Tag: FDA
-
Patent Issued for Technology to Suppress Stem Cell Rejection
Athersys Inc., a biotechnology company in Cleveland, Ohio, has received a patent for its process to reduce or suppress graft-versus-host disease associated with bone-marrow stem cell transplants used to treat leukemia and related disorders. Patent 8,147,824 was issued yesterday by the U.S. Patent and Trademark Office and assigned to Athersys, as well as the Oregon…
-
Biotech Secures $25 Million in Series B Financing
AlloCure Inc., a privately-held biotechnology company in Burlington, Massachusetts, says it has closed a $25 million deal for series B venture financing. The series B round — the second financing installment after initial start-up — includes new syndicate member Lundbeckfond Ventures, as well as previous investors SV Life Sciences and Novo A/S. The company is…
-
Trial Highlights Metastatic Breast Cancer Drug Effectiveness
First results from a clinical trial of the drug trastuzumab emtansine (T-DM1) made by Genentech, a division of the global pharmaceutical company Roche, show the drug extended the lives of metastatic breast cancer patients without the disease getting worse. The study enrolled people with HER2-positive metastatic breast cancer who had previously received treatment with the…
-
Trial of ALS Stem Cell Treatment Reports First Results
Researchers from the biotechnology company Neuralstem in Rockville, Maryland and three universities report that an early clinical trial of transplanted spinal cord stem cells to treat amyotrophic lateral sclerosis (ALS or Lou Gehrig’s disease) shows the 12 patients were able to tolerate the treatment without long-term complications. The team reports its findings online in the…
-
FDA Approves Implanted Reflux Disease Treatment Device
The U.S. Food and Drug Administration approved the Linx Reflux Management System, a surgical implant device for people diagnosed with gastroesophageal reflux disease (GERD). The Linx system is made by Torax Medical Inc. in St. Paul, Minnesota. GERD is a condition where the stomach contents leak backwards from the stomach into the esophagus, irritating or…
-
Agilent to Develop Salmonella, Fish Species Tests for FDA
Agilent Technologies Inc. in Santa Clara, California, a developer of instrumentation for chemical and life science analysis, unveiled its agreement with the U.S. Food and Drug Administration to develop new tests for the agency’s regulation of food. One set of tests for FDA will identify salmonella more precisely, while a different test suite will use…
-
Algorithm Mines FDA Reports for Drug Interactions
Researchers at Stanford University’s medical school and bioengineering program have devised a computer algorithm that can query millions of adverse drug reports to the U.S. Food and Drug Administration (FDA) by patients and their physicians, and identify many more drug interactions and side effects than were previously known. Their work is described in the journal…
-
FDA Approves Cell Product for Dental Tissue Regeneration
The Food and Drug Administration has approved the product Gintuit for regenerating oral soft tissue, made by Organogenesis Inc. in Canton, Massachusetts. The product combines skin cells and connective tissue with bovine collagen and proteins to regrow soft tissue in the mouth resulting from gingival recession, or receding gums. Gingival recession occurs when the gingiva…
-
FDA Issues New Label Requirements for Statins
The Food and Drug Administration has issued new labeling regulations for statins, a class of drugs used to lower cholesterol levels. When taken in combination with changes in diet and exercise, statins can can reduce levels of low-density lipoprotein (LDL or “bad”) cholesterol in the blood. LDL cholesterol circulating in the blood can deposit on…
-
FDA Approves Drug for Glaucoma, Ocular Hypertension
The pharmaceutical company Merck in Whitehouse Station, New Jersey says the Food and Drug Administration has approved its drug Zioptan to reduce elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension. Zioptan is the brand name for Merck’s tafluprost ophthalmic solution to reduce pressure inside the eye. Glaucoma is the second most common…