Russia has registered a total of four coronavirus vaccines and has reached agreements with close to 70 countries on selling Sputnik V or sharing the technology to manufacture it. Moscow’s active efforts to market the two-shot vaccine around the world has been viewed […]
Russia has put into circulation about 32 million sets of coronavirus vaccines since the beginning of the year, and new sites are joining in the production effort to ensure vaccination, the Industry and Trade Ministry told TASS. “All the four national vaccines are produced rhythmically in line with the plans drawn up together with the manufacturers. The difference in their time availability is caused by different times of their registration, namely August 2020 (Sputnik V), October 2020 (EpiVacCorona), February 2021 (CoviVac) and May 2021 (Sputnik Light),” the Industry and Trade Ministry said. Since the beginning of the year, more than 30 million sets of Sputnik V, nearly 1.5 million [sets] of EpiVacCorona and 352,000 [sets] of CoviVac, which was registered later than the first two vaccines, have been put into circulation,” the ministry said noting that the difference in the vaccines’ availability was caused by different timeframes of their authorization. The press service explained that from the stage of authorization to large-scale production, each vaccine had to undergo a series of steps related to the scaling up of technology and quality control of the vaccines. “New production sites are joining in the production of each of the vaccines to ensure […]
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.
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 Russian Health Ministry has issued a permit to conduct the post-registration clinical trials of the CoviVac shot against the coronavirus infection with the participation of 32,000 volunteers. The corresponding information was published on the website of the state register of clinical trial permits of the Russian Health Ministry on Tuesday. (TASS) “An open comparative study of the preventive efficacy and a non-comparative study of the immunogenicity and safety of the CoviVac preparation (a whole-virion inactivated concentrated purified coronavirus vaccine), produced by the Federal State Budgetary Scientific Institution Chumakov Federal Scientific Center for Research and Development of Immune and Biological Products of the Russian Academy of Sciences on healthy volunteers aged 18-60. The beginning of the trials kicked off on June 2, 2021, and will end on December 30, 2022. The number of patients amounts to 32,000,” – according to the information posted on the website. The register also indicates that the trials will be held on the basis of 16 medical organizations in Kirov, St. Petersburg, Moscow, Obninsk, Chelyabinsk, Tatarstan, Zheleznogorsk, Stary Oskol, and Novotroitsk. On February 19, the Russian Healthcare Ministry certified the whole-virion inactivated CoviVac vaccine, developed by the Chumakov Federal Scientific Center for Research and Development […]
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 […]
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 […]
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 […]
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 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 […]
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 […]
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).
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 […]
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.
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 […]
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.
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 […]
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.
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 […]
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 […]
The U.S. Food and Drug Administration has approved Pfizer Inc.’s (PFE) PREVNAR 20 or Pneumococcal 20-valent Conjugate Vaccine for the prevention of invasive disease and pneumonia caused by the 20 Streptococcus pneumoniae or pneumococcus serotypes in the vaccine in adults ages 18 years and older.
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 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.
The production of Sputnik V, a vaccine for the coronavirus developed by Russia, began at an Iranian company on Saturday, 26 June. In a ceremony attended by Iranian Health Minister Saeed Namaki, the production of Russia’s Sputnik V vaccine under license started in Iran. Iran has become the first country in the Middle East to produce Sputnik V. The vaccine produced in Iran will be used in the national vaccination program. To date, Sputnik V has been registered in 67 countries globally with a total population of over 3.5 billion people. The data obtained by regulators of a number of countries during the vaccination of the population, including Argentina, Serbia, Bahrain, Hungary, Mexico and others, demonstrates that Sputnik V is one of the safest and most effective vaccines against coronavirus. Sputnik V is based on a proven and well-studied platform of human adenoviral vectors and uses two different vectors for the two shots in a course of vaccination, providing immunity with a longer duration than vaccines using the same delivery mechanism for both shots. Officials say the permission for the rollout of another homegrown vaccine developed jointly by Cuba and the Pasteur Institute of Iran will be granted in the […]
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.
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 […]