Hypersensitivity News and Research

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

Lilly and Boehringer Ingelheim's Basaglar (insulin glargine injection) gets FDA's tentative approval

The U.S. Food and Drug Administration today granted tentative approval for Basaglar (insulin glargine injection), which is indicated to improve glycemic control in adults with type 2 diabetes and in combination with mealtime insulin in adults and pediatric patients with type 1 diabetes.

19 Aug 2014

Sanofi, MannKind sign licensing agreement to develop and commercialize Afrezza Inhalation Powder

Sanofi and MannKind Corporation announced today that they have entered into a worldwide exclusive licensing agreement for development and commercialization of Afrezza (insulin human) Inhalation Powder, a new rapid-acting inhaled insulin therapy for adults with type 1 and type 2 diabetes.

11 Aug 2014

Mylan announces launch of Capecitabine Tablets USP, 150 mg and 500 mg

Mylan Inc. today announced that it has launched Capecitabine Tablets USP, 150 mg and 500 mg, the generic version of Genentech's Xeloda Tablets. Mylan received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application for this product, which is indicated as monotherapy, adjuvant therapy and combination therapy for certain types of breast, colon and colorectal cancers.

11 Aug 2014

Access Pharmaceuticals enters into exclusive license agreement with Norgine

ACCESS PHARMACEUTICALS, INC., an emerging biopharmaceutical company, today announced that it had entered into an exclusive license agreement with Norgine B.V., a leading independent European specialty pharmaceutical company, for the commercialization of MuGard in Europe.

7 Aug 2014

Researchers find differences in brain wiring between children with SPD and those with autism

Researchers at UC San Francisco have found that children with sensory processing disorders have decreased structural brain connections in specific sensory regions different than those in autism, further establishing SPD as a clinically important neurodevelopmental disorder.

31 Jul 2014

GSK announces availability of once-weekly Tanzeum in pharmacies throughout the U.S.

GSK today announced that once-weekly Tanzeum (albiglutide), a prescription injectable treatment for type 2 diabetes in adults, as an adjunct to diet and exercise, is now available in pharmacies throughout the U.S.

29 Jul 2014

Phase 3 trial: NEXAVAR tablets fail to meet primary endpoint in HER2-negative breast cancer patients

Bayer HealthCare and Onyx Pharmaceuticals Inc., an Amgen subsidiary, today announced that an investigational Phase 3 trial of NEXAVAR (sorafenib) tablets in patients with advanced breast cancer did not meet its primary endpoint of improving progression-free survival (PFS).

25 Jul 2014

Phase 3 VIVID-DME trial of EYLEA Injection for treatment of DME shows improvement in visual acuity

Regeneron Pharmaceuticals, Inc. today announced that in the Phase 3 VIVID-DME trial of EYLEA® (aflibercept) Injection for the treatment of diabetic macular edema (DME), EYLEA 2 milligrams (mg) dosed monthly (2Q4) and EYLEA 2 mg dosed every two months (after 5 initial monthly injections, 2Q8) showed a sustained improvement from baseline in best corrected visual acuity (BCVA) at week 100 (2 years), compared to laser photocoagulation.

18 Jul 2014

Urge incontinence therapy may relieve stress incontinence

Anticholinergic medication appears to be effective as a treatment for stress and mixed urinary incontinence, results of a small clinical trial indicate.

15 Jul 2014

New research opens up potential new therapeutic targets for hard-to-treat food allergy

New research in Nature Genetics identifies a novel genetic and molecular pathway in the esophagus that causes eosinophillic esophagitis (EoE), opening up potential new therapeutic strategies for an enigmatic and hard-to-treat food allergy.

14 Jul 2014

Medac Pharma's Rasuvo injection gets FDA approval for RA, pJIA and psoriasis

Medac Pharma, Inc., a privately held pharmaceutical company focused on the development of new molecules and improving the effectiveness of existing medicines, announced that the U.S. Food and Drug Administration has approved Rasuvo, a subcutaneous injectable methotrexate (MTX) therapy delivered in an auto-injector for rheumatoid arthritis (RA), polyarticular-course juvenile idiopathic arthritis (pJIA) and psoriasis.

14 Jul 2014

New method to repair pain

A study published in the scientific journal Nature Neuroscience by Yves De Koninck and Robert Bonin, two researchers at Universit- Laval, reveals that it is possible to relieve pain hypersensitivity using a new method that involves rekindling pain so that it can subsequently be erased.

9 Jul 2014

Researchers discover how metal beryllium triggers deadly immune response in the lungs

Using exquisitely detailed maps of molecular shapes and the electrical charges surrounding them, researchers at National Jewish Health have discovered how the metal beryllium triggers a deadly immune response in the lungs.

3 Jul 2014

UCB, Dermira enter into licensing agreement for development, commercialization of Cimzia

UCB, a global biopharmaceutical leader, and Dermira, Inc., a privately held US-based dermatology company, announced today that they have entered into an exclusive licensing agreement for the development and future commercialization of Cimzia (certolizumab pegol) in dermatology.

3 Jul 2014

Henry Ford launches clinical trial for treatment of tinnitus caused by noise trauma

Henry Ford Health System has launched a clinical trial to investigate a new drug for the treatment of tinnitus, a chronic ringing of the head or ears that affects more than 600 million people worldwide.

25 Jun 2014

OAB and interstitial cystitis/bladder pain syndrome show considerable overlap

There is considerable overlap between symptoms in patients with interstitial cystitis/bladder pain syndrome and those with overactive bladder, US researchers have shown.

23 Jun 2014

Celgene: OTEZLA phase III study for psoriatic arthritis meets primary endpoint

Celgene International Sàrl, a wholly-owned subsidiary of Celgene Corporation (NASDAQ:CELG), today announced results of additional analyses from the phase III clinical trials of OTEZLA, the Company's oral, selective inhibitor of phosphodiesterase 4 (PDE4).

11 Jun 2014

Bayer HealthCare seeks EU marketing authorization of EYLEA for macular edema following BRVO

Regeneron Pharmaceuticals, Inc. and Bayer HealthCare today announced that Bayer HealthCare has submitted an application to the European Medicines Agency (EMA) seeking marketing authorization in the European Union (EU) for EYLEA (aflibercept) Injection for the treatment of macular edema following branch retinal vein occlusion (BRVO).

11 Jun 2014

Merck enrolls first patient in reformulated raltegravir Phase 3 trial for treatment of HIV-1 infection

Merck, known as MSD outside the United States and Canada, today announced that the first patient has been enrolled in the company's global Phase 3 clinical trial, ONCEMRK.

6 Jun 2014

NEJM publishes results from SOLO I Phase 3 clinical trial of ORBACTIV for ABSSSI

The Medicines Company today announced the publication of the results from the SOLO I Phase 3 clinical trial of ORBACTIV (oritavancin), an investigational intravenous antibiotic treatment for Acute Bacterial Skin and Skin Structure Infections (ABSSSI), in the New England Journal of Medicine.

5 Jun 2014