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Monthly Archives: February 2016

Surescripts Supports White House to Advance Precision Medicine Initiative

ARLINGTON, Va.–(BUSINESS WIRE)–Today Surescripts, the nation’s leading health information network, announces its support of President Obama’s Precision Medicine Initiative (PMI). Surescripts will participate in the White House Precision Medicine Initiative Summit and pledge its support to provide Surescripts’ infrastructure and technology to help the Precision Medicine Initiative aggregate the medical …

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AbbVie Announces Positive CHMP Opinion for Viekirax without Ribavirin in HCV

NORTH CHICAGO, Ill., Feb. 26, 2016 /PRNewswire/ — AbbVie (NYSE: ABBV), a global biopharmaceutical company, announced today that the European Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has granted a positive opinion for the use of VIEKIRAX® (ombitasvir/paritaprevir/ritonavir tablets) + EXVIERA® (dasabuvir tablets) without …

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CHMP Recommends Approval of BMS’ Opdivo for Two New Indications

PRINCETON, N.J.–(BUSINESS WIRE)–Bristol-Myers Squibb Company (NYSE: BMY) today announced that the Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Opdivo (nivolumab) for two new indications – adults with locally advanced or metastatic non-small cell lung cancer (NSCLC) after prior chemotherapy, and adults with advanced renal …

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FDA Approves Pfizer’s Xeljanz XR for Treatment of Rheumatoid Arthritis

Pfizer Inc. (NYSE:PFE) announced today that the U.S. Food and Drug Administration (FDA) has approved XELJANZ® XR (tofacitinib citrate) extended-release 11 mg tablets for the once-daily treatment of moderate to severe rheumatoid arthritis (RA) in patients who have had an inadequate response or intolerance to methotrexate (MTX). XELJANZ XR is the …

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Baxalta and Precision Biosciences Form Global Genome Editing Collaboration in Immuno-Oncology

BANNOCKBURN, Ill. & DURHAM, N.C.–(BUSINESS WIRE)–Baxalta Incorporated (NYSE: BXLT), a global biopharmaceutical leader dedicated to delivering transformative therapies to patients with orphan diseases and underserved conditions, and Precision BioSciences, the genome editing company, today announced a global collaboration to develop a broad series of allogeneic chimeric antigen receptor (CAR) T …

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AstraZeneca and Acerta Pharma’s Acalabrutinib Recommended for EU Orphan Status for 3 Indications

AstraZeneca and Acerta Pharma BV, a company in which AstraZeneca has a majority equity investment, today announced that the European Medicines Agency (EMA) Committee for Orphan Medicinal Products (COMP) adopted three positive opinions recommending acalabrutinib (ACP-196) for designation as an orphan medicinal product. The three positive opinions are for the …

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Turning Patients into Partners

Education opens minds. For patients, education often means the difference between adherence and non-adherence, which in turn determines the effectiveness of treatment. More than ever before, the health care community understands that an active partnership between patients and their health care team can empower patients and lead to better outcomes. …

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Regen BioPharma Completes Preclinical Experimentation of its Novel siRNA NR2F6 Checkpoint Inhibitor

SAN DIEGO, February 24, 2016 /PRNewswire/ — Regen BioPharma, Inc., (OTCBB: RGBP) and (PINK: RGBP) announced today completion of experiments, in collaboration with Dr.Santosh Kesari, demonstrating immunological mechanisms of its novel NR2F6 gene silencing approach.  Subsequent to these experiments, the Company has begun the process of compiling an Investigational New Drug …

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FDA Accepts and Grants Priority Review to Allergan’s Avycaz sNDA

DUBLIN, Feb. 24, 2016 /PRNewswire/ — Allergan plc (NYSE: AGN), a leading global pharmaceutical company, today announced the U.S. Food and Drug Administration (FDA) has accepted for filing the company’s supplemental New Drug Application (sNDA) for AVYCAZ® (ceftazidime and avibactam). This filing will add important new clinical data to the current label …

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