Hypersensitivity News and Research

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

EMA adopts positive opinion for Pfizer’s bosutinib conditional approval in the EU

Pfizer Inc. announced today that the Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a positive opinion regarding the conditional marketing authorization of bosutinib in the European Union for the treatment of adult patients with chronic phase (CP), accelerated phase (AP), and blast phase (BP) Philadelphia chromosome positive chronic myelogenous leukemia previously treated with one or more tyrosine kinase inhibitor(s) (TKIs) and for whom imatinib, nilotinib and dasatinib are not considered appropriate treatment options.

19 Jan 2013

Women with emotional exhaustion exhibit sound hypersensitivity when exposed to stress

Women suffering from stress-related exhaustion exhibit hypersensitivity to sounds when exposed to stress. In some cases, a sound level corresponding to a normal conversation can be perceived as painful. This according to a study from Karolinska Institutet and Stockholm University's Stress Research Institute in Sweden, which tested sensitivity to sounds immediately after a few minutes' artificially induced stress.

16 Jan 2013

Elan, Biogen Idec submit applications to FDA and EMA for updation of TYSABRI labels

Today Biogen Idec and Elan Corporation, plc announced that they have submitted applications to the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) requesting updates to the TYSABRI (natalizumab) labels.

16 Jan 2013

GE Healthcare submits Optison sNDA to aid in detection of cardiovascular diseases

GE Healthcare today announced that it has filed a supplemental new drug application (sNDA) that will allow the company to manufacture Optison (Perflutren Protein-Type A Microspheres Injectable Suspension, USP), within its own facility.

16 Jan 2013

EC approves Pfizer’s Prevenar 13 to prevent pneumococcal disease

Pfizer Inc. announced today that the European Commission has approved expanding the use of the company's pneumococcal conjugate vaccine, Prevenar 13(pneumococcal polysaccharide conjugate vaccine [13-valent, adsorbed]), to older children and adolescents aged 6 to 17 years for active immunization for the prevention of invasive disease, pneumonia and acute otitis media caused by vaccine-type Streptococcus pneumoniae.

9 Jan 2013

Merck’s resubmission of the NDA for suggammadex sodium injection accepted for review by the FDA

Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the resubmission of the New Drug Application (NDA) for sugammadex sodium injection has been accepted for review by the U.S. Food and Drug Administration (FDA). Merck expects the FDA’s review to be completed in the first half of 2013.

7 Jan 2013

Researchers discover new pathway to reduce paradoxical pain

For individuals with agonizing pain, it is a cruel blow when the gold-standard medication actually causes more pain. Adults and children whose pain gets worse when treated with morphine may be closer to a solution, based on research published in the January 6 on-line edition of Nature Neuroscience.

7 Jan 2013

Bristol-Myers Squibb, Pfizer receive FDA approval for ELIQUIS to reduce risk of stroke and SE

Bristol-Myers Squibb Company and Pfizer Inc. announced that the U.S. Food and Drug Administration (FDA) approved ELIQUIS (apixaban) to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation.

2 Jan 2013

AMAG seeks FDA sNDA approval for Feraheme Injection

AMAG Pharmaceuticals, Inc. today announced that it has submitted a supplemental new drug application (sNDA) to the United States Food and Drug Administration (FDA) for Feraheme (ferumoxytol) Injection for Intravenous (IV) use.

25 Dec 2012

Updated U.S. prescribing information for Boehringer Ingelheim’s Pradaxa

Boehringer Ingelheim Pharmaceuticals, Inc. today announced that the U.S. prescribing information for Pradaxa (dabigatran etexilate mesylate) capsules was updated to include a contraindication related to use in patients with mechanical prosthetic heart valve replacement.

21 Dec 2012

Biologic changes after delivery may prevent development of chronic pain

Chronic pain from childbirth is remarkably rare, according to a study from the January issue of Anesthesiology. Additionally, in a second study, researchers at Wake Forest School of Medicine, Winston-Salem, N.C., found the biologic changes after delivery may prevent the development of pain.

19 Dec 2012

Human nociception genes mapped out

Researchers have uncovered a “network map” of genes that are involved in pain perception, which they say may help identify new analgesic drugs.

17 Dec 2012

AMAG presents new data from two ferumoxytol phase III trials on IDA at ASH annual meeting

AMAG Pharmaceuticals, Inc. today announced that new data from two pivotal phase III clinical trials were presented at the American Society of Hematology's (ASH) annual meeting in Atlanta, Georgia.

