Hypersensitivity News and Research

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

FDA approves BENLYSTA for active, autoantibody-positive systemic lupus erythematosus

Human Genome Sciences, Inc. and GlaxoSmithKline PLC today announced that the U.S. Food and Drug Administration has approved BENLYSTA® (belimumab) for the treatment of adult patients with active, autoantibody-positive systemic lupus erythematosus (SLE) who are receiving standard therapy.

10 Mar 2011

Merck to present VICTRELIS phase III study data against HCV at EASL annual meeting

Merck, known as MSD outside of the United States and Canada, announced that several new data analyses from Phase III studies of VICTRELIS, its investigational oral hepatitis C protease inhibitor, will be presented at The International Liver CongressTM / 46th European Association for the Study of the Liver annual meeting.

9 Mar 2011

Mississippi researchers work on drug discovey for poison ivy skin rash

Each year nearly 50 million Americans develop an annoying skin rash after coming in contact with poison ivy. But University of Mississippi researchers are working on a pharmaceutical product to rein in the allergic reaction in people already sensitive to the plants and prevent it altogether in those who aren't.

8 Mar 2011

Grifols receives FDA approval for Alphanate to treat vCJD

Grifols, a global healthcare company and biopharmaceutical manufacturer based in Barcelona, Spain today announced that it received approval from the US Food and Drug Administration for revised labeling for Alphanate Antihemophilic Factor/von Willebrand Factor Complex indicating that certain manufacturing steps have been shown to reduce the infectivity of a experimental TSE agent that is a model for variant Creutzfeldt Jakob Disease.

5 Mar 2011

Eisai receives FDA approval for BANZEL Oral Suspension to treat seizures linked with LGS

Eisai Inc. today announced that the U.S. Food and Drug Administration has approved BANZEL Oral Suspension, 40 mg/mL, for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome in children 4 years and older and adults.

3 Mar 2011

Ipsen 2010 total revenues increase 5.2% to €1,170.3 million

In 2010, Group drug sales grew 5.1% year-on-year - at constant currency - exceeding the objective set a year ago of 3.0% to 5.0%, fuelled notably by the sales of Specialty Care products throughout all the geographical regions where the Group operates.

2 Mar 2011

Regeneron's ARCALYST meets primary, secondary endpoints in second Phase 3 gout flare study

Regeneron Pharmaceuticals, Inc. announced that in a second Phase 3 study (PRE-SURGE 2) in gout patients initiating allopurinol therapy, ARCALYST (rilonacept) met the primary and all secondary study endpoints. The primary endpoint was the number of gout flares per patient over the 16-week treatment period.

28 Feb 2011

Preclinical data of Zalicus sodium channel compound published in journal PAIN

Zalicus Inc. today announced the publication of preclinical data in the journal PAIN. The paper describes the activity of Z212, a novel proprietary small organic compound that acts to modulate Nav1.7 and Nav1.8 sodium channels and to reduce neuropathic pain by targeting the hyper-excitability associated with chronic pain signaling pathways.

25 Feb 2011

AMAG fourth quarter total revenues increase to $17.2 million

AMAG Pharmaceuticals, Inc. a biopharmaceutical company focused on the development and commercialization of a therapeutic iron compound to treat iron deficiency anemia, today reported unaudited consolidated financial results for the fourth quarter and year ended December 31, 2010.

25 Feb 2011

Salix anticipates receipt of FDA's CRL for XIFAXAN 550 mg sNDA

Salix Pharmaceuticals, Ltd. today announced that based on a telephone conversation with the U.S. Food and Drug Administration held last evening, the Company anticipates receiving a Complete Response Letter on or before the March 7, 2011 PDUFA goal date for the supplemental New Drug Application for XIFAXAN 550 mg tablets for the proposed indication of treatment of non-constipation irritable bowel syndrome and IBS-related bloating.

25 Feb 2011

FDA approves sBLA for CSL's Hizentra to treat PI

CSL Behring announced today that the U.S. Food and Drug Administration has approved a supplemental Biologics License Application to extend the shelf life of Hizentra, Immune Globulin Subcutaneous, 20% Liquid, from 24 months to 30 months.

24 Feb 2011

Genzyme reports 3-year follow-up data from eliglustat tartrate Phase 2 trial for Gaucher disease

Genzyme Corporation today announced three-year follow-up data from patients enrolled in the phase 2 clinical trial for its investigational oral therapy for Gaucher disease type 1 known as eliglustat tartrate. Sustained or further improvements were observed across all endpoints, including bone disease, at the three-year timepoint.

