Hypersensitivity News and Research

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

Santarus announces commercial U.S. launch of CYCLOSET for type 2 diabetes mellitus

Santarus, Inc., a specialty biopharmaceutical company, today announced the commercial U.S. launch of CYCLOSET (bromocriptine mesylate) tablets. CYCLOSET is a prescription drug approved by the U.S. Food and Drug Administration (FDA) as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus both as monotherapy and in combination with other oral antidiabetic agents.

15 Nov 2010

Dyax to present data of KALBITOR inhibitor for Angioedema at ACAAI Meeting

Dyax Corp. today announced that an abstract featuring KALBITOR (ecallantide) data was accepted for oral presentation at the American College of Allergy, Asthma and Immunology (ACAAI) Annual Meeting held November 11-16, at the Phoenix Convention Center in Phoenix, AZ. Two additional abstracts were selected as poster sessions.

15 Nov 2010

Results of RE-LY trial evaluating Pradaxa capsules to be presented at American Heart Association Session

Results of two pre-specified sub-study analyses of the 18,113 patient RE-LY trial, involving the newly approved oral anticoagulant Pradaxa (dabigatran etexilate mesylate) capsules, will be presented at the American Heart Association's Annual Scientific Sessions on Monday, November 15, 2010.

12 Nov 2010

Pharmaxis to present ARIDOL Bronchial Challenge Test Kit at 2010 ACAAI

Pharmaxis, a global specialty pharmaceutical company focused on therapeutic products for respiratory and immune disorders, will present ARIDOL™ (mannitol inhalation powder) Bronchial Challenge Test Kit, at the 2010 Annual Meeting of the American College of Allergy, Asthma and Immunology (ACAAI), November 11-16 in Phoenix, AZ.

11 Nov 2010

Covidien analysis finds lower incidence of GI adverse events with topical NSAIDs versus oral

Covidien, a leading global provider of healthcare products, announced the results of an analysis that will be presented at the American College of Rheumatology's Annual Scientific Meeting. A pooled analysis of safety data suggests that patients with knee osteoarthritis (OA) receiving the topical PENNSAID® (diclofenac sodium topical solution) 1.5% w/w had significantly fewer gastrointestinal (GI)-related adverse events than those receiving an oral non-steroidal anti-inflammatory drug (NSAID).

10 Nov 2010

EUSA completes BLA filing for ERWINASE in treatment of acute lymphoblastic leukemia

EUSA Pharma, a transatlantic specialty pharmaceutical company focused on oncology, oncology supportive care and critical care, today announced that it has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for ERWINASE(R) (L-asparaginase derived from Erwinia chrysanthemi) for use in the treatment of acute lymphoblastic leukemia in patients with hypersensitivity to E. coli-derived asparaginase.

9 Nov 2010

Genta commences tesetaxel Phase 2b clinical trial as 1st-line chemotherapy for metastatic breast cancer

Genta Incorporated today announced that the Company has initiated a new Phase 2b clinical trial of tesetaxel as 1st-line chemotherapy for women with metastatic breast cancer. Tesetaxel is the leading oral taxane currently in clinical development. The new trial will be conducted at Memorial Sloan-Kettering Cancer Center, New York, NY and at the Accelerated Community Oncology Research Network (ACORN) based in Memphis, TN.

9 Nov 2010

Merz to present data on Xeomin clinical studies for cervical dystonia at AAPM&R

Merz Pharmaceuticals announced today that data from stability and clinical studies evaluating Xeomin (incobotulinumtoxinA), a botulinum toxin type A free from accessory proteins, will be presented at the 71st Annual Assembly of the American Academy of Physical Medicine and Rehabilitation (AAPM&R) in Seattle, Wash.

8 Nov 2010

Phase III study suggests CYCLOSET tablets improve glycemic control

Santarus, Inc. and VeroScience LLC today announced that analyses of 379-patient subset data from a 3,070-patient Phase III safety study conducted with CYCLOSET (bromocriptine mesylate) tablets suggested that CYCLOSET as an add-on to oral antidiabetes drugs produced improvements in glycemic control irrespective of baseline duration of disease.

4 Nov 2010

Hyperion HPN-100 phase III pivotal study for urea cycle disorders meets primary endpoint

Hyperion Therapeutics, Inc. today announced that the Company's phase III pivotal study of glycerol phenylbutyrate (HPN-100), an investigational drug for the treatment of urea cycle disorders (UCDs), met its primary endpoint. The non-inferiority study, conducted under a Special Protocol Assessment (SPA) granted by the U.S. Food and Drug Administration (FDA) in June 2009, evaluated the ammonia control of glycerol phenylbutyrate as compared to sodium phenylbutyrate (BUPHENYL®).

3 Nov 2010

FDA grants Cadence marketing approval for OFIRMEV injection in management of pain and fever

Cadence Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (FDA) has granted marketing approval for OFIRMEV™ (acetaminophen) injection, the first and only intravenous (IV) formulation of acetaminophen to be approved in the United States. OFIRMEV is indicated for the management of mild to moderate pain, the management of moderate to severe pain with adjunctive opioid analgesics, and the reduction of fever.

3 Nov 2010

Talecris announces launch of PROLASTIN-C in Canada

Talecris Biotherapeutics announced today the Canadian launch of PROLASTIN®-C (Alpha1-Proteinase Inhibitor [Human])(A1PI), a more concentrated and purified formulation of PROLASTIN®, the only approved alpha1-augmentation therapy in Canada for more than 20 years. PROLASTIN-C delivers twice the active protein per milliliter as PROLASTIN, cutting the infusion volume and time in half when given at the recommended rate of 0.08 mL/kg/min.

