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Amicus Therapeutics Commences Phase 3 Trial Evaluating Amigal(TM) For The Treatment Of Fabry Disease
Amicus Therapeutics (Nasdaq: FOLD) announced it has commenced the U.S. registration Phase 3 trial with its investigational drug, Amigal(TM) (migalastat hydrochloride) for the treatment of Fabry disease. The Company has reached agreement with the U.S. Food and Drug Administration (FDA) on the key protocol design elements of the pivotal trial, including the use of the surrogate primary endpoint of the change in the amount of kidney interstitial capillary GL-3, the substrate that accumulates in the cells of Fabry patients. In addition, the FDA is in agreement that the Company is eligible to seek Accelerated Approval for Amigal according to Subpart H regulations. The Company has begun submitting the Phase 3 protocol to investigational sites worldwide and expects to begin the dosing of subjects in the second half of this year.
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BioCryst Pharmaceuticals Reports Positive Results Of Shionogi & Co. Sponsored Phase 3 Studies Of I.v. Peramivir For Influenza
BioCryst Pharmaceuticals (Nasdaq: BCRX) announced positive results from two Phase 3 studies of intravenous (i.v.) peramivir in patients with seasonal influenza. The studies were sponsored by BioCryst"s partner Shionogi & Co., Ltd. of Osaka, Japan and conducted during the 2008-2009 influenza season. Shionogi and Green Cross Corporation, the license holder of peramivir in Korea, co-conducted the portion of the studies in Korea.
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Common Cold Virus Efficiently Delivers Corrected Gene To Cystic Fibrosis Cells
Scientists have worked for 20 years to perfect gene therapy for the treatment of cystic fibrosis, which causes the body to produce dehydrated, thicker-than-normal mucus that clogs the lungs and leads to life threatening infections.
Health Insurance

Health Care Reform Debate Renews Focus On Insurance Coverage Of Abortion Care

The issue of whether government-subsidized health care programs should include coverage for abortion procedures is gaining attention as Congress continues drafting health care reform legislation, Time reports. Currently, the Hyde Amendment -- a legislative provision attached annually to major spending bills since 1976 -- prohibits states from using federal Medicaid funds to pay for abortion. All but 17 states have similar restrictions on their own funds. Although current versions of health reform legislation do not yet address the issue of abortion, congressional s involved in the process say that an explicit ban on abortion coverage could have "much further-reaching implications" than the Hyde Amendment. According to Time, the restrictions could deny abortion coverage to women whose private insurance plans currently cover the procedure. A 2002 Guttmacher Institute survey found that nearly 90% of private insurers cover abortion procedures. Under the legislation being worked on in three House committees, U.S. residents with incomes up to 400% of the poverty level -- about $88,000 annually for a family of four, or $43,000 for an individual -- would be eligible for government subsidies to help purchase coverage. However, antiabortion-rights lawmakers are pushing to prohibit those subsidies from being used to purchase health insurance policies that include abortion coverage, Time reports. Such restrictions would mean that women who currently have abortion coverage in their private plans would have to give up the benefit. According to Time, such a provision also "would raise all sorts of other questions if insurers were allowed to discriminate among their customers based on whether or not they are using federal dollars to pay for their policies."Pelosi Negotiating With House Dems Over ConcernsLast week, 19 House Democrats sent a letter to House Speaker Nancy Pelosi (D-Calif.) stating that they "cannot support any health care reform proposal unless it explicitly excludes abortion from the scope of any government-defined or subsidized health insurance plan." They also said that abortion "must be addressed clearly in the bill text" of the legislation. The signers of the letter include Reps. Bart Stupak (Mich.) and Charlie Melancon (La.), both members of the House Energy and Commerce Committee, one of the three panels with jurisdiction over health care reform. According to Time, Pelosi"s office is attempting to address the concerns through negotiations.Poll Shows Support for Reproductive Health CoverageMeanwhile, abortion-rights advocates are "pushing back" against those seeking to specifically exclude abortion coverage in health care reform legislation, Time reports. The National Women"s Law Center on Monday released results of a nationwide poll of 1,000 likely voters showing that 71% of respondents favor including reproductive services like birth control and abortion in health care reform (Tumulty, Time, 7/8). The poll also found that 72% would oppose exclusion of abortion coverage from any national health care plan (Eaton, Plain Dealer, 7/7). In addition, 75% of respondents said that an independent commission, not Congress, should determine what medical services are included in the basic benefits offered under health reform. Congress also is weighing giving that power to HHS Secretary Kathleen Sebelius (Time, 7/8).Judy Waxman, NWLC vice president, said that 80% of employer-based insurance plans provide coverage for abortion services, adding that "people will be angry if they don"t get to keep what they already have" under any public insurance option (Cleveland Plain Dealer, 7/7). Waxman said Congress should "refrain from practicing medicine and instead let medical professionals determine what health care services will be included in a benefits package" (Time, 7/8). Reprinted with kind permission from http://www.nationalpartnership.org. You can view the entire Daily Women"s Health Policy Report, search the archives, or sign up for email delivery here. The Daily Women"s Health Policy Report is a free service of the National Partnership for Women & Families, published by The Advisory Board Company. © 2009 The Advisory Board Company. All rights reserved.


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