Hypersensitivity News and Research

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

AMAG Pharmaceuticals' abstract on ferumoxytol for CKD accepted for presentation at NKF 2010

AMAG Pharmaceuticals, Inc. today announced that one abstract has been accepted for presentation at the National Kidney Foundation 2010 Spring Clinical Meeting being held April 13-17, 2010 in Orlando, FL.

19 Mar 2010

FDA approves Somaxon Pharmaceuticals' Silenor for treatment of insomnia

Somaxon Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for Silenor® (doxepin) for the treatment of insomnia characterized by difficulty with sleep maintenance.

19 Mar 2010

Prevenar 13: Immunogenic and well tolerated in young children previously vaccinated with Prevenar

According to results from a Phase III safety and immunogenicity study presented today, Prevenar 13 (Pneumococcal polysaccharide conjugate vaccine, [13-valent, adsorbed]) was shown to be immunogenic and generally well tolerated in healthy young children who had received at least three prior doses of Prevenar (Pneumococcal Saccharide Conjugated Vaccine, Adsorbed). These data were presented today at the 7th International Symposium on Pneumococci and Pneumococcal Diseases (ISPPD) in Tel Aviv, Israel.

17 Mar 2010

Abraxis BioScience's Phase 3 trial comparing ABRAXANE with Taxol injection meets primary endpoint

Abraxis BioScience, Inc. today announced that its randomized registrational Phase 3 clinical trial comparing ABRAXANE® (protein-bound paclitaxel) with Taxol® (paclitaxel) injection, both in combination with carboplatin, met the study’s primary endpoint by demonstrating that ABRAXANE showed a significant improvement in overall response rate as compared to Taxol, in the first-line treatment of patients with advanced non-small cell lung cancer (NSCLC), as assessed by independent radiologist review.

17 Mar 2010

Pathway Genomics' personal Genetic Health Report now available

Pathway Genomics Inc., a U.S. based genetic testing company, announced the immediate availability of its personal Genetic Health Report. This customized and innovative personal genetic health report contains information on more than 70 health conditions, including pharmacogenetics (prescription medication response), propensity for complex disease, and carrier status (pre-pregnancy health).

17 Mar 2010

Genentech submits ACTEMRA sBLA to FDA

Genentech, Inc., a wholly-owned member of the Roche Group, today announced that the company submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) for ACTEMRA® (tocilizumab) for the prevention of structural joint damage (as assessed by radiograph) and improvement in physical function in adults with moderately to severely active rheumatoid arthritis (RA).

17 Mar 2010

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

Hypersensitivity News and Research

AMAG Pharmaceuticals' abstract on ferumoxytol for CKD accepted for presentation at NKF 2010

FDA approves Somaxon Pharmaceuticals' Silenor for treatment of insomnia

Prevenar 13: Immunogenic and well tolerated in young children previously vaccinated with Prevenar

Abraxis BioScience's Phase 3 trial comparing ABRAXANE with Taxol injection meets primary endpoint

Pathway Genomics' personal Genetic Health Report now available

Genentech submits ACTEMRA sBLA to FDA

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

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

U.S. prescribing information for PLAVIX revised

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

Aton Pharma introduces authorized generic version of Timoptic-XE

Usage of gonadotropins in assisted reproductive technologies significantly improves outcomes

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

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

FDA approves CSL Behring's Hizentra for PI

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

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

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

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

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

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From Discovery Biology to ELRIG Chair

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