Hypersensitivity News and Research

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

FDA approves Contrave extended-release tablets for chronic weight management

Takeda Pharmaceuticals U.S.A., Inc. and Orexigen® Therapeutics, Inc. jointly announced today that the U.S. Food and Drug Administration has approved Contrave® extended-release tablets as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial body mass index of 30 kg/m2 or greater (obese), or 27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbid condition.

11 Sep 2014

FDA approves Epaned for treatment of symptomatic and asymptomatic heart failure

Silvergate Pharmaceuticals, Inc., focused on the development and commercialization of innovative and safe medicines for children, today announced that the United States Food and Drug Administration approved Epaned for the treatment of symptomatic heart failure and the treatment of asymptomatic left ventricular dysfunction (to decrease the rate of development of overt heart failure and to reduce hospitalization for heart failure).

9 Sep 2014

FDA approves use of Menactra for booster vaccination against meningococcal disease

Sanofi Pasteur, the vaccines division of Sanofi, announced today that the U.S. Food and Drug Administration approved use of Menactra® [Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine] for booster vaccination against meningococcal disease in persons 15 years through 55 years of age.

9 Sep 2014

Restarting infliximab therapy after drug holiday is safe for patients with IBD

Restarting infliximab therapy after a drug holiday is safe and effective for patients with inflammatory bowel disease (IBD), according to a new study1 in Clinical Gastroenterology and Hepatology, the official clinical practice journal of the American Gastroenterological Association.

8 Sep 2014

FDA approves ViiV Healthcare's Triumeq tablets for treatment of HIV-1 infection

ViiV Healthcare announced today that the US Food and Drug Administration has approved Triumeq (abacavir 600mg, dolutegravir 50mg and lamivudine 300mg) tablets for the treatment of HIV-1 infection.

23 Aug 2014

Baxter reports positive results from BAX 855 Phase 3 trial for hemophilia A

Nektar Therapeutics reports Baxter International Inc. today announced positive results from its Phase 3 pivotal clinical trial of BAX 855, an investigational, extended half-life recombinant factor VIII (rFVIII) treatment for hemophilia A based on ADVATE [Antihemophilic Factor (Recombinant)], which met its primary endpoint in reducing annualized bleed rates (ABR) in the prophylaxis arm compared to the on-demand arm.

From Baxter International Inc. 22 Aug 2014

FDA approves GlaxoSmithKline’s Arnuity Ellipta for treatment of asthma

GlaxoSmithKline plc today announced that the FDA has approved Arnuity™ Ellipta® (fluticasone furoate inhalation powder), a once-daily inhaled corticosteroid (ICS) medicine for maintenance treatment of asthma as prophylactic therapy in patients aged 12 years and older. Arnuity is not indicated for relief of acute bronchospasm.

21 Aug 2014

NASA study reveals how spaceflight affects immune system of crew members

There is nothing like a head cold to make us feel a little dazed. We get things like colds and the flu because of changes in our immune system. Researchers have a good idea what causes immune system changes on Earth-think stress, inadequate sleep and improper nutrition.

19 Aug 2014

New research finds that early use of antibiotics can alter immunity later on

New University of British Columbia research found that receiving antibiotic treatments early in life can increase susceptibility to specific diseases later on.

19 Aug 2014

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

Hypersensitivity News and Research

FDA approves Contrave extended-release tablets for chronic weight management

FDA approves Epaned for treatment of symptomatic and asymptomatic heart failure

FDA approves use of Menactra for booster vaccination against meningococcal disease

Restarting infliximab therapy after drug holiday is safe for patients with IBD

FDA approves ViiV Healthcare's Triumeq tablets for treatment of HIV-1 infection

Baxter reports positive results from BAX 855 Phase 3 trial for hemophilia A

FDA approves GlaxoSmithKline’s Arnuity Ellipta for treatment of asthma

NASA study reveals how spaceflight affects immune system of crew members

New research finds that early use of antibiotics can alter immunity later on

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

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

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

Access Pharmaceuticals enters into exclusive license agreement with Norgine

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

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

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

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

Urge incontinence therapy may relieve stress incontinence

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

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

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