Hypersensitivity News and Research

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

Purdue Pharma to present Butrans Transdermal System CIII clinical program data at PAINWeek 2010

Purdue Pharma L.P. will present data from the clinical program for Butrans™ (buprenorphine) Transdermal System CIII in a series of posters at PAINWeek®2010, September 8-10 in Las Vegas.

10 Sep 2010

Children with severe, therapy-resistant asthma more likely to have poorer lung function: SARP

A subset of children with asthma suffers from severe, treatment-resistant disease associated with more illness and greater allergic hypersensitivity, according to the results of the National Heart, Blood, and Lung Institute's Severe Asthma Research Program, presented in a recently published article in Pediatric Allergy, Immunology, and Pulmonology, a peer-reviewed journal published by Mary Ann Liebert, Inc..

10 Sep 2010

Research into role of genetic variation in drug-induced hypersensitivity reactions

The International Serious Adverse Events Consortium (SAEC) announced today it will collaborate with The University of Liverpool (www.liv.ac.uk/pharmacogenetics) to research the genetics of a form of serious adverse drug reaction called hypersensitivity. These are thought to involve the body's immune system, and mostly involve serious skin rashes.

10 Sep 2010

DARA BioSciences presents KRN5500 study results at World Congress on Pain

DARA BioSciences announced today that it presented study results from its Phase 2 multicenter, placebo controlled, double-blind, randomized dose escalation study for KRN5500 at the 13th World Congress on Pain held recently in Montreal.

9 Sep 2010

USPTO awards Medicis new patent for SOLODYN Extended Release Tablets

Medicis today announced that the United States Patent and Trademark Office (USPTO) has issued U.S. Patent No. 7,790,705 related to the use of SOLODYN® (minocycline HCI, USP) Extended Release Tablets. The new patent, entitled "Minocycline Oral Dosage Forms for the Treatment of Acne," relates to the use of dosage forms of SOLODYN which provide approximately 1 mg/kg dosing based on the body weight of the person, and expires in 2027.

8 Sep 2010

Celgene receives Paragraph IV Certification Letter on submission of ANDA for REVLIMID

Celgene Corporation today announced it has received a Paragraph IV Certification Letter advising that Natco Pharma Limited of Hyderabad, India, submitted an Abbreviated New Drug Application to the U.S. Food and Drug Administration. The application requests authorization to manufacture and market generic versions of REVLIMID (lenalidomide) 5, 10, 15 and 25 mg capsules in the United States.

3 Sep 2010

European Commission approves MSD's MAA for SYCREST in manic episodes associated with bipolar I disorder

MSD announced today that the European Commission has approved the Marketing Authorization Application (MAA) for SYCREST® (asenapine) sublingual tablets for the treatment of moderate to severe manic episodes associated with bipolar I disorder in adults. Today's decision was based on recommendations from the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP). The Commission Decision applies to all 27 European Member States.

3 Sep 2010

BRINAVESS IV granted marketing approval in EU for conversion of recent onset AF to sinus rhythm

MSD and Cardiome Pharma Corp. today announced that the intravenous (IV) formulation of BRINAVESS™ (vernakalant) has been granted marketing approval in the European Union (EU), Iceland and Norway for the conversion of recent onset atrial fibrillation (AF) to sinus rhythm in adults.

2 Sep 2010

Study: IV ibuprofen decreases pain, morphine use in pre and post-operative orthopedic surgery patients

Cumberland Pharmaceuticals Inc. today announced the publication of new data supporting the safety and efficacy of Caldolor® (ibuprofen) Injection in pre and post-operative orthopedic surgery patients. The study, which was published in the August edition of the peer-reviewed journal Pain Medicine, concludes that IV ibuprofen significantly decreased pain and morphine use when compared with placebo.

31 Aug 2010

Ipsen 2010 first half revenue increases to €31.7 million

The Board of Directors of Ipsen, chaired by Jean-Luc Bélingard, met on August 30, 2010 to review the Group's results for the first half 2010, published today

31 Aug 2010

FDA approves additional strengths of SOLODYN for inflammatory lesions treatment

Medicis today announced that the U.S. Food and Drug Administration (FDA) has approved additional strengths of SOLODYN (minocycline HCl, USP) Extended Release Tablets in 55 mg, 80 mg and 105 mg dosages for the treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 12 years of age and older.

30 Aug 2010

Shire receives European marketing approval for VPRIV therapy to treat type 1 Gaucher disease

Shire, the global specialty biopharmaceutical company, announced today that the European Commission has granted marketing authorisation for VPRIV(R) (velaglucerase alfa), a human cell line derived enzyme replacement therapy (ERT) for the long-term treatment of type 1 Gaucher disease.

