Hypersensitivity News and Research

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Hypersensitivity is an exaggerated response by the immune system to a drug or other substance.

Cytheris study: rhIL-7 treatment restores T cell trafficking and improves survival in animal model of sepsis

Cytheris SA, a clinical stage biopharmaceutical company focused on research and development of new therapies for immune modulation, today announced publication of data from a preclinical study in a clinically relevant animal model of sepsis showing that recombinant human Interleukin-7 (rhIL-7) treatment not only restores T cell trafficking and function, but also translates into improved survival.

16 Mar 2010

Valsartan delays progression to type 2 diabetes in IGT patients: NAVIGATOR study

Results from a landmark study involving more than 9,000 people showed that the high blood pressure medicine valsartan delayed progression to type 2 diabetes in patients with cardiovascular disease or risk factors and impaired glucose tolerance (IGT), a common pre-diabetic condition.

15 Mar 2010

U.S. prescribing information for PLAVIX revised

Sanofi-aventis U.S. and Bristol-Myers Squibb Company today announced revisions to the U.S. prescribing information for PLAVIX® (clopidogrel bisulfate), which include a boxed warning. The boxed warning concerns the diminished effectiveness of PLAVIX in patients who have a genetic variation leading to reduced formation of the active metabolite.

15 Mar 2010

Watson Pharmaceuticals' TRELSTAR receives FDA approval for treatment of advanced prostate cancer

Watson Pharmaceuticals, Inc., today announced the U.S. Food and Drug Administration approval of TRELSTAR® 22.5 mg (triptorelin pamoate for injectable suspension), a new twice-yearly formulation of TRELSTAR®, a proven, simple and effective palliative treatment of advanced prostate cancer.

11 Mar 2010

Aton Pharma introduces authorized generic version of Timoptic-XE

Aton Pharma, Inc., a diversified specialty pharmaceutical company, today announced that it has launched an authorized generic version of its Timoptic-XE® (timolol maleate ophthalmic gel forming solution). Timoptic-XE is a non-selective beta-adrenergic receptor blocking agent indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma. Aton also announced that it will continue to make available branded Timoptic-XE.

9 Mar 2010

Usage of gonadotropins in assisted reproductive technologies significantly improves outcomes

The U.S. infertility specialty has empirically incorporated greater amounts of human menopausal gonadotropin (hMG) into stimulation protocols, according to a new review article, "Gonadotropins in the Treatment of Infertility" by George T. Koulianos, MD, published in a recent issue of US Obstetrics & Gynecology, supported by an educational grant from Ferring Pharmaceuticals. The article reviews the wealth of clinical evidence supporting this trend, and demonstrates how the use of gonadotropins in the treatment of infertility, especially in assisted reproductive technologies, has significantly improved outcomes.

9 Mar 2010

KAPIDEX to be marketed as DEXILANT in the U.S.

Takeda Pharmaceuticals North America, Inc. announced today that KAPIDEX™ (dexlansoprazole) will be marketed in the United States under the new product trade name DEXILANT™ (dexlansoprazole). The product is indicated for heartburn associated with symptomatic non-erosive gastroesophageal reflux disease (GERD), the healing of erosive esophagitis (EE) and the maintenance of healed EE.

5 Mar 2010

Dermatologist addresses common parasitic infestations and latest treatment options at Academy Annual Meeting

If simply the thought of bedbugs, scabies and head lice makes you feel a little itchy, imagine how those affected by these common infestations feel when they learn what has been creeping around them and causing symptoms such as intense itching, red bite marks or irritated scalps.

5 Mar 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

Merck’s MF/F Phase III study data presented at AAAAI annual meeting

Data from two Phase III studies of Merck’s investigational fixed-dose combinations of mometasone furoate and formoterol fumarate (MF/F) were presented by researchers today in two poster presentations at the American Academy of Allergy, Asthma & Immunology (AAAAI) annual meeting.

3 Mar 2010

Data demonstrating effectiveness of KALBITOR to treat acute HAE presented at AAAAI 2010 Annual Meeting

Data demonstrating the effectiveness of KALBITOR (ecallantide) to treat hereditary angioedema (HAE) acute attacks by primary attack location were provided in an oral presentation yesterday at the American Academy of Allergy, Asthma and Immunology 2010 Annual Meeting in New Orleans.

