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Affordable Care Act Program to Provide Temporary Coverage for Americans Without Insurance Due to Pre-Existing Conditions Now Through 2014 When the New Insurance Exchanges Are Established
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These regulations are important for people with disabilities.
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MIAMI, FL – August 24, 2010. The Alpha-1 Association commends Baxter International Inc. and Kamada Ltd. on their recent announcement of an agreement for Baxter’s exclusive right to distribute and ultimately manufacture Kamada’s intravenous liquid AAT product, GlassiaTM to the United States, Canada, Australia and New Zealand.
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Average Medicare Part D (prescription drug) plan likely to cost just $1 more in 2011, CMS estimates
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AFFORDABLE CARE ACT SAVING MONEY FOR MEDICARE AND TAXPAYERS
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The AARC held a successful Virtual Lobby Day on August 5.
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The FY2011 appropriations bills have been moving through House and Senate subcommittees and full appropriations committee's over the past few weeks.
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HHS Announces Availability of $51 Million in Resources for States to Build New Competitive Health Insurance Marketplace
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Leading National Patient Advocacy Organization Applauds New Regulations to Make Insurance Claims Appeal Process More Uniform & Patient Focused
The National Health Council (NHC) released the following statement in support of today’s White House announcement of new federal regulations to strengthen patients’ rights to appeal health insurance denials.
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The COPD Foundation has released a new guide on how the changes to the way Medicare pays for home oxygen will impact patients.
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The Cochrane study was poorly designed, ignores wealth of data,and does disservice to rare disease patients
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Kamada wins FDA approval for GlassiaTM - a new liquid, ready- to-use treatment for Alpha-1 Antitrypsin Deficiency
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New government plan offers medical coverage for uninsured Americans with pre-existing health conditions.
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On April 15, 2010, the President issued a Presidential memorandum to HHS calling for the initiation of rulemaking that would ensure that hospitals that participate in Medicare or Medicaid respect the rights of patients to designate visitors, regardless of whether the visitors are legally related to the patients.
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The Senate reached agreement last week on a temporary fix to the Medicare physician payment cut and successfully passed the bill.
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More Medicare beneficiaries will qualify for “Extra Help” with their prescription drug costs.
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The following link provides access to current documents relating to The Patient Protection and Affordable Care Act and the Health Care and Education Reconciliation Act.
http://dpc.senate.gov/dpcdoc-sen_health_care_bill.cfm
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According to the Wall Street Journal on Sunday, Europe’s largest blood-plasma products maker Grifols SA is said to be in talks to acquire Talecris Biotherapeutics Holdings Corp.
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In recent months, legislators have been traveling to Washington to voice concerns and get clarification about state responsibilities.
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US Food and Drug Administration (FDA) has awarded the commercial name "Glassia" for the company's intravenous AAT (Alpha-1 Antitrypsin) drug for congenital respiratory diseases.
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Talecris Biotherapeutics is in the final stages of planning studies with their intravenous, plasma-derived alpha-1 proteinase inhibitor and have decided not to pursue studies evaluating inhaled, plasma-derived alpha-1 antitrypsin.
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The U.S. Food and Drug Administration (FDA) announced that seven metered-dose inhalers (MDI) used to treat asthma and chronic obstructive pulmonary disease (COPD) will be gradually removed from the U.S. marketplace.
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On April 5, 2010, the Centers for Medicare & Medicaid Services (CMS) issued a notice to Aetna Insurance Company
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The White House’s top health care expert will answer your questions in a live webchat as part of their weekly series on health reform.
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The Third Annual George Washington Bridge Walk is Saturday, May 8th.
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On Sunday, March 21, 2010, the House of Representatives approved historic health care reform legislation.
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Kamada, a bio-pharmaceutical company engaged in the development, manufacturing and marketing of specialty life-saving therapeutics, announced that it has enrolled the first patient into its pivotal clinical trial with its new compound of inhaled alpha-1 antitrypsin (AAT) delivered by an Investigational eFlow Nebulizer System (PARI Pharma GmbH), in patients with alpha-1 antitrypsin deficiency.