3 Nov 2010

Positive preliminary data from Protalix's taliglucerase alfa switchover trial for Gaucher disease

Protalix BioTherapeutics, Inc., announced today positive preliminary data from the first 15 patients that completed the Company's nine month, worldwide, multi-center, open-label, switchover trial of taliglucerase alfa for the treatment of Gaucher disease under a protocol cleared by the U.S. Food and Drug Administration (FDA). The data indicate that patients can safely be switched to taliglucerase alfa from imiglucerase (Cerezyme®).

2 Nov 2010

EMA issues Scientific Advice to Genta's clinical development plan for tesetaxel in patients with gastric cancer

Genta Incorporated today announced that the Company has received Scientific Advice from the European Medicines Agency (EMA) on the Company's clinical development plan for tesetaxel in patients with advanced gastric cancer, which includes a pivotal, randomized, controlled, Phase 3 trial.

2 Nov 2010

Boehringer Ingelheim announces availability of PRADAXA in U.S. pharmacies

Boehringer Ingelheim Pharmaceuticals, Inc. today announced that its new oral anticoagulant, Pradaxa® (dabigatran etexilate mesylate) 150mg capsules, will be available starting Wednesday by prescription in pharmacies across the United States, including CVS/pharmacy, Rite Aid, Walmart, Target, Kmart® and The Kroger Co. In addition, leading independents under the Health Mart®, Good Neighbor Pharmacy® and Medicine Shoppe® banners will be stocked.

2 Nov 2010

Shield signs strategic commercialization agreement for ST10-021 iron therapy product

Shield Holdings AG (Shield), the independent specialty pharmaceutical company focused on the development and commercialisation of late-stage hospital pharmaceuticals, today announces that it has signed a strategic commercialisation agreement for its lead asset, ST10-021, an iron therapy product which has commenced Phase III clinical development, with AOP Orphan Pharmaceuticals AG.

1 Nov 2010

Salix to discuss XIFAXAN therapy for hepatic encephalopathy at AASLD 2010 Annual Meeting

Salix Pharmaceuticals, Inc. today announced that the 61st Annual Meeting of the American Association for the Study of Liver Diseases (AASLD 2010) will be an important venue for ongoing discussion of hepatic encephalopathy, or HE.

1 Nov 2010

FDA approves Teflaro for treatment of community-acquired bacterial pneumonia

Forest Laboratories, Inc. announced today that Teflaro(ceftaroline fosamil), a broad-spectrum bactericidal cephalosporin with activity against both gram-positive and gram-negative microorganisms, was approved by the U.S. Food and Drug Administration (FDA) for the treatment of community-acquired bacterial pneumonia (CABP), including cases caused by Streptococcus pneumoniae bacteremia, and acute bacterial skin and skin structure infection (ABSSSI), including cases caused by methicillin-resistant Staphylococcus aureus (MRSA).

30 Oct 2010

FDA approves NUEDEXTA capsules for pseudobulbar affect

AVANIR Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved NUEDEXTA (dextromethorphan hydrobromide and quinidine sulfate) capsules, as the first treatment for pseudobulbar affect.

30 Oct 2010

Coadministration of INTUNIV tablets with stimulant reduces ADHD symptoms

Shire plc the global specialty biopharmaceutical company, today presented research results of once-daily INTUNIV (guanfacine) Extended-Release Tablets, coadministered with stimulants in children and adolescents diagnosed with Attention Deficit Hyperactivity Disorder (ADHD) who had suboptimal response to treatment with a long-acting stimulant alone.

29 Oct 2010

Hypersensitivity News and Research

Santarus announces commercial U.S. launch of CYCLOSET for type 2 diabetes mellitus

Dyax to present data of KALBITOR inhibitor for Angioedema at ACAAI Meeting

Results of RE-LY trial evaluating Pradaxa capsules to be presented at American Heart Association Session

Pharmaxis to present ARIDOL Bronchial Challenge Test Kit at 2010 ACAAI

Covidien analysis finds lower incidence of GI adverse events with topical NSAIDs versus oral

EUSA completes BLA filing for ERWINASE in treatment of acute lymphoblastic leukemia

Genta commences tesetaxel Phase 2b clinical trial as 1st-line chemotherapy for metastatic breast cancer

Merz to present data on Xeomin clinical studies for cervical dystonia at AAPM&R

Phase III study suggests CYCLOSET tablets improve glycemic control

Hyperion HPN-100 phase III pivotal study for urea cycle disorders meets primary endpoint

FDA grants Cadence marketing approval for OFIRMEV injection in management of pain and fever

Talecris announces launch of PROLASTIN-C in Canada

Positive preliminary data from Protalix's taliglucerase alfa switchover trial for Gaucher disease

EMA issues Scientific Advice to Genta's clinical development plan for tesetaxel in patients with gastric cancer

Boehringer Ingelheim announces availability of PRADAXA in U.S. pharmacies

Shield signs strategic commercialization agreement for ST10-021 iron therapy product

Salix to discuss XIFAXAN therapy for hepatic encephalopathy at AASLD 2010 Annual Meeting

FDA approves Teflaro for treatment of community-acquired bacterial pneumonia

FDA approves NUEDEXTA capsules for pseudobulbar affect

Coadministration of INTUNIV tablets with stimulant reduces ADHD symptoms

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