Hypersensitivity News and Research

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

Pfizer provides update on Prevnar 13

Pfizer Inc. announced today that the U.S. Food and Drug Administration (FDA) has not yet completed its review of the Biologics License Application (BLA) for Prevnar 13™, (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]), the Company’s candidate 13-valent pneumococcal conjugate vaccine.

31 Dec 2009

Eli Lilly and Kowa Pharmaceuticals America to co-promote LIVALO in the U.S

Eli Lilly and Company (NYSE: LLY), Kowa Company, Limited, and Kowa's U.S. subsidiary, Kowa Pharmaceuticals America, Inc., today announced that Lilly and Kowa Pharmaceuticals America have entered into a co-promotion agreement in the United States to commercialize LIVALO® (pitavastatin). Lilly and Kowa have also entered into a licensing agreement in Latin America. LIVALO is a statin approved by the U.S. Food and Drug Administration (FDA) in August 2009 for the treatment of primary hyperlipidemia and mixed dyslipidemia.

24 Dec 2009

Fluzone High-Dose inactivated influenza virus vaccine receives FDA approval

The U.S. Food and Drug Administration today approved Fluzone High-Dose, an inactivated influenza virus vaccine for people ages 65 years and older to prevent disease caused by influenza virus subtypes A and B.

24 Dec 2009

ZEGERID OTC approval triggers $20M milestone payment to Santarus

Santarus, Inc., a specialty biopharmaceutical company, today announced that it has received the $20 million milestone payment previously announced on December 1, 2009 relating to the approval of ZEGERID OTC™ (omeprazole 20 mg/sodium bicarbonate 1100 mg capsules) under its over-the-counter (OTC) licensing agreement with Schering-Plough HealthCare Products, Inc., the consumer healthcare division of Merck & Co., Inc. Schering-Plough and Merck merged on November 3, 2009.

22 Dec 2009

New study suggests nasal allergy may be involved in chronic sinus disease

Exposing patients with chronic sinus disease to allergens and then obtaining repeated images by X-ray or ultrasound reveals that nasal allergies may be involved in some cases of chronic sinus disease, according to a report in the December issue of Archives of Otolaryngology-Head & Neck Surgery, one of the JAMA/Archives journals.

22 Dec 2009

ZymoGenetics restructures license and collaboration agreements on RECOTHROM

ZymoGenetics, Inc. today announced a restructuring of the U.S. co-promotion and ex-U.S. license and collaboration agreements with Bayer Schering Pharma AG and Bayer HealthCare relating to RECOTHROM® Thrombin, topical (Recombinant).

21 Dec 2009

Initial data from REVLIMID Phase III trial in multiple myeloma patients announced

Celgene Corporation today announced the National Cancer Institute (NCI), a part of the National Institutes of Health, reported initial data from a Phase III, randomized, double-blind, multi-center clinical study led by the Cancer and Leukemia Group B (CALGB).

18 Dec 2009

Positive results from Onset Therapeutics' BenzEFoam Emollient Foam skin moisturization study

Onset Therapeutics, a specialty pharmaceutical company focused in dermatology, today announced positive results from a skin moisturization study that compared the Company’s recently launched BenzEFoam™ (benzoyl peroxide 5.3%) Emollient Foam to a market leading combination gel containing clindamycin 1% - benzoyl peroxide 5%. BenzEFoam™ Emollient Foam is indicated for the topical treatment of mild to moderate acne vulgaris and is the first prescription foam formulation containing benzoyl peroxide as the active ingredient.

16 Dec 2009

Positive results from Auxilium Pharmaceuticals' XIAFLEX Peyronie's disease phase IIb trial

Auxilium Pharmaceuticals, Inc., a specialty biopharmaceutical company, today announced top-line efficacy and safety results for the phase IIb clinical trial for XIAFLEX™ (collagenase clostridium histolyticum) in the treatment of Peyronie's disease.

16 Dec 2009

AstraZeneca's CRESTOR receives favorable vote from FDA Advisory Committee

The U.S. Food and Drug Administration (FDA) Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) today voted 12 yes, 4 no, and 1 abstention that AstraZeneca has established sufficient benefit to offset the observed risks to support the use of CRESTOR®

16 Dec 2009

Pfizer's Prevenar 13 granted European marketing authorization

The European Commission has granted Pfizer Inc. a European marketing authorization for its pneumococcal conjugate vaccine, Prevenar 13 (Pneumococcal Polysaccharide Conjugate Vaccine [13-valent, adsorbed]). Prevenar 13 is indicated for active immunization for the prevention of invasive disease, pneumonia, and acute otitis media caused by 13 Streptococcus pneumoniae serotypes in infants and children from 6 weeks to 5 years of age. Invasive pneumococcal disease includes sepsis, meningitis, bacteremia, bacteremic pneumonia, and empyema.

11 Dec 2009

Pfizer announces IES analysis of Aromasin in breast cancer recurrence

Pfizer today announced results from an exploratory analysis of the Intergroup Exemestane Study (IES) at a median follow-up of 91 months in estrogen-receptor positive (ER+) or estrogen-receptor unknown (ER-unknown) women that looked at breast cancer free survival (BCFS) and censored deaths that occurred prior to breast cancer relapse.

