Salzburg-Eintracht, postponed due to storm threat

first_imgThe meeting between Salzburg Austrian and the German Frankfurt Eintracht, corresponding to the return of the round of 16 of the Europa League, has been postponed due to threat storm, UEFA reports in a statement.It states that the Austrian public authorities have recommended this decision in view of the expected weather situation for the time of the match, set at 21.00 CET.UEFA notes that it will soon communicate the date and time in which will be played the game.Frankfurt Eintracht won in the first leg 4-1.last_img read more

AntiAbortion Protestors Move In on Clinics after SCOTUS Buffer Zones Decision

first_imgShareTweetShareEmail0 SharesJune 28, 2014; Boston GlobeOn Thursday, in McCullen v. Coakley, the Supreme Court unanimously struck down a Massachusetts law that provided for a 35-foot “buffer zone” around clinics providing abortions. The Saturday after, protestors showed up in greater numbers in Boston and Worcester, pushing beyond that previously established line.The “buffer zone” was established to keep protestors at a distance from women seeking to enter clinics.In Boston, where the Saturday protests at a Boston Planned parenthood clinic were expected, protestors pushed past the 35-foot lines to yell at women entering. “Please don’t kill your baby! You can celebrate a birthday next year!” They waved signs, some depicting infants in their mothers’ arms and a bloody baby in hands marked by stigmata.The decision only applies to Massachusetts at this point, but it could set a precedent for similar actions in other states where there are smaller buffer zones in place. For instance, San Francisco’s law is virtually identical but with a 25-foot zone—recently raised from eight feet, which city officials saw as inadequate.Massachusetts Attorney General Martha Coakley said that she, Gov. Deval Patrick, Boston Mayor Marty Walsh, and state lawmakers were working to establish a plan that would protect women’s access to the five affected clinics and that officials would seek court injunctions against any protestor that threatened a woman’s safety. Meanwhile, the clinics are beefing up on their number of escorts to accompany women through the gauntlet of protestors. They had been using them on Saturdays but now will make them available on other days as well.—Ruth McCambridgeShareTweetShareEmail0 Shareslast_img read more

FDA approves first oral medication for treatment of adults with Fabry disease

first_imgAug 10 2018The U.S. Food and Drug Administration today approved Galafold (migalastat), the first oral medication for the treatment of adults with Fabry disease. The drug is indicated for adults with Fabry disease who have a genetic mutation determined to be responsive (“amenable”) to treatment with Galafold based on laboratory data. Fabry disease is a rare and serious genetic disease that results from buildup of a type of fat called globotriaosylceramide (GL-3) in blood vessels, the kidneys, the heart, the nerves and other organs.”Thus far, treatment of Fabry disease has involved replacing the missing enzyme that causes the particular type of fat buildup in this disease. Galafold differs from enzyme replacement in that it increases the activity of the body’s deficient enzyme,” said Julie Beitz, M.D., director of the Office of Drug Evaluation III in FDA’s Center for Drug Evaluation and Research.Fabry disease is an inherited disorder caused by mutations (alterations) in the alpha-galactosidase A (GLA) gene located on the X-chromosome. Fabry disease is rare and affects both males and females. It is estimated that classic Fabry disease (the most severe type) affects approximately one in 40,000 males. The later-onset type is more frequent, and in some populations, may occur in one in 1,500 to 4,000 males. Patients with Fabry disease develop slowly progressive kidney disease, cardiac hypertrophy (enlargement of the heart), arrhythmias (abnormal heart rhythm), stroke and early death.The efficacy of Galafold was demonstrated in a six-month, placebo-controlled clinical trial in 45 adults with Fabry disease. In this trial, patients treated with Galafold over six months had a greater reduction in globotriaosylceramide (GL-3) in blood vessels of the kidneys (as measured in kidney biopsy samples) as compared to patients on placebo.The safety of Galafold was studied in four clinical trials which included a total of 139 patients with Fabry disease.Related StoriesDoes genetic testing affect psychosocial health?Genetic contribution to distractibility helps explain procrastinationLiving a healthy lifestyle may help offset genetic risk of dementiaThe most common adverse drug reactions in patients taking Galafold in clinical trials were headache, nasal and throat irritation (nasopharyngitis), urinary tract infection, nausea, and fever (pyrexia).Galafold was approved using the Accelerated Approval pathway, under which the FDA may approve drugs for serious conditions where there is an unmet medical need and where a drug is shown to have certain effects that are reasonably likely to predict a clinical benefit to patients. A further study is required to verify and describe the clinical benefits of Galafold, and the sponsor will be conducting a confirmatory clinical trial of Galafold in adults with Fabry disease.Galafold was granted Priority Review designation, under which the FDA’s goal is to take action on an application within six months of application filing where the agency determines that the drug, if approved, would provide a significant improvement in treating, diagnosing or preventing a serious condition over available therapies. Galafold also received Orphan Drug designation, which provides incentives to assist and encourage the development of drugs for rare diseases.The FDA granted approval of Galafold to Amicus Therapeutics U.S., Inc.Source: https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm616598.htmlast_img read more