Tag: FDA
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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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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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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…
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St. Jude Medical Invests in Pain Therapy Device Developer
Medical device manufacturer St. Jude Medical in St. Paul, Minnesota is investing $40 million in pain therapy systems developer Spinal Modulation Inc. in Menlo Park, California. The equity investment deal, says St. Jude Medical, includes an option for the outright purchase of the privately-owned Spinal Modulation. Under the agreement, St. Jude Medical becomes the exclusive…
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FDA Approves Robotic Device for Stroke Rehabilitation
Oregon Health and Science University in Portland reports that the Food and Drug Administration approved for marketing in the U.S. a robotics device that helps stroke patients move limbs and improve muscle function during their rehabilitation. The device was developed by Paul Cordo, a biomedical engineering professor at Oregon Health and AMES Technology, a spin-off…
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New Hepatitis C Treatment Given FDA Breakthrough Status
A new anti-viral combination treatment for hepatitis C developed by the biopharmaceutical company AbbVie received a breakthrough therapy designation by the U.S. Food and Drug Administration. AbbVie, in North Chicago, Illinois was spun-off from Abbott Laboratories as a separate company on 1 January 2013. Hepatitis C is an infection that attacks the liver and usually…
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FDA Designates Orphan Drug for Rare Pain Condition
The U.S. Food and Drug Administration designated as an orphan drug the compound XEN402 to treat erythromelalgia, a rare disease that causes a burning pain in the feet and hands. XEN402 is being developed Xenon Pharmaceuticals in Burnaby, British Columbia, Canada. Erythromelalgia is a disorder that affects the skin of the feet or hands or…
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FDA OKs Trial of Biopolymer to Treat Spinal Cord Injury
InVivo Therapeutics, a medical device developer in Cambridge, Massachusetts, says it received approval from the U.S. Food and Drug Administration to begin a clinical trial to test the company’s bio-based polymer scaffolding as a treatment for acute traumatic spinal cord injury. The agency’s approval came in the form of an Investigational Device Exemption that allows…