19 Feb 2011

FDA grants CSL Behring marketing approval for Corifact in treatment of congenital FXIII deficiency

CSL Behring announced today that the U.S. Food and Drug Administration (FDA) has granted marketing approval for Corifact™, Factor XIII Concentrate (Human), for the routine prophylactic treatment of congenital factor XIII (FXIII) deficiency. Corifact, already available for use in 12 countries throughout the world under the trade name Fibrogammin®- P, is the first and only FXIII concentrate approved in the U.S.

19 Feb 2011

U.S. FDA approves Corifact to prevent bleeding in people with Factor XIII deficiency

The U.S. Food and Drug Administration today approved Corifact, the first product intended to prevent bleeding in people with the rare genetic defect congenital Factor XIII deficiency.

18 Feb 2011

Astellas' Protopic receives Health Canada approval for prevention of eczema flares

Astellas Pharma Canada, Inc. has announced that it has received approval from Health Canada for a new indication for its topical eczema therapy, Protopic® (tacrolimus ointment 0.03% and 0.1%). The new indication means that tacrolimus ointment can be prescribed for maintenance therapy to prevent flares and prolong flare free intervals in patients with moderate to severe atopic dermatitis (commonly called eczema).

17 Feb 2011

State court jury rules in favor of Merck in FOSAMAX trial

Merck & Co., Inc. today said a state court jury in New Jersey found in its favor in the Rosenberg v. Merck case, rejecting the claims of a woman who blamed her dental and jaw related problems on her FOSAMAX use.

15 Feb 2011

Genta initiates new Phase 2 clinical trial of tesetaxel in patients with advanced prostate cancer

Genta Incorporated today announced that the Company has initiated a new Phase 2 clinical trial of tesetaxel in patients with advanced prostate cancer. Tesetaxel, the leading oral taxane in clinical development, will be evaluated for its use as both first- and second-line chemotherapy.

10 Feb 2011

Mallinckrodt receives FDA approval for Fentanyl Transdermal System patch ANDA

Covidien, a leading global provider of healthcare products, today announced that Mallinckrodt Inc., a Covidien company, has received U.S. Food and Drug Administration (FDA) approval of its Abbreviated New Drug Application (ANDA) for its Fentanyl Transdermal System (FTS) patch. Covidien is the largest supplier of controlled pain medications in the United States based on number of prescriptions.

10 Feb 2011

Zogenix receives 2011 DDP Industry Achievement Award for SUMAVEL DosePro

Zogenix, Inc. today announced that it has received the 2011 Drug Delivery Partnerships™ ("DDP") Innovation Award in the Industry Achievement category for SUMAVEL DosePro (sumatriptan injection) Needle-free Delivery System.

9 Feb 2011

AMAG receives Health Canada Notice of Non-Compliance for Feraheme NDS

AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG) today announced that it has received a Notice of Non-Compliance (NON) from Health Canada regarding its New Drug Submission (NDS) for Feraheme® (ferumoxytol) injection for intravenous (IV) use for the treatment of iron deficiency anemia in adult chronic kidney disease patients.

9 Feb 2011

Hypersensitivity News and Research

FDA approves BENLYSTA for active, autoantibody-positive systemic lupus erythematosus

Merck to present VICTRELIS phase III study data against HCV at EASL annual meeting

Mississippi researchers work on drug discovey for poison ivy skin rash

Grifols receives FDA approval for Alphanate to treat vCJD

Eisai receives FDA approval for BANZEL Oral Suspension to treat seizures linked with LGS

Ipsen 2010 total revenues increase 5.2% to €1,170.3 million

Regeneron's ARCALYST meets primary, secondary endpoints in second Phase 3 gout flare study

Preclinical data of Zalicus sodium channel compound published in journal PAIN

AMAG fourth quarter total revenues increase to $17.2 million

Salix anticipates receipt of FDA's CRL for XIFAXAN 550 mg sNDA

FDA approves sBLA for CSL's Hizentra to treat PI

Genzyme reports 3-year follow-up data from eliglustat tartrate Phase 2 trial for Gaucher disease

FDA grants CSL Behring marketing approval for Corifact in treatment of congenital FXIII deficiency

U.S. FDA approves Corifact to prevent bleeding in people with Factor XIII deficiency

Astellas' Protopic receives Health Canada approval for prevention of eczema flares

State court jury rules in favor of Merck in FOSAMAX trial

Genta initiates new Phase 2 clinical trial of tesetaxel in patients with advanced prostate cancer

Mallinckrodt receives FDA approval for Fentanyl Transdermal System patch ANDA

Zogenix receives 2011 DDP Industry Achievement Award for SUMAVEL DosePro

AMAG receives Health Canada Notice of Non-Compliance for Feraheme NDS

Pioneering Live Cell Imaging - Yokogawa's Impact and Innovations

Revolutionizing Life Science: An Interview with SCIEX on ASMS, the SCIEX 7500+ System, and AI-Driven Quantitation

From Discovery Biology to ELRIG Chair

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