Hypersensitivity News and Research

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

Shire's INTUNIV for treating ADHD now available in the U.S.

Shire plc, the global specialty biopharmaceutical company, today announced the availability of INTUNIV(TM) (guanfacine) Extended Release Tablets in pharmacies across the United States for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in children and adolescents ages 6 to 17.

9 Nov 2009

Evaluation of DX-88 to resolve symptoms of acute HAE attacks to be presented

An analysis demonstrating the ability of DX-88 (ecallantide) to resolve symptoms of acute hereditary angioedema (HAE) attacks in all anatomic locations and to sustain effect will be presented in an oral presentation this week at the American College of Allergy, Asthma and Immunology (ACAAI) 2009 Annual Meeting in Miami Beach.

9 Nov 2009

Interim data from Schering-Plough's narlaprevir Phase IIa study

Schering-Plough Corporation reported that interim results from an ongoing Phase IIa study of narlaprevir (SCH 900518), its investigational, once-daily protease inhibitor, demonstrated potent antiviral activity in treatment-naive patients with chronic hepatitis C virus (HCV) genotype 1.

3 Nov 2009

Sanofi Pasteur presents Menactra vaccine safety data at the IDSA

Sanofi Pasteur, the vaccines division of sanofi-aventis Group, presented Safety of a Quadrivalent (A,C,Y,W-135) Meningococcal Vaccine When Given to Infants with Other Pediatric Vaccines at the 47th Annual Meeting of the Infectious Diseases Society of America (IDSA) this past weekend.

2 Nov 2009

Shire to present key data on ADHD treatments at national psychiatric meeting

Shire plc, the global specialty biopharmaceutical company, announced today that it will present key scientific data on its Attention-Deficit/Hyperactivity Disorder (ADHD) treatments, INTUNIV- (guanfacine) Extended Release Tablets, Vyvanse- (lisdexamfetamine dimesylate) Capsules CII, and Daytrana- (methylphenidate transdermal system) CII, at a national meeting of psychiatrists to be held October 27 - November 1 in Honolulu.

31 Oct 2009

New study results of INTUNIV presented at a major psychiatric medical meeting

Shire plc, the global specialty biopharmaceutical company, announced new study results on INTUNIV- (guanfacine) Extended Release Tablets, at a major psychiatric medical meeting today.

31 Oct 2009

Schering-Plough receives FDA complete response letter regarding PEGINTRON

Schering-Plough Corp. announced the U.S. Food and Drug Administration (FDA) has issued a complete response letter to the company's supplemental Biologics License Application regarding PEGINTRON® (pegylated interferon alfa-2b) for the adjuvant treatment of patients with stage III malignant melanoma after complete lymphadenectomy.

31 Oct 2009

Four abstracts on RSV and influenza prevention in pediatric health to be presented

MedImmune announced today it will present four abstracts at the 47th Annual Meeting of Infectious Disease Society of America (IDSA) being held here October 29 through November 1, 2009. These abstracts advance the body of data surrounding respiratory syncytial virus (RSV) and influenza prevention, highlighting MedImmune's leadership in pediatric health.

31 Oct 2009

Shire's ADHD treatment data to be presented at the Honolulu psychiatric meeting

Shire plc, the global specialty biopharmaceutical company, announced today that it will present key scientific data on its Attention-Deficit/Hyperactivity Disorder (ADHD) treatments, INTUNIV(TM) (guanfacine) Extended Release Tablets, Vyvanse®( ) (lisdexamfetamine dimesylate) Capsules CII, and Daytrana®( ) (methylphenidate transdermal system) CII, at a national meeting of psychiatrists to be held October 27 - November 1 in Honolulu.

30 Oct 2009

Women more likely to suffer from adverse drug reactions than men; proactive approach may help reduce problems

Most people have taken a prescription medication at one time or another, but according to a report from the Agency of Healthcare Research and Quality (AHRQ) in Rockville, Md., not only do women take more medications during their lifetimes, women are more likely to suffer from adverse drug events than men.