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Omni Bio Pharmaceutical, Inc. ("Omni Bio") (OTCBB: OMBP) today announced that its acting Chief Executive Officer, Dr. Charles A. Dinarello, will moderate a panel at the 8th World Congress on Trauma, Shock, Inflammation and Sepsis ("TSIS") (www.tsis2010.org) in Munich, Germany on Friday, March 12, 2010.
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More than 100 members of the AARC’s Political Advocacy Contact Team (PACT) converged on Washington, DC, March 8, 9, and 10 for the Association’s 11th annual Capitol Hill lobbying event. Representing 44 states and the District of Columbia, they worked tirelessly over the three-day session to bring a cohesive message to their members of Congress during nearly 300 scheduled appointments on The Hill.
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Canadian regulators have granted approval to Talecris Pharmaceuticals to sell a new version of its protein therapy Prolastin, the Research Triangle Park-based company announced Wednesday.
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Talecris Biotherapeutics, Inc. (Nasdaq: TLCR) announced today that it was granted orphan drug designation by the U.S. Food and Drug Administration (FDA) for the development of an aerosol formulation of Alpha1-Proteinase Inhibitor (Human, A1PI) to treat congenital alpha1-antitrypsin (AAT) deficiency
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The National Organization for Rare Disorders and 33 other patient advocacy groups are warning that the Senate health care reform bill would not eliminate annual and lifetime insurance caps for many Americans, contrary to common belief.
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Approximately 1.5 million Medicare beneficiaries suffer from chronic obstructive pulmonary disease or
other serious respiratory illnesses that require long-term use of home oxygen.
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After obtaining marketing approval from Brazil's National Health Surveillance Agency (Anvisa) for its intravenous Alpha-1 Antitrypsin (AAT) protein for the treatment of congenital emphysema, Kamada Ltd. (TASE: KMDA) today announced that it has obtained export orders for AAT for the treatment of congenital emphysema and cystic fibrosis for patients lacking the AAT protein, type D emphysema, and to vaccinate against fetal hemolytic disease, a fatal blood disease.
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NORD and 60 other patient advocacy groups, including many of NORD's Member Organizations, have sent a letter to Senate Majority Leader Harry Reid (D-NV) and House Speaker Nancy Pelosi (D-CA) urging adoption of the strongest possible patient protections in the final health reform legislation.
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The Federal Aviation Administration (FAA) announced today that passengers needing medical oxygen now have the option of using four additional portable oxygen concentrators while traveling, bringing the total number of approved units to 11.
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Researchers from Boston University School of Medicine (BUSM) have developed a technique to deliver therapeutic genes in vivo to mice with emphysema.
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Please contact your senators today to ensure that the ELIMINATION OF LIFETIME CAPS is included in the current legislation for the Health Care Reform Bill. Inadequate lifetime limits pose considerable challenges to people with high-cost chronic diseases and disorders such as Alpha-1.
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Individuals throughout the US affected by Alpha-1 Antitrypsin Deficiency (Alpha-1), are sharing their stories and creating awareness of this serious genetic disorder that is widely under-diagnosed and affects an estimated 100,000 Americans.
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New, concentrated version of PROLASTIN® delivers the same amount of active protein in half the infusion volume
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Drug developer Kamada Ltd. (TASE: KMDA) today announced that it is beginning the Phase II/III clinical trial in Europe of inhalable alpha-1 antitrypsin (AAT) for the treatment hereditary emphysema. The trial will begin at sites in the Netherlands during the fourth quarter of 2009.
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The National Institutes of Health announced today a second phase of the
Rare Diseases Clinical Research Network (RDCRN) including funds for 19
research consortia.
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Individuals’ genetic information will have greater protections through new regulations issued today by the U.S. Departments of Health and Human Services (HHS), Labor, and the Treasury.
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Talecris Biotherapeutics Holdings Corp.
(“Talecris” or the “Company”) today announced the pricing of its initial public offering of 50,000,000 shares
of its common stock at a price of $19.00 per share.
