Generics Drugs - news, views, reports - Biotech, Pharma and Life Science Channel
A generic drug (generic drugs, short: generics) is a drug defined as "a drug product that is comparable to brand/reference listed drug product in dosage form, strength, route of administration, quality and performance characteristics, and intended use." It has also been defined as a term referring to any drug marketed under its chemical name without advertising.
Although they may not be associated with a particular company, generic drugs are subject to the regulations of the governments of countries where they are dispensed. Generic drugs are labelled with the name of the manufacturer.
A generic drug must contain the same active ingredients as the original formulation. According to the U.S. Food and Drug Administration (FDA), generic drugs are identical or within an acceptable bioequivalent range to the brand name counterpart with respect to pharmacokinetic and pharmacodynamic properties. By extension, therefore, generics are considered (by the FDA) identical in dose, strength, route of administration, safety, efficacy, and intended use. The FDA's use of the word identical is very much a legal interpretation, and is not literal. In most cases, generic products are available once the patent protections afforded to the original developer have expired. When generic products become available, the market competition often leads to substantially lower prices for both the original brand name product and the generic forms. The time it takes a generic drug to appear on the market varies. In the US, drug patents give twenty years of protection, but they are applied for before clinical trials begin, so the effective life of a drug patent tends to be between seven and twelve years.
Source: Wikipedia
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News Articles
Impax Board of Directors Establishes Compliance Committee
Impax Laboratories, Inc. (NASDAQ: IPXL) today announced that its Board of Directors has established a Compliance Committee composed of three independent directors to provide overs...
Valeant Pharmaceuticals To Present At 34th Annual Goldman Sachs Global Healthcare Conference
LAVAL, Quebec, May 20, 2013 /PRNewswire/ -- Valeant Pharmaceuticals International, Inc. (NYSE: VRX) (TSX: VRX) today announced members of its senior management team will make a presentati...
Poll: Over One Million Seniors Have Problems with Medicare 'Preferred Pharmacy' Drug Plans
ALEXANDRIA, Va., May 20, 2013 /PRNewswire-USNewswire/ -- National Community Pharmacists Association (NCPA) CEO B. Douglas Hoey, RPh, MBA issued the following statement today regarding a survey by...
Impax Laboratories to Present at the UBS Global Healthcare Conference
Impax Laboratories, Inc. (NASDAQ: IPXL) today announced that the Company will present at the UBS Global Healthcare Conference on Wednesday, May 22, at 9:00 a.m. Eastern Standard T...
Elcelyx Therapeutics Enrolling Phase 2b Trial of NewMet for Type 2 Diabetes
SAN DIEGO, May 20, 2013 /PRNewswire/ -- Enrollment of patients with Type 2 diabetes is underway in Elcelyx Therapeutics' Phase 2b dose-finding clinical trial of product candidate NewMet™, a dela...
Orion Corporation is preparing to issue a bond
ORION CORPORATION STOCK EXCHANGE RELEASE 20 MAY 2013 at 09.50 EEST Orion Corporation is preparing to issue a EUR 100-150 million senior, unsecured bond that w...
225,000 Orion A-shares converted into B-shares
ORION CORPORATION STOCK EXCHANGE RELEASE 20 MAY 2013 at 09.15 a.m. EEST In accordance with Section 3 of the Articles of Association of Orion Corporation, 225...
Mylan Launches Generic Tricor® Tablets
PITTSBURGH, May 17, 2013 /PRNewswire/ -- Mylan Inc. (Nasdaq: MYL) today announced that its subsidiary Mylan Pharmaceuticals Inc. has shipped Fenofibrate Tablets, 48 mg and 145 mg. Mylan Pharmaceutical...
Following the conclusion of the Pharmacovigilance Risk Assessment Committee (PRAC) that the benefits of Diane 35 and its generics outweigh the risks in a specific patient group, the French National Ag...
AmerisourceBergen Receives Regulatory Approval of Walgreens and Alliance Boots Equity Investment
AmerisourceBergen Corporation (NYSE: ABC) today announced that the parties have received regulatory approval of the previously disclosed agreement for Walgreen Co. and Alliance Bo...
Events
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Companies
Aradigm Corporation and Grifols S.A.
Aradigm is an emerging specialty pharmaceutical company focused on the development and commercialization of drugs delivered by inhalation for the prevention and treatment of sever...
Monarch Medical Technologies is a privately held medical technology company founded by clinicians with a vision of dramatically improving hospital-based glucose management by repl...
R-Tech Ueno is a bio-venture company established in September 1989 for the purpose of marketing and R&D of drugs. Under leadership of the president, also a medical doctor, the company is developing ne...
Physician Therapeutics is a division of Targeted Medical Pharma, Inc., a specialty pharmaceutical company that develops and sells prescription medical foods to physi...
Novartis's name, derived from the Latin novae artes, means "new skills" and reflects Novartis's commitment to focus research and development to bring new healthcare products to the...
Xenetic is a leading UK-based biopharmaceutical company providing leading-edge expertise in the development of a whole new generation of drugs and vaccines. Working with some of the largest pharma...
Verastem, Inc. is a private biopharmaceutical company focused on discovering and developing novel drugs that selectively target cancer stem cells. Cancer stem cells are an underly...
Etubics Corporation, based in Seattle, Wash., is a clinical stage bio-pharmaceutical company, which has developed a proprietary platform technology consisting of a next generation...
