Hypersensitivity News and Research

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

Baxter to commence second GAMMAGARD LIQUID Phase III trial in Alzheimer's

Baxter International Inc. today provided an update on its clinical program evaluating the use of its GAMMAGARD LIQUID 10%, for the treatment of mild to moderate Alzheimer's disease.

From Baxter International Inc. 24 Jan 2012

EMA CHMP issues positive opinion to MSD's REMICADE for treatment of pediatric UC

MSD today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending the use of REMICADE (infliximab) in the treatment of severely active ulcerative colitis (UC) in pediatric patients ages 6 to 17 years, who have had an inadequate response to conventional therapy, including corticosteroids and 6-mercaptopurine or azathioprine, or who are intolerant to or have medical contraindications for such therapies.

21 Jan 2012

FDA approves product label change for Biogen Idec's TYSABRI to treat MS

Today Biogen Idec and Elan Corporation, plc announced that the U.S. Food and Drug Administration (FDA) has approved a product label change for TYSABRI that will help enable individual benefit risk assessment for patients with multiple sclerosis.

21 Jan 2012

ViroPharma's NDS for Cinryze receives Health Canada's Priority Review status

ViroPharma Incorporated today announced that Health Canada has granted the company Priority Review status for its New Drug Submission (NDS) for Cinryze (C1 inhibitor [human]).

13 Jan 2012

Shire, Janssen enter development and marketing agreement for Resolor

Shire plc, the global specialty biopharmaceutical company, announced today that it has acquired the rights to develop and market Resolor (prucalopride) in the United States (US) in an agreement with Janssen Pharmaceutica N.V.

11 Jan 2012

Shire acquires rights to develop and market Resolor in the U.S.

10 Jan 2012

Baxter submits GAMMAGARD LIQUID sBLA to FDA for treatment of MMN

Baxter International Inc. today announced that the company has submitted a supplemental biologics license application (sBLA) to the U.S. Food and Drug Administration (FDA) for approval of GAMMAGARD LIQUID 10% for the treatment of multifocal motor neuropathy.

From Baxter International Inc. 9 Jan 2012

Baxter commences BAX 855 Phase I trial in hemophilia A

Baxter International Inc. today announced the dosing of the first patients in a Phase I clinical trial of its lead investigational candidate, BAX 855, a longer-acting (PEGylated) form of a full-length recombinant factor VIII (rFVIII) protein.

From Baxter International Inc. 5 Jan 2012

CMS assigns J-code for Pharmaxis ARIDOL Bronchial Challenge Test Kit

Pharmaxis, Inc. today announced that the Centers for Medicare and Medicaid Services (CMS) has assigned a product-specific billing code, or J-code, for ARIDOL (mannitol inhalation powder) Bronchial Challenge Test Kit.

4 Jan 2012

Oral and tactile sensitivities in childhood can lead to OCD

In childhood, rituals like regular schedules for meal, bath, and bed times are a healthy part of behavioral development. But combined with oral and tactile sensitivities, such as discomfort at the dentist or irritation caused by specific fabrics, these rituals could be an early warning sign of adult Obsessive Compulsive Disorder.

27 Dec 2011

ACTF, Merck announce new HIV initiatives

Today, Merck, known as MSD outside the United States and Canada, and the ADAP Crisis Task Force (ACTF) announced a number of new initiatives to help struggling state AIDS Drug Assistance Programs (ADAPs) continue to provide access to medicines to people living with HIV.

22 Dec 2011

Anxious individuals are less sensitive to their environments: Study

Anxious people have long been classified as "hypersensitive" - they're thought to be more fearful and feel threatened more easily than their counterparts. But new research from Tel Aviv University shows that the anxious may not be hypersensitive at all - in fact, they may not be sensitive enough.

21 Dec 2011

UCB initiates EXXELERATE study in rheumatoid arthritis

UCB today announced the start of the EXXELERATE study which will evaluate the short- and long-term efficacy of Cimzia (certolizumab pegol) plus methotrexate (MTX) compared with that of Humira(adalimumab) plus MTX in the treatment of moderate to severe rheumatoid arthritis (RA). The start of this study confirms previously announced plans.

21 Dec 2011

Baxter receives FDA approval for ADVATE to prevent hemophilia A

Baxter International Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved ADVATE [Antihemophilic Factor (Recombinant) Plasma/Albumin Free Method] for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in patients with hemophilia A.

From Baxter International Inc. 17 Dec 2011

FDA approves modernized labeling for ViroPharma's Vancocin Capsules

ViroPharma Incorporated today announced the modernization of labeling for Vancocin (vancomycin hydrochloride, USP) Capsules made effective through the U.S. Food and Drug Administration's (FDA) approval of a supplemental new drug application.

15 Dec 2011

$Celgene reports final results from REVLIMID-rituximab combination phase II study for relapsed/refractory CLL$

Celgene reports final results from REVLIMID-rituximab combination phase II study for relapsed/refractory CLL

Celgene International Sàrl, a subsidiary of Celgene Corporation, (NASDAQ: CELG), announced final results from a phase II investigational study evaluating the combination of REVLIMID® (lenalidomide) and rituximab in 59 patients with relapsed or refractory chronic lymphocytic leukemia (CLL). These data were presented at the 53rd Annual Meeting of the American Society of Hematology in San Diego, CA.

14 Dec 2011

Celgene announces data from REVLIMID Phase III study on high-risk asymptomatic smoldering MM

Celgene International Sàrl, a subsidiary of Celgene Corporation, announced that updated data evaluating continuous treatment with REVLIMID (lenalidomide) in patients with high-risk asymptomatic smoldering multiple myeloma were presented at the 53rd Annual Meeting of the American Society of Hematology.

14 Dec 2011

Celgene reports final results from REVLIMID plus VIDAZA phase II study on higher-risk MDS

Celgene International Sàrl, a subsidiary of Celgene Corporation, today reported final results from the phase II portion of a multi-center phase I/II study evaluating combination therapy with REVLIMID (lenalidomide) and VIDAZA (azacitidine) in patients with higher-risk myelodysplastic syndromes (MDS) not previously treated with either drug.

13 Dec 2011

Celgene announces interim results of REVLIMID study on CLL

Celgene International Sàrl, a subsidiary of Celgene Corporation, announced interim results of CLL-009, a study evaluating three starting doses of REVLIMID (lenalidomide), followed by step-wise dose escalation as tolerated in patients with chronic lymphocytic leukemia (CLL) who have received at least one prior therapy.

12 Dec 2011

Novartis to showcase 160 presentations on breast cancer, hematological disease drugs at SABCS and ASH

Novartis Pharmaceuticals Corporation will showcase more than one hundred and sixty presentations on data from its robust oncology portfolio at two key medical congresses this month, demonstrating significant advances for patients with cancers and hematological diseases.

3 Dec 2011