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Four members of the United States Senate introduced legislation today to allow patients with rare diseases to participate in clinical drug studies without losing their eligibility for public healthcare coverage, echoing a move by the House of Representatives last month.
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After months of contentious provider-vs.-provider wrangling on the components of a Medicare oxygen reform plan, on Wednesday, Rep. Mike Ross, D-Ark., presented his oxygen proposal to the House Energy and Commerce Committee as an amendment to H.R. 3200, the House health care reform bill. But now there's another hitch.
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Talecris Biotherapeutics Holdings Corp. (Nasdaq: TLCR) has filed an amended registration statement with the SEC for an initial public offering of its common stock. The Company is offering 15,789,474 shares and expects the offering price to be between $18-$20 per share. The Company plans to list on the NASDAQ under the symbol "TLCR".
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NESS ZIONA, Israel--(Business Wire)--
Kamada, a bio-pharmaceutical company engaged in the development, manufacturing
and marketing of specialty life-saving therapeutics, announced that data on its
next-generation alpha-1 antitrypsin (Inhaled-AAT) in cystic fibrosis patients
was presented today, at the Annual Congress of the European Respiratory Society
(ERS) 2009, Vienna. As previously reported, the study showed that inhaled-AAT
was safe and biologically effective.
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GAINESVILLE, Fla. — University of Florida researchers have safely given new, functional genes to patients with a hereditary defect that can lead to fatal lung and liver diseases, according to clinical trial findings slated to appear this week in the online early edition of the Proceedings of the National Academy of Sciences.
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This week, President Obama announced his nominee to be the new Director of NIH, Francis Collins, M.D., Ph.D. Dr. Collins, a geneticist, was Director of the National Human Genome Research Institute from 1993 to 2008. He is credited with leading the institute's Human Genome Project, which successfully mapped and sequenced human DNA, culminating with the publishing of the finished human DNA sequence in 2003. Dr. Collins is also known for discovering the genes of numerous diseases, including cystic fibrosis.
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RESEARCH TRIANGLE PARK, N.C. (May 28, 2009) — Talecris Biotherapeutics presented results last week from two phase III studies assessing the safety, tolerability and pharmacokinetic comparability of a more concentrated formulation of Prolastin® (Alpha1-Proteinase Inhibitor [Human]) produced via a modification of the current manufacturing process that incorporates technological changes.
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RESEARCH TRIANGLE PARK, N.C. (May 28, 2009) — Talecris Biotherapeutics, Inc. yesterday was informed that the U.S. Federal Trade Commission (FTC) would file an administrative complaint challenging CSL’s proposed acquisition of Talecris and a complaint in U.S. Federal District Court to enjoin the transaction.
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--Initial delivery anticipated to begin in September, pending regulatory approval--
King of Prussia, PA, May 29, 2009—CSL Biotherapies, Inc. announced today that it has signed a contract with the U.S. Department of Health and Human Services (HHS) to provide Novel A (H1N1) influenza vaccine antigen in bulk form to support HHS’
pandemic influenza preparedness efforts. The initial order under contract will be for an
amount of at least $180 million. CSL Biotherapies anticipates initial delivery of the antigen by September, subject to regulatory approval. The new vaccine antigen will be tested in clinical trials funded by HHS.
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Melbourne, Australia - October 13, 2008 - CSL Limited today announced that it has received a request for additional information, commonly referred to as a Second Request, from the U.S. Federal Trade Commission ("FTC") regarding its proposed acquisition of Talecris Biotherapeutics, which was announced on August 13, 2008. CSL intends to responds expeditiously to the Second Request.
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The Centers for Medicare & Medicaid Services (CMS) today launched Ask Medicare, a new initiative to help family caregivers -those who are family members or friends who help people with Medicare -- access and use valuable healthcare information, services and resources.
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Alpha-1 Foundation, Association Celebrate GINA signing; Plans
Under Way to Discuss Implications, Opportunities for Alpha-1 Detection
MIAMI The Alpha-1 Foundation and Alpha-1 Association today applauded President Bushs signing into law the Genetic Information Nondiscrimination Act (GINA), and began making plans to take action based on the new federal legal protections.
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