Hypersensitivity News and Research

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

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

AstraZeneca's CRESTOR approved for treating pediatric patients with HeFH

AstraZeneca today announced the U.S. Food and Drug Administration (FDA) approved CRESTOR® (rosuvastatin calcium) for use in pediatric patients ages 10-17 with heterozygous familial hypercholesterolemia (HeFH) when diet therapy fails to reduce elevated cholesterol. HeFH, a genetic disease, is characterized by high LDL cholesterol (the "bad" cholesterol) and increased risk of early cardiovascular disease.

19 Oct 2009

FDA grants marketing approval for Elitek

Sanofi-aventis U.S. announced that the U.S. Food and Drug Administration (FDA) has granted marketing approval for Elitek (rasburicase) to be used for the initial management of plasma uric acid (PUA) levels in adult patients with leukemia, lymphoma, and solid tumor malignancies who are receiving anti-cancer therapy expected to result in tumor lysis syndrome (TLS) and subsequent elevations of plasma uric acid.

19 Oct 2009

Migraine can stimulate alcohol-induced headache

Migraine sufferers, beware. You may be more prone to an alcohol-induced headache after a night of drinking, according to researchers from the Jefferson Headache Center.

19 Oct 2009

Positive results from Protalix BioTherapeutics Phase III UPLYSO clinical trial

Protalix BioTherapeutics, Inc., announced today positive top-line results from the Company's pivotal Phase III clinical trial of UPLYSO (taliglucerase alfa, previously referred to as prGCD) in treatment naive patients diagnosed with Gaucher disease.

15 Oct 2009

Study shows type 2 diabetes patients treated with ACTOplus met experience blood sugar reduction

A study, published online in the journal Current Medical Research and Opinion, showed that a greater percentage of patients with type 2 diabetes treated with the fixed-dose combination ACTOplus met® (pioglitazone HCl and metformin HCl) as initial therapy reached the study goal of hemoglobin A1c (HbA1c) of less than or equal to 7 percent compared to either component alone.

15 Oct 2009

Interim data from Sanofi Pasteur's Influenza A 2009 Monovalent Vaccine clinical trials in infants and children

Sanofi Pasteur, the vaccines division of the sanofi-aventis Group, announced today an interim analysis of data from clinical trials of the U.S. licensed Influenza A (H1N1) 2009 Monovalent Vaccine in infants and children 6 months through 9 years of age. The data indicate the vaccine is immunogenic and that one dose may protect many children.

15 Oct 2009

Meda Pharmaceuticals introduces Onsolis for treating breakthrough cancer pain

Meda Pharmaceuticals Inc. today announced the launch of Onsolis(TM)(fentanyl buccal soluble film) in the U.S. for the management of breakthrough pain (BTP) in patients with cancer, eighteen years of age and older, who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain.

13 Oct 2009

FDA grants marketing approval for CSL Behring's Berinert C1-Esterase Inhibitor

CSL Behring announced today that the U.S. Food and Drug Administration (FDA) has granted marketing approval for Berinert® C1-Esterase Inhibitor, Human for the treatment of acute abdominal or facial attacks of hereditary angioedema (HAE), a rare and serious genetic disorder, in adult and adolescent patients. Berinert is the first and only therapy approved for this indication in the U.S.

12 Oct 2009

Hypersensitivity News and Research

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

AstraZeneca's CRESTOR approved for treating pediatric patients with HeFH

FDA grants marketing approval for Elitek

Migraine can stimulate alcohol-induced headache

Positive results from Protalix BioTherapeutics Phase III UPLYSO clinical trial

Study shows type 2 diabetes patients treated with ACTOplus met experience blood sugar reduction

Interim data from Sanofi Pasteur's Influenza A 2009 Monovalent Vaccine clinical trials in infants and children

Meda Pharmaceuticals introduces Onsolis for treating breakthrough cancer pain

FDA grants marketing approval for CSL Behring's Berinert C1-Esterase Inhibitor

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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