Hypersensitivity News and Research

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

EMA CHMP issues positive opinion for Baxter's IVIG therapy for multifocal motor neuropathy

Baxter International Inc. announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion for extension of the therapeutic indications of KIOVIG to include a new indication for multifocal motor neuropathy (MMN), a severe, debilitating disorder requiring lifelong treatment.

From Baxter International Inc. 24 Jun 2011

Endo's complete response for new formulation of OPANA ER NDA accepted by the FDA

Endo Pharmaceuticals announced today that it received notification from the U.S. Food and Drug Administration (FDA) that Endo's complete response to the FDA's Jan. 7, 2011 Action Letter relating to Endo's new drug application (NDA) for a new formulation of OPANA ER has been accepted.

24 Jun 2011

Pfizer Lyrica Phase 3 study on Central Neuropathic Pain meets primary endpoint

Pfizer Inc. announced today that top-line results for Lyrica Study A0081107 - Central Neuropathic Pain Following Spinal Cord Injury - demonstrated that the study met its primary endpoint: positive efficacy in reducing Central Neuropathic Pain following Spinal Cord Injury with Lyrica compared to placebo.

22 Jun 2011

Acura, Pfizer receive FDA approval for OXECTA Tablets to manage severe pain

Pfizer Inc. and Acura Pharmaceuticals Inc. announce the marketing approval from the U.S. Food and Drug Administration (FDA) of OXECTATM Tablets CII.

20 Jun 2011

Celgene announces data from REVLIMID plus rituximab Phase II study on malignant lymphomas

Celgene International Sàrl announced that clinical data from a Phase II study, conducted by investigators from the MD Anderson Cancer Center in Houston, TX, evaluating the combination regimen of REVLIMID plus rituximab (R2) in untreated, advanced stage, indolent B-cell non-Hodgkin's lymphomas, were presented at the 11th International Conference on Malignant Lymphoma in Lugano, Switzerland.

18 Jun 2011

Celgene, GELA to conduct REVLIMID/rituximab combination study on newly diagnosed FL

Groupe d'Etude des Lymphomes de l'Adulte (GELA) and Celgene International Sarl today announced a collaboration to conduct an international randomized study to evaluate the therapeutic potential of the REVLIMID/rituximab combination regimen (R2) in patients with newly diagnosed follicular lymphoma.

17 Jun 2011

REVLIMID-R-CHOP Phase I/II data in untreated DLBCL presented at malignant lymphoma conference

Celgene International Sàrl announced that clinical data from two studies evaluating the use of REVLIMID® (lenalidomide) with standard R-CHOP chemotherapy in patients with untreated diffuse large B cell (DLBCL) or grade 3 follicular lymphoma were presented at the 11th International Conference on Malignant Lymphoma in Lugano, Switzerland.

17 Jun 2011

ViroPharma receives European Centralized Marketing Authorization for Cinryze for treatment of HAE

ViroPharma Incorporated today announced that the European Commission has granted ViroPharma Centralized Marketing Authorization for Cinryze (C1 inhibitor [human]) in adults and adolescents with hereditary angioedema (HAE) for routine prevention, pre-procedure prevention and acute treatment of angioedema attacks.

16 Jun 2011

GE Healthcare announces results of Optison heart ultrasound contrast agent presented at ASE

Today, GE Healthcare Medical Diagnostics announced results of a study that evaluated the cardiopulmonary safety of Optison- (Perflutren Protein-Type A Microspheres Injectable Suspension, USP), a diagnostic ultrasound contrast agent for use in improving suboptimal echocardiograms.

14 Jun 2011

Cinryze data on hereditary angioedema presented at EAACI 2011

ViroPharma Incorporated today announced that data relating to Cinryze from nine accepted abstracts were presented as poster presentations at the 30th Congress of the European Academy of Allergy and Clinical Immunology (EAACI), June 11 through 15, in Istanbul, Turkey.

14 Jun 2011

Cypress receives FDA approval for ZUTRIPRO, REZIRA NDA to treat cough and common cold

Cypress Pharmaceutical announced today that the Food and Drug Administration (FDA) approved a new drug application (NDA) for ZUTRIPRO Oral Solution (CIII) and REZIRA Oral Solution.

14 Jun 2011

Merck announces changes to high-dose simvastatin prescribing information in the U.S.

Merck, known as MSD outside the United States and Canada, today announced changes to the prescribing information in the United States for the highest dose of simvastatin, 80 mg, and the use of simvastatin with certain other medicines.

9 Jun 2011

ACAAI issues updated guidelines for treating stinging insect hypersensitivity

Spring and summer bring bees, wasps, hornets and yellow jackets and, this year, updated advice for those who are allergic to these pesky stinging insects. More than half a million people go to emergency rooms and at least 50 die each year from insect stings.