30 Oct 2009

Cumberland Pharmaceuticals and Phebra team up to commercialize Caldolor injection

Cumberland Pharmaceuticals Inc. and Phebra Pty Ltd., an Australian-based specialty pharmaceutical company, today announced they have entered into an exclusive partnership for the commercialization of Caldolor® (ibuprofen) Injection in Australia and New Zealand.

30 Oct 2009

Dysport drug for treatment of cervical dystonia launched in the United States

Ipsen, an innovation-driven global specialty pharmaceutical group, today announced that Dysport® is now available in the United States for the treatment of cervical dystonia in adults.

29 Oct 2009

New data from CIMZIA WELCOME trial to be presented at the ACG meeting

According to new results from the WELCOME trial, exploratory data analyzing the impact of treatment with CIMZIA(®) (certolizumab pegol) - the only PEGylated anti-TNF (alpha) (Tumor Necrosis Factor alpha) - administered either every two weeks or every four weeks, showed that the majority of Crohn's disease patients in both dosing groups experienced no hospitalizations and surgical procedures during the course of the 26-week study.

28 Oct 2009

Treatment with TYSABRI reduces the rate of hospitalization in Crohn’s patients

Elan Corporation, plc and Biogen Idec today announced data showing that treatment with TYSABRI® (natalizumab) significantly reduced the rate of hospitalization compared with placebo in patients with moderate–to–severe Crohn’s disease during both induction and maintenance treatment.

28 Oct 2009

Hyperion Therapeutics enrolls first patient in HPN-100 phase III clinical trial for urea cycle disorders

Hyperion Therapeutics today announced that the first patient has been enrolled in its pivotal phase III clinical trial of investigational compound HPN-100 (glycerol phenylbutyrate). The 4-week, multi-center, randomized, double-blind, cross-over study is designed to evaluate the non-inferiority of glycerol phenylbutyrate to BUPHENYL® (sodium phenylbutyrate) Tablets and Powder in adults with urea cycle disorders.

27 Oct 2009

New data on KAPIDEX for nighttime heartburn in adults with non-erosive GERD presented at the 2009 ACG

New data being presented at the American College of Gastroenterology (ACG) 2009 Annual Scientific Meeting in San Diego showed that treatment with KAPIDEX(TM) (dexlansoprazole) delayed release capsules over a four-week period resulted in a statistically significant greater percentage of nights without heartburn in subjects with non-erosive gastroesophageal reflux disease (GERD), compared to placebo (p<0.001).

27 Oct 2009

New data from efficacy study of CIMZIA in Crohn's disease patients presented

New data from an open-label extension study evaluating the long-term safety and efficacy of CIMZIA® (certolizumab pegol) in moderate to severe Crohn's disease patients demonstrate that 82 percent of patients actively treated with CIMZIA - the only PEGylated anti-TNF-alpha (Tumor Necrosis Factor alpha) - remained in long-term remission without dose escalation up to 3.5 years.

27 Oct 2009

Shire reports results of Lialda and 5-ASA persistency analyses

Shire plc, the global specialty biopharmaceutical company, presented the results of three 5-aminosalicylic acid (5-ASA) persistency analyses at ACG 2009 Annual Scientific Meeting, evaluating persistency of Lialda® (mesalamine), Asacol® (mesalamine), Pentasa® (mesalamine) (250mg and 500mg), balsalazide [combined results from generic balsalazide disodium and Colazal® (balsalazide disodium)], and Dipentum® (olsalazine sodium) (500mg).

27 Oct 2009

FDA approves Berinert for adults and adolescents with HAE

The U.S. Food and Drug Administration today approved Berinert, the first treatment for acute abdominal attacks and facial swelling associated with a rare and potentially life-threatening genetic disease called hereditary angioedema (HAE).

27 Oct 2009

Santarus to present results from two investigator-initiated studies with ZEGERID at 2009 ACG meeting

Santarus, Inc., a specialty biopharmaceutical company, today announced that positive data from two investigator-initiated studies with ZEGERID® (omeprazole/sodium bicarbonate) will be presented in poster sessions at the American College of Gastroenterology (ACG) 2009 Annual Scientific Meeting taking place in San Diego. These studies were supported by grants from Santarus.

26 Oct 2009