3 Mar 2010

My Little Miracle Essay Contest: Winners to receive education fund prizes to support their children's future

If you are a parent who has conceived using Ferring Pharmaceuticals' fertility products, you can win a $10,000 education fund to support your child's future. Two other education fund prizes will also be awarded.

2 Mar 2010

Canyon Pharmaceuticals announces the availability of Iprivask inhibitor for prevention of DVT

Canyon PharmaceuticalsTM (www.canyonpharma.com) today announced the availability of Iprivask (desirudin for injection), the first direct thrombin inhibitor (DTI) approved in the United States by the Food and Drug Administration for the prevention of deep vein thrombosis (DVT), which may lead to pulmonary embolism in patients undergoing elective hip replacement surgery.

2 Mar 2010

AMAG Pharmaceuticals reports fourth-quarter 2009 net product revenues of $12.8M attributable to Feraheme

AMAG Pharmaceuticals, Inc., a biopharmaceutical company focused on the development and commercialization of a therapeutic iron compound to treat iron deficiency anemia and novel imaging agents to aid in the diagnosis of cancer and cardiovascular disease, today reported unaudited consolidated financial results for the fourth quarter and year ended December 31, 2009.

1 Mar 2010

Shire receives marketing approval from FDA for VPRIV

Shire plc, the global specialty biopharmaceutical company, announced today that the U.S. Food and Drug Administration has granted marketing approval for VPRIV, a human cell line derived enzyme replacement therapy (ERT) for the long-term treatment of Type 1 Gaucher disease in pediatric and adult patients.

27 Feb 2010

Genta initiates new dose-ranging study of tesetaxel drug

Genta Incorporated announced that the Company has initiated a new dose-ranging study of tesetaxel, the Company’s novel oral tubulin inhibitor, using a weekly dosing regimen. Tesetaxel -- a late Phase 2 oncology product -- is the leading oral taxane currently in clinical development.

26 Feb 2010

FDA approves Pfizer's Prevnar 13 pneumococcal conjugate vaccine

Pfizer Inc. announced today that the United States Food and Drug Administration has granted approval for Prevnar 13™ (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]), the Company’s 13-valent pneumococcal conjugate vaccine.

25 Feb 2010

ViiV Healthcare highlights S/GSK1349572, SELZENTRY and EPZICOM for HIV/AIDS at 17th CROI

At the 17th Conference on Retroviruses and Opportunistic Infections (CROI), ViiV Healthcare presented new data across its broad range of investigational and current medicines for the treatment of HIV/AIDS. Highlighted data at the conference included an oral presentation on the investigational integrase inhibitor, S/GSK1349572, as well as data presentations on SELZENTRY® (maraviroc) and EPZICOM® (abacavir/lamivudine).

24 Feb 2010

Phase III data reveals potential of Merck’s GARDASIL in preventing HPV and HPV-related cancers

Merck & Co., Inc. announced today that in new Phase III data, GARDASIL® [Human Papillomavirus Quadrivalent (Types 6, 11, 16 and 18) Vaccine, Recombinant] was 77.5 percent (95 percent CI: 39.6, 93.3) efficacious against anal intraepithelial neoplasia (AIN) associated with human papillomavirus (HPV) types 6, 11, 16 and 18 in 16-to-26 year-old men who have sex with men. The data were presented at the European Research Organization on Genital Infection and Neoplasia (EUROGIN) conference in Monte Carlo, Monaco.

18 Feb 2010

Health Canada approves Talecris Biotherapeutics' PROLASTIN-C for AAT deficiency

Talecris Biotherapeutics announced today that it has received approval from Health Canada for PROLASTIN®-C (Alpha1-Proteinase Inhibitor [Human]), a more purified and concentrated version of PROLASTIN® produced using advances in manufacturing technology. A similar approval for PROLASTIN-C was granted by the U.S. Food and Drug Administration on October 17, 2009.

17 Feb 2010