Hypersensitivity News and Research

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

FDA accepts for review Bristol-Myers Squibb's ORENCIA sBLA for severe RA

Bristol-Myers Squibb Company today announced that the U.S. Food and Drug Administration (FDA) has accepted for review a supplemental Biologics License Application (sBLA) for the subcutaneous formulation of ORENCIA® (abatacept), a treatment for adult patients with moderate to severe rheumatoid arthritis (RA) administered through an injection into the skin. Bristol-Myers Squibb submitted the sBLA to the FDA for the subcutaneous formulation of ORENCIA and received confirmation of its receipt on October 4, 2010.

7 Dec 2010

Study: REVLIMID and dexamethasone for high-risk smoldering multiple myeloma reduce risk of disease progression

Celgene International Sàrl (NASDAQ: CELG) announced that data evaluating combination therapy REVLIMID® (lenalidomide) and dexamethasone in patients with high-risk asymptomatic smoldering multiple myeloma were presented during the American Society of Hematology's annual meeting. The study reported REVLIMID and dexamethasone prolonged time to progression.

6 Dec 2010

Investigational study data of REVLIMID with rituximab or rituximab-containing regimen in CLL patients presented at ASH

Celgene International Sàrl announced that clinical data from two investigational studies evaluating the use of REVLIMID (lenalidomide) either with rituximab or following a rituximab-containing regimen in patients with chronic lymphocytic leukaemia were presented at the 52nd American Society of Hematology annual meeting.

6 Dec 2010

Amgen to present data on Nplate studies for chronic ITP at ASH Annual Meeting

Amgen today announced that it will present data from several key Nplate (romiplostim) studies at the 52nd Annual Meeting and Exposition of the American Society of Hematology (ASH), Dec. 4-7, 2010, in Orlando, Fla.

2 Dec 2010

Denmark grants marketing authorization for SUMAVEL DosePro Needle-Free Delivery System

Zogenix, Inc. and Desitin Pharmaceuticals GmbH today announced that the Danish Medicines Agency of Denmark has approved the Marketing Authorization Application (MAA) for SUMAVEL® DosePro™ (sumatriptan injection) Needle-Free Delivery System. Denmark is the first country in Europe to grant marketing authorization for SUMAVEL DosePro for the acute treatment of migraine attacks, with or without aura, and the acute treatment of cluster headache.

2 Dec 2010

Data on UCB’s anti-epileptic drugs to be presented at AES annual meeting

New data on UCB's anti-epileptic drug (AED) Vimpat (lacosamide) C-V will be presented at the 64th annual meeting of the American Epilepsy Society (AES), taking place at the San Antonio Convention Center in San Antonio, Texas from December 3 to 7, 2010. Data will also be presented on Keppra XR and the investigative epilepsy therapy, brivaracetam.

1 Dec 2010

Merck announces initial results from ISENTRESS Phase III study in HIV-1

Merck today reported initial results from the Phase III study investigating the efficacy and safety of a treatment regimen including ISENTRESS® (raltegravir) Tablets once daily in treatment-naïve adult patients infected with HIV-1. ISENTRESS is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in treatment-naïve and treatment-experienced adults.

29 Nov 2010

AMAG updates product label of Feraheme Injection

AMAG Pharmaceuticals, Inc. today announced that the company has reached agreement with the U.S. Food and Drug Administration (FDA) regarding an update to the product label for Feraheme (ferumoxytol) Injection for intravenous (IV) use.

29 Nov 2010

Phase 3 trial: TYSABRI improves vision in MS patients

Results recently presented from a study of multiple sclerosis (MS) patients taking TYSABRI (natalizumab) are supported by a Canadian woman's improved vision since starting the therapy.

25 Nov 2010

Erbitux development program featured in ASCO's Clinical Cancer Advances report for third consecutive year

For the third year in a row, the American Society of Clinical Oncology (ASCO) has included Erbitux® (cetuximab) research in its annual report, Clinical Cancer Advances, which features the most significant studies of 2010. The report cites as a notable advance this year the finding that BRAF mutation status is a prognostic, not predictive, marker for Erbitux efficacy in metastatic colorectal cancer (mCRC).

