Hypersensitivity News and Research

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

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

FDA approves new vial size for CSL Behring’s Privigen to treat primary immunodeficiency

CSL Behring today announced that the United States Food and Drug Administration has approved a 40 g (400 mL) vial size for Privigen, immune globulin intravenous [human].

21 Feb 2013

Dabigatran decreases risk of recurrent venous thromboembolism

New findings from two double-blind, randomized trials, RE-MEDY and RE-SONATE, show that dabigatran 150 mg twice daily reduces the risk of recurrent venous thromboembolism (VTE).

21 Feb 2013

UCB seeks FDA and EMA marketing authorization for Cimzia to treat active psoriatic arthritis

UCB announced today two new regulatory filings with the US Food and Drug Administration (FDA) and with the European Medicines Agency (EMA) to extend the marketing authorization for Cimzia (certolizumab pegol) for the treatment of adult patients with active psoriatic arthritis (PsA) and for adult patients with active axial spondyloarthritis (axSpA).

20 Feb 2013

Meloxicam recognizes and treats osteoarthritis in cats

Scientists at the University of Montreal's Quebec Research Group in Animal Pharmacology have found a way to recognize and treat osteoarthritis in cats - a condition that the owner might not notice and that can make even petting painful.

20 Feb 2013

Sucampo's RESCULA 0.15% now available by prescription across the U.S.

Sucampo Pharmaceuticals, Inc. today announced that RESCULA (unoprostone isopropyl ophthalmic solution) 0.15% is now available by prescription across the United States. The U.S. Food and Drug Administration (FDA) approved a sNDA for RESCULA for the lowering of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension on December 7, 2012.

19 Feb 2013

rEVO Biologics announces results from Atryn phase 3 studies on pregnant AT-deficient women

rEVO Biologics announced today the results of a major retrospective study analysis of its pivotal phase 3 studies which demonstrate that pregnant patients with hereditary antithrombin deficiency (HD) benefit from ATryn Antithrombin (Recombinant) therapy to prevent venous thromboembolic events (VTE).

16 Feb 2013

FDA approves Novartis’ Zortress to prevent organ rejection after liver transplantation in adults

Novartis announced today that the US Food and Drug Administration (FDA) has approved Zortress (everolimus) for the prophylaxis of organ rejection in adult patients receiving a liver transplant.

16 Feb 2013

Positive new data from Genzyme’s eliglustat tartrate Phase 3 studies on Gaucher disease type 1

Genzyme, a Sanofi company, today announced positive new data from the Phase 3 ENGAGE and ENCORE studies of eliglustat tartrate, its investigational oral therapy for Gaucher disease type 1.

15 Feb 2013

Dyax fourth quarter total revenues increase to $16.0 million

Dyax Corp. today announced financial results for the fourth quarter and year ended December 31, 2012.

14 Feb 2013

Celgene receives FDA approval for POMALYST to treat multiple myeloma

Celgene Corporation today announced the U.S. Food and Drug Administration (FDA) has approved POMALYST brand therapy (pomalidomide) for patients with multiple myeloma who have received at least two prior therapies including lenalidomide and bortezomib and have demonstrated disease progression on or within 60 days of completion of the last therapy.

10 Feb 2013

Shire commences ABH001 Phase 3 study in Epidermolysis Bullosa

Shire plc, today announced the initiation of a Phase 3 study designed to evaluate the efficacy and safety of ABH001, its dermal substitute therapy, for the treatment of non-healing wounds in patients with Epidermolysis Bullosa (EB), a group of rare genetic skin disorders that begin to manifest at birth or early childhood and occur in approximately 19 per 1 million live births in the US.