Hypersensitivity News and Research

RSS

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

FDA takes actions to help women, doctors better understand potential problems associated with Essure

The U.S. Food and Drug Administration announced today actions to provide important information about the risks of using Essure and to help women and their doctors be better informed of the potential complications associated with implantable forms of sterilization.

1 Mar 2016

Study assesses health problems related to food hypersensitivity

A study by researchers at the University of Southampton and Southampton General Hospital, is the first to assess the prevalence of two different types of food hypersensitivity and the risk factors associated with them.

1 Mar 2016

Baxalta seeks FDA approval for ADYNOVATE to treat children with hemophilia A and for use in surgical settings

Baxalta Incorporated, a global biopharmaceutical leader dedicated to delivering transformative therapies to patients with orphan diseases and underserved conditions, announced today that it has submitted supplemental Biologics License Applications (sBLAs) to the U.S. Food and Drug Administration seeking approval for the use of ADYNOVATE [Antihemophilic Factor (Recombinant), PEGylated] to treat children under the age of 12 with hemophilia A and for use in surgical settings.

26 Feb 2016

Romosozumab for postmenopausal women with osteoporosis meets co-primary endpoints in Phase 3 study

Amgen and UCB today announced top-line results from the Phase 3 placebo-controlled FRActure study in postmenopausal woMen with ostEoporosis (FRAME).

22 Feb 2016

Study: Many school children avoid basic foods due to perceived hypersensitivity

A study on hypersensitivity to the basic foods milk, egg, fish and wheat among young school children showed that reported food hypersensitivity was eight times more common than allergies confirmed by allergy tests. This according to a new dissertation at Umeå University.

17 Feb 2016

Allergan's sNDA for TEFLARO (ceftaroline fosamil) accepted by FDA

Allergan plc today announced the U.S. Food and Drug Administration has accepted for filing the company's supplemental New Drug Application (sNDA) for TEFLARO (ceftaroline fosamil).

16 Feb 2016

Iroko announces availability of VIVLODEX capsules in U.S. pharmacies for patients with OA pain

Iroko Pharmaceuticals, LLC, a global specialty pharmaceutical company dedicated to advancing the science of analgesia, announced today that VIVLODEX (meloxicam) capsules, a nonsteroidal anti-inflammatory drug (NSAID), is now available by prescription at pharmacies across the United States.

16 Feb 2016

Drugs designed to curb Rac1 signaling pathway may help relieve inflammatory pain in sufferers

New research uncovers a cascade of reactions within nerve cells that relay sensations of pain associated with inflammation. The findings, which are published in the British Journal of Pharmacology, indicate that drugs designed to curb this pathway may help relieve inflammatory pain in sufferers.

11 Feb 2016

Children with sensory processing disorder have altered pathways for brain connectivity

Researchers at UC San Francisco have found that boys and girls with sensory processing disorder (SPD) have altered pathways for brain connectivity when compared to typically developing children, and the difference predicts challenges with auditory and tactile processing.

27 Jan 2016

Amgen announces approval of cholesterol-lowering medication Repatha (evolocumab) Injection in Japan

Amgen today announced that the Japanese Ministry of Health, Labour and Welfare has approved the cholesterol-lowering medication Repatha (evolocumab) Injection, the first proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor to be approved in Japan.

22 Jan 2016

FDA approves Allergan's sNDA to update label for DALVANCE (dalbavancin) for injection

Allergan plc, a leading global pharmaceutical company, today announced the U.S. Food and Drug Administration has approved the company's supplemental new drug application (sNDA) to update the label for DALVANCE (dalbavancin) for injection.

21 Jan 2016

Lilly receives FDA approval for Humulin R U-500 KwikPen

The U.S. Food and Drug Administration has approved Eli Lilly and Company's Humulin R U-500 KwikPen(insulin human injection) 500 units/mL, a pre-filled device containing Humulin R U-500, a highly concentrated formulation of insulin.

21 Jan 2016

Novartis announces FDA approval of Cosentyx for treatment of adult patients with AS and PsA

Novartis announced today that the US Food and Drug Administration has approved Cosentyx (secukinumab) for two new indications - the treatment of adult patients with active ankylosing spondylitis (AS) and active psoriatic arthritis (PsA).

17 Jan 2016

FDA-approved, once-daily 24-hour aspirin now available for prevention of stroke and acute cardiac events

New Haven Pharmaceuticals, Inc. today announced the availability by prescription of DURLAZA, the first and only 24-hour, extended-release aspirin capsules (162.5mg) approved by the U.S. Food and Drug Administration (FDA) for the secondary prevention of stroke and acute cardiac events, including myocardial infarction (heart attack) in high-risk cardiovascular patients.

7 Jan 2016

NEJM publishes results of Cosentyx Phase III studies in ankylosing spondylitis

Novartis announced today that the results of the MEASURE 1 and MEASURE 2 Phase III studies for Cosentyx® (secukinumab) in ankylosing spondylitis (AS) were published in The New England Journal of Medicine (NEJM). These pivotal studies demonstrated significant clinical improvements with Cosentyx versus placebo in reducing the signs and symptoms of active AS – a long-term, painful and debilitating inflammation of the spine.

24 Dec 2015

Baxalta announces initial results from ADYNOVATE Phase 3 trial for treatment of hemophilia patients

Baxalta Incorporated, a global biopharmaceutical leader dedicated to delivering transformative therapies to patients with orphan diseases and underserved conditions, today announced initial results from a Phase 3 clinical trial of ADYNOVATE [Antihemophilic Factor (Recombinant), PEGylated], an extended circulating half-life recombinant Factor VIII (rFVIII) treatment for hemophilia A based on ADVATE [Antihemophilic Factor (Recombinant)].

22 Dec 2015

Basaglar (insulin glargine injection) approved to improve glycemic control in diabetes patients

The U.S. Food and Drug Administration today approved Basaglar (insulin glargine injection), a long-acting human insulin analog to improve glycemic control in adult and pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus.

17 Dec 2015

Bridion injection approved to reverse effects of neuromuscular blocking drugs used during certain types of surgery

The U.S. Food and Drug Administration today approved Bridion (sugammadex) injection to reverse the effects of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide, which are used during certain types of surgery in adults.

16 Dec 2015

Egalet, Teva sign agreement to commercialize SPRIX Nasal Spray in Israel, Gaza and the West Bank

Egalet Corporation, a fully integrated specialty pharmaceutical company focused on developing, manufacturing and commercializing innovative treatments for pain and other conditions, today announced a collaboration agreement with Teva Pharmaceutical Industries Ltd., a leading global pharmaceutical company.

14 Dec 2015

Impax's NUMIENT granted EC marketing authorization for symptomatic treatment of adult patients with Parkinson's disease

Impax Laboratories, Inc. today announced that the European Commission has granted marketing authorization for NUMIENT (Levodopa and Carbidopa), a modified-release oral capsule formulation for the symptomatic treatment of adult patients with Parkinson's disease.

25 Nov 2015