Telesta Therapeutics
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Telesta Therapeutics
Telesta Therapeutics Inc. was a publicly traded, Canadian pharmaceutical company based in Montreal, Quebec. It was acquired by ProMetic Life Sciences in 2016. CEO Michael Berendt; prior to joining Telesta, was the president and CEO of Aegera Therapeutics. Telesta was listed on the Toronto Stock Exchange under the symbol TST. History As part of the strategic push to focus on late stage human therapeutics, effective May 2014, the company divested its Animal Health unit to Vétoquinol, a family-owned, global animal health company led by CEO Matthieu Frechin. In 2014, a court decision involving a group of Bioniche shareholders and the Bioniche board of directors established a precedent in the Canadian court system for conditions under which a board may choose not to select the date proposed by shareholders for an Annual Meeting, but rather schedule on a date of the board's choosing, thus confirming "that directors have wide latitude to manage corporate affairs." In February 2 ...
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Public Company
A public company is a company whose ownership is organized via shares of stock which are intended to be freely traded on a stock exchange or in over-the-counter markets. A public (publicly traded) company can be listed on a stock exchange (listed company), which facilitates the trade of shares, or not (unlisted public company). In some jurisdictions, public companies over a certain size must be listed on an exchange. In most cases, public companies are ''private'' enterprises in the ''private'' sector, and "public" emphasizes their reporting and trading on the public markets. Public companies are formed within the legal systems of particular states, and therefore have associations and formal designations which are distinct and separate in the polity in which they reside. In the United States, for example, a public company is usually a type of corporation (though a corporation need not be a public company), in the United Kingdom it is usually a public limited company (plc), i ...
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Orphan Drug
An orphan drug is a pharmaceutical agent developed to treat medical conditions which, because they are so rare, would not be profitable to produce without government assistance. The conditions are referred to as orphan diseases. The assignment of orphan status to a disease and to drugs developed to treat it is a matter of public policy in many countries and has yielded medical breakthroughs that might not otherwise have been achieved, due to the economics of drug research and development. In the U.S. and the EU, it is easier to gain marketing approval for an orphan drug. There may be other financial incentives, such as an extended period of exclusivity, during which the producer has sole rights to market the drug. All are intended to encourage development of drugs which would otherwise lack sufficient profit motive to attract corporate research budgets and personnel. Definition According to the US Food and Drug Administration (FDA), an orphan drug is defined as one "intended for ...
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TMX Group
TMX Group Limited is a Canadian financial services company that operates equities, fixed income, derivatives, and energy markets exchanges. The company provides services encompassing listings, trading, clearing, settling and depository facilities, information services as well as technology services for the international financial community. TMX Group is best known for its stock exchanges, Toronto Stock Exchange (TSX), which serves the senior equity markets, and TSX Venture Exchange (TSXV), which serves the public venture equity market. TSXV was formerly known as the Canadian Venture Exchange (CDNX), but it also owns and operates other exchanges in Canada, including Montréal Exchange, NGX, a North American exchange for the trading and clearing of natural gas and electricity contracts, TSX Alpha Exchange, as well as the country's depository, clearing and settlement business, CDS. TMX Group also owns and operates TMX Equity Transfer Services, Shorcan Brokers Limited, the Canadian ...
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NewsRx
NewsRx is a media and technology company focusing on digital media, printed media, news services, and knowledge discovery through its BUTTER platform. In 1995 the company was the world's largest producer of health news.Fernandes, Manuela. "Health Letters: Let the Reader Beware." ''The New York Times'' News Service 18 Aug, 1995 The company publishes 194 newsweeklies in health and other fields, which are distributed to subscribers and partners including Factiva, the ''Wall Street Journal Professional Edition'', Thomson Reuters, ProQuest, and Cengage Learning.Bellury, Phillip. ''Enlightening The World''. Atlanta, GA: The Storyline Group, 2009. C W Henderson founded the company in 1984 and its first publication was ''AIDS Weekly.'' Taylor, Ron. "Private Enterprise Jumps into AIDS Marketplace." ''Atlanta Constitution''. February 4, 1986 In the early 2000s, the firm added the imprint, VerticalNews to publish newsweeklies in non-health fields."NewsRx's VerticalNews Division Launches ...
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Biotech Week
''Biotech Week'' is a weekly biotechnology and pharmaceutical trade magazine. The magazine was established in 1999. It is published by NewsRX. The magazine covers a broad range of medical issues and financial related information about companies in these industries. The magazine is headquartered in Atlanta, Georgia Atlanta ( ) is the capital and most populous city of the U.S. state of Georgia. It is the seat of Fulton County, the most populous county in Georgia, but its territory falls in both Fulton and DeKalb counties. With a population of 498,7 .... References External links * * 1999 establishments in Georgia (U.S. state) English-language magazines Magazines established in 1999 Magazines published in Atlanta Medical magazines Professional and trade magazines Science and technology magazines published in the United States Weekly magazines published in the United States {{italic title ...
