Von Willebrand Disease News and Research

Latest Von Willebrand Disease News and Research

CSL Behring creates Interlaken Leadership Awards to support innovative immunoglobulin research

To demonstrate its continued commitment to innovative immunoglobulin (Ig) research, CSL Behring announced today it has created the Interlaken Leadership Awards. This global awards program will provide monetary grants to advance medical research and knowledge about the potential role of immunoglobulin therapy in the treatment of neurologic disorders.

29 Oct 2010

Octapharma USA accepts applications for 25th Anniversary Grants Program

Octapharma USA is accepting applications for the Octapharma 25th Anniversary Grants Program, which supports clinical or pre-clinical research focused on human protein therapies in coagulation disorders, immune therapy, intensive care and emergency medicine. The application deadline is April 1, 2011.

15 Oct 2010

Vivaglobin therapy effective for patients with primary immunodeficiency

Vivaglobin (subcutaneous immunoglobulin [IgG]) (SCIg) is an effective and safe initial therapy for treatment-naive patients with primary immunodeficiency (PI) and may offer an attractive alternative to intravenous IgG (IVIg) therapy in the newly diagnosed, according to data presented today at the XIVth Meeting of the European Society for Immunodeficiencies.

7 Oct 2010

Privigen IVIg therapy effective for primary, secondary immunodeficiencies: Study

Privigen, the first and only 10% liquid intravenous immunoglobulin (IVIg) therapy stabilized with proline, is effective and well tolerated in patients with several primary and secondary immunodeficiencies, according to data presented today at the XIVth Meeting of the European Society for Immunodeficiencies. Results also demonstrate that Privigen offers significant protection against infection.

7 Oct 2010

Hizentra therapy effective for primary immunodeficiency patients

Hizentra (IgPro20) provides primary immunodeficiency (PI) patients with a safe and effective alternative to other immunoglobulin therapies when given in equivalent doses, according to Phase III pivotal trial data presented today at the XIVth Meeting of the European Society for Immunodeficiencies (ESID).

7 Oct 2010

Octapharma USA launches wilate replacement therapy Web site for von Willebrand Disease

Octapharma USA has launched a comprehensive Web site for wilate® at www.wilateusa.com to provide von Willebrand disease healthcare professionals and patients with easily accessible information, news and updates. The U.S. Food and Drug Administration (FDA) has granted orphan drug exclusivity for wilate® (von Willebrand Factor/Factor VIII Concentrate, Human), the first replacement therapy developed specifically for von Willebrand Disease (VWD).

5 Oct 2010

FDA approves CSL Behring's sBLA to extend shelf life of Hizentra from 18 to 24 months

CSL Behring announced today that the U.S. Food and Drug Administration (FDA) has approved a supplemental Biologics License Application (sBLA) to extend the shelf life of Hizentra®, Immune Globulin Subcutaneous (Human), 20% Liquid, from 18 months to 24 months. Hizentra, the first and only 20 percent subcutaneous immunoglobulin (SCIg) approved in the U.S. by the FDA, is also the first and only SCIg in the U.S. that may be stored at room temperature.

19 Aug 2010

FDA approves Pfizer's Prefilled Dual-Chamber Syringe for XYNTHA administration in hemophilia A patients

Pfizer Inc. announced today that the U.S. Food and Drug Administration has granted approval of the use of a Prefilled Dual-Chamber Syringe for administration of XYNTHA® Antihemophilic Factor (Recombinant) Plasma/Albumin-Free to hemophilia A patients. XYNTHA is a recombinant factor VIII product indicated for both the control and prevention of bleeding episodes in patients with hemophilia A (congenital factor VIII deficiency or classic hemophilia) and for surgical prophylaxis in patients with hemophilia A.

9 Aug 2010

Rush University Medical Center first to receive Octapharma grant under anniversary program

Octapharma USA today announced the first grant recipient of the Octapharma 25th Anniversary Grants Program is the Rush Hemophilia & Thrombophilia Center at Rush University Medical Center. The Octapharma grants program supports clinical or pre-clinical research focused on human protein therapies in hematology, immune therapy, intensive care and emergency medicine.

3 Aug 2010

Octapharma USA receives confirmation of orphan drug exclusivity from FDA for wilate

Octapharma USA has received confirmation of orphan drug exclusivity from the U.S. Food and Drug Administration for wilate (von Willebrand Factor/Factor VIII Concentrate, Human), the replacement therapy developed specifically for von Willebrand Disease. The approval comes from the FDA Office of Orphan Products Development, which helps to advance the development of products that demonstrate promise for the treatment of rare diseases.

2 Aug 2010

CSL Behring granted authorization to market Berinert for HAE in Italy and Luxembourg

CSL Behring announced today it has been granted national marketing authorization in Italy and Luxembourg to market Berinert® for the treatment of acute hereditary angioedema (HAE) attacks in any body location. This latest authorization brings the number of countries to 28 (in Europe, Asia, North America, South America and Australia) in which Berinert is now licensed.

28 May 2010

U.S. healthcare practitioners can resume use of Rotarix, says FDA

GlaxoSmithKline announced that the Food and Drug Administration has determined that U.S. healthcare practitioners can resume the use of Rotarix (Rotavirus Vaccine, Live, Oral), effective immediately. This action supersedes the FDA's recommendation from March 22, 2010 and reflects the agency's assessment that the presence of porcine circovirus type 1 in the vaccine poses no safety risk.

