Neratinib Demonstrates Potential in Breast Cancer Trial

Neratinib Demonstrates Potential in Breast Cancer Trial

This article was originally posted by Monthly Prescribing Reference. Puma Biotechnology announced results from its Phase 3 ExteNET trial of neratinib (PB272) for the extended adjuvant treatment of breast cancer. The ExteNET trial is a double-blind, placebo-controlled trial of neratinib vs. placebo after adjuvant treatment with Herceptin (trastuzumab; Genentech) in women (n=2821) with early stage HER2-positive breast cancer who had undergone surgery and adjuvant treatment with trastuzumab. After completion of adjuvant treatment with trastuzumab, patients were randomized to receive extended adjuvant treatment with either…

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FDA Accepts sBLA, Grants Priority Review

FDA Accepts sBLA, Grants Priority Review

FDA Accepts sBLA, Grants Priority Review for Avastin in Ovarian Cancer This article was originally posted by Monthly Prescribing Reference. Genentech announced that the FDA has accepted its supplemental Biologics License Application (sBLA) and granted Priority Review for Avastin (bevacizumab) plus chemotherapy for the treatment of women with recurrent platinum-resistant ovarian cancer. The sBLA for Avastin plus chemotherapy is based on data from the Phase 3 AURELIA trial. AURELIA is a multicenter, randomized, open-label study in 361 women with platinum-resistant recurrent…

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Romidepsin activates latent HIV

Romidepsin activates latent HIV

Romidepsin activates latent HIV, but does not decrease viral reservoir This article was originally posted by Liz Highleyman at Aidmap.com in collaboration with hivandhepatitis.com. The HDAC inhibitor romidepsin was able to awaken latent HIV in resting T-cells, causing it to start producing new virus, but this was not associated with a decrease in the size of the viral reservoir on T-cells, researchers reported on Tuesday at the 20th International AIDS Conference (AIDS 2014) in Melbourne. This finding suggests that kicking HIV out of hiding…

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AMS Adds Alice Jamba as VP of Clinical Services

AMS Adds Alice Jamba as VP of Clinical Services

Advanced Medical Strategies Adds Alice Jamba as Vice President of Clinical Services   Advanced Medical Strategies, the vanguard firm of physician-led claim specialists to health care payors, and publishers of the PredictDx diagnosis cost prediction software, has expanded its staff to include Alice Jamba, RN, as Vice President of Clinical Services. Her role will be to assist the company with clinical research and product development. Jamba joins as AMS continues to solidify its status as the premier clinical review organization. Jamba…

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AMS Adds Alice Jamba

AMS Adds Alice Jamba

Advanced Medical Strategies Adds Alice Jamba as Vice President of Clinical Services   Advanced Medical Strategies, the vanguard firm of physician-led claim specialists to health care payors, and publishers of the PredictDx diagnosis cost prediction software, has expanded its staff to include Alice Jamba, RN, as Vice President of Clinical Services. Her role will be to assist the company with clinical research and product development. Jamba joins as AMS continues to solidify its status as the premier clinical review organization. Jamba…

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Ruconest Approved for Rare Genetic Disease

Ruconest Approved for Rare Genetic Disease

This article was originally posted Scott Roberts of HealthDay at USNews.com  Ruconest has been approved by the U.S. Food and Drug Administration to treat hereditary angioedema, a genetic disease that leads to sudden and potentially fatal swelling of the hands, feet, limbs, face, intestinal tract or airways. The disease, affecting as many as 10,000 people in the United States, is caused by the body’s inability to produce enough of a plasma protein called C1-esterase inhibitor. The remedy is produced from the milk…

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Waiving Copays and Deductibles

Waiving Copays and Deductibles

 This Article was originally posted by Kim Stanger on Hollandhart.com   Providers sometimes waive patients’ cost-sharing amounts (e.g., copays or deductibles) as an accommodation to the patient, professional courtesy, employee benefit, and/or a marketing ploy; however, doing so may violate fraud and abuse laws and/or payor contracts. From a payor’s perspective, waiving cost-sharing amounts creates two problems. First, payors often contract with providers to pay based in part on the provider’s usual charges. The Office of Inspector General (“OIG”) has argued…

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Medac Pharma, Inc. Secures FDA Approval of Rasuvo

Medac Pharma, Inc. Secures FDA Approval of Rasuvo

Medac Pharma, Inc. Secures FDA Approval of Rasuvo (methotrexate) injection for Rheumatoid Arthritis, Poly-Articular-Course Juvenile Idiopathic Arthritis and Psoriasis Originally Posted By: The Wall Street Journal Market Watch CHICAGO, July 14, 2014 /PRNewswire/ — Medac Pharma, Inc., a privately held pharmaceutical company focused on the development of new molecules and improving the effectiveness of existing medicines, announced that the U.S. Food and Drug Administration (FDA) has approved Rasuvo™, a subcutaneous injectable methotrexate (MTX) therapy delivered in an auto-injector for rheumatoid arthritis…

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FDA approves Beleodaq to treat non-Hodgkin lymphoma

FDA approves Beleodaq to treat non-Hodgkin lymphoma

FDA approves Beleodaq to treat rare, aggressive form of non-Hodgkin lymphoma Originally posted: FDA U.S. Food and Drug Administration The U.S. Food and Drug Administration today approved Beleodaq (belinostat) for the treatment of patients with peripheral T-cell lymphoma (PTCL), a rare and fast-growing type of non-Hodgkin lymphoma (NHL). The action was taken under the agency’s accelerated approval program. PTCL comprises a diverse group of rare diseases in which lymph nodes become cancerous. In 2014, the National Cancer Institute estimates that…

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Merck Announces Data from Investigational Phase 3

Merck Announces Data from Investigational Phase 3

Merck Announces Data from Investigational Phase 3 Study on EMEND®(aprepitant) for the Prevention of Chemotherapy-Induced Nausea and Vomiting (CINV) in Children Undergoing Emetogenic Chemotherapy Originally posted by: BioSpace Merck Planning Regulatory Submissions in the U.S. for EMEND® in Pediatric Setting Including New Suspension Formulation in Second Half of 2014 WHITEHOUSE STATION, N.J.–(BUSINESS WIRE)–Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced results from a global, investigational Phase 3 study to evaluate the safety and efficacy of…

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