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Wiki Wiki Summary
Company A company, abbreviated as co., is a legal entity representing an association of people, whether natural, legal or a mixture of both, with a specific objective. Company members share a common purpose and unite to achieve specific, declared goals.
Grasshopper Manufacture Grasshopper Manufacture Inc. (株式会社グラスホッパー・マニファクチュア, Kabushiki Gaisha Gurasuhoppā Manifakuchua) is a Japanese video game developer founded on March 30, 1998 by Goichi Suda.
Bavarian Nordic Bavarian Nordic A/S is a fully integrated biotechnology company focused on the development, manufacturing and commercialization of vaccines for infectious diseases and cancer immunotherapies. The company is headquartered in Hellerup, Denmark, with a manufacturing facility in Kvistgård, and an additional site in Hørsholm.
Contract manufacturing organization A contract manufacturing organization (CMO), more recently referred to (and more commonly used now) as a contract development and manufacturing organization (CDMO) to avoid the acronym confusion of Chief Medical Officer or Clinical Monitoring Organization in the pharma industry, is a company that serves other companies in the pharmaceutical industry on a contract basis to provide comprehensive services from drug development through drug manufacturing. This allows major pharmaceutical companies to outsource those aspects of the business, which can help with scalability or can allow the major company to focus on drug discovery and drug marketing instead.
Automotive industry The automotive industry comprises a wide range of companies and organizations involved in the design, development, manufacturing, marketing, and selling of motor vehicles. It is one of the world's largest industries by revenue (from 16 % such as in France up to 40 % to countries like Slovakia).
Future (rapper) Nayvadius DeMun Wilburn (born November 20, 1983), better known by the stage name Future, is an American rapper and singer. Known for his mumble-influenced vocal range and prolific output, Future is considered a pioneer of the use of melodies and vocal effects in modern trap music.
Regulation Regulation is the management of complex systems according to a set of rules and trends. In systems theory, these types of rules exist in various fields of biology and society, but the term has slightly different meanings according to context.
Research and development Research and development (R&D or R+D), known in Europe as research and technological development (RTD), is the set of innovative activities undertaken by corporations or governments in developing new services or products, and improving existing ones. Research and development constitutes the first stage of development of a potential new service or the production process.
Expense An expense is an item requiring an outflow of money, or any form of fortune in general, to another person or group as payment for an item, service, or other category of costs. For a tenant, rent is an expense.
Public expenditure Public expenditure is spending made by the government of a country on collective needs and wants, such as pension, provisions (which includes education, healthcare and housing), security, infrastructure, etc. Until the 19th century, public expenditure was limited as laissez faire philosophies believed that money left in private hands could bring better returns.
List of countries by total health expenditure per capita This article includes 2 lists of countries of the world and their total expenditure on health per capita. Total expenditure includes both public and private expenditures.
Vehicle regulation Vehicle regulations are requirements that automobiles must satisfy in order to be approved for sale or use in a particular country or region. They are usually mandated by legislation, and administered by a government body.
Australian Government The Australian Government, also known as the Commonwealth Government, is the national government of Australia, a federal parliamentary constitutional monarchy. Like other Westminster-style systems of government, the Australian Government is made up of three branches: the executive (the prime minister, the ministers, and government departments), the legislative (the Parliament of Australia), and the judicial.
Government agency A government or state agency, sometimes an appointed commission, is a permanent or semi-permanent organization in the machinery of government that is responsible for the oversight and administration of specific functions, such as an administration. There is a notable variety of agency types.
Executive (government) The executive (short for executive branch or executive power) is the part of government that enforces law, and has responsibility for the governance of a state.\nIn political systems based on the principle of separation of powers, authority is distributed among several branches (executive, legislative, judicial)—an attempt to prevent the concentration of power in the hands of a single group of people.
Local government Local government is a generic term for the lowest tiers of public administration within a particular sovereign state. This particular usage of the word government refers specifically to a level of administration that is both geographically-localised and has limited powers.
Military government A military government is generally any government that is administered by military forces, whether or not this government is legal under the laws of the jurisdiction at issue, and whether this government is formed by natives or by an occupying power. It is usually carried out by military workers.