15 May 2010

FDA assigns Cadence Pharmaceuticals' OFIRMEV NDA new PDUFA action date

Cadence Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (FDA) has classified the OFIRMEV™ (acetaminophen) injection New Drug Application (NDA) resubmission as a complete Class 2 response to the FDA's February 10, 2010 action letter and assigned a new Prescription Drug User Fee Act (PDUFA) action date of November 4, 2010.

15 May 2010

CSL Behring donates life-saving medicines to assist earthquake victims in Haiti

Direct Relief International announced today that CSL Behring has donated life-saving medicines valued at more than $100,000 to assist earthquake victims in Haiti who are at risk of tetanus or hepatitis B infections. The products will be used in clinics at Hopital Albert Schweitzer in Deschapelles.

14 May 2010

Jennerex to present key data on JX-594 Phase 1 dose escalation clinical study at ASGCT Annual Meeting

Jennerex, Inc., a clinical-stage cancer biotherapeutics company, today announced that key data from its JX-594 intravenous administration Phase 1 dose escalation clinical study will be presented at the American Society of Gene and Cell Therapy (ASGCT) Annual Meeting taking place May 19-22, 2010, in Washington DC.

14 May 2010

Derma Sciences first-quarter net sales up 23% to $12,844,382

Derma Sciences, Inc., a specialty medical device/pharmaceutical company focused on advanced wound care, reported financial and operating results today for the three months ended March 31, 2010.

14 May 2010

CSL Behring calls for grant requests through LEAD program

CSL Behring, a global leader in the plasma protein biotherapeutics industry, is calling for grant requests through its Local Empowerment for Advocacy Development program. The LEAD program awards funds to United States patient organizations that assist people with rare diseases in advocating for continued access to health care and life-saving plasma protein therapies.

13 Apr 2010

FDA approves CSL Behring's Hizentra for PI

CSL Behring announced today that the U.S. Food and Drug Administration (FDA) has granted marketing approval for HizentraTM, Immune Globulin Subcutaneous (Human), 20% Liquid, for treating patients diagnosed with primary immunodeficiency (PI). A once weekly immunoglobulin (Ig) replacement therapy, Hizentra provides effective protection against infection by maintaining a steady and normal level of immunoglobulin in the body.

4 Mar 2010

Majority of PI patients can be switched to IgPro20 without dose adjustment

Data from a European multicenter (non-IND study) showing that patients with PI who switched to IgPro20 from previously available SCIg formulations achieved comparable IgG trough levels without dosage adjustment, resulting in significantly less administration volume. The data were presented at the American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting in New Orleans, US.

3 Mar 2010

C1-INH replacement therapy effective for treating acute swelling attacks in HAE

C1-esterase inhibitor (C1-INH) concentrate is an effective, well-tolerated therapy that rapidly relieves acute swelling attacks and successive attacks at any body location in patients with hereditary angioedema (HAE), a rare and serious genetic disorder, according to data presented today at the 2010 American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting. Additional pharmacokinetic data presented at the meeting confirms that C1-INH concentrate has a longer half-life than other treatment options for HAE, which protects patients from rebound attacks.

2 Mar 2010

Von Willebrand Disease News and Research

Latest Von Willebrand Disease News and Research

CSL Behring creates Interlaken Leadership Awards to support innovative immunoglobulin research

Octapharma USA accepts applications for 25th Anniversary Grants Program

Vivaglobin therapy effective for patients with primary immunodeficiency

Privigen IVIg therapy effective for primary, secondary immunodeficiencies: Study

Hizentra therapy effective for primary immunodeficiency patients

Octapharma USA launches wilate replacement therapy Web site for von Willebrand Disease

FDA approves CSL Behring's sBLA to extend shelf life of Hizentra from 18 to 24 months

FDA approves Pfizer's Prefilled Dual-Chamber Syringe for XYNTHA administration in hemophilia A patients

Rush University Medical Center first to receive Octapharma grant under anniversary program

Octapharma USA receives confirmation of orphan drug exclusivity from FDA for wilate

CSL Behring granted authorization to market Berinert for HAE in Italy and Luxembourg

U.S. healthcare practitioners can resume use of Rotarix, says FDA

FDA assigns Cadence Pharmaceuticals' OFIRMEV NDA new PDUFA action date

CSL Behring donates life-saving medicines to assist earthquake victims in Haiti

Jennerex to present key data on JX-594 Phase 1 dose escalation clinical study at ASGCT Annual Meeting

Derma Sciences first-quarter net sales up 23% to $12,844,382

CSL Behring calls for grant requests through LEAD program

FDA approves CSL Behring's Hizentra for PI

Majority of PI patients can be switched to IgPro20 without dose adjustment

C1-INH replacement therapy effective for treating acute swelling attacks in HAE

Expanding research and clinical options for children with cancer

Examining how pain could play a direct protective role in the gut

From Puberty to Menopause: Clue’s CEO, Audrey Tsang on the Power of Femtech

Von Willebrand Disease News and Research

Latest Von Willebrand Disease News and Research

Expanding research and clinical options for children with cancer

Examining how pain could play a direct protective role in the gut

From Puberty to Menopause: Clue’s CEO, Audrey Tsang on the Power of Femtech

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