Hypersensitivity News and Research

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

GE Healthcare announces commercial availability of new Alzheimer’s diagnostic tool

GE Healthcare today announced the first seven markets where Vizamyl (Flutemetamol F18 injection), a radioactive diagnostic agent approved by the FDA will be available. Late in the second quarter of 2014, Vizamyl will be available to imaging centers near East Rutherford, NJ, Woburn, MA, Beltsville, MD, East Lansing, MI, Dallas, TX, Phoenix, AZ and Colton, CA.

29 Apr 2014

GSK, Theravance announce availability of Anoro Ellipta in the US for COPD treatment

GlaxoSmithKline plc and Theravance, Inc. today announced that Anoro Ellipta (umeclidinium and vilanterol inhalation powder), the first once-daily product approved in the US that combines two long-acting bronchodilators in a single inhaler for the maintenance treatment of chronic obstructive pulmonary disease (COPD), is now available to retail pharmacies in the US.

28 Apr 2014

Researchers identify genetic factors that contribute to ADHD in humans

The 60 trillion cells that comprise our bodies communicate constantly. Information travels when chemical compounds released by some cells are received by receptors in the membrane of another cell.

26 Apr 2014

FDA approves GSK's Tanzeum as once-weekly treatment for type 2 diabetes

GlaxoSmithKline plc today announced that the US Food and Drug Administration has approved Tanzeum (albiglutide) for injection, for subcutaneous use, as a once-weekly treatment for type 2 diabetes. Tanzeum has been approved as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

16 Apr 2014

Access provides update on new formulation of anti-inflammatory drug amlexanox

ACCESS PHARMACEUTICALS, INC. (OTCBB: ACCP) provided an update on a new formulation of the anti-inflammatory drug amlexanox, called LexaGard™, for the treatment of inflammatory and ulcerative conditions of the esophagus.

8 Apr 2014

Pradaxa receives FDA approval for treatment and reduction of risk of recurrence of DVT and PE

Boehringer Ingelheim Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved Pradaxa® (dabigatran etexilate mesylate) for the treatment of deep venous thrombosis (DVT) and pulmonary embolism (PE) in patients who have been treated with a parenteral anticoagulant for five to 10 days, and to reduce the risk of recurrent DVT and PE in patients who have been previously treated. DVT and PE are collectively referred to as venous thromboembolism (VTE).

8 Apr 2014

rEVO Biologics commences ATryn Phase 3 clinical program for treatment of preeclampsia in pregnant women

rEVO Biologics Inc., a subsidiary of LFB SA, today announced the initiation of the Phase 3 clinical program for ATryn for the treatment of preeclampsia in pregnant women during the 24th to 28th week of pregnancy.

31 Mar 2014

Halozyme meets primary endpoint in Hylenex CONSISTENT 1 trial

Halozyme Therapeutics, Inc. today announced that the primary endpoint of non-inferiority of A1C levels at six months was met for the CONSISTENT 1 trial. The trial is evaluating Hylenex® recombinant and a new formulation of Hylenex currently under U.S Food and Drug Administration (FDA) review, when used as pretreatment of the insulin infusion site in patients with type 1 diabetes receiving continuous subcutaneous insulin infusion (CSII) in comparison to no pre-treatment.

31 Mar 2014

Pierre Fabre Dermatologie receives FDA marketing authorization for pediatric drug Hemangeol

Pierre Fabre Dermatologie has obtained marketing authorization from the FDA for the pediatric drug Hemangeol (propranolol hydrochloride), which is the first and only approved treatment for "proliferating infantile hemangioma requiring systemic therapy".

18 Mar 2014

Merck's NOXAFIL injection gets FDA approval for intravenous use

Merck, known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration has approved NOXAFIL (posaconazole) injection (18 mg/ mL), a new formulation of NOXAFIL for intravenous (IV) use.

16 Mar 2014

Bristol-Myers Squibb, Pfizer announce FDA approval of Eliquis for DVT prophylaxis

Bristol-Myers Squibb Company and Pfizer Inc. today announced that the U.S. Food and Drug Administration approved a Supplemental New Drug Application (sNDA) for Eliquis (apixaban) for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE), in patients who have undergone hip or knee replacement surgery.

16 Mar 2014

AbbVie's PEARL-III study meets primary, secondary endpoints in patients with chronic GT1b HCV infection

The first detailed results from AbbVie's pivotal phase III study, PEARL-III, were presented today as part of the 21st Conference on Retroviruses and Opportunistic Infections (CROI) press conference and will also be presented as a late-breaker at the conference on March 4.

4 Mar 2014

Bayer Yakuhin submits marketing authorization application in Japan for EYLEA Injection

Regeneron Pharmaceuticals, Inc. today announced that Bayer HealthCare's Japanese subsidiary, Bayer Yakuhin, Ltd., has submitted an application for marketing authorization for EYLEA (aflibercept) Injection for the treatment of patients with diabetic macular edema (DME) to the Japanese Ministry of Health, Labour and Welfare.

3 Mar 2014

Regeneron receives FDA acceptance for EYLEA injection for treatment of macular edema

Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has accepted for standard review the Company's supplemental Biologics License Application (sBLA) for EYLEA® (aflibercept) Injection for the treatment of Macular Edema following Branch Retinal Vein Occlusion (BRVO).

26 Feb 2014

FDA approves Iroko Pharmaceuticals’ TIVORBEX 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 TIVORBEX™ (indomethacin) capsules, a nonsteroidal anti-inflammatory drug (NSAID), at 20 mg and 40 mg doses for the treatment of mild to moderate acute pain in adults.

25 Feb 2014

Onset Dermatologics launches 75mg strength of MINOCIN pellet-filled capsules to treat bacterial infections

Onset Dermatologics, a leader in developing and commercializing prescription products for improving skin health, today announced the launch of a 75mg strength of MINOCIN (minocycline hydrochloride) Pellet-Filled Capsules.

25 Feb 2014

Researchers find new drug compound that treats laboratory mice with congenital heart disease

Congenital heart disease is the most common form of birth defect, affecting one out of every 125 babies, according to the National Institutes of Health. Researchers from the University of Missouri recently found success using a drug to treat laboratory mice with one form of congenital heart disease, hypertrophic cardiomyopathy - a weakening of the heart caused by abnormally thick muscle.

23 Feb 2014

Guerbet: FDA approves manufacturing plant for Lipiodol (ethiodized oil) Injection

Guerbet (GBT), the contrast agent specialist for medical imaging, today announced that it had received approval from the U.S. Food and Drug Administration (FDA) for a new manufacturing plant for Lipiodol® (ethiodized oil) Injection, in Montreal, Canada.

20 Feb 2014

Forest Laboratories plans to discontinue sale of NAMENDA 5 mg and 10 mg tablets

Forest Laboratories, Inc., a leading, fully integrated, specialty pharmaceutical company largely focused on the United States market, today announced that it plans to discontinue the sale of NAMENDA (memantine HCl) 5 mg and 10 mg tablets effective August 15, 2014.

16 Feb 2014

Jazz Pharmaceuticals' Versacloz now commercially available in the U.S. for schizophrenia

Jazz Pharmaceuticals plc today announced U.S. commercial availability of Versacloz (clozapine, USP) oral suspension, the first and only oral suspension clozapine for severely ill treatment-resistant schizophrenia patients or those at risk of recurrent suicidal behavior with schizophrenia or schizoaffective disorder.

11 Feb 2014