Hypersensitivity News and Research

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

Lupin grants Salix exclusive worldwide rights to rifaximin

Salix Pharmaceuticals, Ltd. today announced that as of March 31, 2011 Lupin Ltd. granted Salix exclusive worldwide rights (except for India) to exploit Lupin technology and technology jointly developed by Lupin and Salix for all rifaximin products for human use. This agreement expands the collaboration that Salix and Lupin entered into as of September 30, 2009.

6 Apr 2011

Results of study evaluating potential inhibitory effects of PPIs on Plavix presented at ACC 2011

Takeda Pharmaceuticals North America, Inc. announced the presentation of new study results, which evaluated the potential inhibitory effects of certain proton pump inhibitors (PPIs) on Plavix (clopidogrel bisulfate). The results showed that in healthy subjects, clopidogrel's active metabolite and inhibition of platelet function were reduced less by the co-administration of clopidogrel with dexlansoprazole or lansoprazole, rather than esomeprazole.

6 Apr 2011

RE-LY trial results suggest Pradaxa capsule reduces risk of stroke in AF patients

Two new retrospective subanalyses of the RE-LY trial, involving Pradaxa capsules, suggested that the reduction in stroke risk achieved with PRADAXA 150mg over warfarin occurred irrespective of CHA2DS2-VASc risk score and the type of non-valvular atrial fibrillation.

5 Apr 2011

Boehringer Ingelheim receives FDA approval for Viramune XR to treat HIV-1 infection

Boehringer Ingelheim Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration has approved Viramune XR extended-release tablets, a one-pill, once-daily formulation of nevirapine for use in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults.

5 Apr 2011

Avanir files IND for NUEDEXTA/AVP-923 Phase II clinical trial for central neuropathic pain in MS patients

Avanir Pharmaceuticals, Inc. today announced that it has filed an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) to begin a large Phase II clinical trial of AVP-923, an investigational drug for the treatment of central neuropathic pain in patients with multiple sclerosis (MS). The FDA has acknowledged receipt of the submission and the company expects that the IND filing will be subject to standard 30-day review.

4 Apr 2011

Merck's VICTRELIS phase III study results against HCV presented at EASL annual meeting

Merck, known as MSD outside of the United States and Canada, announced results from several new data analyses from the pivotal Phase III studies evaluating the addition of its investigational oral protease inhibitor VICTRELIS to peginterferon alfa-2b and ribavirin in adult patients with chronic hepatitis C virus genotype 1 infection.

1 Apr 2011

Watson, GeneraMedix receive FDA approval for Nulecit to treat iron deficiency anemia

Watson Pharmaceuticals, Inc. today announced that it is initiating launch activities of Nulecit, following FDA approval of GeneraMedix Inc.'s, Abbreviated New Drug Application.

1 Apr 2011

Amgen appeals EMA CHMP negative opinion on Vectibix-chemotherapy combination for wild-type KRAS mCRC

Amgen announced today that it has submitted a request to the European Medicines Agency (EMA) for a re-examination of the negative opinion issued in March by the Committee For Medicinal Products for Human Use (CHMP) for the use of Vectibix in combination with chemotherapy for patients with wild-type KRAS metastatic colorectal cancer (mCRC).

31 Mar 2011

Merck submits Erbitux indication extension to EMA for NSCLC treatment

Merck Serono, a division of Merck KGaA, Darmstadt, Germany, announced today that it has submitted an indication extension to the European Medicines Agency for the approval of Erbitux in combination with standard 1st line platinum-based chemotherapy in patients with advanced or metastatic non-small cell lung cancer with high epidermal growth factor receptor expression.

30 Mar 2011

Consumption of popular pain reliever during pregnancy may put children at increased risk for asthma

A new study published in the journal Clinical & Experimental Allergy reveals that children whose mothers used the popular pain reliever paracetamol during pregnancy were at an increased risk of wheezing when compared to non-users.

28 Mar 2011

Researchers identify gene that can predict hypersensitivity to epilepsy drug

Research published this week in the New England Journal of Medicine. A multinational team of scientists led by the Royal College of Surgeons in Ireland and the University of Liverpool has identified a gene that could indicate if epilepsy patients starting a common drug treatment are likely to experience side-effects ranging from a mild skin irritation to the potentially fatal Steven-Johnson Syndrome.

25 Mar 2011

ViroPharma presents Cinryze data against HAE at AAAAI Annual Meeting

ViroPharma Incorporated today announced data presented in two poster presentations relating to Cinryze at the 2011 American Academy of Allergy Asthma & Immunology Annual Meeting, March 18 through 22, in San Francisco, CA.

23 Mar 2011

Astellas announces positive results from mirabegron phase III trials against OAB

Astellas Pharma Inc. today announced the results of two pivotal phase III clinical trials for mirabegron, the first of a new class of compounds under development for the treatment of overactive bladder, show mirabegron significantly improves key OAB symptoms - urinary incontinence and frequency of micturition.

23 Mar 2011

Shire's Replagal and VPRIV data on Gaucher and Fabry patients presented at ACMG meeting

Shire plc, the global specialty biopharmaceutical company, presented new data for Replagal in patients with Fabry disease, and VPRIV in patients with type 1 Gaucher disease, at the 2011 American College of Medical Genetics' Annual Clinical Genetics Meeting, held in Vancouver, BC, from March 16-20, 2011.

22 Mar 2011

CSL Behring presents Hizentra study data against PI at AAAAI meeting

Data presented by CSL Behring today suggest that treatment with higher dose Hizentra correlates with reduced risk of infection and missed school or work among patients with primary immunodeficiencies.

22 Mar 2011

CHMP recommends approval of Centralized Marketing Authorization for Cinryze

ViroPharma Incorporated today announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a positive opinion at its plenary meeting in March 2011 recommending approval of a Centralized Marketing Authorization for Cinryze (C1 inhibitor [human]) in adults and adolescents with hereditary angioedema for routine prevention, pre-procedure prevention and acute treatment of angioedema attacks.

19 Mar 2011

EMA CHMP adopts negative opinion for Amgen's Vectibix in treatment of wild-type KRAS metastatic colorectal cancer

Amgen has received notice that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a negative opinion for Amgen's application to extend the marketing authorization in Europe for Vectibix® (panitumumab) to include combination with chemotherapy for the treatment of patients with wild-type KRAS metastatic colorectal cancer (mCRC).

18 Mar 2011

Updated NCCN Guidelines for Ovarian Cancer outline new treatment options for women

Although finding effective screening tools remains a priority, new treatment options for women with ovarian cancer, such as the ones outlined in the updated NCCN Guidelines for Ovarian Cancer, are vital to making steady progress against the disease according to Robert J. Morgan, MD, of City of Hope Comprehensive Cancer Center and chair of the NCCN Guidelines Panel for Ovarian Cancer.

16 Mar 2011

Gadavist approved by FDA for use in central nervous system MRI scans

The U.S. Food and Drug Administration approved Gadavist (gadobutrol), a gadolinium-based contrast agent, for use in patients undergoing magnetic resonance imaging (MRI) of the central nervous system.