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Valneva SE
__NOTOC__ Valneva SE is a French biotech company headquartered in Saint-Herblain, France, developing and commercializing vaccines for infectious diseases. It has manufacturing sites in Livingston, Scotland; Solna, Sweden, and Vienna, Austria, with other offices in France, Canada and the United States. __TOC__ Background Valneva was founded in 2013 through the merger of Austrian company Intercell and French company Vivalis SA. It has been listed since 28 May 2013 on the Euronext Paris in Paris and used to be listed on the Vienna Stock Exchange. Products Released Vaccines Vaccines marketed by Valneva include Ixiaro, a vaccine against Japanese encephalitis (approved in Europe, America and Australia) and Dukoral, a vaccine against cholera (approved in Europe and Australia). Failed developments Some of its candidates have failed in clinical trials: VLA43, a therapeutic vaccine against Pseudomonas aeruginosa, V710, a therapeutic vaccine against Staphylococcus aureus (in collabora ...
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Societas Europaea
A ''societas Europaea'' (, ; "European society" or "company"; plural: ; abbr. SE) is a public company registered in accordance with the corporate law of the European Union (EU), introduced in 2004 with the Council Regulation on the Statute for a European Company. Such a company may more easily transfer to or merge with companies in other member states. As of April 2018, more than 3,000 registrations have been reported, including the following nine components (18%) of the Euro Stoxx 50 stock market index of leading eurozone companies (excluding the SE designation): Airbus, Allianz, BASF, E.ON, Fresenius, LVMH Moët Hennessy Louis Vuitton (and its parent company Dior), SAP, Schneider Electric and Unibail-Rodamco-Westfield. National law continues to supplement the basic rules in the Regulation on formation and mergers. The European Company Regulation is complemented by an Employee Involvement Directive which manages the rules for participation by employees on the company ...
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Cholera
Cholera is an infection of the small intestine by some strains of the bacterium ''Vibrio cholerae''. Symptoms may range from none, to mild, to severe. The classic symptom is large amounts of watery diarrhea that lasts a few days. Vomiting and muscle cramps may also occur. Diarrhea can be so severe that it leads within hours to severe dehydration and electrolyte imbalance. This may result in sunken eyes, cold skin, decreased skin elasticity, and wrinkling of the hands and feet. Dehydration can cause the skin to turn bluish. Symptoms start two hours to five days after exposure. Cholera is caused by a number of types of ''Vibrio cholerae'', with some types producing more severe disease than others. It is spread mostly by unsafe water and unsafe food that has been contaminated with human feces containing the bacteria. Undercooked shellfish is a common source. Humans are the only known host for the bacteria. Risk factors for the disease include poor sanitation, not enough clea ...
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European Commission
The European Commission (EC) is the executive of the European Union (EU). It operates as a cabinet government, with 27 members of the Commission (informally known as "Commissioners") headed by a President. It includes an administrative body of about 32,000 European civil servants. The Commission is divided into departments known as Directorates-General (DGs) that can be likened to departments or ministries each headed by a Director-General who is responsible to a Commissioner. There is one member per member state, but members are bound by their oath of office to represent the general interest of the EU as a whole rather than their home state. The Commission President (currently Ursula von der Leyen) is proposed by the European Council (the 27 heads of state/governments) and elected by the European Parliament. The Council of the European Union then nominates the other members of the Commission in agreement with the nominated President, and the 27 members as a team are then ...
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Medicines And Healthcare Products Regulatory Agency
The Medicines and Healthcare products Regulatory Agency (MHRA) is an executive agency of the Department of Health and Social Care in the United Kingdom which is responsible for ensuring that medicines and medical devices work and are acceptably safe. The MHRA was formed in 2003 with the merger of the Medicines Control Agency (MCA) and the Medical Devices Agency (MDA). In April 2013, it merged with the National Institute for Biological Standards and Control (NIBSC) and was rebranded, with the MHRA identity being used solely for the regulatory centre within the group. The agency employs more than 1,200 people in London, York and South Mimms, Hertfordshire. Structure The MHRA is divided into three main centres: * MHRA Regulatory – the regulator for the pharmaceutical and medical devices industries * Clinical Practice Research Datalink – licences anonymised health care data to pharmaceutical companies, academics and other regulators for research * National Institute for Biolog ...
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Brexit
Brexit (; a portmanteau of "British exit") was the withdrawal of the United Kingdom (UK) from the European Union (EU) at 23:00 GMT on 31 January 2020 (00:00 1 February 2020 CET).The UK also left the European Atomic Energy Community (EAEC or Euratom). The UK is the only sovereign country to have left the EU or the EC. Greenland left the EC (but became an OTC) on 1 February 1985. The UK had been a member state of the EU or its predecessor the European Communities (EC), sometimes of both at the same time, since 1 January 1973. Following Brexit, EU law and the Court of Justice of the European Union no longer have primacy over British laws, except in select areas in relation to Northern Ireland. The European Union (Withdrawal) Act 2018 retains relevant EU law as domestic law, which the UK can now amend or repeal. Under the terms of the Brexit withdrawal agreement, Northern Ireland continues to participate in the European Single Market in relation to goods, and to be a member o ...
