Tag: FDA
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FDA Grants Orphan Drug Status for ALS Candidate
BrainStorm Cell Therapeutics Inc. in Petach Tikvah, Israel says the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to the company’s NurOwn adult stem cell product candidate for the treatment of amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig’s Disease. ALS is a progressive neurodegenerative disease of nerve cells in the…
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FDA Clearance Granted for Blood Tissue Monitor
Ornim Inc. in Santa Clarita, California said it received clearance from the U.S. Food and Drug Administration (FDA) to market its the CerOx 3210F monitor. The FDA action, known as a 510(k) clearance, is a pre-market notification required for medical devices to be sold in the U.S. Ornim says the FDA action clears the CerOx…
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FDA Blocks Obesity Drug Over Cardiac Concerns
The U.S. Food and Drug Administration (FDA) has told Orexigen Therapeutics Inc. in San Diego, California and Takeda Pharmaceutical Company Limited in Osaka, Japan that the agency is withholding approval of the companies’ candidate obesity management drug Contrave pending results of another clinical trial to address risks of heart disease. The companies released excerpts from…
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FDA Approves Trial of Nanotech Cancer Cell Markers
The U.S. Food and Drug Administration (FDA) has approved the first clinical trial in humans of brightly glowing nanoparticles to light up cancer cells to aid in diagnosing and treating cancer. The trial with five melanoma patients at Memorial Sloan-Kettering Cancer Center (MSKCC) in New York City will test if the technology is safe and…
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Orphan Drug Status Granted for Melanoma Vaccine
BioSante Pharmaceuticals Inc. said today it received from the U.S. Food and Drug Administration orphan drug designation for its melanoma cancer vaccine to treat stage IIb to IV melanoma. BioSante Pharmaceuticals is a specialty pharmaceutical company in Lincolnshire, Illinois. Orphan drug designation, as granted by the Orphan Drug Act, is for a product to treat…
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FDA Plans Update of Medical Device Review Process
The U.S. Food and Drug Administration (FDA) has released a plan with 25 actions it intends to implement in 2011, which it says will improve the path to market for many medical devices. The new procedures affect the “510(k) process,” named for the section of FDA’s enabling legislation that applies to medical device approval. Before…
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Study: Longer Drug Exclusivity Hikes Costs, Adds Approvals
A new study in the January 2011 issue of the journal Health Affairs (paid subscription required) calculates the financial and social costs of regulations that limit access to pharmaceutical companies’ clinical trial data, used in the manufacture of generic drugs. The study suggests that extending the term of exclusive access for that data would likely…
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FDA Clears Stem Cell Trial for Macular Degeneration
Advanced Cell Technology Inc. (ACT), a biotechnology company in Marlborough, Massachusetts, said today that the U.S. Food and Drug Administration (FDA) has cleared its application to test-treat dry age-related macular degeneration using human embryonic stem cells. Dry age-related macular degeneration (AMD) is the leading cause of vision loss and blindness among Americans who are age…
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FDA Approval Sought for Heart Failure Device
HeartWare International Inc., in Sydney, Australia says today it submitted a Pre-Market Approval application to the U.S. Food and Drug Administration (FDA) for its HeartWare Ventricular Assist System. The system acts as a bridge to heart transplantation for patients with end-stage heart failure. Premarket approval by FDA is the required process of scientific review to…
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Pharma R&D Q3 Output Keeps Pace, But Revenue Slides
The financial research company Fitch Ratings said in a report issued today that the global pharmaceutical companies followed by the company maintained a modest, but steady pace of new product approvals and regulatory filings to U.S., European, and Japanese regulators in the third quarter of 2010. The report, “Global Pharmaceutical R&D Pipeline: Third-Quarter 2010” (subscription…