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.

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

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.

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.

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.

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.

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.

Researchers from Boston University School of Medicine (BUSM) have developed a technique to deliver therapeutic genes in vivo to mice with emphysema.

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.

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.

New, concentrated version of PROLASTIN® delivers the same amount of active protein in half the infusion volume

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.

The National Institutes of Health announced today a second phase of the Rare Diseases Clinical Research Network (RDCRN) including funds for 19 research consortia.

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.

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.

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.

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.

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".

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.

Injectable AAT has already passed its Phase III clinical trial, and the agreement will come into effect when the FDA gives the drug marketing clearance

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.

Kamada (TASE:KMDA), a bio-pharmaceutical company engaged in the development, manufacturing and marketing of specialty life-saving therapeutics, announced today that the United States Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA) for intravenous alpha-1 antitrypsin (IV-AAT), the Company’s flagship product for the treatment of alpha-1 antitrypsin deficiency.

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.

HHS Secretary Kathleen Sebelius congratulated the National Conference of State Legislatures (NCSL) after the conference approved an amendment in favor of health insurance reform. The amendment was approved by a vote of 38-11. According to NCSL rules, amendments must receive 75 percent of the vote in order to pass.

The Plasma Protein Therapeutics Association (PPTA) strongly supports S.1213, the Patient-Centered Outcomes Research Act of 2009, a bill that would establish a nonprofit corporation called the Patient-Centered Outcomes Research Institute to contract with appropriate Federal agencies or the private sector to conduct comparative effectiveness research (CER).

News reports claiming that pop singer Michael Jackson has severe lung disease due to Alpha-1 Antitrypsin Deficiency have led to media interviews with prominent physicians, describing and clarifying Alpha-1.

Kamada, a bio-pharmaceutical company engaged in the development, manufacturing and marketing of specialty life-saving therapeutics, announced that it has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for its lead clinical candidate, intravenous alpha-1 antitrypsin (AAT-IV), for the treatment of Alpha-1 Antitrypsin Deficiency.

CSL Limited (ASX: CSL) and Talecris Biotherapeutics, Inc. announced today that they have mutually agreed to terminate their merger agreement, announced on August 12, 2008, under which CSL agreed to acquire Talecris for US$3.1 billion in cash.

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.

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.

--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.

CSL Limited (ASX: CSL) today was informed that the US Federal Trade Commission (“FTC”) will file a complaint in the US Federal District Court to challenge CSL’s proposed acquisition of Talecris Biotherapeutics.

CSL Ltd., a plasma-products maker, said the U.S. Federal Trade Commission is likely to block its US$3.1 billion takeover of U.S. rival Talecris Biotherapeutics Inc.

The Federal Trade Commission has authorized a lawsuit to block CSL Limited’s proposed $3.1 billion acquisition of Talecris Biotherapeutics Holdings Corporation, charging that the deal would be illegal and would substantially reduce competition in the U.S. markets for four plasma-derivative protein therapies – Immune globulin (Ig), Albumin, Rho-D, and Alpha-1. These therapies are used to treat patients suffering from illnesses such as primary immunodeficiency diseases, chronic inflammatory demyelinating polyneuropathy, alpha-1 antitrypsin disease, and hemolytic disease of the newborn.

(Boston) � Researchers from Boston University School of Medicine (BUSM) have, for the first time, identified a gene variant on chromosome 4 that may be a potential risk factor for chronic obstructive pulmonary disease (COPD). These findings will be published in PLoS Genetics on March 20th.

ST. PAUL, MN, March 18, 2009 � Today individuals with primary immunodeficiency diseases and Alpha-1 Antitrypsin Deficiency (genetic COPD) will testify at a hearing of the Senate Committee on Health, Housing and Family Security to press for the passage of legislation that will ensure them access to their life-saving therapies.

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.

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.

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 Bush�s signing into law the Genetic Information Nondiscrimination Act (GINA), and began making plans to take action based on the new federal legal protections.