Hypersensitivity News and Research

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

Feraheme as safe and effective as iron sucrose in patients with anemia, CKD

AMAG Pharmaceuticals, Inc. today announced positive new data from the FIRST head-to-head trial comparing Feraheme (ferumoxytol) Injection for intravenous (IV) use to iron sucrose in patients with iron deficiency anemia and chronic kidney disease.

14 Nov 2011

Positive results from Alkermes VIVITROL addiction study

Alkermes plc today presented positive results from a long-term study of VIVITROL (naltrexone for extended-release injectable suspension) at the 24th Annual U.S. Psychiatric and Mental Health Congress in Las Vegas, NV.

10 Nov 2011

DuoCort Pharma granted marketing authorization for adrenal insufficiency drug, Plenadren in Europe

The Swedish specialty pharma company, DuoCort Pharma, announced today that the European Commission has granted a European Marketing Authorisation for Plenadren (hydrocortisone, modified release tablet), an orphan drug for treatment of adrenal insufficiency in adults, bringing these patients their first pharmaceutical innovation in over 50 years.

7 Nov 2011

UCB to sponsor several key sets of Cimzia data on RA at ACR 2011 meeting

UCB, a leading biopharmaceutical company at the forefront of immunology treatment and research, is proud to sponsor several key sets of Cimzia (certolizumab pegol) data at the American College of Rheumatology's 2011 Annual Scientific Meeting in Chicago, November 5-9.

7 Nov 2011

Human Genome Sciences to present abstracts regarding BENLYSTA, SLE at ACR/ARHP meeting

Human Genome Sciences, Inc. announced today that several abstracts related to BENLYSTA (belimumab) and systemic lupus erythematosus will be presented at the annual meeting of the American College of Rheumatology/ Association of Rheumatology Health Professionals, being held in Chicago, IL from November 4 to November 9, 2011.

5 Nov 2011

AMAG reports third quarter total revenues of $17.6 million

AMAG Pharmaceuticals, Inc. today reported unaudited consolidated financial results for the third quarter ended September 30, 2011.

4 Nov 2011

Baxter launches NUMETA emulsion for infusion in Europe

Baxter International Inc. announced today the European launch of NUMETA (emulsion for infusion).

From Baxter International Inc. 4 Nov 2011

FDA EMDAC votes to recommend approval of Merck's VYTORIN for pre-dialysis CKD

Merck, known as MSD outside the United States and Canada, announced today that the Endocrinologic and Metabolic Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) unanimously voted to recommend approval of Merck's VYTORIN (ezetimibe/simvastatin) for use in patients with pre-dialysis chronic kidney disease.

3 Nov 2011

UCB to present new data on Cimzia at ACG annual scientific meeting

UCB, a leading biopharmaceutical company at the forefront of immunology treatment and research, will present new data on Cimzia at the American College of Gastroenterology (ACG) Annual Scientific Meeting, taking place in Washington D.C. from October 28 to November 2.

1 Nov 2011

J&JPRD submits NUCYNTA ER sNDA to FDA for DPN associated neuropathic pain

Johnson & Johnson Pharmaceutical Research & Development, L.L.C. announced today that it has submitted a supplemental New Drug Application to the U.S. Food and Drug Administration for NUCYNTA ER (tapentadol) extended-release tablets, an oral analgesic, for the management of neuropathic pain associated with diabetic peripheral neuropathy in adults.

31 Oct 2011

Avanir seeks EMA marketing authorization for NUEDEXTA to treat pseudobulbar affect

Avanir Pharmaceuticals, Inc. announced today that it has submitted an application to the European Medicines Agency seeking marketing authorization for NUEDEXTA (dextromethorphan HBr and quinidine sulfate) for the treatment of pseudobulbar affect.

31 Oct 2011

EC approves Pfizer's pneumococcal conjugate vaccine, Prevenar 13

Pfizer Inc. announced today that the European Commission has approved the Company's pneumococcal conjugate vaccine, Prevenar 13 (pneumococcal polysaccharide conjugate vaccine, for active immunization for the prevention of vaccine-type invasive disease caused by Streptococcus pneumoniae in adults aged 50 years and older.

27 Oct 2011

FDA accepts Ironwood and Forest Laboratories' linaclotide NDA for review

Ironwood Pharmaceuticals, Inc. and Forest Laboratories, Inc. today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for linaclotide for the treatment of irritable bowel syndrome with constipation (IBS-C) and chronic constipation.

24 Oct 2011

Positive top line results from Shire's LDX phase III study on ADHD

Shire plc, the global specialty biopharmaceutical company, today presented positive top line results of the first European phase III study of once-daily lisdexamfetamine dimesylate (LDX) in children and adolescents aged 6 to 17 years with Attention-Deficit/Hyperactivity Disorder.

22 Oct 2011

Genentech announces 96-week results from ocrelizumab Phase II study on RRMS

Genentech, a member of the Roche Group, today announced 96-week results from a Phase II study of ocrelizumab in patients with relapsing-remitting multiple sclerosis (RRMS), the most common clinical form of the disease.

21 Oct 2011

Study evaluates pain associated with surgical incisions/scars before repeat cesarean procedures

A study presented at ANESTHESIOLOGY 2011 in Chicago is perhaps the first to evaluate pain associated with surgical incisions or scars before repeat cesarean (CS) procedures, and the data could lead to improved care for a rapidly growing and unique group of patients.

18 Oct 2011

Engineered HBLs could prevent deadly allergic reactions

Researchers from the University of Notre Dame have announced a breakthrough approach to allergy treatment that inhibits food allergies, drug allergies, and asthmatic reactions without suppressing a sufferer's entire immunological system.

14 Oct 2011

Shield commences two ST10 Phase 3 studies in iron deficiency anaemia

Shield Therapeutics (Shield), the independent specialty pharmaceutical company focused on the development and commercialisation of late-stage, mineral-derived hospital pharmaceuticals which address areas of high unmet medical need, today announced that the first patients have been treated in the two Phase 3 clinical studies of ST10 for the treatment of iron deficiency anaemia (IDA) in subjects with inflammatory bowel disease.

12 Oct 2011

FDA approves NDA for Edgemont's Fluoxetine 60 mg tablet

Edgemont Pharmaceuticals, LLC, a neuroscience focused company, today announced that the U.S. Food and Drug Administration (FDA) has approved its New Drug Application (NDA) for Fluoxetine Tablets 60 mg.

12 Oct 2011

DARA BioSciences' KRN5500 reduces neuropathic pain in patients with cancer

DARA BioSciences, Inc. today announced the Journal of Pain and Symptom Management, an internationally respected, peer-reviewed journal, has published results of a Phase II safety and efficacy study of KRN5500 for the treatment of neuropathic pain in patients with cancer.

11 Oct 2011