Hypersensitivity News and Research

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

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.

19 Oct 2013

FDA approves Cimzia for treatment of adults with active ankylosing spondylitis

UCB announced today that the U.S. Food and Drug Administration has approved Cimzia (certolizumab pegol) for the treatment of adults with active ankylosing spondylitis.

18 Oct 2013

Merck to present pharmacokinetic data on once-daily ISENTRESS at EACS

Merck, known as MSD outside the United States and Canada, is presenting pharmacokinetic data this week on investigational formulations of a once daily dose of ISENTRESS at the 14th European AIDS Conference, sponsored by the European AIDS Clinical Society.

17 Oct 2013

New England publishes results of phase III clinical trial of ABRAXANE for metastatic pancreatic cancer

Celgene International Sàrl, a wholly-owned subsidiary of Celgene Corporation , today announced the results of the MPACT phase III clinical trial of ABRAXANE® in combination with gemcitabine were published online in the October 16th edition of the New England Journal of Medicine.

17 Oct 2013

Neuroscientist receives CAREER grant to research on auditory processing and sound localization

Twenty years ago Khaleel A. Razak was an electronics engineering student focused on creating a telephone for hearing-impaired children in Chennai, India. Today he is a neuroscientist at the University of California, Riverside whose research on how the brain processes everyday sounds may lead to therapies for age-related hearing problems and Fragile X Syndrome.

10 Oct 2013

Researchers made breakthrough development in inhibitory therapeutic for hypersensitive allergic reactions

New research published in the journal Nature Chemical Biology shows that a group of scientists, led by faculty at the University of Notre Dame, has made concrete progress toward the development of the first-ever inhibitory therapeutic for Type I hypersensitive allergic reactions.

10 Oct 2013

FDA approves Clinolipid injectable emulsion for intravenous feeding in adult patients

The U.S. Food and Drug Administration today approved Clinolipid (lipid injectable emulsion, USP) for intravenous feeding (parenteral nutrition) in adult patients, providing a source of calories and essential fatty acids for adult patients who are unable to eat or drink. Clinolipid was granted a priority review to help alleviate a drug shortage.

5 Oct 2013

Amgen presents data from several romosozumab and Prolia at ASBMR 2013 Annual Meeting

Amgen today announced that it will present data from several romosozumab and Prolia® (denosumab) studies at the American Society for Bone and Mineral Research (ASBMR) 2013 Annual Meeting in Baltimore from Oct. 4-7, 2013.

5 Oct 2013

Exposure to farming environment may reduce symptoms of hypersensitivities, allergies

Adults who move to farming areas where they experience a wider range of environmental exposures than in cities may reduce the symptoms of their hypersensitivities and allergies considerably. This is the result of new research from Aarhus University.

1 Oct 2013

FDA grants accelerated approval to Perjeta for neoadjuvant treatment of breast cancer

The U.S. Food and Drug Administration today granted accelerated approval to Perjeta (pertuzumab) as part of a complete treatment regimen for patients with early stage breast cancer before surgery (neoadjuvant setting). Perjeta is the first FDA-approved drug for the neoadjuvant treatment of breast cancer.