Hypersensitivity News and Research

RSS

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

Bayer, Regeneron commence EYLEA Phase 3 clinical trial for wet AMD in China

Regeneron Pharmaceuticals, Inc. and Bayer HealthCare today announced that they have initiated a Phase 3 clinical trial evaluating the efficacy and safety of EYLEA (aflibercept) Injection in the neovascular form of age-related macular degeneration (wet AMD) in China.

28 Nov 2011

Celgene to discontinue docetaxel and prednisone plus lenalidomide Phase III trial on CRPC

Celgene International Sàrl, a subsidiary of Celgene Corporation, announced that based on the recommendation from the Data Monitoring Committee (DMC) it will discontinue its pivotal double-blinded Phase III MAINSAIL trial that was designed to evaluate the efficacy and safety of docetaxel and prednisone with or without lenalidomide in patients with castrate-resistant prostate cancer.

23 Nov 2011

FDA accepts Regeneron's ARCALYST sBLA for review

Regeneron Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Company's supplemental Biologics License Application (sBLA) for ARCALYST Injection for Subcutaneous Use for the prevention of gout flares in patients initiating uric acid-lowering therapy.

22 Nov 2011

Scientists search for main culprit behind Sj-gren's syndrome

Researchers want to find the main culprit behind the dry, irritated eyes, mouth, throat, skin, nose and more afflicting 1-3 percent of the population.

22 Nov 2011

Swissmedic approves REVLIMID for treatment of myelodysplastic syndromes

Celgene International Sàrl, a subsidiary of Celgene Corporation, today announced that REVLIMID (lenalidomide) has been granted approval by the Swiss agency for Therapeutic Products (Swissmedic) for use in patients with transfusion-dependent anemia due to low-or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenic abnormality with or without additional cytogenic abnormalities.

21 Nov 2011

FDA approves EUSA's orphan drug ERWINAZE for acute lymphoblastic leukemia

EUSA Pharma, a transatlantic specialty pharmaceutical company focused on oncology, oncology supportive care and critical care, today announced that the US Food and Drug Administration (FDA) has approved its orphan drug ERWINAZE (asparaginase Erwinia chrysanthemi) for the treatment of acute lymphoblastic leukemia (ALL) in patients with hypersensitivity to E. coli-derived asparaginase.

19 Nov 2011

FDA approves EYLEA for treatment of wet Age-related Macular Degeneration

Regeneron Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration has approved EYLEA (aflibercept) Injection, known in the scientific literature as VEGF Trap-Eye, for the treatment of patients with neovascular (wet) Age-related Macular Degeneration (AMD) at a recommended dose of 2 milligrams every four weeks for the first 12 weeks, followed by 2 mg every eight weeks.

19 Nov 2011

EUSA Pharma receives FDA approval for Erwinaze to treat ALL

The U.S. Food and Drug Administration today approved Erwinaze to treat patients with acute lymphoblastic leukemia (ALL), who have developed an allergy (hypersensitivity) to E. coli derived asparaginase and pegaspargase chemotherapy drugs used to treat ALL.

18 Nov 2011

Amgen receives EC approval to extend therapeutic indications for Vectibix

Amgen today announced that the European Commission (EC) has approved a variation to the marketing authorization for Vectibix (panitumumab) to include indications for the treatment of patients with wild-type KRAS metastatic colorectal cancer (mCRC) in first-line in combination with FOLFOX and in second-line in combination with FOLFIRI in patients who have received first-line fluoropyrimidine-based chemotherapy.

16 Nov 2011

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