23 Nov 2010

Arthritis Foundation, Covidien join forces to help Americans suffering from osteoarthritis

The Arthritis Foundation and Covidien have joined forces to help advance awareness and support for millions of people suffering from osteoarthritis in the United States.

23 Nov 2010

VYTORIN reduces major vascular events in patients with chronic kidney disease

In a new investigational study of VYTORIN, the cholesterol-lowering medicine from Merck, VYTORIN 10/20 mg reduced the incidence of first major vascular events defined as non-fatal heart attacks or cardiac death, stroke or any revascularization procedure by a highly statistically significant 16.1 percent compared to placebo, Study of Heart and Renal Protection study involved more than 9,000 patients who, on average, had advanced or end-stage chronic kidney disease (CKD)

22 Nov 2010

Celldex presents ACT III Phase 2 clinical trial data for glioblastoma multiforme at SNO Meeting

Celldex Therapeutics, Inc., today announced the presentation of complete data for the primary endpoint of ACT III, a multi-center, single arm, Phase 2 clinical trial of rindopepimut (CDX-110) in patients with newly diagnosed glioblastoma multiforme (GBM).

21 Nov 2010

Pfizer's Phase 3 AXIS 1032 trial for metastatic renal cell carcinoma meets primary endpoint

Pfizer Inc. announced today that the Phase 3 AXIS 1032 trial (A4061032), studying the investigational compound axitinib in previously treated patients with metastatic renal cell carcinoma (mRCC), has met its primary endpoint, demonstrating that axitinib significantly extended progression-free survival when compared to sorafenib, in the study population.

20 Nov 2010

Merck wins third FOSAMAX bellwether trial

Merck & Co., Inc. today said a federal court jury in New York found in its favor in the Graves v. Merck case, rejecting the claims of a Florida woman who blamed her dental and jaw related problems on her FOSAMAX use. With today's verdict, Merck has won three of the first four bellwether cases in the FOSAMAX litigation.

20 Nov 2010

FDA approves new drug application for NEXTERONE Premixed Injection

Prism Pharmaceuticals, Inc. announced today that the U.S. Food & Drug Administration has approved the supplemental new drug application for NEXTERONE (amiodarone HCl) Premixed Injection, the first and only premixed intravenous (IV) bag formulation of the antiarrhythmic agent amiodarone IV.

19 Nov 2010

Merck announces FDA Advisory Committee approval of GARDASIL for anal cancer and AIN treatment

Merck announced today that the U.S. Food and Drug Administration's (FDA) Vaccines and Related Biological Products Advisory Committee has advised that the data presented support an indication for GARDASIL® [Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant] for the prevention of anal cancer and anal intraepithelial neoplasia (AIN) in both males and females 9 through 26 years of age.

18 Nov 2010

Enzon presents data on three investigational mRNA antagonists at EORTC-NCI-AACR Symposium

Enzon Pharmaceuticals, Inc. today presented data from preclinical studies of three investigational messenger RNA (mRNA) antagonists. These antagonists are based on the locked nucleic acid (LNA) technology platform targets licensed from Santaris Pharma A/S.

17 Nov 2010

ViroPharma presents data on Cinryze C1 esterase inhibitor for HAE at ACAAI Meeting

ViroPharma Incorporated today announced data in four poster presentations and two oral presentations relating to Cinryze (C1 esterase inhibitor [human]) at the 2010 Annual Meeting of the American College of Allergy, Asthma & Immunology (ACAAI), November 11 through 16 in Phoenix, Ariz.

16 Nov 2010

Talecris announces publication of A1PI studies for AAT deficiency in Respiratory Research journal

Talecris Biotherapeutics announced today the publication of combined data from two studies demonstrating that augmentation therapy with Alpha(1)-Proteinase Inhibitor (Human) (A1PI) significantly reduces lung tissue loss in patients with emphysema related to Alpha(1)-antitrypsin (AAT) deficiency.

15 Nov 2010