Hypersensitivity News and Research

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

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

Shire announces new pharmacokinetic data of ADHD medication

Shire plc, the global specialty biopharmaceutical company, announced new data about the pharmacokinetics of its Attention-Deficit/Hyperactivity Disorder (ADHD) medication, Vyvanse- (lisdexamfetamine dimesylate) Capsules CII, which showed that Vyvanse provided similar concentrations of its active medication in the blood when administered either intranasally or when administered orally.

23 Oct 2009

MedImmune announces interim data from its live attenuated influenza vaccine studies

MedImmune announced today that interim data from human studies of its nasal spray vaccine for the 2009 novel Influenza A (H1N1) virus demonstrate a similar clinical profile in children and adults 2 to 49 years of age as previously studied seasonal formulations of the vaccine.

23 Oct 2009

Advisory Committee on Immunization Practices supports the permissive use of GARDASIL

Merck & Co., Inc. announced today that the U.S. Centers for Disease Control and Prevention’s (CDC’s) Advisory Committee on Immunization Practices (ACIP) supports the permissive use of GARDASIL® [Human Papillomavirus Quadrivalent (Types 6, 11, 16 and 18) Vaccine, Recombinant] for boys and young men ages 9 to 26, which means that GARDASIL may be given to males ages 9 to 26 to reduce the likelihood of acquiring genital warts at the discretion of the patient's health care provider.

22 Oct 2009

Millennium commences Vc-R-CHOP Phase II trial for diffuse large B-cell lymphoma

Millennium: The Takeda Oncology Company today announced the initiation of a Phase II clinical trial examining rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone (R-CHOP) with or without VELCADE® (bortezomib) for Injection for patients with a common type of lymphoma. The study will examine previously untreated patients with a genomically defined subtype of lymphoma called non-germinal center B-cell-like (non-GCB) diffuse large B-cell lymphoma.

22 Oct 2009

Clinical data supports continued development of ORENCIA administration for rheumatoid arthritis

Bristol-Myers Squibb Company announced today that new clinical data support continued development of a subcutaneous administration of ORENCIA® (abatacept) for patients with moderate to severe rheumatoid arthritis.

21 Oct 2009

Interim study analysis comparing MENOPUR with rFSH in GnRH Antagonist IVF cycles

Ferring Pharmaceuticals presented an interim study analysis indicating that MENOPUR® (menotropins for injection, USP) is effective in in vitro fertilization (IVF) cycles using a gonadotropin-releasing hormone (GnRH) antagonist. The results were presented in a poster at the 65th Annual Meeting of the American Society for Reproductive Medicine (ASRM) in Atlanta, October 17-21, 2009.

21 Oct 2009

Bristol-Myers Squibb presents study data on ORENCIA for treating rheumatoid arthritis

Bristol-Myers Squibb Company today announced two-year results of a study that supports use of ORENCIA® (abatacept) for methotrexate-naive patients with moderate to severe rheumatoid arthritis of less than or equal to two years duration.

20 Oct 2009

Elan and Biogen Idec to present TYSABRI study data at ACG meeting

Elan Corporation, plc and Biogen Idec today announced multiple presentations at the American College of Gastroenterology (ACG) Annual Scientific Meeting, taking place October 23-28 in San Diego.

20 Oct 2009

Cumberland Pharmaceuticals publishes data on its Phase III intravenous ibuprofen study

Cumberland Pharmaceuticals Inc. announced today that its Phase III study on intravenous ibuprofen as a post-operative analgesic was published in Volume 31, Number 9 of the peer-reviewed journal Clinical Therapeutics, distributed in October. The study concludes that patients emerging from orthopedic and abdominal surgeries required less narcotic and experienced less pain with 800 mg of intravenous ibuprofen every six hours compared to morphine alone.

20 Oct 2009

UCB reports on the outcome of Cimzia and MTX treatment for rheumatoid arthritis

UCB today announced data that showed rapid and sustained improvements in ACR20, physical function, pain and fatigue of rheumatoid arthritis (RA) as early as the first week, and inhibition of progression of structural joint damage (seen at week 24) following treatment with Cimzia (certolizumab pegol), together with methotrexate (MTX), was sustained up to 100 weeks.

19 Oct 2009

Schering-Plough to present data on boceprevir at the AASLD 2009 Annual Meeting

Schering-Plough announced that data on boceprevir, an investigational hepatitis C virus (HCV) protease inhibitor, will be reported in an oral presentation at the American Association for the Study of Liver Diseases (AASLD) Annual Meeting in Boston, Oct. 30-Nov. 3.

19 Oct 2009

Genentech reports results of ACTEMRA Phase III study for rheumatoid arthritis

Genentech, Inc., a wholly-owned member of the Roche Group, today announced two-year results from a Phase III study, which showed that people with rheumatoid arthritis (RA) who received either a 4 mg/kg or 8 mg/kg dose of ACTEMRA® (tocilizumab), in combination with methotrexate, had no progression of joint damage, (75 and 83 percent, respectively, as assessed by radiograph) compared with people who received methotrexate alone (66 percent).

19 Oct 2009

Hypersensitivity News and Research

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

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

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

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

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

Shire reports results of Lialda and 5-ASA persistency analyses

FDA approves Berinert for adults and adolescents with HAE

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

Shire announces new pharmacokinetic data of ADHD medication

MedImmune announces interim data from its live attenuated influenza vaccine studies

Advisory Committee on Immunization Practices supports the permissive use of GARDASIL

Millennium commences Vc-R-CHOP Phase II trial for diffuse large B-cell lymphoma

Clinical data supports continued development of ORENCIA administration for rheumatoid arthritis

Interim study analysis comparing MENOPUR with rFSH in GnRH Antagonist IVF cycles

Bristol-Myers Squibb presents study data on ORENCIA for treating rheumatoid arthritis

Elan and Biogen Idec to present TYSABRI study data at ACG meeting

Cumberland Pharmaceuticals publishes data on its Phase III intravenous ibuprofen study

UCB reports on the outcome of Cimzia and MTX treatment for rheumatoid arthritis

Schering-Plough to present data on boceprevir at the AASLD 2009 Annual Meeting

Genentech reports results of ACTEMRA Phase III study for rheumatoid arthritis

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