Borne government The Borne government is the forty-third and current government of the French Fifth Republic, formed on 16 May 2022 and headed by Élisabeth Borne as Prime Minister under the presidency of Emmanuel Macron.\n\n\n== Context ==\n\n\n=== Formation ===\nOn 16 May 2022, Jean Castex tendered the resignation of his government to the President of the Republic.
Government of Canada The government of Canada (French: gouvernement du Canada) is the body responsible for the federal administration of Canada. A constitutional monarchy, the Crown is the corporation sole, assuming distinct roles: the executive, as the Crown-in-Council; the legislature, as the Crown-in-Parliament; and the courts, as the Crown-on-the-Bench.
Exponential distribution In probability theory and statistics, the exponential distribution is the probability distribution of the time between events in a Poisson point process, i.e., a process in which events occur continuously and independently at a constant average rate. It is a particular case of the gamma distribution.
Binomial distribution In probability theory and statistics, the binomial distribution with parameters n and p is the discrete probability distribution of the number of successes in a sequence of n independent experiments, each asking a yes–no question, and each with its own Boolean-valued outcome: success (with probability p) or failure (with probability q = 1 − p). A single success/failure experiment is also called a Bernoulli trial or Bernoulli experiment, and a sequence of outcomes is called a Bernoulli process; for a single trial, i.e., n = 1, the binomial distribution is a Bernoulli distribution.
Beta distribution In probability theory and statistics, the beta distribution is a family of continuous probability distributions defined on the interval [0, 1] parameterized by two positive shape parameters, denoted by alpha (α) and beta (β), that appear as exponents of the random variable and control the shape of the distribution. The generalization to multiple variables is called a Dirichlet distribution.
Pareto distribution The Pareto distribution, named after the Italian civil engineer, economist, and sociologist Vilfredo Pareto, (Italian: [paˈreːto] US: pə-RAY-toh), is a power-law probability distribution that is used in description of social, quality control, scientific, geophysical, actuarial, and many other types of observable phenomena. Originally applied to describing the distribution of wealth in a society, fitting the trend that a large portion of wealth is held by a small fraction of the population.
Manufacturing Consent Manufacturing Consent: The Political Economy of the Mass Media is a 1988 book by Edward S. Herman and Noam Chomsky. It argues that the mass communication media of the U.S. "are effective and powerful ideological institutions that carry out a system-supportive propaganda function, by reliance on market forces, internalized assumptions, and self-censorship, and without overt coercion", by means of the propaganda model of communication.
Operation Mincemeat Operation Mincemeat was a successful British deception operation of the Second World War to disguise the 1943 Allied invasion of Sicily. Two members of British intelligence obtained the body of Glyndwr Michael, a tramp who died from eating rat poison, dressed him as an officer of the Royal Marines and placed personal items on him identifying him as the fictitious Captain (Acting Major) William Martin.
Bitwise operation In computer programming, a bitwise operation operates on a bit string, a bit array or a binary numeral (considered as a bit string) at the level of its individual bits. It is a fast and simple action, basic to the higher-level arithmetic operations and directly supported by the processor.
Operations management Operations management is an area of management concerned with designing and controlling the process of production and redesigning business operations in the production of goods or services. It involves the responsibility of ensuring that business operations are efficient in terms of using as few resources as needed and effective in meeting customer requirements.
Internet In finance and economics, interest is payment from a borrower or deposit-taking financial institution to a lender or depositor of an amount above repayment of the principal sum (that is, the amount borrowed), at a particular rate. It is distinct from a fee which the borrower may pay the lender or some third party.
Antibiotic use in livestock Antibiotic use in livestock is the use of antibiotics for any purpose in the husbandry of livestock, which includes treatment when ill (therapeutic), treatment of a group of animals when at least one is diagnosed with clinical infection (metaphylaxis), and preventative treatment (prophylaxis). Antibiotics are an important tool to treat animal as well as human disease, safeguard animal health and welfare, and support food safety.
Beta-lactam antibiotics β-lactam antibiotics (beta-lactam antibiotics) are antibiotics that contain a beta-lactam ring in their chemical \nstructure. This includes penicillin derivatives (penams), cephalosporins and cephamycins (cephems), monobactams, carbapenems and carbacephems.
