Category: Regulations
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FDA Grants Experimental Leukemia Drug Orphan Status
16 June 2014. Agios Pharmaceuticals Inc. in Cambridge, Massachusetts says the U.S. Food and Drug Administration designated its therapy for acute myelogenous leukemia an orphan drug, qualifying it for tax incentives and other benefits. The orphan drug status comes at the same time of new findings reported from an early clinical trial of the drug,…
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Trial Shows Single-Dose Antibiotic Effective with MRSA
5 June 2014. Researchers at Duke University in Durham, North Carolina and the Medicines Company in Parsippany, New Jersey show in a late-stage clinical trial that a single dose of the antibiotic oritavancin works as well in treating acute bacterial skin infections, including those from methicillin-resistant Staphylococcus aureus (MRSA) bacteria, as the current standard of care…
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Remote Heart Failure Monitoring Device Approved by FDA
29 May 2014. The U.S. Food and Drug Administration yesterday approved an implanted device that measures pulmonary artery pressure and heart rate of patients with moderate heart failure who were hospitalized in the previous year. The device, the CardioMEMS HF System, is made by CardioMEMS Inc. in Atlanta. St. Jude Medical, a medical device manufacturer…
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Five Pharma Companies to Share Clinical Researcher Data
27 May 2014. Five pharmaceutical companies are joining together to share their files on researchers conducting clinical trials, to speed the administrative process of starting up new studies. The Investigator Databank is a joint project of Novartis, Janssen (a division of Johnson & Johnson), Merck, Eli Lilly and Co., and Pfizer, and administered by DrugDev,…
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Genetic Blood Transfusion Diagnostic Approved by FDA
23 May 2014. The U.S. Food and Drug Administration approved a molecular diagnostic test to help determine genetic compatibility for blood transfusions, a particular need for people requiring frequent transfusions. The PreciseType HEA Molecular BeadChip Test is made by BioArray Solutions, a subsidiary of Immucor, a developer of diagnostics for transplants and transfusions in Norcross,…
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Engineered Antibody Given FDA Breakthrough Tag for Myeloma
19 May 2014. Bristol-Myers Squibb in New York says its engineered antibody elotuzumab received a breakthrough therapy designation from the U.S. Food and Drug Administration to treat multiple myeloma, when used with two other cancer drugs. Elotuzumab is being developed by Bristol-Myers Squibb and AbbVie, in North Chicago, Illinois. Multiple myeloma is a progressive cancer…
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Trial Shows Polymer Dressing Reduces Surgical Scarring
15 May 2014. A follow-up study of patients one year after cosmetic surgery shows a polymer adhesive dressing applied after the surgery reduced the formation of scars compared to untreated areas of the incision. The researchers tested the bandage made by Neodyne Biosciences of Menlo Park, California, and reported the results online earlier this month…
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Bayer, Boehringer Ingelheim Open Clinical Trial Data
14 May 2014. Two more pharmaceutical companies, Bayer HealthCare and Boehringer Ingelheim, are making detailed data from clinical trials available to the larger scientific community. The two companies join several other pharmaceutical companies taking similar actions over the past several months. Bayer HealthCare in Leverkusen, Germany is making its trial data available through the joint industry…
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Antioxidant-Rich Diets Fail to Reduce Heart Disease, Cancer
13 May 2014. In a study of Italians age 65 and older, researchers at Johns Hopkins University in Baltimore find people with diets high in the antioxidant resveratrol — found in berries, dark chocolate, and red wine — develop cardiac problems and cancer, and live no longer than people who consume smaller amounts. A team…
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Remote Device Monitoring Linked to Higher Survival Rates
9 May 2014. A study of more than 260,000 patients with implanted heart devices shows those who took part in frequent remote monitoring by device maker St. Jude Medical, also had more than twice the survival rate of patients without remote monitoring. The findings from the study, which show a correlation and not necessarily cause-and-effect,…