Hypersensitivity News and Research

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

Ipsen reports positive initial results from Dysport phase III study in Adult Upper Limb spasticity

Ipsen today announced positive initial results from the double-blind phase III study of Dysport (abobotulinumtoxinA) in Adult Upper Limb spasticity. Regarding the primary endpoints, treatment with Dysport showed statistically significant response versus placebo in the improvement of muscle tone, as measured by the Modified Ashworth Scale.

17 Dec 2013

Research findings could provide better understanding of anxiety disorders

In a new study published today in Science, John McGann, associate professor of behavioral and systems neuroscience in the Department of Psychology, and his colleagues, report that neurons in the noses of laboratory animals reacted more strongly to threatening odors before the odor message was sent to the brain.

13 Dec 2013

Celgene subsidiary presents REVLIMID study results on lymphoma at ASH annual meeting

Celgene International Sàrl, a wholly-owned subsidiary of Celgene Corporation (NASDAQ:CELG) today announced that results from two studies of REVLIMID (lenalidomide) combinations in patients with diffuse large B-cell lymphoma (DLBCL) were presented at the American Society of Hematology annual meeting in New Orleans, La.

11 Dec 2013

Navidea receives Fast Track designation for Lymphoseek injection

Navidea Biopharmaceuticals, Inc. (NYSE MKT:NAVB), a biopharmaceutical company focused on precision diagnostic radiopharmaceuticals, announced today that the US Food and Drug Administration (FDA) has granted Fast Track designation to Lymphoseek® (technetium 99m tilmanocept) Injection for sentinel lymph node detection in patients with head and neck cancer.

11 Dec 2013

EMA expands administration options for Hizentra

CSL Behring UK Ltd announced today that the European Medicines Agency (EMA) has expanded the administration options for Hizentra®▼, human normal immunoglobulin, SCIg, 20% liquid, to include dosing once every two weeks (fortnightly).

5 Dec 2013

Forest Laboratories to acquire exclusive rights in the U.S. for Saphris sublingual tablets

Forest Laboratories Holdings Limited, a wholly owned subsidiary of Forest Laboratories, Inc. today announced that the company is acquiring exclusive rights in the United States for Saphris (asenapine) sublingual tablets, a treatment for adult patients with schizophrenia or acute bipolar mania, from Merck Sharp & Dohme B.V., a wholly owned subsidiary of Merck & Co., Inc.

3 Dec 2013

Merck announces approval of NOXAFIL delayed-release tablets by FDA

Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved NOXAFIL® (posaconazole) 100 mg delayed-release tablets.

27 Nov 2013

CHMP adopts positive opinion for ABRAXANE with gemcitabine for treatment of metastatic pancreas

Celgene International Sàrl, a wholly-owned subsidiary of Celgene Corporation, today announced that the European Medicines Agency's: Committee for Medicinal Products for Human Use has adopted a positive opinion for ABRAXANE (paclitaxel formulated as albumin bound nanoparticles, or nab-paclitaxel) in combination with gemcitabine for first-line treatment of adult patients with metastatic adenocarcinoma of the pancreas.

25 Nov 2013

EYLEA Injection gets approval in Japan for treatment of macular edema following CRVO

Regeneron Pharmaceuticals, Inc. today announced that EYLEA (aflibercept) Injection has received approval for the treatment of Macular Edema Following Central Retinal Vein Occlusion from the Japanese Ministry of Health, Labour and Welfare.

22 Nov 2013

FDA accepts Merck's NOXAFIL IV solution NDA for priority review

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

18 Nov 2013

Novel combination anti-psoriasis therapy targets genetic abnormalities in deeper layers of the skin

A novel combination anti-psoriasis therapy has potential for superior and longer-lasting therapeutic effects than current topical treatments by targeting genetic abnormalities in deeper layers of the skin. This research is being presented at the 2013 American Association of Pharmaceutical Scientists Annual Meeting and Exposition, the world's largest pharmaceutical sciences meeting, in San Antonio, Nov. 10-14.

15 Nov 2013

Shield Therapeutics files IND application with FDA to initiate ST10 Phase 3 study

Shield Therapeutics, an independent specialty pharmaceutical company focused on the development of mineral-derived hospital pharmaceuticals, today announces that it has filed an investigational new drug application with the US Food and Drug Administration to initiate a Phase 3 pivotal study of ST10, its novel oral iron-replacement therapy, for the treatment of iron deficiency anaemia in pre-dialysis patients with chronic kidney disease.

12 Nov 2013

Cumberland Pharmaceuticals net revenue decreases from $12.5 to $6.5 million

Cumberland Pharmaceuticals Inc. (NASDAQ: CPIX), a specialty pharmaceutical company focused on hospital acute care and gastroenterology, today announced third quarter 2013 financial results.

5 Nov 2013

FDA approves Prior Approval Supplement for EMBEDA Extended Release Capsules CII

Pfizer Inc. announced today that the U.S. Food and Drug Administration has approved a Prior Approval Supplement for EMBEDA (morphine sulfate and naltrexone hydrochloride) Extended Release Capsules CII.

4 Nov 2013

Absence of vision from birth leads to permanent state of pain hypersensitivity, shows report

Absence of vision from birth leads to a permanent state of pain hypersensitivity, reports PAIN. An international team of scientists investigated whether congenitally blind subjects experience pain differently than sighted individuals. Their results, published in the current issue of PAIN®, reveal compelling evidence that congenitally blind individuals are hypersensitive to pain caused by thermal stimuli.

3 Nov 2013

Once-daily prescription medicine for COPD now available throughout the U.S.

GlaxoSmithKline plc and Theravance, Inc. today announced that BREO ELLIPTA, a once-daily prescription medicine for chronic obstructive pulmonary disease, is now available to pharmacies throughout the U.S.

30 Oct 2013

Regeneron announces topline results from Phase 3 study of EYLEA Injection in patients with Macular Edema following BRVO

Regeneron Pharmaceuticals, Inc. today announced positive topline results for EYLEA® (aflibercept) Injection from the Phase 3 VIBRANT study in patients with Macular Edema following Branch Retinal Vein Occlusion (BRVO).

21 Oct 2013

Pfizer announces top-line results from phase 3b studies with Lyrica Capsules

Pfizer Inc. (NYSE:PFE) announced top-line results from two phase 3b, placebo-controlled studies with Lyrica® (pregabalin) Capsules CV in patients with fibromyalgia (FM) and painful diabetic peripheral neuropathy (DPN), respectively.

19 Oct 2013

FDA approves Iroko Pharmaceuticals’ ZORVOLEX capsules

Iroko Pharmaceuticals, LLC, a global specialty pharmaceutical company dedicated to advancing the science of analgesia, today announced that the U.S. Food and Drug Administration (FDA) has approved ZORVOLEX™ (diclofenac) capsules, a nonsteroidal anti-inflammatory drug (NSAID), for the treatment of mild to moderate acute pain in adults. ZORVOLEX was approved at dosage strengths that are 20 percent lower than currently available diclofenac products.