9 Jun 2011

ABRAXANE and bevacizumab clinical studies on unresectable melanoma presented at ASCO 2011

Celgene International Sàrl today announced that results from two investigator initiated studies including ABRAXANE, and bevacizumab in unresectable melanoma were presented at the 2011 American Society of Clinical Oncology Annual Meeting in Chicago, IL.

7 Jun 2011

Celgene announces ABRAXANE plus gemcitabine, bevacizumab phase II trial data on breast cancer

Celgene International Sàrl today announced that results from an investigator-initiated phase II study of ABRAXANE, gemcitabine and bevacizumab as first-line treatment in metastatic breast cancer were presented at the 2011 American Society of Clinical Oncology Annual Meeting in Chicago, IL.

7 Jun 2011

Celgene announces results of REVLIMID, docetaxel/prednisone phase II combination study on mCRPC

Celgene International Sàrl today announced results from a phase II investigator initiated study of REVLIMID (lenalidomide) in combination with Avastin (bevacizumab), docetaxel and prednisone in patients with metastatic castration-resistant prostate cancer were presented at the 2011 American Society of Clinical Oncology Annual Meeting in Chicago, Ill.

6 Jun 2011

New positive Cimzia phase IIIb study data on rheumatoid arthritis presented at EULAR meeting

UCB today announced data which showed that the addition of Cimzia to current therapy was associated with a rapid and consistent clinical response in a diverse group of rheumatoid arthritis (RA) patients.

30 May 2011

4SC to present pre-clinical data on vidofludimus in systemic lupus erythematosus at EULAR 2011

4SC AG, a discovery and development company of targeted small molecule drugs for autoimmune and cancer diseases, will present pre-clinical data on vidofludimus - its lead small-molecule drug candidate against autoimmune diseases - in systemic lupus erythematosus at EULAR 2011, Europe's largest scientific conference on rheumatic diseases, in London, UK, from May 25-28, 2011.

27 May 2011

Biogen Idec joins global multiple sclerosis community to celebrate third annual World MS Day

Today, Biogen Idec will join the global multiple sclerosis (MS) community in celebrating the third annual World MS Day. Biogen Idec continues to be the industry leader in researching and providing groundbreaking therapies for MS. So far in 2011, the company has brought more hope to MS patients through a number of significant milestones.

25 May 2011

ViroPharma commences VP 20621 Phase 2 study for prevention of recurrent Clostridium difficile infection

ViroPharma Incorporated today announced initiation of a Phase 2 dose-ranging clinical study to evaluate the safety, tolerability, and efficacy of VP 20621 for prevention of recurrence of Clostridium difficile infection (CDI) in adults previously treated for CDI.

20 May 2011

Hypersensitivity News and Research

EMA CHMP issues positive opinion for Baxter's IVIG therapy for multifocal motor neuropathy

Endo's complete response for new formulation of OPANA ER NDA accepted by the FDA

Pfizer Lyrica Phase 3 study on Central Neuropathic Pain meets primary endpoint

Acura, Pfizer receive FDA approval for OXECTA Tablets to manage severe pain

Celgene announces data from REVLIMID plus rituximab Phase II study on malignant lymphomas

Celgene, GELA to conduct REVLIMID/rituximab combination study on newly diagnosed FL

REVLIMID-R-CHOP Phase I/II data in untreated DLBCL presented at malignant lymphoma conference

ViroPharma receives European Centralized Marketing Authorization for Cinryze for treatment of HAE

GE Healthcare announces results of Optison heart ultrasound contrast agent presented at ASE

Cinryze data on hereditary angioedema presented at EAACI 2011

Cypress receives FDA approval for ZUTRIPRO, REZIRA NDA to treat cough and common cold

Merck announces changes to high-dose simvastatin prescribing information in the U.S.

ACAAI issues updated guidelines for treating stinging insect hypersensitivity

ABRAXANE and bevacizumab clinical studies on unresectable melanoma presented at ASCO 2011

Celgene announces ABRAXANE plus gemcitabine, bevacizumab phase II trial data on breast cancer

Celgene announces results of REVLIMID, docetaxel/prednisone phase II combination study on mCRPC

New positive Cimzia phase IIIb study data on rheumatoid arthritis presented at EULAR meeting

4SC to present pre-clinical data on vidofludimus in systemic lupus erythematosus at EULAR 2011

Biogen Idec joins global multiple sclerosis community to celebrate third annual World MS Day

ViroPharma commences VP 20621 Phase 2 study for prevention of recurrent Clostridium difficile infection

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