Production of antibiotics Production of antibiotics is a naturally occurring event, that thanks to advances in science can now be replicated and improved upon in laboratory settings. Due to the discovery of penicillin by Alexander Flemming, and the efforts of Florey and Chain in 1938, large-scale, pharmaceutical production of antibiotics has been made possible.
The Journal of Antibiotics The Journal of Antibiotics is a peer-reviewed medical journal published by the Nature Publishing Group for the Japan Antibiotics Research Association.
Glycopeptide antibiotic Glycopeptide antibiotics are a class of drugs of microbial origin that are composed of glycosylated cyclic or polycyclic nonribosomal peptides. Significant glycopeptide antibiotics include the anti-infective antibiotics vancomycin, teicoplanin, telavancin, ramoplanin and decaplanin, corbomycin, complestatin and the antitumor antibiotic bleomycin.
Antibiotic misuse Antibiotic misuse, sometimes called antibiotic abuse or antibiotic overuse, refers to the misuse or overuse of antibiotics, with potentially serious effects on health. It is a contributing factor to the development of antibiotic resistance, including the creation of multidrug-resistant bacteria, informally called "super bugs": relatively harmless bacteria (such as Staphylococcus, Enterococcus and Acinetobacter) can develop resistance to multiple antibiotics and cause life-threatening infections.
Risk Factors
ALPHARMA INC Item 1A RISK FACTORS The Companyapstas reports filed from time to time pursuant to the Securities Exchange Act of 1934 include certain forward-looking statements
Like any company subject to a competitive and changing business environment, the Company cannot guarantee the results predicted in any of the Companyapstas forward-looking statements
Important factors that could cause actual results to differ materially from those in the forward-looking statements include the following: The Company depends on the development, manufacture and marketing of new products for its future success
The Companyapstas future success is largely dependent upon its ability to develop, manufacture and market commercially successful new products
Generally, the successful commercial marketing of the Companyapstas products depends on completing the following steps in a time frame to allow the Company to be among the first to market a particular product: * developing and testing the product; * proving that the product is safe and effective; and * filing for and receiving regulatory approvals to manufacture and sell the product in a timely manner
Delays in the development, manufacture or marketing of new products will impact the Companyapstas expenses and revenues
The Company cannot be sure that any product presently going through the process set forth above, or which may be chosen by the Company to enter this process in the future, will result in the timely and profitable commercial launch of a new product
Research and development expenditures will negatively impact the Companyapstas earnings in the short term, and there is no guarantee of success
The Company, in its continuing businesses, expended approximately dlra26dtta9 million and dlra25dtta4 million on research and development efforts in 2005 and 2004, respectively, and expects to increase these expenditures to approximately dlra50 million in 2006, principally for the development of additional pain products
Such research and development expenditures will have an adverse impact on the Companyapstas earnings in the short term
Further, the Company cannot be sure that its research and development expenditures will, in the long term, result in the commercialization of products, including a next-generation pain product, which prove to be economically successful
The Company is subject to government regulations and actions that increase the Companyapstas costs and could prevent it from marketing and selling some of its products in certain countries
The research, development, manufacturing and marketing of the Companyapstas products are subject to extensive government regulation
Government regulation includes inspection of and controls over testing, manufacturing, safety, efficacy, labeling, record keeping, pricing, sale and distribution of pharmaceutical products
While the Company does not keep records that segregate the cost of compliance with these government regulations, in the aggregate such regulations substantially increase the cost of manufacturing, developing and selling the Companyapstas products
The US and other governments regularly review manufacturing operations, including APIapstas plants in Oslo, Copenhagen and Budapest where products for the US market are, or are intended to be, manufactured
These reviews can result in regulatory concerns requiring a response by the Company
Failure to adequately address these concerns could have a material adverse effect on the Company, including product approval delays, reduced production and production interruptions, among other things
The significance of the effect of any such failures depends on the severity of the remedy chosen by the government agency
Non-compliance with applicable requirements can result in fines, recall or seizure of products, suspension of production or distribution and debarment of individuals from providing services to drug companies in any capacity or debarment of the Company from obtaining new drug approvals, resulting in current charges to income and the potential for future loss of income and increased operating expenses
