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Blueprint Medicines Receives FDA Authorization to Proceed with Clinical Trials for Two Drug Candidates

(MarketWatch) July 13, 2015 - Blueprint Medicines today announced that the U.S. Food and Drug Administration (FDA) accepted the Company's Investigational New Drug (IND) applications to begin Phase 1 clinical trials for its two lead drug candidates: BLU-554 for the treatment of advanced hepatocellular carcinoma (HCC) and cholangiocarcinoma, and BLU-285 for unresectable, treatment-resistant gastrointestinal stromal tumor (GIST).
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EU Drug Regulator Starts Safety Review of HPV Vaccines

(ABC News/Associated Press) July 13, 2015 - The European Medicines Agency says it has started a review of cervical cancer vaccines to see if they are linked to two rare conditions, but emphasized it hasn't changed its recommendations for how the shots should be used.
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Exelixis Announces Start of Phase 1 Trial of Cabozantinib in Combination with Nivolumab or Nivolumab Plus Ipilimumab in Patients with Advanced/Metastatic Urothelial Carcinoma and Other Genitourinary Tumors

(StreetInsider) July 13, 2015 - Exelixis, Inc. today announced the initiation of a phase 1 trial of cabozantinib in combination with nivolumab alone or in combination with nivolumab plus ipilimumab in patients with advanced/metastatic urothelial (bladder) and other genitourinary tumors.
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Researchers Identify Critical Genes Responsible for Brain Tumor Growth

(Cedars-Sinai) July 9, 2015 - After generating new brain tumor models, Cedars-Sinai scientists in the Board of Governors Regenerative Medicine Institute identified the role of a family of genes underlying tumor growth in a wide spectrum of high grade brain tumors.
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Combining MRI, NIRST Increases Specificity in Breast Imaging

(Dartmouth-Hitchcock/Norris Cotton) July 9, 2015 - By combining two modalities of imaging, investigators from Norris Cotton Cancer Center at Dartmouth demonstrated that a dual breast exam using MRI and Near Infrared Spectral Tomography (NIRST) is feasible and more accurate than MRI alone.
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Interim PET/CT No Help Guiding Lymphoma Tx

(MedPage Today) July 11, 2015 - An interim positron emission tomography (PET/CT) scan following two cycles of rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone given every 14 days (R-CHOP-14) does not help guide treatment decisions in patients with diffuse large B-cell lymphoma (DLBCL) who go on to receive six cycles of R-CHOP-14, a large prospective trial indicates.
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JAX Researchers And Collaborators Identify Recurrent Fusion Genes In Gastric Cancers Using New Genomic Analysis Approach

(The Jackson Laboratory) July 9, 2015 - Studying the gastric cancers of 15 Southeast Asian patients, researchers at The Jackson Laboratory, the Genome Institute of Singapore and other institutions identified five recurrent fusion genes, one of which appears to lead to cellular changes involved in acute gastritis and cancer.
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Survivors Of Teenage Cancer Struggle With Jobs, Emotions Later In Life

(Reuters Health) July 10, 2015 - Even decades later, people diagnosed with cancer in their teenage years are less likely to have college degrees, to work full time, to be married or to live independently, a recent U.S. study found.
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Cancer Survivors May Face Unique Challenges When Trying to Adopt

(Wiley) July 13, 2015 - A new study has found that cancer survivors’ options for adoption may be limited by adoption agencies’ policies. Published early online in CANCER, a peer-reviewed journal of the American Cancer Society, the study also indicates that a training program for oncology healthcare providers can help them provide valuable information to patients who are making decisions about fertility and adoption.
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Another Genetic Error Linked to Childhood Leukemia

(U.S. News & World Report/HealthDay News) July 9, 2015 - Scientists say they've identified a gene mutation associated with childhood acute lymphoblastic leukemia.
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The Double Mastectomy Rebellion

(Wall Street Journal) July 10, 2015 - More women with cancer in one breast are choosing to remove both, even when not medically necessary, worrying doctors.
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Roche's PD-L1 Inhibitor Shows Promise In Bladder Cancer

