Hypersensitivity News and Research

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

Exclusion diet boosts anal fissure healing

Research published in the American Journal of Gastroenterology shows that an exclusion diet combined with medical treatment can increase healing rates in patients with chronic anal fissure who have been referred for surgery.

30 Apr 2013

Merck, Pfizer sign collaboration agreement for development and commercialization of ertugliflozin

Merck & Co., Inc., known as MSD outside the United States and Canada, and Pfizer Inc. today announced that they have entered into a worldwide (except Japan) collaboration agreement for the development and commercialization of Pfizer's ertugliflozin (PF-04971729), an investigational oral sodium glucose cotransporter (SGLT2) inhibitor being evaluated for the treatment of type 2 diabetes.

From Pfizer, Inc. 30 Apr 2013

Dyax reports Q1 2013 financial results; LFRP portfolio continues to be a growth driver

Dyax Corp. today announced financial results for the first quarter ended March 31, 2013. The Company will host a webcast and conference call at 5:00 p.m. (ET) today to review financial results and updates regarding its key value drivers - the KALBITOR® (ecallantide) business, the broader angioedema portfolio and the Licensing and Funded Research Program (LFRP).

26 Apr 2013

Data from MK-5172 Phase II study for treatment of HCV genotype 1 infection to be presented at EASL meeting

Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced the presentation of the latest interim data from a Phase II, multi-center, randomized, dose-ranging clinical trial evaluating the safety and antiviral activity of MK-5172, for the treatment of chronic hepatitis C virus genotype 1 infection.

24 Apr 2013

Navidea presents Phase 3 Lymphoseek study results at international symposium in Athens

Navidea Biopharmaceuticals, Inc., a biopharmaceutical company focused on precision diagnostic radiopharmaceuticals, today announced that a presentation of results from its Phase 3 clinical trial of Lymphoseek (technetium 99m tilmanocept) Injection in patients with head and neck squamous cell carcinoma received the 1st Investigator Award at the 2nd InternationaI Symposium on Thoracic and Upper Aerodigestive Malignancies.

15 Apr 2013

New data on Merck’s VICTRELIS for chronic HCV to be presented at EASL annual meeting

Merck, known as MSD outside of the United States and Canada, announced today that two analyses of VICTRELIS (boceprevir) and data from Phase II studies of two of Merck's investigational medicines for chronic hepatitis C virus (HCV) genotype 1, MK-5172 and vaniprevir (MK-7009), will be presented at the 2013 International Liver Congress (EASL) Annual Meeting.

11 Apr 2013

FDA accepts Merck's NDA for NOXAFIL tablets

Merck, known as MSD outside the United States and Canada, today announced that its New Drug Application for an investigational, tablet formulation of the company's antifungal agent, NOXAFIL (posaconazole), has been accepted for review by the U.S. Food and Drug Administration.

11 Apr 2013

Study offers new insights into how nervous system processes hot and cold temperatures

A study from the University of North Carolina School of Medicine offers new insights into how the nervous system processes hot and cold temperatures. The research led by neuroscientist Mark J. Zylka, PhD, associate professor of cell biology and physiology, found an interaction between the neural circuits that detect hot and cold stimuli: cold perception is enhanced when nerve circuitry for heat is inactivated.

9 Apr 2013

Biogen acquires TYSABRI stake from Elan

Biogen Idec today announced it has completed its purchase of Elan Corporation's interest in TYSABRI (natalizumab) and has gained full strategic, commercial and decision-making rights to TYSABRI.

3 Apr 2013

Invokana tablets receive FDA approval to treat adults with type 2 diabetes

The U.S. Food and Drug Administration today approved Invokana (canaglifozin) tablets, used with diet and exercise, to improve glycemic control in adults with type 2 diabetes.

30 Mar 2013

GE Healthcare seeks approval to supply Optison to EU market from Oslo manufacturing facility

GE Healthcare today announced that it has submitted an application to amend its European Marketing Authorisation that will allow the company to manufacture Optison 0.19 mg/ml dispersion for injection within its own facility.

30 Mar 2013

European Commission grants conditional marketing authorization for Pfizer's BOSULIF

Pfizer Inc. announced today that the European Commission has granted conditional marketing authorization for BOSULIF (bosutinib) in the European Union for the treatment of adult patients with chronic phase, accelerated phase and blast phase Philadelphia chromosome positive chronic myelogenous leukemia previously treated with one or more tyrosine kinase inhibitor(s) and for whom imatinib, nilotinib and dasatinib are not considered appropriate treatment options.

28 Mar 2013

Study projects potential impact of FDA-approved anti-obesity medications on Medicare spending

VIVUS, Inc. announced today that a new study demonstrates that effective medical treatment providing 10% to 15% weight loss could lead to significant improvements in Medicare spending by reversing or reducing significant health consequences such as type 2 diabetes, hypertension and dyslipidemia in obese or overweight patients.

25 Mar 2013

Botulism Antitoxin Heptavalent gets FDA approval for patients showing signs of botulism

The U.S. Food and Drug Administration announced today that it has approved Botulism Antitoxin Heptavalent (A, B, C, D, E, F, G)-(Equine) to treat patients showing signs of botulism following documented or suspected exposure to botulinum neurotoxin.

25 Mar 2013

Study reveals treatments for pain at site of injury may not always be good enough

Treatments for pain at the site of an injury may not always be good enough, according to a novel study by University of Maryland (UM) scientists reported March 20 in The Journal of Neuroscience.

21 Mar 2013

Laboratorios Grifols, Cadence announce new supply agreement for OFIRMEV

Cadence Pharmaceuticals, Inc., a biopharmaceutical company focused on acquiring, in-licensing, developing and commercializing proprietary products principally for use in the hospital setting, today announced a new supply agreement with Laboratorios Grifols, S.A. for the development, manufacture and supply of commercial quantities of OFIRMEV (acetaminophen) injection in flexible plastic bags.

6 Mar 2013

FDA accepts AMAG’s Feraheme sNDA for review

AMAG Pharmaceuticals, Inc. today announced that the United States Food and Drug Administration (FDA) has accepted for review the company's supplemental new drug application (sNDA) for Feraheme (ferumoxytol) Injection for Intravenous (IV) use, which was submitted to the FDA in December 2012.

6 Mar 2013

Otsuka receives FDA approval for ABILIFY MAINTENA to treat schizophrenia

Otsuka Pharmaceutical Co., Ltd. (Otsuka) and H. Lundbeck A/S (Lundbeck) announced the U.S. Food and Drug Administration (FDA) has approved ABILIFY MAINTENA (aripiprazole) for extended- release injectable suspension, an intramuscular (IM) depot formulation indicated for the treatment of schizophrenia.

1 Mar 2013

Baxter files FEIBA NF BLA with FDA for prophylactic treatment of hemophilia A or B

Baxter International Inc. today announced that the company has submitted a biologics license application (BLA) supplement to the U.S. Food and Drug Administration (FDA) for the approval of prophylaxis treatment of FEIBA NF [Anti-Inhibitor Coagulant Complex], Nanofiltered and Vapor Heated, in patients with hemophilia A or B and inhibitors.

From Baxter International Inc. 26 Feb 2013

FDA alerts patients and health care providers of voluntary recall of Omontys by Affymax

The U.S. Food and Drug Administration is alerting health care providers and patients of a voluntary nationwide recall of all lots of Omontys Injection by Affymax, Inc., of Palo Alto, Calif., and Takeda Pharmaceuticals Company Limited, of Deerfield, Ill.

25 Feb 2013