PAVmed Announces First Human CarpX™ Procedures
20 mai 2019 09h30 HE
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PAVmed Inc.
First nine patients undergo successful CarpX procedures as part of FIH clinical safety study NEW YORK, May 20, 2019 (GLOBE NEWSWIRE) -- PAVmed Inc. (Nasdaq: PAVM, PAVMZ) (the “Company” or...
OpGen Completes Initial FDA 510(k) Submission for its Acuitas® AMR Gene Panel Test to Identify Presence of Antibiotic Resistance
14 mai 2019 07h30 HE
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OpGen, Inc.
GAITHERSBURG, Md., May 14, 2019 (GLOBE NEWSWIRE) -- OpGen, Inc. (Nasdaq: OPGN) announced today that it has filed its 510(k) submission with the U.S. Food and Drug Administration (FDA) for clearance...
Adoption of Artificial Intelligence Is High Across Pharmaceutical Industry, According to Tufts Center for the Study of Drug Development
07 mai 2019 09h00 HE
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Tufts Center for the Study of Drug Development
BOSTON, May 07, 2019 (GLOBE NEWSWIRE) -- The pharmaceutical industry is adopting artificial intelligence (AI) on numerous fronts, from discovery and clinical development to risk assessment and...
Axsome Therapeutics Announces Expedited Development and Pivotal Status for AXS-05 in the Treatment of Major Depressive Disorder based on FDA Breakthrough Therapy Meeting
06 mai 2019 06h30 HE
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Axsome Therapeutics, Inc.
Previously completed active-controlled ASCEND trial in MDD now considered as pivotal; sufficient with ongoing STRIDE-1 Phase 3 trial for NDA in MDD Target randomization for STRIDE-1 Phase 3 trial...
Corbus Pharmaceuticals Announces Change of Primary Endpoint in Ongoing RESOLVE-1 Phase 3 Study in Systemic Sclerosis in U.S. to ACR CRISS from mRSS Following Meeting with FDA
18 avr. 2019 08h05 HE
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Corbus Pharmaceuticals Holdings, Inc.
Phase 3 primary endpoint will now be aligned with that of previous Phase 2 studyACR CRISS is a composite index (composed of multiple outcomes including mRSS) and was secondary endpoint in current...
Hemostemix Announces Convertible Debenture Financing
15 avr. 2019 08h30 HE
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Hemostemix Inc.
NOT FOR DISTRIBTUTION TO U.S. NEWS WIRE SERVICES OR DISSEMINATION IN THE UNITED STATES CALGARY, Alberta, April 15, 2019 (GLOBE NEWSWIRE) -- Hemostemix Inc. (“Hemostemix” or the “Company”) (TSX...
Sorrento Therapeutics Expands Resiniferatoxin (RTX) Clinical Development Program to Life-Threatening Cardiovascular Diseases With Completion of Major Animal Toxicology Study
15 avr. 2019 04h00 HE
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Sorrento Therapeutics, Inc.
SAN DIEGO, April 15, 2019 (GLOBE NEWSWIRE) -- Sorrento Therapeutics, Inc. (NASDAQ: SRNE, "Sorrento"), announced that its Neuro-Therapeutics unit is pursuing clinical development of resiniferatoxin...
Immuron Aims to Secure FDA Approval for IMM-124E to Prevent Travelers’ Diarrhea
11 avr. 2019 09h00 HE
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Immuron Limited
Key Points Immuron to develop U.S. registration dossier for IMM-124E for Travelers’ DiarrheaCompany anticipates significant inflection in sales with successful FDA registration of IMM-124ECompany to...
Hemostemix Announces Enrollment Milestone in the ACP-01 Phase II Critical Limb Ischemia Clinical Trial
09 avr. 2019 08h30 HE
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Hemostemix Inc.
CALGARY, Alberta, April 09, 2019 (GLOBE NEWSWIRE) -- Hemostemix Inc. (“Hemostemix” or the “Company”) (TSX VENTURE: HEM; OTCQB: HMTXF) is pleased to announce that it has reached an enrollment...
uniQure Receives FDA Fast Track Designation for AMT-130 Gene Therapy for the Treatment of Huntington’s Disease
08 avr. 2019 07h00 HE
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uniQure Inc.
LEXINGTON, Mass. and AMSTERDAM, the Netherlands, April 08, 2019 (GLOBE NEWSWIRE) -- uniQure N.V. (NASDAQ: QURE), a leading gene therapy company advancing transformative therapies for patients with...