Hypersensitivity News and Research

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

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

FDA approves Berinert for the treatment of hereditary angioedema

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).

12 Oct 2009

BioDelivery Sciences' partner Meda to launch ONSOLIS for managing breakthrough pain

BioDelivery Sciences International, Inc. announced that its commercial partner Meda will launch the FDA-approved ONSOLIS (fentanyl buccal soluble film) next week 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.

8 Oct 2009

Schering-Plough receives FDA recommendation approval for PEGINTRON

Schering-Plough Corp. announced that the U.S. Food and Drug Administration's (FDA) Oncologic Drugs Advisory Committee (ODAC) recommended approval by a vote of six to four for PEGINTRON® (pegylated interferon alfa-2b) in the adjuvant treatment of patients with Stage III malignant melanoma.

6 Oct 2009

Baxter launches HYLENEX recombinant for pediatric rehydration at the 2009 ACEP

Baxter International Inc. today announced the commercial launch of HYLENEX recombinant (hyaluronidase human injection) for use in pediatric rehydration at the 2009 American College of Emergency Physicians (ACEP) scientific assembly (Boston). HYLENEX, an enzyme, allows fluids to be administered under the skin (subcutaneously) rather than through a vein.

From Baxter International Inc. 5 Oct 2009

Cumberland to present clinical trial data of Caldolor at the AAPM annual meeting

Cumberland Pharmaceuticals Inc. announced today that data from two key clinical trials for Caldolor®, an intravenous formulation of ibuprofen approved for treatment of pain and fever in adults, will be presented at the American Academy of Pain Management's (AAPM) 20th Annual Clinical Meeting to be held in Phoenix, Ariz., on October 8-11, 2009.

5 Oct 2009

Interim results of Sanofi Pasteur's Influenza A (H1N1) 2009 Monovalent Vaccine clinical trials announced

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 adults 18 years through 64 years of age and over the age of 65 years.

3 Oct 2009

First prescription foam formulation of benzoyl peroxide available

Onset Therapeutics, a specialty pharmaceutical company focused on dermatology, announced today the commercial availability of BenzEFoam (benzoyl peroxide) 5.3% Emollient Foam, the first prescription foam formulation of benzoyl peroxide.

1 Oct 2009

Januvia in combination with metformin or taken alone lowers blood sugar

A post-hoc analysis, presented at the 45th Annual Meeting of the European Association for the Study of Diabetes (EASD), of data pooled from studies of 104 weeks in duration showed ‘Januvia’ (sitagliptin), when taken alone or in combination with metformin, provided significant blood sugar lowering over two years.

29 Sep 2009

Heparin-induced skin lesions may indicate platelets deficit

Heparin, a commonly used anticoagulant, can cause skin lesions, reports a study http://www.cmaj.ca/press/cmaj081729.pdf in CMAJ (Canadian Medical Association Journal) www.cmaj.ca.

29 Sep 2009

Safety profiles of JANUVIA and JANUMET drugs established through clinical development program

Merck has thoroughly reviewed the safety data for sitagliptin, and sitagliptin was not associated with an increase in the incidence of pancreatitis in preclinical studies or in clinical trials of up to two years in duration with more than 6,000 patients.

28 Sep 2009