Entries by PR Newswire

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21st Century Cures: A Regulatory Game-Changer for the Pharmaceutical Industry

Regulatory leaders in the pharmaceutical industry continue to watch closely the newly released bipartisan discussion draft called “21st Century Cures.” This 393-page draft document is planned to be taken up by Congress soon and if enacted into law, it could alter how pharmaceutical and medical device products are developed and marketed in the United States. […]

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Kaiser Permanente Reveals TV Ads Featuring Stephen Curry as Latest Game Plan in Partnership with NBA

OAKLAND, Calif., April 17, 2015 /PRNewswire/ — In an effort to connect with individuals and create stronger, healthier communities, Kaiser Permanente is debuting two new television advertisements as part of its partnership with the National Basketball Association. The advertisements, the first of which will air on Saturday, April 18, will coincide with the start of the […]

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Real World Data Support Use of Blood Test for EGFR Mutation in Advanced NSCLC

AstraZeneca today presented results from two key studies showing the effectiveness of plasma circulating tumour DNA (ctDNA) testing for epidermal growth factor receptor (EGFR) mutation status in newly diagnosed patients with advanced non-small cell lung cancer (NSCLC) in clinical practice.[1],[2] Data from the studies – ASSESS and IGNITE – were reported at the European Lung […]

Avanir Pharmaceuticals Announces Multiple Data Presentations Highlighting Its Central Nervous System (CNS) Therapeutics Franchise at the American Academy of Neurology (AAN) 2015 Annual Meeting

ALISO VIEJO, Calif., April 15, 2015 /PRNewswire/ — Avanir Pharmaceuticals, Inc. today announced that data highlighting its central nervous system (CNS) therapeutics franchise, including data from the Phase 2 study of AVP-923 for the treatment of agitation in Alzheimer’s disease, data from the Alzheimer’s cohort of PRISM II of NUEDEXTA® for the treatment of Pseudobulbar […]

Oncobiologics announces completion of clinical dosing for bevacizumab (Avastin biosimilar) candidate

CRANBURY, N.J., April 15, 2015 /PRNewswire/ — Oncobiologics, Inc., a biotherapeutics company focused on developing and commercializing biosimilars, today announced that clinical development for ONS-1045, an Avastin®/bevacizumab biosimilar candidate, is underway with dosing completed in its pivotal pharmacokinetic (PK) study.  This study is currently being conducted at the Center for Human Drug Research (CHDR) in Leiden, […]

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The Lancet Publishes The First Ever Successful Series of Clinical Heart Transplants From DCD Donors Using The TransMedics Organ Care System (OCS)

ANDOVER, Mass., April 15, 2015 /PRNewswire/ — TransMedics, the company that developed the Organ Care System (OCS™) announces that the groundbreaking series of adult heart transplants from a new potential source of donors completed in the latter half of 2014 has today been published in The Lancet. The OCS™ platform is the only medical device […]

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FDA Advisory Committee Reviews Takeda’s Alogliptin EXAMINE Cardiovascular Safety Outcomes Trial

DEERFIELD, Ill. and OSAKA, Japan, April 14, 2015 /PRNewswire/ — Takeda Pharmaceuticals U.S.A. Inc. and Takeda Pharmaceutical Company Limited, (“Takeda”) today announced that members of the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) of the United States (U.S.) Food and Drug Administration (FDA) convened to review one of the first cardiovascular (CV) outcomes trials (CVOT) […]