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Scotland
Scotland (, ) is a country that is part of the United Kingdom. Covering the northern third of the island of Great Britain, mainland Scotland has a border with England to the southeast and is otherwise surrounded by the Atlantic Ocean to the north and west, the North Sea to the northeast and east, and the Irish Sea to the south. It also contains more than 790 islands, principally in the archipelagos of the Hebrides and the Northern Isles. Most of the population, including the capital Edinburgh, is concentrated in the Central Belt—the plain between the Scottish Highlands and the Southern Uplands—in the Scottish Lowlands. Scotland is divided into 32 administrative subdivisions or local authorities, known as council areas. Glasgow City is the largest council area in terms of population, with Highland being the largest in terms of area. Limited self-governing power, covering matters such as education, social services and roads and transportation, is devolved from the Scott ...
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National Institute For Health Research
The National Institute for Health and Care Research (NIHR) is the British government’s major funder of clinical, public health, social care and translational research. With a budget of over £1.2 billion in 2020–21, its mission is to "improve the health and wealth of the nation through research". The NIHR was established in 2006 under the government's Best Research for Best Health strategy, and is funded by the Department of Health and Social Care. As a research funder and research partner of the NHS, public health and social care, the NIHR complements the work of the Medical Research Council. NIHR focuses on translational research (translating discoveries from the laboratory to the clinic), clinical research and applied health and social care research. History The NIHR (originally named National Institute for Health Research) was created in April 2006 under the government's health research strategy, Best Research for Best Health. This strategy outlined the direction that ...
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Phases Of Clinical Research
The phases of clinical research are the stages in which scientists conduct experiments with a health intervention to obtain sufficient evidence for a process considered effective as a medical treatment. For drug development, the clinical phases start with testing for safety in a few human subjects, then expand to many study participants (potentially tens of thousands) to determine if the treatment is effective. Clinical research is conducted on drug candidates, vaccine candidates, new medical devices, and new diagnostic assays. Summary Clinical trials testing potential medical products are commonly classified into four phases. The drug development process will normally proceed through all four phases over many years. If the drug successfully passes through Phases I, II, and III, it will usually be approved by the national regulatory authority for use in the general population. Phase IV trials are 'post-marketing' or 'surveillance' studies conducted to monitor safety over sever ...
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Coronavirus Disease 2019
Coronavirus disease 2019 (COVID-19) is a contagious disease caused by a virus, the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The first known case was identified in Wuhan, China, in December 2019. The disease quickly spread worldwide, resulting in the COVID-19 pandemic. The symptoms of COVID‑19 are variable but often include fever, cough, headache, fatigue, breathing difficulties, loss of smell, and loss of taste. Symptoms may begin one to fourteen days after exposure to the virus. At least a third of people who are infected do not develop noticeable symptoms. Of those who develop symptoms noticeable enough to be classified as patients, most (81%) develop mild to moderate symptoms (up to mild pneumonia), while 14% develop severe symptoms (dyspnea, hypoxia, or more than 50% lung involvement on imaging), and 5% develop critical symptoms (respiratory failure, shock, or multiorgan dysfunction). Older people are at a higher risk of developing seve ...
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Inactivated Vaccine
An inactivated vaccine (or killed vaccine) is a vaccine consisting of virus particles, bacteria, or other pathogens that have been grown in culture and then killed to destroy disease-producing capacity. In contrast, live vaccines use pathogens that are still alive (but are almost always attenuated, that is, weakened). Pathogens for inactivated vaccines are grown under controlled conditions and are killed as a means to reduce infectivity and thus prevent infection from the vaccine. Inactivated vaccines were first developed in the late 1800s and early 1900s for cholera, plague, and typhoid. Today, inactivated vaccines exist for many pathogens, including influenza, polio (IPV), rabies, hepatitis A and pertussis. Because inactivated pathogens tend to produce a weaker response by the immune system than live pathogens, immunologic adjuvants and multiple "booster" injections may be required in some vaccines to provide an effective immune response against the pathogen. Attenuated vacci ...
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Hepatitis C
Hepatitis C is an infectious disease caused by the hepatitis C virus (HCV) that primarily affects the liver; it is a type of viral hepatitis. During the initial infection people often have mild or no symptoms. Occasionally a fever, dark urine, abdominal pain, and yellow tinged skin occurs. The virus persists in the liver in about 75% to 85% of those initially infected. Early on, chronic infection typically has no symptoms. Over many years however, it often leads to liver disease and occasionally cirrhosis. In some cases, those with cirrhosis will develop serious complications such as liver failure, liver cancer, or dilated blood vessels in the esophagus and stomach. HCV is spread primarily by blood-to-blood contact associated with injection drug use, poorly sterilized medical equipment, needlestick injuries in healthcare, and transfusions. Using blood screening, the risk from a transfusion is less than one per two million. It may also be spread from an infected mother to her ...
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Merck & Co
Merck & Co., Inc. is an American multinational pharmaceutical company headquartered in Rahway, New Jersey, and is named for Merck Group, founded in Germany in 1668, of whom it was once the American arm. The company does business as Merck Sharp & Dohme or MSD outside the United States and Canada. Merck & Co. was originally established as the American affiliate of Merck Group in 1891. Merck develops and produces medicines, vaccines, biologic therapies and animal health products. It has multiple blockbuster drugs or products each with 2020 revenues including cancer immunotherapy, anti-diabetic medication and vaccines against HPV and chickenpox. The company is ranked 71st on the 2022 ''Fortune'' 500 and 87th on the 2022 ''Forbes'' Global 2000, both based on 2021 revenues. Products The company develops medicines, vaccines, biologic therapies and animal health products. In 2020, the company had 6 blockbuster drugs or products, each with over $1 billion in revenue: ''Keytruda'' ( ...
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