Hypersensitivity News and Research

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

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

New Haven Pharmaceuticals' DURLAZA drug delivers sustained antiplatelet control for full 24 hours

New Haven Pharmaceuticals, Inc. today announced new study data that shows the company's FDA-approved drug DURLAZA delivers sustained antiplatelet control for a full 24-hour period in high-risk patients.

10 Nov 2015

Inner ear damage brain warnings from nerve cells

Some nerve cells in the inner ear can signal tissue damage in a way similar to pain-sensing nerve cells in the body, according to new research from Johns Hopkins.

10 Nov 2015

New funding for Centenary's life saving research

The Centenary Institute has welcomed the Federal Government’s announcement of funding for 9 new and innovative medical research projects via the latest round of NHMRC grant rounds funding, officially confirmed today.

9 Nov 2015

Researchers uncover important mechanism that could help protect against infection, allergy and cancer

New research has uncovered an important mechanism in the drive to understand immunological processes that protect us against infection, allergy and cancer.

5 Nov 2015

Nucala (mepolizumab) approved for treatment of asthma patients

The U.S. Food and Drug Administration today approved Nucala (mepolizumab) for use with other asthma medicines for the maintenance treatment of asthma in patients age 12 years and older. Nucala is approved for patients who have a history of severe asthma attacks (exacerbations) despite receiving their current asthma medicines.

5 Nov 2015

FDA approves Yondelis (trabectedin) for treatment of specific soft tissue sarcomas

The U.S. Food and Drug Administration today approved Yondelis (trabectedin), a chemotherapy, for the treatment of specific soft tissue sarcomas (STS) – liposarcoma and leiomyosarcoma – that cannot be removed by surgery (unresectable) or is advanced (metastatic).

24 Oct 2015

Strensiq approved for treatment of patients with juvenile-onset HPP

Today, the U.S. Food and Drug Administration approved Strensiq (asfotase alfa) as the first approved treatment for perinatal, infantile and juvenile-onset hypophosphatasia (HPP).

24 Oct 2015

Researchers to present case report of acute inhalation lung injury related to use of e-cigarettes

Researchers from White River Junction VA Hospital, in Junction, Vermont, will present a case report of acute inhalation lung injury related to the use of e-cigarettes and a flavored e-cigarette liquid containing diacetyl.

20 Oct 2015

Takeda highlights safety, efficacy of vedolizumab for UC and CD at ACG Annual Scientific Meeting

Takeda Pharmaceuticals, U.S.A., Inc., today announced that data highlighting the efficacy and safety of vedolizumab for the treatment of adults with moderately to severely active ulcerative colitis (UC) and Crohn's disease (CD), will be presented during the 2015 American College of Gastroenterology Annual Scientific Meeting in Honolulu, Hawaii, held on October 16-21.

20 Oct 2015

Boehringer Ingelheim announces FDA approval of Praxbind (idarucizumab)

Boehringer Ingelheim Pharmaceuticals, Inc. today announced the U.S. Food and Drug Administration granted approval of Praxbind (idarucizumab). PRAXBIND is indicated for patients treated with Pradaxa (dabigatran etexilate mesylate), when reversal of the anticoagulant effects of dabigatran is needed for emergency surgery/urgent procedures or in life-threatening or uncontrolled bleeding.

16 Oct 2015

Loyola University successfully performs double-lung transplant in patient with debilitating lung disease

Before he developed a debilitating lung disease, outdoorsman Michael Olson had taken 57 canoe and fishing trips to Canada.

13 Oct 2015