11 Dec 2012

Almirall, Forest Laboratories' Tudorza Pressair now available in the U.S. pharmacies

Forest Laboratories, Inc. and Almirall, S.A. announced today that Tudorza Pressair (aclidinium bromide inhalation powder) 400mcg is now available in pharmacies throughout the United States.

11 Dec 2012

Celgene announces results from REVLIMID plus VIDAZA phase II study on AML

Celgene International Sàrl today announced that results from a study evaluating the combination of REVLIMID (lenalidomide) plus VIDAZA (azacitidine) in patients 60 years or older with untreated acute myeloid leukemia (AML) were presented at the American Society of Hematology annual meeting in Atlanta, GA.

11 Dec 2012

New survival results from Genentech’s Perjeta Phase III combination study on HER2-positive mBC

Genentech, a member of the Roche Group, today announced updated survival results from the Phase III CLEOPATRA study, which showed that the combination of Perjeta (pertuzumab), Herceptin (trastuzumab) and docetaxel chemotherapy significantly extended the lives (overall survival) of people with previously untreated HER2-positive metastatic breast cancer (mBC), compared to Herceptin, chemotherapy and placebo.

10 Dec 2012

Bayer submits MAA in Europe for EYLEA to treat macular edema after CRVO

Regeneron Pharmaceuticals, Inc. and Bayer HealthCare today announced that Bayer HealthCare has submitted an application for marketing authorization in Europe for EYLEA (aflibercept) Injection for the treatment of macular edema following Central Retinal Vein Occlusion (CRVO).

6 Dec 2012

New data from AstraZeneca's FASLODEX studies on breast cancer to be presented at SABSC

AstraZeneca today announced the presentation of important new data from studies of FASLODEX (fulvestrant) Injection at the 2012 CTRC-AACR San Antonio Breast Cancer Symposium taking place from 4-8 December at the Henry B. Gonzalez Convention Center, San Antonio, Texas.

5 Dec 2012

NeuroVive announce results from CicloMulsion Phase I trial on cardiac reperfusion injury

NeuroVive announces publication of the results of a Phase I clinical trial of lead product CicloMulsion in the scientific journal Clinical Drug Investigation. The paper highlights that the intravenous cyclosporine formulation CicloMulsion demonstrates bioequivalence and improved tolerability when compared with Sandimmune Injection.

3 Dec 2012

Novartis to highlight key data from extensive oncology portfolio at SABCS and ASH meeting

Novartis will highlight more than 140 presentations on key data from its extensive oncology portfolio at the leading year-end scientific meetings devoted to hematology and breast cancer, demonstrating continued innovation in research and development efforts to advance the care of patients with cancer and rare diseases.

30 Nov 2012

Hypersensitivity News and Research

EMA adopts positive opinion for Pfizer’s bosutinib conditional approval in the EU

Women with emotional exhaustion exhibit sound hypersensitivity when exposed to stress

Elan, Biogen Idec submit applications to FDA and EMA for updation of TYSABRI labels

GE Healthcare submits Optison sNDA to aid in detection of cardiovascular diseases

EC approves Pfizer’s Prevenar 13 to prevent pneumococcal disease

Merck’s resubmission of the NDA for suggammadex sodium injection accepted for review by the FDA

Researchers discover new pathway to reduce paradoxical pain

Bristol-Myers Squibb, Pfizer receive FDA approval for ELIQUIS to reduce risk of stroke and SE

AMAG seeks FDA sNDA approval for Feraheme Injection

Updated U.S. prescribing information for Boehringer Ingelheim’s Pradaxa

Biologic changes after delivery may prevent development of chronic pain

Human nociception genes mapped out

AMAG presents new data from two ferumoxytol phase III trials on IDA at ASH annual meeting

Almirall, Forest Laboratories' Tudorza Pressair now available in the U.S. pharmacies

Celgene announces results from REVLIMID plus VIDAZA phase II study on AML

New survival results from Genentech’s Perjeta Phase III combination study on HER2-positive mBC

Bayer submits MAA in Europe for EYLEA to treat macular edema after CRVO

New data from AstraZeneca's FASLODEX studies on breast cancer to be presented at SABSC

NeuroVive announce results from CicloMulsion Phase I trial on cardiac reperfusion injury

Novartis to highlight key data from extensive oncology portfolio at SABCS and ASH meeting

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