11 Dec 2009

Tasigna demonstrates greater efficacy over Gleevec in chronic Ph+ CML patients

In a large Phase III clinical trial, Tasigna (nilotinib capsules) demonstrated greater efficacy over Gleevec (imatinib) in the treatment of adult patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase. The new clinical data were just presented as a late breaking abstract at the 51st annual meeting of the American Society of Hematology (ASH), in New Orleans, Louisiana.

11 Dec 2009

VERTICAL Phase II trial results for NHL released

The Takeda Oncology Company today reported data from a clinical trial evaluating a VELCADE based combination for patients with relapsed/refractory non-Hodgkin’s lymphoma (NHL).

9 Dec 2009

Data evaluating combination therapy with REVLIMID and rituximab in patients with NHL presented

Celgene International Sàrl announced that investigational data evaluating combination therapy with REVLIMID (lenalidomide) and rituximab in patients with indolent non-Hodgkin’s lymphoma (NHL) were presented during the 51st American Society of Hematology’s annual meeting in New Orleans, LA.

9 Dec 2009

GSK updates long-term survival data of BEXXAR Therapeutic Regimen for Non-Hodgkin's lymphoma

GlaxoSmithKline announced today updated long-term survival data from two Phase II studies of BEXXAR® (tositumomab and iodine I-131 tositumomab) used in either patients with previously untreated cancer of the immune system (follicular lymphoma) or in patients with cancer of the lymphocytes (non-Hodgkin's lymphoma, NHL) that no longer responded to rituximab.

9 Dec 2009

Interim data from Geron's GRNVAC1 phase II trial for AML presented

Geron Corporation today announced the presentation of interim data from its phase II trial of GRNVAC1, an autologous dendritic cell vaccine targeting telomerase, in patients with acute myelogenous leukemia (AML) at the 51st Annual Meeting of the American Society of Hematology (ASH) in New Orleans, Louisiana.

8 Dec 2009

Clinical trial results of VELCADE based combinations for MM to be presented at the ASH meeting

Millennium: The Takeda Oncology Company today reported the presentation of results from a double randomized Phase III clinical trial of VELCADE based combinations for the treatment of patients with previously untreated multiple myeloma (MM). The VELCADE based combinations evaluated in the study demonstrated two-year overall survival rates ranging between 81 and 88 percent.

8 Dec 2009

Study data of REVLIMID-dexamethasone combination therapy for high-risk smoldering multiple myeloma

Celgene International Sàrl announced that data evaluating combination therapy REVLIMID (lenalidomide) and dexamethasone in patients with high-risk smoldering multiple myeloma were presented during the American Society of Hematology’s annual meeting in New Orleans, LA. The landmark study demonstrated REVLIMID and dexamethasone prolonged time to progression, including complete responses, with manageable toxicity.

8 Dec 2009

Study results comparing REVLIMID regimen to stem cell transplant in multiple myeloma patients

Celgene International Sàrl announced clinical data from an investigational study of patients with multiple myeloma who were younger than 65 years old and received either REVLIMID (lenalidomide), melphalan and prednisone (MPR) or melphalan plus autologous stem cell transplant (MEL200) following an induction treatment of REVLIMID plus low-dose dexamethasone (Rd) were presented during the 51st American Society of Hematology’s annual meeting in New Orleans, LA.

8 Dec 2009

Hypersensitivity News and Research

Pfizer provides update on Prevnar 13

Eli Lilly and Kowa Pharmaceuticals America to co-promote LIVALO in the U.S

Fluzone High-Dose inactivated influenza virus vaccine receives FDA approval

ZEGERID OTC approval triggers $20M milestone payment to Santarus

New study suggests nasal allergy may be involved in chronic sinus disease

ZymoGenetics restructures license and collaboration agreements on RECOTHROM

Initial data from REVLIMID Phase III trial in multiple myeloma patients announced

Positive results from Onset Therapeutics' BenzEFoam Emollient Foam skin moisturization study

Positive results from Auxilium Pharmaceuticals' XIAFLEX Peyronie's disease phase IIb trial

AstraZeneca's CRESTOR receives favorable vote from FDA Advisory Committee

Pfizer's Prevenar 13 granted European marketing authorization

Pfizer announces IES analysis of Aromasin in breast cancer recurrence

Tasigna demonstrates greater efficacy over Gleevec in chronic Ph+ CML patients

VERTICAL Phase II trial results for NHL released

Data evaluating combination therapy with REVLIMID and rituximab in patients with NHL presented

GSK updates long-term survival data of BEXXAR Therapeutic Regimen for Non-Hodgkin's lymphoma

Interim data from Geron's GRNVAC1 phase II trial for AML presented

Clinical trial results of VELCADE based combinations for MM to be presented at the ASH meeting

Study data of REVLIMID-dexamethasone combination therapy for high-risk smoldering multiple myeloma

Study results comparing REVLIMID regimen to stem cell transplant in multiple myeloma patients

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