Category: Regulations
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Early Trial Results Show Venous Leg Ulcer Drug Efficacy
The biotechnology company Pergamum AB in Solna, Sweden reports an early-stage clinical trial shows its drug to treat venous leg ulcers improved healing among patients taking the drug compared to a placebo. The trial also showed the drug, code-named LL-37, was well-tolerated at lower doses. Venous leg ulcers are shallow wounds appearing on the skin…
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FDA Giving Roche Leukemia Antibody Priority Review
An engineered antibody to treat chronic lymphocytic leukemia developed by the pharmaceutical company Roche is receiving priority review from the U.S. Food and Drug Administration, which sets a goal of six months to complete its evaluation. The therapy is obinutuzumab, code-named GA101, which in May, FDA designated as a “breakthrough” that expedites the review process…
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Arthritis Drug Shown to Reduce Glucose in Type 2 Diabetes
Researchers at Joslin Diabetes Center, affiliated with Harvard Medical School in Boston, found the arthritis drug salsalate helps lower blood glucose levels and improves control of blood sugar among people with type 2 diabetes. Results of the clinical trial, which included researchers from several other universities and hospitals, appear in today’s issue of the journal…
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FDA Approves Protein to Prevent Hemophilia B Bleeding
The U.S. Food and Drug Administration approved an engineered form of a human protein to prevent and control bleeding episodes in people with hemophilia B, age 16 or older. The protein known as Coagulation Factor IX (Recombinant) is marketed under the brand name Rixubis by Baxter Healthcare in Deerfield, Illinois. Hemophilia B, also known as factor…
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Supreme Court Rules Federal Drug Rules Preempt State Laws
The U.S. Supreme Court yesterday ruled 5-4 that in cases involving generic drugs, federal laws take precedence over an individual’s right to sue in state courts. The case, Mutual Pharmaceutical Co., v. Bartlett, overturned lower-court rulings in favor of the plaintiff, who sued the generic drug manufacturer Mutual Pharmaceutical — now part of Sun Pharmaceutical Industries…
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Intensive Care Units in U.K. Cut Blood Infection Rates
Intensive care units at hospitals in England sharply cut their rates of serious blood stream infections over a two-year period, according to researchers at University of Leicester and University of Birmingham in the U.K. The latest results were reported last week in the journal Implementation Science, following up on an evaluation of an infection-reduction program…
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Late-Stage Trial to Test Biosimilar Psoriasis Treatment
The Sandoz division of the global pharmaceutical company Novartis started a late stage clinical trial of a treatment for psoriasis biologically similar to the therapy etanercept, marketed by Amgen and Pfizer as Enbrel. The trial is expected to support the company’s application for regulatory approval in the U.S. and Europe. Biosimilars is the name given…
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FDA Grants Breakthrough Status to Heart Failure Drug
The pharmaceutical company Novartis, based in Switzerland, says the U.S. Food and Drug Administration designated its drug candidate RLX030 (serelaxin) a breakthrough therapy for the treatment of acute heart failure. Serelaxin is an engineered form of the natural hormone human relaxin-2 proposed for use in emergency rooms. FDA assigns breakthrough status to expedite drugs in…
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Study: Walking and Talking with Mobile Phone Don’t Mix
Urban planning researchers at Ohio State University in Columbus found more than 1,500 pedestrians using mobile phones were treated in emergency rooms in 2010, with the number of inuries rising sharply since 2004. Jack Nasar, a professor in Ohio State’s architecture school, and former graduate student Derek Troyer published their findings in the August 2013…
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FDA Clears Sanofi Four-Strain Flu Vaccine for Adults, Kids
Sanofi Pasteur, the vaccine division of the global pharmaceutical company Sanofi, says the Food and Drug Administration cleared for sale in the U.S. its Fluzone Quadrivalent vaccine that covers four influenza strains. The FDA action, says the company, will make the vaccine available for infants, adolescents, and adults. The Centers for Disease Control and Prevention…