Pharmaceutical industry
Sorafenib, a medication developed by Bayer Pharmaceuticals Corporation and Onyx Pharmaceuticals, Inc., is now available to individuals with advanced renal cell carcinoma (RCC) through a treatment protocol announced by the two companies. This program, known as the Advanced Renal Cell Carcinoma Sorafenib (ARCCS) study, has been reviewed by the U.
Pharmaceutical industry
Pharmaceutical companies have been criticized for misleading consumers through the use of inaccurate information, distractions, and unsubstantiated claims in their advertising campaigns. The Food and Drug Administration (FDA) has taken action against several companies, including Amgen, Novartis, Wyeth Pharmaceuticals, and GlaxoSmithKline, for violating the Food, Drug and Cosmetic Act by
Pharmaceutical industry
The pharmaceutical industry is undergoing a shift in marketing practices, driven by regulatory pressure and public concern over medication safety. The Pharmaceutical Research and Manufacturers of America (PhRMA), the industry's chief trade association, is developing new guidelines for television and other consumer ads, while lawmakers are pushing for
Pharmaceutical industry
Able Laboratories, Inc., a pharmaceutical company based in New Jersey, has suspended its manufacturing operations and recalled its product line due to apparent departures from standard operating procedures and noncompliance with current good manufacturing practices. The company had previously announced several product recalls earlier this year due to improper laboratory
Pharmaceutical industry
A recent study by Tufts University researchers has revealed that more people suffer serious side effects from the cholesterol-lowering drug Crestor than from other similar medications, despite the FDA's assertions that it is safe. The study's findings are likely to have significant implications for the millions
Pharmaceutical industry
The Food and Drug Administration (FDA) may soon approve a novel treatment for severe depression, a condition that affects millions of Americans, despite concerns about its limited effectiveness. The treatment, a vagus nerve stimulator, was originally approved in 1997 for epilepsy patients and has since been studied as a potential
Pharmaceutical industry
Tamiflu, the leading prescription antiviral medication for influenza, is currently indicated for the prophylaxis of influenza in adult patients and adolescents 13 years and older. In a move to expand its market reach, Roche has filed a supplemental new drug application (sNDA) with the U.S. Food and Drug Administration
Pharmaceutical industry
The year 2004 was a significant one for the development of oncology drugs, with several new treatments gaining FDA approval and others showing promise in clinical trials. According to a study by Research and Markets, key highlights of 2004 included the fast-track designation of several drugs by the US Food
Pharmaceutical industry
OSI Pharmaceuticals, Inc. and Genentech, Inc. have submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for the use of Tarceva (erlotinib) in combination with gemcitabine chemotherapy for the treatment of advanced pancreatic cancer in patients who have not received any previous treatment.
Medical equipment industry
Spinal implant manufacturer Archus Orthopedics Inc has received an Investigational Device Exemption (IDE) from the US Food and Drug Administration (FDA) for its total facet arthroplasty system (TFAS), designed to treat spinal stenosis. The device, which replaces degenerative facet joints with a prosthetic joint implant, aims to restore stability and
Medical equipment industry
Mentor Corp's silicone gel breast implants have cleared marketing clearance from the US Food and Drug Administration (FDA), although with conditions attached, in a move that contrasts with the rejection of a similar application by competitor Inamed Corp. The FDA's General and Plastic Surgery Devices Advisory
Pharmaceutical industry
A first-of-its-kind diabetes drug, Byetta, is set to hit pharmacies by June 1, marking a significant milestone in the treatment of type 2 diabetes. Developed by Eli Lilly and Co. and Amylin Pharmaceuticals, Byetta works by stimulating the pancreas to produce natural insulin after meals, providing a unique solution for
