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Tag Archives: FDA

ESSENTIEL – BIOTECHFINANCES N°850 – 01/04/2019

Janssen, Atai Life Sciences, bluebird bio, Thermo Fisher, Brammer Bio, Lexicon Pharmaceuticals, Sanofi, Cerenis, H4 Orphan Pharma, Theradiag, Genomic Vision, Transgene, SE Immunotherapeutics, genOway, Quantum Genomic, Clean Cells, Genopole, Servier, BPIFrance, Cellnovo, Genfit, Celyad, Sensorion, OSE Immunotherapeutics, Polyneuron Pharmaceuticals, LNC therapeutics, L’Institut Curie, Igyxos, Sofimac Innovation, SEQONE, Elaia Partners.

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Seattle Genetics Completes Enrollment in Phase 2 Clinical Trial of Tisotumab Vedotin in Recurrent or Metastatic Cervical Cancer

Friday, March 29th 2019 at 12:00pm UTC -Phase 2 innovaTV 204 Trial Designed to Support Potential Accelerated Approval Pathway in U.S.- BOTHELL, Wash.–(BUSINESS WIRE)– Seattle Genetics, Inc. (Nasdaq:SGEN) today announced completion of enrollment in the potentially pivotal innovaTV 204 phase 2 clinical trial evaluating the efficacy, safety and tolerability of …

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Dicerna™ Announces the Presentation of Updated Data Demonstrating Utility of its Lead Compound DCR-PHXC in Treating Primary Hyperoxaluria Type 1 (PH1) and Type 2 (PH2)

Friday, March 29th 2019 at 10:30am UTC —PHYOX™1 Investigators Reported Potent, Durable Response in Phase 1 Study in Patients with PH1 and PH2 at German Society of Pediatric Nephrology 50th Annual Meeting— —Company Announces Initiation of Participant Screening for PHYOX2 Pivotal Trial in PH1 and PH2— CAMBRIDGE, Mass.–(BUSINESS WIRE)– Dicerna™ …

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CORRECTING and REPLACING OARtrac® Radiation Dose Monitoring System Receives Expanded FDA Clearance for Electron Radiation Therapy

Thursday, March 28th 2019 at 10:48pm UTC LATHAM, N.Y.–(BUSINESS WIRE)– Second paragraph, first sentence of release should read: The additional indications clear the OARtrac System for use with patient-specific, pre-calibrated Plastic Scintillating Detector (PSD) sensors used during cancer treatments to measure photon and electron radiation therapy as an adjunct to …

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OARtrac® Radiation Dose Monitoring System Receives Expanded FDA Clearance for Electron Radiation Therapy

Thursday, March 28th 2019 at 8:01pm UTC LATHAM, N.Y.–(BUSINESS WIRE)– AngioDynamics, Inc. (NASDAQ: ANGO), a leading provider of innovative, minimally invasive medical devices for vascular access, peripheral vascular disease and oncology, today announced that the United States Food and Drug Administration (FDA) granted an expanded 510(k) clearance for the OARtrac …

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First US Patient Treated with Cook Medical’s Recently Approved Zenith® Dissection Endovascular System

Thursday, March 28th 2019 at 7:18pm UTC BLOOMINGTON, Ind.–(BUSINESS WIRE)– Following the recent FDA approval of Cook Medical’s Zenith Dissection Endovascular System, Cooper University Health Care in Camden, New Jersey, has treated the first patient in the US with the device as part of Cook’s US commercial launch. This press …

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Imbrium Therapeutics Announces U.S. FDA Orphan Drug Designation for Tinostamustine for the Treatment of T-cell Prolymphocytic Leukemia

Thursday, March 28th 2019 at 12:30pm UTC STAMFORD, Conn.–(BUSINESS WIRE)– Imbrium Therapeutics L.P., a clinical-stage biopharmaceutical company and operating subsidiary of Purdue Pharma L.P., in conjunction with Mundipharma EDO GmbH, today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to its investigational drug …

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Seattle Genetics and Astellas Announce Positive Topline Results from Pivotal Trial of Enfortumab Vedotin in Locally Advanced or Metastatic Urothelial Cancer

Thursday, March 28th 2019 at 7:01am UTC – Companies Plan to Submit Biologics License Application Later This Year – – Seattle Genetics to Hold Conference Call Today at 9:00 a.m. EDT – BOTHELL, Wash. & TOKYO–(BUSINESS WIRE)– Seattle Genetics, Inc. (Nasdaq:SGEN) and Astellas Pharma Inc. (TSE: 4503, President and CEO: …

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Vaxart Completes Dosing of the Lead-In Cohort in Bivalent Norovirus Vaccine Phase 1b Clinical Trial

Wednesday, March 27th 2019 at 12:00pm UTC First Oral Norovirus GII.4 Tablet Vaccine Used in Clinical Trial SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)– Vaxart, Inc., a clinical-stage biotechnology company developing oral recombinant vaccines that are administered by tablet rather than by injection, today announced the completion of dosing of the lead-in …

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Compulink Previews New User Interface for its Ophthalmology SMART EHR at AAPOS 2019

Tuesday, March 26th 2019 at 1:00pm UTC NEWBURY PARK, Calif.–(BUSINESS WIRE)– Compulink Healthcare Solutions, the creator of Advantage SMART Practice®, an all-in-one EHR and practice management solution powered by artificial intelligence (AI), will preview the new user interface for its Ophthalmology Advantage™ at the annual meeting of the American Association …

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