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CHMP

EU's CHMP Grants Conditional Marketing Authorization to Novartis' Personalized NSCLC Rx Zykadia
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Zykadia received conditional marketing authorization as a treatment for advanced NSCLC patients who've previously received the ALK inhibitor Xalkori, and so are known to be ALK positive.

CHMP Recommends Conditional Marketing Authorization for Pfizer's Leukemia Drug
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Originally published Jan. 18. EU's Committee for Medicinal Products for Human Use this week recommended that the European Medicine's Agency grant conditional marketing authorization for Pfizer's leukemia drug bosutinib.

European Regulators Grant Conditional Approval for Pfizer's Xalkori; Abbott Begins Marketing ALK CDx
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The European Commission has granted conditional marketing authorization to Pfizer's Xalkori (crizotinib), a personalized treatment for non-small cell lung cancer.

European Regulatory Body Seeks Stakeholder Input on Future PGx Guidance
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Originally published Jan. 30. The European Medicines Agency is seeking stakeholder input on how best to use pharmacogenomics data to advance personalized medicines.

CHMP Recommends EU Approval of Roche PGx Drug Zelboraf
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The European Commission's Committee for Medicinal Products for Human Use last eek recommended marketing authorization for Roche's Zelboraf as a monotherapy for the treatment of patients with BRAF V600 mutation-positive unresectable or metastatic melanoma.
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The Scan

Positive Framing of Genetic Studies Can Spark Mistrust Among Underrepresented Groups

Researchers in Human Genetics and Genomics Advances report that how researchers describe genomic studies may alienate potential participants.

Small Study of Gene Editing to Treat Sickle Cell Disease

In a Novartis-sponsored study in the New England Journal of Medicine, researchers found that a CRISPR-Cas9-based treatment targeting promoters of genes encoding fetal hemoglobin could reduce disease symptoms.

Gut Microbiome Changes Appear in Infants Before They Develop Eczema, Study Finds

Researchers report in mSystems that infants experienced an enrichment in Clostridium sensu stricto 1 and Finegoldia and a depletion of Bacteroides before developing eczema.

Acute Myeloid Leukemia Treatment Specificity Enhanced With Stem Cell Editing

A study in Nature suggests epitope editing in donor stem cells prior to bone marrow transplants can stave off toxicity when targeting acute myeloid leukemia with immunotherapy.