27 Aug 2010

FDA accepts Sanofi Pasteur's Menactra vaccine sBLA for active immunization of infants and toddlers

Sanofi Pasteur, the vaccines division of the sanofi-aventis Group, announced today that the U.S. Food and Drug Administration (FDA) has accepted for review a supplemental Biologics License Application (sBLA) for use of Menactra® (Meningococcal [Groups A, C, Y and W-135] Polysaccharide Diphtheria Toxoid Conjugate Vaccine) for active immunization of infants and toddlers for the prevention of invasive meningococcal disease caused by serogroups A, C, Y, and W-135.

26 Aug 2010

Biogen to publish data on two-step assay for anti-JC virus antibody detection

Biogen Idec and Elan Corporation, plc today announced data has been published in the Annals of Neurology on an investigational, two-step assay to detect anti-JC virus (JCV) antibodies in human serum and plasma

26 Aug 2010

Celgene to enforce REVLIMID intellectual property rights following receipt of Paragraph IV notification letter

Celgene Corporation today announced that information was posted on the FDA Web site indicating that an Abbreviated New Drug Application (ANDA) has been received by the Office of Generic Drugs (OGD) containing a "Paragraph IV" patent certification, for REVLIMID (lenalidomide) 25 mg capsules. Celgene has not yet received the Paragraph IV notification letter identifying the filer.

25 Aug 2010

Baxter announces definitive agreement with Kamada for GLASSIA alpha1-proteinase inhibitor

Baxter International Inc. today announced a definitive agreement with Kamada Ltd. for exclusive commercial rights to GLASSIA™ [Alpha 1-Proteinase Inhibitor (Human)], the first and only liquid alpha1-proteinase inhibitor, in the United States, Australia, New Zealand and Canada.

From Baxter International Inc. 24 Aug 2010

Pfizer's Prevenar 13-valent pneumococcal conjugate vaccine receives WHO prequalification

The World Health Organization (WHO) has granted prequalification to Prevenar 13 (Pneumococcal polysaccharide conjugate vaccine [13-valent, adsorbed])for active immunization of infants and children from 6 weeks through five years of age against invasive disease, pneumonia and otitis media caused by the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) contained in the vaccine.

24 Aug 2010

Genzyme announces publication of phase 2 clinical trial results of eliglustat tartrate for Gaucher disease

Genzyme Corporation announced today that the two-year follow-up results from the phase 2 clinical trial of its investigational therapy known as eliglustat tartrate have been accepted for publication in the journal Blood. The results have been pre-published on the journal's website and are available to subscribers.

23 Aug 2010

FDA extends review on Acetadote for non-acetaminophen acute liver failure

Cumberland Pharmaceuticals Inc. today announced the U.S. Food and Drug Administration (FDA) has extended its review of the supplemental new drug application (sNDA) for the use of Acetadote® (acetylcysteine) Injection in patients with non-acetaminophen acute liver failure.

21 Aug 2010

Research on gut mucosa enables effective drug treatment for irritable bowel syndrome

Irritable bowel syndrome makes life miserable for those affected an estimated ten percent or more of the population. And what irritates many of them even more is that they often are labeled as hypochondriacs, since physical causes for irritable bowel syndrome have never been identified. Now, biologists at the Technische Universitaet Muenchen (TUM) have shed new light on the matter: They have discovered mini-inflammations in the mucosa of the gut, which upset the sensitive balance of the bowel and are accompanied by sensitization of the enteric nervous system.

20 Aug 2010

Hypersensitivity News and Research

Purdue Pharma to present Butrans Transdermal System CIII clinical program data at PAINWeek 2010

Children with severe, therapy-resistant asthma more likely to have poorer lung function: SARP

Research into role of genetic variation in drug-induced hypersensitivity reactions

DARA BioSciences presents KRN5500 study results at World Congress on Pain

USPTO awards Medicis new patent for SOLODYN Extended Release Tablets

Celgene receives Paragraph IV Certification Letter on submission of ANDA for REVLIMID

European Commission approves MSD's MAA for SYCREST in manic episodes associated with bipolar I disorder

BRINAVESS IV granted marketing approval in EU for conversion of recent onset AF to sinus rhythm

Study: IV ibuprofen decreases pain, morphine use in pre and post-operative orthopedic surgery patients

Ipsen 2010 first half revenue increases to €31.7 million

FDA approves additional strengths of SOLODYN for inflammatory lesions treatment

Shire receives European marketing approval for VPRIV therapy to treat type 1 Gaucher disease

FDA accepts Sanofi Pasteur's Menactra vaccine sBLA for active immunization of infants and toddlers

Biogen to publish data on two-step assay for anti-JC virus antibody detection

Celgene to enforce REVLIMID intellectual property rights following receipt of Paragraph IV notification letter

Baxter announces definitive agreement with Kamada for GLASSIA alpha1-proteinase inhibitor

Pfizer's Prevenar 13-valent pneumococcal conjugate vaccine receives WHO prequalification

Genzyme announces publication of phase 2 clinical trial results of eliglustat tartrate for Gaucher disease

FDA extends review on Acetadote for non-acetaminophen acute liver failure

Research on gut mucosa enables effective drug treatment for irritable bowel syndrome

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