Hypersensitivity News and Research

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

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

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

Hypersensitivity News and Research

Elan agrees to restructure Tysabri collaboration with Biogen Idec

Regular exercise reduces development of painful diabetic neuropathy in animals

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

FDA approves Genzyme’s KYNAMRO to treat homozygous familial hypercholesterolemia

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

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

Basal tryptase linked to severe reactions in children with sting allergy

Neuromuscular blockade (NMB) reversal

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

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

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