Food and Drug Administration
The Food and Drug Administration (FDA or USFDA) is a federal agency of the United States Department of Health and Human Services, one of the United States federal executive departments. The FDA is res...
Food and Drug Administration - Wikipedia
Roche Products v. Bolar Pharmaceutical
Roche Products v. Bolar Pharmaceutical, 733 F.2d 858 (Fed. Cir. 1984), was a court case in the United States related to the manufacturing of generic pharmaceuticals. See Research exemption.Bolar was a...
Roche Products v. Bolar Pharmaceutical - Wikipedia
Research exemption
In patent law, the research exemption or safe harbour exemption is an exemption to the rights conferred by patents, which is especially relevant to drugs. According to this exemption, despite the pate...
Cabilly patents
The Cabilly patents are two US patents issued to Genentech and City of Hope which relate to the "fundamental technology required for the artificial synthesis of antibody molecules." The name refers t...
Ariad v. Lilly
Ariad Pharmaceuticals et al. v. Eli Lilly and Company, 598 F.3d 1336 (Fed. Cir. 2010) (en banc), is a United States court case regarding accusations of infringement by Eli Lilly on U.S. Patent 6,410,5...
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), which is a part of the U.S. Department of Health and Human Services....
Pemtumomab
Pemtumomab (trade name Theragyn) is a mouse monoclonal antibody used to treat cancer. The substance has affinity to various types of cancer, like ovarian cancer and peritoneal cancer, via the polymorp...
Lintuzumab
Lintuzumab (SGN-33) is a humanized monoclonal antibody used in the treatment of cancer. The drug had been developed by Seattle Genetics as a treatment for acute myeloid leukemia (AML), a condition whi...
Diamond v. Chakrabarty
Diamond v. Chakrabarty, 447 U.S. 303 (1980), was a United States Supreme Court case dealing with whether genetically modified organisms can be patented.
Genetic engineer Ananda Mohan Chakrabarty, ...
Orphan drug
An orphan drug is a pharmaceutical agent that has been developed specifically to treat a rare medical condition, the condition itself being referred to as an orphan disease.In the US and EU it is easi...
LabCorp v. Metabolite, Inc
LabCorp v. Metabolite, Inc. is a court case related to the patentability of scientific principles which the U.S. Supreme Court agreed to hear, and later dismissed, in 2006.In 1999, Metabolite sued Lab...
Merck KGaA v. Integra Lifesciences I, Ltd.
Merck KGaA v. Integra Lifesciences I, Ltd., 545 U.S. 193 (2005), is a United States Supreme Court case with ramifications for patent law. The dispute dates to approximately 1996 and centers on a feder...
Stem cell laws
Stem cell laws are the law rules, and policy governance concerning the sources, research, and uses in treatment of stem cells in humans. These laws have been the source of much controversy and vary si...
Biological patent
A biological patent is a patent on an invention in the field of biology that by law allows the patent holder to exclude others from making, using, selling, or importing the protected invention for a l...
Eculizumab
Eculizumab (INN and USAN; trade name Soliris) is a humanized monoclonal antibody that is a first-in-class terminal complement inhibitor and the first therapy approved for the treatment of paroxysmal n...
MedImmune, Inc. v. Genentech, Inc.
MedImmune, Inc. v. Genentech, Inc., 549 U.S. 118 (2007) was a decision by the Supreme Court of the United States involving patent law. It arose from a lawsuit filed by MedImmune which challenged one ...
Biodefense and Pandemic Vaccine and Drug Development Act of 2005
The Biodefense and Pandemic Vaccine and Drug Development Act of 2005 (S. 1873), nicknamed "Bioshield Two" and sponsored by Senator Richard Burr (R-North Carolina), aims shorten the pharmaceutical deve...
Discovery and development of thalidomide and its analogs
The development of analogs of thalidomide was precipitated by the discovery of the anti-angiogenic and anti-inflammatory properties of the drug yielding a new way of fighting cancer as well as some in...
Discovery and development of thalidomide and its analogs - Wikipedia
Animal and Plant Health Inspection Service
The Animal and Plant Health Inspection Service (APHIS) is an agency of the United States Department of Agriculture (USDA) responsible for protecting animal health, animal welfare, and plant health. A...
Animal and Plant Health Inspection Service - Wikipedia
Plant Variety Protection Act of 1970
The Plant Variety Protection Act of 1970 (PVPA), 7 U.S.C. §§ 2321-2582, is an intellectual property statute in the United States. The PVPA gives breeders up to 25 years of exclusive control over new,...
Fidarestat
Fidarestat (SNK-860) is an aldose reductase inhibitor used for treatment of diabetic neuropathy.
Aldose reductase inhibitor for treatment of diabetic complications. Prepn (stereo unspec): M. Kuron...
Plant Patent Act of 1930
The Plant Patent Act of 1930 (enacted on 1930-06-17 as Title III of the Hawley-Smoot Tariff, ch. 497, 46 Stat. 703, codified as 35 U.S.C. Ch. 15) is a United States federal law spurred by th...
Health Canada
Health Canada (French: Santé Canada) is the department of the government of Canada with responsibility for national public health.The current Minister of Health is Rona Ambrose, a Conservative Member ...
Environment Canada
Environment Canada (EC) (French: Environnement Canada), legally incorporated as the Department of the Environment under the Department of the Environment Act (R.S., 1985, c. E-10 ), is the departm...
Environment Canada - Wikipedia
United States Environmental Protection Agency
The United States Environmental Protection Agency (EPA or sometimes USEPA) is an agency of the U.S. federal government which was created for the purpose of protecting human health and the environment ...
United States Environmental Protection Agency - Wikipedia
European Medicines Agency
The European Medicines Agency (EMA) is a European Union agency for the evaluation of medicinal products. From 1995 to 2004, the European Medicines Agency was known as European Agency for the Evaluatio...