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Phase 3 study shows Vectibix meets primary endpoint in patients with chemorefractory wild-type KRAS mCRC

Phase 3 study shows Vectibix meets primary endpoint in patients with chemorefractory wild-type KRAS mCRC

Amgen today announced that a Phase 3 study evaluating Vectibix (panitumumab) and best supportive care (BSC) met its primary endpoint, demonstrating a statistically significant improvement in overall survival (OS) in patients with chemorefractory wild-type KRAS (exon 2) metastatic colorectal cancer (mCRC) compared to those patients treated with BSC alone. [More]
Boehringer announces LUX-Lung 8 data that compares efficacy of afatinib, erlotinib in patients with advanced SCC

Boehringer announces LUX-Lung 8 data that compares efficacy of afatinib, erlotinib in patients with advanced SCC

Boehringer Ingelheim today announced overall survival (OS) results from the LUX-Lung 8 trial (NCT01523587) that directly compared the efficacy and safety of two EGFR-directed treatments, afatinib and erlotinib, in patients with advanced squamous cell carcinoma (SCC) of the lung, progressing after treatment with first-line chemotherapy. Treatment with afatinib significantly reduced the risk of death by 19%, extending the survival of patients to a median of 7.9 months compared to 6.8 months on erlotinib. [More]
Eisai Phase 3 trial of eribulin meets primary endpoint in patients with advanced soft tissue sarcoma

Eisai Phase 3 trial of eribulin meets primary endpoint in patients with advanced soft tissue sarcoma

Eisai Inc. announced today the results of its Phase 3 trial (Study 309), which showed that eribulin met the study's primary endpoint evaluating overall survival in patients who had advanced leiomyosarcoma (LMS) or adipocytic sarcoma (ADI), two types of advanced soft tissue sarcoma. [More]
FDA approves Humalog 200 units/mL KwikPen to improve glycemic control in diabetic patients

FDA approves Humalog 200 units/mL KwikPen to improve glycemic control in diabetic patients

The U.S. Food and Drug Administration (FDA) has approved Humalog® 200 units/mL KwikPen® (insulin lispro 200 units/mL; U-200), a pre-filled pen containing a concentrated formulation of Lilly's rapid-acting insulin Humalog® (insulin lispro 100 units/mL) to improve glycemic control in people with type 1 and type 2 diabetes, Eli Lilly and Company announced today. Humalog U-200 KwikPen marks the first FDA approval of a concentrated mealtime insulin analog. [More]
Amgen to present clinical data on multiple blood cancer treatments at EHA 2015

Amgen to present clinical data on multiple blood cancer treatments at EHA 2015

Amgen today announced that it will present data from multiple Kyprolis (carfilzomib) for Injection, BLINCYTO (blinatumomab), oprozomib and Nplate (romiplostim)‎ studies at the 20th Congress of the European Hematology Association taking place in Vienna, June 11 - 14, 2015. [More]
Amgen's Vectibix (panitumumab) receives EC approval for treatment patients with WT RAS mCRC

Amgen's Vectibix (panitumumab) receives EC approval for treatment patients with WT RAS mCRC

Amgen today announced that the European Commission approved a new use of Vectibix (panitumumab) as first-line treatment in combination with FOLFIRI for the treatment of adult patients with wild-type (WT) RAS metastatic colorectal cancer (mCRC). [More]
United Therapeutics announces FDA approval of dinutuximab for treatment of high-risk neuroblastoma

United Therapeutics announces FDA approval of dinutuximab for treatment of high-risk neuroblastoma

United Therapeutics Corporation announced today that the United States Food and Drug Administration has approved Unituxin (dinutuximab) Injection (formerly called ch14.18), in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF), interleukin-2 (IL-2), and 13-cis-retinoic acid (RA), for the treatment of pediatric patients with high-risk neuroblastoma who achieve at least a partial response to prior first-line multiagent, multimodality therapy. [More]
FDA approves Astellas' CRESEMBA for treatment of invasive aspergillosis, invasive mucormycosis

FDA approves Astellas' CRESEMBA for treatment of invasive aspergillosis, invasive mucormycosis

Astellas today announced that the U.S. Food and Drug Administration has approved its New Drug Application (NDA) for the use of CRESEMBA (isavuconazonium sulfate), the prodrug for isavuconazole, for patients 18 years of age and older in the treatment of invasive aspergillosis and invasive mucormycosis (also known as zygomycosis). [More]
Amgen announces new data from BLINCYTO Phase 2 study for treatment of patients with ALL

Amgen announces new data from BLINCYTO Phase 2 study for treatment of patients with ALL

Amgen today announced that new data from a pivotal Phase 2 study evaluating BLINCYTO (blinatumomab) for the treatment of adult patients with relapsed/refractory B-cell precursor acute lymphoblastic leukemia (ALL) was presented at the 56th American Society of Hematology Annual Meeting and Exposition. [More]
ZS Pharma reports positive ZS-9 Phase 3 clinical trial for treatment of hyperkalemia

