Hypersensitivity News and Research

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

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

UCB presents data on Vimpat AED at AES meeting

UCB today announced new findings on its antiepileptic drug (AED) Vimpat® that offer additional clinical evidence supporting the use of this AED as adjunctive therapy in adult patients with partial-onset seizures. Results of presented research demonstrate sustained efficacy in adult patients taking Vimpat® for up to three years, and a consistent long-term tolerability profile.

7 Dec 2009

VELCADE based regimens are cost-effective for payers and patients, finds study

Millennium: The Takeda Oncology Company today announced that two studies presented at the 51st American Society of Hematology (ASH) Annual Meeting found that VELCADE based regimens are more cost-effective for payers and reduced out-of-pocket costs for patients than other commonly used multiple myeloma treatments.

7 Dec 2009

FDA approves Santarus’ NDA for immediate-release prescription tablet product

Santarus, Inc., a specialty biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has approved the company’s New Drug Application (NDA) for immediate-release omeprazole/sodium bicarbonate/ magnesium hydroxide tablets in 40 mg and 20 mg dosage strengths of omeprazole.

5 Dec 2009

Results from Phase III pivotal study of FIRMAGON presented

Drs. Neal Shore and E. David Crawford presented results for prostate-specific antigen (PSA) recurrence from the additional analysis of secondary end points of biochemical recurrence rate in a Phase III pivotal study of FIRMAGON® (monthly degarelix for injection) or monthly leuprolide in prostate cancer patients during the first year of treatment.

4 Dec 2009

Pfizer to present study findings from its expanded breast cancer portfolio

Pfizer Oncology announced today that it will be presenting study findings evaluating several compounds including those from its newly expanded breast cancer portfolio following the recent acquisition of Wyeth, focusing on the needs of multiple breast cancer patient populations at the CTRC-AACR San Antonio Breast Cancer Symposium (SABCS) being held December 9 – 13.

4 Dec 2009

Data from recent clinical trial for Caldolor Injection to be presented

Cumberland Pharmaceuticals Inc. announced today that data from a recent clinical trial for Caldolor® (ibuprofen) Injection, an intravenous treatment for pain and fever, will be presented at the 44th American Society of Health-System Pharmacists (ASHP) Midyear Clinical Meeting in Las Vegas, Nevada, in December.

4 Dec 2009

Hyperion Therapeutics commences enrollment in its HPN-100 episodic hepatic encephalopathy trial

Hyperion Therapeutics, Inc. today announced that the first patient has been enrolled in its phase II clinical trial of investigational compound HPN-100 (glycerol phenylbutyrate).

3 Dec 2009

New data demonstrating the strength of Novartis' hematology portfolio to be presented

Novartis announced today that new data, including a late-breaking presentation on Tasigna® (nilotinib) 200 mg capsules in a form of chronic myeloid leukemia, demonstrate the strength of the company's hematology portfolio in advancing the care of patients.

2 Dec 2009

Hypersensitivity News and Research

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

UCB presents data on Vimpat AED at AES meeting

VELCADE based regimens are cost-effective for payers and patients, finds study

FDA approves Santarus’ NDA for immediate-release prescription tablet product

Results from Phase III pivotal study of FIRMAGON presented

Pfizer to present study findings from its expanded breast cancer portfolio

Data from recent clinical trial for Caldolor Injection to be presented

Hyperion Therapeutics commences enrollment in its HPN-100 episodic hepatic encephalopathy trial

New data demonstrating the strength of Novartis' hematology portfolio to be presented

Achieving and maintaining ISO/IEC 27001 and BS 10012 certifications

Expanding research and clinical options for children with cancer

Examining how pain could play a direct protective role in the gut

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