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Highbeam Research
HighBeam Research was a paid search engine and full text online archive owned by Gale, a subsidiary of Cengage, for thousands of newspapers, magazines, academic journals, newswires, trade magazines, and encyclopedias in English. It was headquartered in Chicago, Illinois. In late 2018, the archive was shut down. History The company was established in August 2002 after Patrick Spain, who had just sold Hoover's, which he had co-founded, bought eLibrary and Encyclopedia.com from Tucows. The new company was called Alacritude, LLC (a combination of Alacrity and Attitude). ELibrary had a library of 1,200 newspaper, magazine and radio/TV transcript archives that were generally not freely available. Original investors included Prism Opportunity Fund of Chicago and 1 to 1 Ventures of Stamford, Connecticut. Spain stated, "There was a glaring gap between free search like Google and high-end offerings like LexisNexis and Factiva." Later in 2002, it bought Researchville.com. By 2003, it ...
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Med Ad News
''Med Ad News'' is a magazine, publishing pharmaceutical business and marketing news. It was started in 1982 and the first issue appeared in September 1982. Its headquarters is in Livingston, New Jersey, United States. Publishing Med Ad News is currently published by Outcomes LLC, formerly by Canon Communications and Engel Publishing Partners Engel means "angel" in some Germanic languages. Engel or Die Engel may refer to: People * Engel (surname) * Engel Beltré (born 1989), Dominican baseball player Music * Engel (band), a Swedish industrial/melodic death metal band * "Engel" (so .... Engel Publishing Partners was sold to Canon Communications in 2007. In January 2014, PharmaLive and Med Ad News brands were acquired by Outcomes LLC from UBM. The content of ''Med Ad News'' appears in print six times annually, distributed around the world and on PharmaLive.com. References External linksPharmaLive Official Website
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Valrubicin
Valrubicin (''N''-trifluoroacetyladriamycin-14-valerate, trade name Valstar) is a chemotherapy drug used to treat bladder cancer. Valrubicin is a semisynthetic analog of the anthracycline doxorubicin, and is administered by infusion directly into the bladder. It was originally launched as Valstar in the U.S. in 1999 for intravesical therapy of Bacille Calmette-Guérin (BCG)-refractory carcinoma in situ of the urinary bladder in patients in whom cystectomy would be associated with unacceptable morbidity or mortality; however, it was voluntarily withdrawn in 2002 due to manufacturing issues. Valstar was relaunched on September 3, 2009. Side effects * Blood in urine *Incontinence Incontinence or Incontinent may refer to: *Fecal incontinence, the involuntary excretion of bowel contents *Urinary incontinence, the involuntary excretion of urine * Lack of moderation or self-control, especially related to sexual desire - see I ... * painful or difficult urination *Unusually frequent ...
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Adverse Event
An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. AEs in patients participating in clinical trials must be reported to the study sponsor and if required could be reported to the local ethics committee. Adverse events categorized as "serious" (results in death, illness requiring hospitalization, events deemed life-threatening, results in persistent or significant incapacity, a congenital anomaly, birth defect or medically important condition) must be reported to the regulatory authorities immediately, whereas non-serious adverse events are ...
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FDA Fast Track Development Program
Fast track is a designation by the United States Food and Drug Administration (FDA) of an investigational drug for expedited review to facilitate development of drugs that treat a serious or life-threatening condition and fill an unmet medical need. Fast Track designation must be requested by the drug company. The request can be initiated at any time during the drug development process. FDA will review the request and attempt to make a decision within sixty days. Purpose Fast Track is one of five Food and Drug Administration (FDA) approaches to make new drugs available as rapidly as possible: the others are priority review, breakthrough therapy, accelerated approval and Regenerative Medicine Advanced Therapy. Fast Track was introduced by the FDA Modernization Act of 1997. Requirements Fast track designation is designed to aid in the development and expedite the review of drugs which show promise in treating a serious or life-threatening disease and address an unmet medical ...
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Biologic License Application
A biologics license application (BLA) is defined by the U.S. Food and Drug Administration (FDA) as follows: The biologics license application is a request for permission to introduce, or deliver for introduction, a biologic product into interstate commerce (21 CFR 601.2). The BLA is regulated under 21 CFR 600 – 680. A BLA is submitted by any legal person or entity who is engaged in manufacture or an applicant for a license who takes responsibility for compliance with product and establishment standards. Form 356h specifies the requirements for a BLA. This includes: * Applicant information * Product/manufacturing information * Pre-clinical studies * Clinical studies * Labeling Some biological products are regulated by the Center for Drug Evaluation and Research (CDER) while others are regulated by Center for Biologics Evaluation and Research The Center for Biologics Evaluation and Research (CBER) is one of six main centers for the U.S. Food and Drug Administration (FDA), w ...
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USFDA
The United States Food and Drug Administration (FDA or US FDA) is a federal agency of the Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, caffeine products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), cosmetics, animal foods & feed and veterinary products. The FDA's primary focus is enforcement of the Federal Food, Drug, and Cosmetic Act (FD&C), but the agency also enforces other laws, notably Section 361 of the Public Health Service Act, as well as associated regulations. Much of this regulatory-enforcement work is not directly related to food or drugs, but involves such things as regulating lasers, cellular phones, and condoms, as well as control of disease in contexts varying from h ...
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