Hypersensitivity News and Research

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

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.

10 Feb 2013

Elan agrees to restructure Tysabri collaboration with Biogen Idec

Elan Corporation, plc today announced that it has agreed to restructure the Tysabri® collaboration with Biogen Idec.

6 Feb 2013

Regular exercise reduces development of painful diabetic neuropathy in animals

Regular exercise reduces the development of painful diabetic neuropathy in animals—apparently related to increased expression of a protective substance called "heat shock protein" 72 (Hsp72), reports an experimental study in the February issue of Anesthesia & Analgesia, official journal of the International Anesthesia Research Society (IARS).

5 Feb 2013

AIBioTech announces implementation of L-asparaginase activity assay for pediatric ALL

AIBioTech is pleased to announce implementation of a new laboratory derived test to measure L-asparaginase levels in patients being treated with any of the current asparaginase drugs including: Oncaspar, Kidrolase, Erwinaze, and Elspar.

5 Feb 2013

FDA approves Genzyme’s KYNAMRO to treat homozygous familial hypercholesterolemia

Genzyme, a Sanofi company, and Isis Pharmaceuticals Inc., today announced that the U.S. Food and Drug Administration (FDA) has approved its New Drug Application (NDA) for KYNAMROTM (mipomersen sodium) injection.

30 Jan 2013

FDA approves Takeda’s NESINA, OSENI and KAZANO for treatment of type 2 diabetes

Takeda Pharmaceutical Company Limited and its wholly-owned subsidiary, Takeda Pharmaceuticals U.S.A., Inc. today announced that the United States (U.S.) Food and Drug Administration (FDA) has approved NESINA (alogliptin) and the fixed-dose combination (FDC) therapies OSENI (alogliptin and pioglitazone) and KAZANO (alogliptin and metformin HCl) for the treatment of type 2 diabetes in adults as adjuncts to diet and exercise.

28 Jan 2013

Takeda receives FDA approval for Nesina, Kazano and Oseni to treat type 2 diabetes

The U.S. Food and Drug Administration today approved three new related products for use with diet and exercise to improve blood sugar control in adults with type 2 diabetes: Nesina (alogliptin) tablets, Kazano (alogliptin and metformin hydrochloride) tablets, and Oseni (alogliptin and pioglitazone) tablets.

28 Jan 2013

Basal tryptase linked to severe reactions in children with sting allergy

Elevated levels of serum basal tryptase are associated with an increased risk for systemic reactions in children with insect venom allergy, research shows.

25 Jan 2013

Neuromuscular blockade (NMB) reversal

General anesthesia is made up of three components: hypnotic medicines, to induce sleep; analgesics, or medicines to inhibit pain; and NMB agents that induce muscle relaxation. Anesthesiology professionals use NMB to relax a patient’s muscles and prevent involuntary movement that could impact surgery.

24 Jan 2013

STA announces results from ABRAXANE plus gemcitabine phase III trial on pancreatic cancer

Australian biopharmaceutical company Specialised Therapeutics Australia announces that a phase III clinical trial of world leading breast cancer drug ABRAXANE (nanoparticle albumin-bound paclitaxel) in combination with current standard of care gemcitabine in patients with advanced pancreatic cancer has demonstrated substantially improved survival times, with double the number of patients surviving two years.

23 Jan 2013