In recent years, besides stepped up enforcement of cGMP requirements, the federal government has utilized equitable disgorgement as a means of enforcing compliance with the FDAapstas cGMP regulations
There can be no assurance that the FDA would not seek to impose similar sanctions on the Company and any such sanction could have a significant effect on the Companyapstas business and operations
In addition, continuing studies of the proper utilization, safety and efficacy of pharmaceuticals and other health care products are continually being conducted by the industry, government agencies (including studies required to be performed from time to time by the pharmaceutical company marketing a particular drug) and others
These studies, which increasingly employ more sophisticated methods and techniques, can question the utilization safety and efficacy of previously marketed products and in some cases have resulted, and may in the future result, in the discontinuance of their marketing and, in certain countries, give rise to claims for damages from person who believe they have been injured as a result of their use
An expansion of the ban of the use of antibiotics used in food-producing animals could result in a decrease in the Companyapstas total sales
The issue of the potential transfer of increased bacterial resistance to certain antibiotics used in certain food-producing animals to human pathogens is the subject of discussions on a worldwide basis and, in certain instances, has led to government restrictions on the use of antibiotics in these food-producing animals
While most of the government activity in this area has involved products other than those that the Company offers for sale, the European Union and one non-EU country banned the use of bacitracin zinc, a feed antibiotic growth promoter manufactured by the Company and others that has been used in livestock feeds for over 40 years
The Company has not sold this product in these countries since the ban took effect
The EU ban is based upon the &quote Precautionary Principle &quote , which states that a product may be withdrawn from the market based upon a finding of a potential threat of serious or irreversible damage even if such finding is not support ed by scientific certainty
Although the EU action negatively impacted the Companyapstas business, it was not material to the Companyapstas financial position or its results of operations
The Company cannot predict whether the present bacitracin zinc ban in the EU will be expanded
If any one of the following occur: (i) the EU or countries within the EU act to prevent the importation of meat products from countries that allow the use of bacitracin-based products, (ii) there is an expansion of the zinc bacitracin ban to additional countries, such as the US, where the Company has material sales of bacitracin-based products, (iii) a similar ban is instituted relating to other antibiotic feed additives sold by the Company in the US or in one or more other countries where the Company has material sales, or (iv) there is an increase in public pressure to discontinue the use of antibiotic feed additives, the resultant loss of sales could be material to the Companyapstas financial condition, cash flows and results of operations
The Company cannot predict whether this antibiotic resistance concern will result in expanded regulations or public pressure adversely affecti ng other antibiotic-based animal health products previously sold by the Company in the EU or in other countries in which those products are presently sold
Discussions of the antibiotic resistance issue continue actively in the US Various sources have published reports concerning possible adverse human effects from the use of antibiotics in food animals
Some of these reports have asserted that major animal producers, some of whom are the Companyapstas customers or the end-users of its products, are reducing the use of antibiotics
In July 2005, the FDA announced a restriction on the distribution and use of a medicated feed additive due to concerns regarding antibiotic resistance in humans
While the Company does not market this drug this ruling would be significant if its conclusions were expanded to the medicated feed additives sold by the Company
It is uncertain what additional actions, if any, the FDA may take for approved animal drug products
However, the FDA has proposed a rating system to be used to compare the risks associated with the use of specific antibiotic products in food producing animals, i ncluding those sold by the Company
While the Company does not believe that the presently proposed risk assessment system would be materially adverse to its business, it is subject to change prior to adoption or to later amendment
The sales of the Companyapstas Animal Health segment are principally antibiotic-based products for use with food producing animals; therefore the future loss of major markets, including the US, or negative publicity regarding this use of antibiotic based products, could have a negative impact on the Companyapstas sales and income
Potential adverse effects on human health linked to the raising or consumption of food producing animals using the Companyapstas products could result in a decrease in the Companyapstas sales
Should the government find, or the public perceive a risk to human health from consumption of food producing animals (such as Avian flu) which utilize the Companyapstas products or as a by-product to the raising of such