The Food and Drug Administration approved 41 first-of-a-kind drugs in 2014, including a record number of medicines for rare diseases, pushing the agency's annual tally of drug approvals to its highest level in 18 years.
Jan 2, 2015
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(AP) -- The pharmaceutical industry won approval to market a record number of new drugs for rare diseases last year, as a combination of scientific innovation and business opportunity spurred new treatments for diseases ...
Jan 25, 2012
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The Food and Drug Administration has failed to ensure that drugs given prized rare-disease status meet the intent of a 35-year-old law, federal officials revealed in a report Friday.
Dec 1, 2018
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Only about one in every 170 children take them. But 'orphan drugs' accounted for 1 in every 15 private insurance dollars spent on children's health care in the United States in 2018, according to a new study. That's up 65% ...
Oct 6, 2020
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(Medical Xpress)—Though pharmaceutical companies that are developing "orphan drugs" do so mainly for the business potential, the companies also consider the effort as part of their corporate social responsibility, management ...
Apr 1, 2013
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The U.S. Food and Drug Administration (FDA) reviews and approves new medicines in a shorter timeframe than its peer agency in Europe, the European Medicines Agency (EMA), says a Yale researcher. This finding, which comes ...
Apr 5, 2017
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Health experts at Johns Hopkins Medicine are calling on lawmakers and regulators to close loopholes in the Orphan Drug Act they claim give drug companies millions of dollars in unintended and misplaced subsidies and tax breaks ...
Nov 19, 2015
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Rising concerns about spending on prescription drugs that treat rare diseases are not justified, according to a new analysis in the journal Health Affairs.
Sep 9, 2016
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In developing an orphan drug policy, Canada must ensure that all orphan drugs for rare diseases—both old and future drugs—should be priced fairly so that Canadians may access life-saving therapy, argue authors of an analysis ...
Feb 23, 2015
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"It was the best of times, it was the worst of times" is a familiar quote from the opening of Charles Dickens' "A Tale of Two Cities," but the phrase is also applicable to the specialty drug market in the United States today.
Jul 6, 2017
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