Category: Regulations
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Trial Shows Weight Loss Drug Can Help Stop Smoking
3 November 2014. First results from an intermediate-stage clinical trial shows lorcaserin HCl, a drug approved to help people lose weight, also helps regular smokers stop smoking. The findings were reported today by Eisai Inc. and Arena Pharmaceuticals Inc., who offer lorcaserin HCl under the brand name Belviq. The companies say more results will be reported at…
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Drug/Device Therapy Trial Shows Fast Migraine Relief
30 October 2014. A late-stage clinical trial shows a medical device designed to deliver migraine drugs deep into nasal cavities achieved headache relief in as little as 30 minutes among patients, and sustained that relief for as long as 48 hours compared to a placebo. The biopharmaceutical company Avanir Pharmaceuticals Inc. in Aliso Viejo, California…
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Costs to Support Stroke Survivors Stay High for 10 Years
24 October 2014. Researchers at Monash University in Australia calculated long-term costs to stroke patients, finding the financial burden on patients and their care givers remains significant for 10 years following the stroke episode. The team led by Monash medical school professor Dominique Cadilhac reported its findings in yesterday’s issue of the journal Stroke (paid…
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FDA Exemption Sought for Ebola Blood Plasma Device
20 October 2014. Cerus Corp., a developer of blood safety devices, is asking the U.S. Food and Drug Administration to allow its system for removing pathogens from blood plasma be used to treat patients in the U.S. with Ebola, while the device is under review. The provision, called a Compassionate Use Investigational Device Exemption, allows…
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Personalized Leukemia Immunotherapy Gets 90 Pct Remission
16 October 2014. Nine in 10 children and adults in early-stage clinical trials of a personalized therapy harnessing the patients’ immune systems achieved full remission of their acute lymphoblastic leukemia. The findings of the team from University of Pennsylvania and Children’s Hospital of Philadelphia are reported today in New England Journal of Medicine (paid subscription…
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Hepatitis C Combination Drug Approved by FDA
Updated 11 October 2014. The U.S. Food and Drug Administration approved a drug combining a new compound, ledipasvir, with the existing drug sofosbuvir to treat hepatitis C genotype 1, the most common form of the disease. The combination of ledipasvir and sofosbuvir is developed and marketed under the brand name Harvoni by Gilead Sciences Inc.…
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Nerve-Blocking Treatment for Diabetes Approved in Europe
29 September 2014. EnteroMedics Inc., a medical device developer in St. Paul, Minnesota, says marketing approval in Europe for its vagus nerve blocking device for obesity is extended to cover type 2 diabetes. A CE Mark, which signifies approval to market regulated products such as medical devices in the European Union and associated countries, is…
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Lower Drug Dose Reduces Cataract Surgery Inflammation, Pain
26 September 2014. A clinical trial of more than 500 patients shows a lower-dose formulation of a current medication reduces eye pain and inflammation among more post-surgical cataract patients than a placebo. Bausch and Lomb, a subsidiary of Valeant Pharmaceuticals in Laval, Quebec, Canada, reported today results of the late-stage clinical trial. The trial tested…
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Safety Trial Underway for Addiction Drug Candidate
23 September 2014. A clinical trial is underway testing the safety of a new therapy designed to treat addictions and compulsive behavior by Savant HWP, a drug development company in San Carlos, California. The study is testing the compound 18-methoxycoronaridine or 18-MC, conducted in South America by a Brazilian partner company identified as Hebron Farmaceutica…
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U.S., Canada Authorities OK Biotech Ebola Treatments
23 September 2014. Tekmira Pharmaceuticals Corp. says the U.S. Food and Drug Administration approved the company providing its experimental therapy for people with suspected or confirmed Ebola infections. The Vancouver, British Columbia biotechnology company says approval of its therapy called TKM-Ebola is part of a larger regulatory framework for the treatments worked out with FDA and…