News tagged with biopharmaceuticals
Biopharmaceuticals are medical drugs (see pharmacology) produced using biotechnology. They include proteins (including antibodies), nucleic acids (DNA, RNA or antisense oligonucleotides) and living microorganisms like virus and bacteria where the virulence of viruses and bacteria is reduced by the process of attenuation, they can be used for therapeutic or in vivo diagnostic purposes, and are produced by means other than direct extraction from a native (non-engineered) biological source.
The first such substance approved for therapeutic use was biosynthetic 'human' insulin made via recombinant DNA technology. Sometimes referred to as rHI, under the trade name Humulin, was developed by Genentech, but licensed to Eli Lilly and Company, who manufactured and marketed the product starting in 1982.
The large majority of biopharmaceutical products are pharmaceuticals that are derived from life forms. Small molecule drugs are not typically regarded as biopharmaceutical in nature by the industry. However members of the press and the business and financial community often extend the definition to include pharmaceuticals not created through biotechnology. That is, the term has become an oft-used buzzword for a variety of different companies producing new, apparently high-tech pharmaceutical products. Research and development investment in new medicines by the biopharmaceutical industry stood at $65.2bn in 2008.
When a biopharmaceutical is developed, the company will typically apply for a patent, which is a grant for exclusive manufacturing rights. This is the primary means by which the developer of the drug can recover the investment cost for development of the biopharmaceutical. The patent laws in the United States and Europe differ somewhat on the requirements for a patent, with the European requirements are perceived as more difficult to satisfy. The total number of patents granted for biopharmaceuticals has risen significantly since the 1970s. In 1978 the total patents granted was 30. This had climbed to 15,600 in 1995, and by 2001 there were 34,527 patent applications.
Within the United States, the Food and Drug Administration (FDA) exerts strict control over the commercial distribution of a pharmaceutical product, including biopharmaceuticals. Approval can require several years of clinical trials, including trials with human volunteers. Even after the drug is released, it will still be monitored for performance and safety risks.
The manufacture of the drug must satisfy the "current Good Manufacturing Practices" regulations of the FDA. They are typically manufactured in a clean room environment with set standards for the amount of airborne particles.
This text uses material from Wikipedia and is available under the GNU Free Documentation License.
(HealthDay)—The injected imaging drug Lymphoseek (technetium Tc 99m tilmanocept) has been approved by the U.S. Food and Drug Administration to help surgeons locate the lymph nodes among people with breast cancer or melanoma.
Cancer Mar 13, 2013 | not rated yet | 0
Case Western Reserve University School of Medicine and AstraZeneca, a global biopharmaceutical company, today announced the first patient enrolled in a Phase 2a trial to assess the effectiveness of AZD5847, a new test drug ...
Diseases, Conditions, Syndromes Dec 11, 2012 | not rated yet | 0
Some animal models developed by researchers at the Institute of Biomedical Research of Bellvitge (IDIBELL) and the Catalan Institute of Oncology (ICO) has served to validate the effectiveness of a new drug ...
Cancer Oct 09, 2012 | not rated yet | 0
(Medical Xpress)—New research from the University of Reading, The Royal Botanic Gardens, Kew and Imperial College London published on 10 September in the Proceedings of the National Academy of Sciences (PNAS) ...
Medications Sep 11, 2012 | 5 / 5 (6) | 0 |
The Infectious Disease Research Institute (IDRI), a Seattle-based non-profit research organization that is a leading developer of adjuvants used in vaccines combating infectious disease, and Medicago Inc. (TSX: MDG; OTCQX: ...
Medications Aug 16, 2012 | not rated yet | 0
(HealthDay) -- Cells that normally form scar tissue after a heart attack can be reprogrammed into functional heart cells in mice, according to an experimental study published online April 18 in Nature.
Medical research Apr 23, 2012 | not rated yet | 0
A new drug, MDV3100, is improving the survival rate in men with advanced prostate cancer, results of a large, phase III clinical trial show. The drug is designed to block a type of cellular receptor that drives progression ...
Cancer Feb 01, 2012 | 5 / 5 (1) | 0 |
A process that prompts a single gene to generate millions of supercharged stem cells, which can then turn into any kind of cell a body needs to repair itself, has been patented at the University of Central ...
Medical research Dec 22, 2011 | 5 / 5 (1) | 0
Permeon Biologics, a biopharmaceutical company pioneering a novel class of intracellular protein biologics, today announced the discovery of an entirely new class of naturally occurring human supercharged proteins called ...
Medications Jul 28, 2011 | 5 / 5 (1) | 0 |