(PharmaTimes [UK]) July 13, 2015 - Roche says data from a Phase II trial of its PD-L1 inhibitor atezolizumab showed that the therapy shrank tumours in patients with a particular type of bladder cancer, thereby meeting its primary goal.
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In A Pivotal Study, Roche’s Investigational Immunotherapy Atezolizumab Shrank Tumours In People With A Specific Type Of Bladder Cancer

(Roche) July 13, 2015 - Roche today announced that in the IMvigor 210 study, the investigational cancer immunotherapy atezolizumab (MPDL3280A; anti-PDL1) shrank tumours (objective response rate, ORR, the primary end point of this Phase II study) in people with locally advanced or metastatic urothelial bladder cancer (UBC) who had progressed on initial treatment (second-line or later).
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OncoGenex Announces Custirsen Phase 3 "ENSPIRIT" Trial Continues Following Completion of Final Futility Survival Analysis

(OncoGenex) July 13, 2015 - OncoGenex Pharmaceuticals, Inc. announced today that its Phase 3 ENSPIRIT trial evaluating custirsen in the treatment of advanced or metastatic non-small cell lung cancer (NSCLC) is continuing as planned per the recommendation of an Independent Data Monitoring Committee (IDMC).
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Imbruvica® (ibrutinib) Now Approved To Treat Waldenstrom's Macroglobulinemia in Europe

(AbbVie) July 10, 2015 - First therapy to be approved specifically for this disease in the EU.
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Obamacare Acting Administrator Slavitt Nominated to Head Agency

(Reuters) July 9, 2015 - Andy Slavitt, the acting administrator of the Centers for Medicare and Medicaid Services, which oversees the Obamacare healthcare program, has been nominated as head of the agency, the White House said on Thursday.
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Previewing the Next Look at Biogen's Alzheimer's Drug

(TheStreet) July 9, 2015 - On Wednesday, July 22, Biogen will present updated results from a closely watched clinical trial involving its Alzheimer's drug candidate aducanumab (formerly known as BIIB037.) Investors first saw aducanumab data from this study in March. The results were both spectacular and controversial.
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Novartis Looking at Ways to Win Over Cost-Concerned Health Insurers

(Wall Street Journal) July 10, 2015 - Novartis AG might offer a bundle of health-care services alongside its promising new heart-failure drug to win over increasingly cost-conscious insurers, its chief executive said.
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FDA Strengthens Heart Safety Warnings on Painkillers

(NBC News) July 9, 2015 - The Food and Drug Administration is strengthening its warnings about painkillers like ibuprofen, saying they do raise the risk of heart attack or stroke.
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White House Gets More Precise About Precision Medicine

(Medscape Medical News) July 9, 2015 - The White House yesterday proposed "privacy and trust principles" for its 6-month-old Precision Medicine Initiative (PMI) that set forth the sometimes clashing goals of safeguarding patient data while sharing it as freely as possible.
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House Overwhelmingly Passes Bill to Speed FDA Drug Approvals

(Washington Post/Wonkblog) July 10, 2015 - A bipartisan bill that would make significant changes to the process for developing new drugs and medical devices overwhelmingly passed the House in a 344-77 vote Friday morning.
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Detroit-Area Cancer Doctor Gets 45 Years in Prison for Fraud

(ABC News/Associated Press) July 10, 2015 - Calling the scheme "horrific," a judge sentenced a Detroit-area cancer doctor to 45 years in prison Friday for collecting millions from insurance companies while poisoning more than 500 patients through needless treatments that wrecked their health.
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Mylan Recalls Cancer and Arthritis Injectables

(in-Pharma Technologist) July 9, 2015 - Mylan is expanding its recall of injectable Gemcitabine and Methotrexate batches after finding visible particulates.
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CMS to Host Provider Call on 2016 PFS Proposals for Quality Reporting Programs

(ACCC) July 9, 2015 - Registration is open for a MLN Connects® National Provider Call that will provide an overview of proposed changes to quality reporting programs in the 2016 Physician Fee Schedule Proposed Rule.
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CMS and AMA Announce ICD-10 Implementation Grace Period

(ASCO in Action) July 9, 2015 - The Centers for Medicare and Medicaid Services (CMS) and the American Medical Association (AMA) have jointly announced a "grace period" for the October 1, 2015, implementation of the International Classification of Diseases, 10th Edition, (ICD-10) diagnosis code set.
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