TPP is a UK-based, drug development company operating in the preclinical area of the drug discovery process. TPP in-licenses novel intellectual property (IP) from universities, re...
Ipsen is a global biopharmaceutical group, with sales exceeding 1 billion euros in 2009. The Group has total worldwide staff of more than 4,400 employees, of which nearly 900 cont...
Clinical Trials
Herpes Simplex Virus Type 2 (HSV-2) Suppression to Prevent HIV Transmission
The University of Washington has received funding to conduct a proof-of-concept trial to assess the impact of suppression of genital herpes on HIV infectiousness. This study (the Partners...
RATIONALE: Androgens can cause the growth of prostate cancer cells. Drugs, such as goserelin, may stop the adrenal glands from making androgens. Drugs used in chemotherapy, such as docetax...
Pixantrone or Other Chemotherapy Drugs in Treating Patients With Relapsed Non-Hodgkin's Lymphoma
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. It is not yet known whether...
RATIONALE: Drugs used in chemotherapy, such as eflornithine, work in different ways to stop tumor cells from dividing so they stop growing or die. Androgens can stimulate the growth of pro...
RATIONALE: Androgens can stimulate the growth of prostate cancer cells. Drugs such as goserelin and leuprolide may fight prostate cancer by stopping the adrenal glands from producing andro...
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Drugs used in immunotherapy such as rituximab can locate cancer cel...
RATIONALE: Androgens can stimulate the growth of prostate cancer cells. Drugs such as nilutamide, bicalutamide, flutamide, or cyproterone may stop the adrenal glands from producing androge...
Pyroxamide in Treating Patients With Advanced Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase I trial to study the effectiveness of pyroxamide in...
This is a 48-week study to collect additional information on the safety, tolerability, pharmacokinetics, and antiviral activity of an investigational regimen (course of therapy) including...
Ketoconazole and Docetaxel in Treating Patients With Metastatic Prostate Cancer
RATIONALE: Androgens can stimulate the growth of prostate cancer cells. Drugs such as ketoconazole may stop the adrenal glands from producing androgens. Drugs used in chemotherapy use diff...
PubMed Articles
TL-118-anti-angiogenic treatment in pancreatic cancer: a case report.
Pancreatic cancer is one of the most aggressive malignant tumors. In recent years, little progress has been made in understanding and treatment of the disease. The two most commonly used chemotherapy...
Coprological examination of the worm lizard Diplometopon zarudnyi Nikolskii revealed the presence of oöcysts of Choleoeimeria zarudnyi (Alyousif & Al-Shawa, 2003) n. comb. in five (17%) of the 30 liz...
This work investigates the possibility of combining Monte Carlo (MC) simulations to a denoising algorithm for the accurate prediction of images acquired using amorphous silicon (a-Si) electronic porta...
Clinically approved organic chemotherapeutic drugs such as cytarabine, dacarbazine and anastrozole were attached to B12via a {CN-trans-Pt(NH3)2}-bridge to yield [{Co}-CN-{trans-Pt(NH3)2}-{drug}](2+)....
Gold amides as anticancer drugs: synthesis and activity studies.
Modular gold amide chemotherapeutics: Access to modern chemotherapeutics with robust and flexible synthetic routes that are amenable to extensive customisation is a key requirement in drug synthesis a...
The decoction of Terminalia chebula fruit is an ayurvedic remedy whose prolonged oral administration is prized as a generic intestinal and hepatic detoxifying agent. Its administration is suggested al...
Simultaneous multi-element imaging using NanoSIMS (nano-scale secondary ion mass spectrometry), exploiting the novel combination of (195)Pt and (15)N in platinum-am(m)ine antitumour drugs, provides in...
Legislations combating counterfeit drugs in Hong Kong.
OBJECTIVE. To understand legislation combating counterfeit drugs in Hong Kong. DESIGN. This study consisted of two parts. In part I, counterfeit drugs-related ordinances and court cases were reviewed....
Inside job: ligand-receptor pharmacology beneath the plasma membrane.
Most drugs acting on the cell surface receptors are membrane permeable and thus able to engage their target proteins in different subcellular compartments. However, these drugs' effects on cell surfac...
OBJECTIVE: Worldwide pharmacists play an increasingly important role in pharmacovigilance. Lareb Intensive Monitoring (LIM) in the Netherlands is a new form of active pharmacovigilance where pharmacis...
Videos
Generic Drugs: Learn about the Lifecycle from Brand Name Prescriptions to Generics
Ever wonder why generic drugs cost $4 at some pharmacies? Generic drugs are the final stage in a long lifecycle that starts with innovator biopharmaceutical ...
Medical and Biotech [MESH] Definitions
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A plant genus of the family ZYGOPHYLLACEAE. It is sometimes called chaparral but that is a generic word which is used with a number of other plants. Members contain NORDIHYDROGUAIARETIC ACID.
Cinnamomum Aromaticum
A plant species of the genus CINNAMOMUM that contains CINNAMATES and has been used in traditional Chinese medicine (DRUGS, CHINESE HERBAL).
Epimedium
A plant genus of the family BERBERIDACEAE which is used in DRUGS, CHINESE HERBAL. Members contain flavonol glycosides including epimedins, icariin and noricariin.
Cuscuta
A plant genus of the family Cuscutaceae. It is a threadlike climbing parasitic plant that is used in DRUGS, CHINESE HERBAL.
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