ZS Pharma reports positive ZS-9 Phase 3 clinical trial for treatment of hyperkalemia

ZS Pharma, a biopharmaceutical company developing novel treatments for kidney, cardiovascular, liver and metabolic disorders, today presented detailed results from HARMONIZE (ZS004) at the late-breaking Clinical Science Special Reports Session of the American Heart Association Scientific Sessions. [More]
Astellas' isavuconazole gets FDA orphan drug designation for treatment of invasive candidiasis

Astellas' isavuconazole gets FDA orphan drug designation for treatment of invasive candidiasis

Astellas announced today that the U.S. Food and Drug Administration has granted orphan drug designation to isavuconazole for the treatment of invasive candidiasis. [More]
Promising results for low-dose insulin in paediatric diabetic ketoacidosis

Promising results for low-dose insulin in paediatric diabetic ketoacidosis

Results of a randomised trial suggest that low-dose insulin may be at least as good as standard-dose insulin for the treatment of children with diabetic ketoacidosis. [More]
Boehringer Ingelheim announces availability of Striverdi Respimat Inhalation Spray 5 mcg in the U.S.

Boehringer Ingelheim announces availability of Striverdi Respimat Inhalation Spray 5 mcg in the U.S.

Boehringer Ingelheim today announced that Striverdi Respimat (olodaterol) Inhalation Spray 5 mcg is now available by prescription in pharmacies across the United States. [More]
Phase 3 COU-AA-302 results show ZYTIGA plus prednisone prolongs overall survival in men with chemotherapy-naive mCRPC

Phase 3 COU-AA-302 results show ZYTIGA plus prednisone prolongs overall survival in men with chemotherapy-naive mCRPC

A final analysis of the Phase 3 COU-AA-302 trial presented today at the European Society for Medical Oncology (ESMO) 2014 Congress in Madrid, Spain showed that ZYTIGA® (abiraterone acetate) plus prednisone significantly prolonged overall survival (OS), compared to an active control of placebo plus prednisone, in men with chemotherapy-naive metastatic castration-resistant prostate cancer (mCRPC). [More]
Mylan launches Potassium Chloride Extended-release Tablets

Mylan launches Potassium Chloride Extended-release Tablets

Mylan Inc. today announced that it has launched Potassium Chloride Extended-release Tablets USP, 8 mEq (600 mg) and 10 mEq (750 mg), which is the generic version of Upsher-Smith's Klor-Con. [More]
Sanofi, MannKind sign licensing agreement to develop and commercialize Afrezza Inhalation Powder

Sanofi, MannKind sign licensing agreement to develop and commercialize Afrezza Inhalation Powder

Sanofi and MannKind Corporation announced today that they have entered into a worldwide exclusive licensing agreement for development and commercialization of Afrezza (insulin human) Inhalation Powder, a new rapid-acting inhaled insulin therapy for adults with type 1 and type 2 diabetes. [More]
Phase 3 trial: NEXAVAR tablets fail to meet primary endpoint in HER2-negative breast cancer patients

Phase 3 trial: NEXAVAR tablets fail to meet primary endpoint in HER2-negative breast cancer patients

Bayer HealthCare and Onyx Pharmaceuticals Inc., an Amgen subsidiary, today announced that an investigational Phase 3 trial of NEXAVAR (sorafenib) tablets in patients with advanced breast cancer did not meet its primary endpoint of improving progression-free survival (PFS). [More]
BRI to present clinical-stage product data at International Symposium on Pediatric Neuro-Oncology

BRI to present clinical-stage product data at International Symposium on Pediatric Neuro-Oncology

The Burzynski Research Institute, Inc. (BRI) announced today that it will present data on two of the Company's clinical-stage product candidates, Antineoplaston A10 injections (Atengenal®) and Antineoplaston AS2-1 injections (Astugenal®), at the 16th International Symposium on Pediatric Neuro-Oncology held in Singapore from June 28, 2014 to July 2, 2014. [More]
Hypertension medication may cause metabolic-related adverse events in older adults

Hypertension medication may cause metabolic-related adverse events in older adults

Adults over 65 who have recently begun thiazide diuretics are at a greater risk for developing metabolic-related adverse events, researchers at UT-Southwestern Medical Center have found. [More]
Amgen presents extended analysis of PEAK study data at ASCO

Amgen presents extended analysis of PEAK study data at ASCO

Amgen today announced results from the Phase 2 PEAK study that reinforce the improved overall survival (OS) benefit of panitumumab (Vectibix®) when used in combination with FOLFOX, an oxaliplatin-based chemotherapy regimen, compared to bevacizumab (Avastin) plus FOLFOX as first-line treatment in patients with wild-type RAS metastatic colorectal cancer (mCRC). [More]
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