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Precision Medicine

Myriad Study Demonstrates EndoPredict Can Guide Chemotherapy Decision for Women with Early-Stage Breast Cancer

SALT LAKE CITY, Dec. 07, 2018 (GLOBE NEWSWIRE) — Myriad Genetics, Inc. (NASDAQ: MYGN), a global leader in personalized medicine, today announced that academic researchers from the Technical University of Munich (TUM) presented the first prospective outcomes data on EndoPredict® at the San Antonio Breast Cancer Symposium in San Antonio, Texas.  …

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Amgen Announces First-In-Human Data Evaluating Investigational Novel BiTE Immunotherapies AMG 420 And AMG 330

THOUSAND OAKS, Calif., Dec. 3, 2018 /PRNewswire/ — Amgen (NASDAQ:AMGN) today announced the first clinical results from studies evaluating investigational novel bispecific T cell engager (BiTE®) immunotherapies AMG 420 and AMG 330. In two separate Phase 1 dose escalation studies, AMG 420, which targets B-cell maturation antigen (BCMA), and AMG 330, which targets CD33, …

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FDA Accepts Editas Medicine’s IND Application for its CRISPR Genome Editing Medicine Being Investigated for Leber Congenital Amaurosis type 10

CAMBRIDGE, Mass., Nov. 30, 2018 (GLOBE NEWSWIRE) —  Editas Medicine, Inc. (NASDAQ: EDIT), a leading genome editing company, today announced the U.S. Food and Drug Administration (FDA) has accepted the Company’s Investigational New Drug (IND) application for EDIT-101, an experimental CRISPR genome editing medicine being investigated for the treatment of …

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AstraZeneca and Biocartis Enter Partnership Aimed at Faster Lung Cancer Biomarker Results

Mechelen, Belgium, 29 November 2018 – Biocartis Group NV (the ‘Company’ or ‘Biocartis’), an innovative molecular diagnostics company (Euronext Brussels: BCART), today announces it has entered into an agreement with AstraZeneca, a global science-led biopharmaceutical company (LON: AZN), aimed at obtaining faster lung cancer molecular diagnostic biomarker results in Europe. …

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FDA Approves Vitrakvi, the First Ever TRK Inhibitor, for Patients with Advanced Solid Tumors Harboring an NTRK Gene Fusion

STAMFORD, Conn. and WHIPPANY, N.J., Nov. 26, 2018 (GLOBE NEWSWIRE) — The U.S. Food and Drug Administration (FDA) today approved Vitrakvi® (larotrectinib), the first ever oral TRK inhibitor, for the treatment of adult and pediatric patients with solid tumors that have a neurotrophic receptor tyrosine kinase (NTRK) gene fusion without a …

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Identification of LZTR1 Leads to Novel Insights into RAS-Driven Diseases

Mutations in RAS proteins initiate many of the most aggressive tumors, and the search for pharmacological inhibitors of these proteins has become a priority in the battle against cancer. Michail Steklov, Francesca Baietti, and colleagues from the Anna Sablina lab (VIB-KU Leuven Center for Cancer Biology) identified LZTR1 as an …

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NantKwest Announces Promising First in Human Clinical Results of 300 Doses Of CD16 Targeted, Off-The-Shelf Cryopreserved Natural Killer Cells in a Novel Cancer Memory Vaccine Immunotherapy

CULVER CITY, Calif.–(BUSINESS WIRE)–The recent successes of immunotherapy, such as checkpoint inhibition, have spawned a wave of enthusiasm for immuno-oncology. Unfortunately, only a subset of cancer patients respond to checkpoint inhibitor monotherapy, and many of these checkpoint-responsive patients will eventually relapse. In addition, cellular therapy in the form of CAR-T …

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23andMe Granted the First and Only FDA Authorization For Direct-to-Consumer Pharmacogenetic Reports

Mountain View, California – October 31, 2018 – In another first, the U.S. Food and Drug Administration (FDA) granted 23andMe de novo authorization to offer reports on pharmacogenetics, indicating how customers’ genetics may influence the way they metabolize certain medications. This is the first authorization of a direct-to-consumer report on pharmacogenetics, and came …

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Lustgarten-Funded Study in Cancer Discovery Reveals Possible New Targets for Therapeutics

WOODBURY, N.Y., Oct. 26, 2018 /PRNewswire/ — Pancreatic cancer has shown to have limited effective treatment strategies.  Researchers in the Lustgarten Foundation Pancreatic Cancer Research Laboratory at Cold Spring Harbor Laboratory (CSHL) have made a discovery that could lead to a different, more effective kind of treatment. Part of the …

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Gottlieb Makes Statement on FDA’s New Steps to Modernize Drug Development, Improve Efficiency and Promote Innovation of Targeted Therapies

The FDA continues to advance new policies, modernize our programs and advance opportunities for developing more targeted therapies. Using new technology platforms such as cell and gene therapies and small molecule drugs that target the genomic basis of disease, there are more opportunities to intervene in the underlying mechanisms that cause a …

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