RAPS Publishes Updated Fundamentals of US Regulatory Affairs Book
17 juil. 2019 11h42 HE
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Regulatory Affairs Professionals Society (RAPS)
Rockville, MD, USA, July 17, 2019 (GLOBE NEWSWIRE) -- The Regulatory Affairs Professionals Society (RAPS) has just published the updated, 11th edition of Fundamentals of US Regulatory Affairs, the...
Capricor Therapeutics Announces Positive Results from its Interim Analysis in the HOPE-2 Trial to Treat Patients with Duchenne Muscular Dystrophy
15 juil. 2019 06h00 HE
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Capricor Therapeutics, Inc.
--Interim Analysis Showed Statistically Significant Improvements in the Performance of the Upper Limb, Grip Strength and Inspiratory Flow Reserve in the Randomized Double-Blind Placebo Controlled...
Public-Private Summit Convenes in New Orleans to Comprehensively Address Challenges in Domestic Shrimp Industry
10 juil. 2019 15h54 HE
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American Shrimp Processors Association
NEW ORLEANS, July 10, 2019 (GLOBE NEWSWIRE) -- Members of the American Shrimp Processors Association (ASPA) participated in an industry summit on July 9, 2019 at the U.S. Customs House in New...
Growth in Rare Disease R&D Is Challenging Development Strategy and Execution, According to Tufts Center for the Study of Drug Development
09 juil. 2019 09h00 HE
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Tufts Center for the Study of Drug Development
BOSTON, July 09, 2019 (GLOBE NEWSWIRE) -- Rare disease drug development, which now accounts for nearly one-third of all drugs in active R&D worldwide, presents scientific and operational...
Hemostemix Announces Ongoing Phase II CLI Trial Abstract Accepted for Presentation by Canadian Society for Vascular Surgery
02 juil. 2019 08h30 HE
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Hemostemix Inc.
CALGARY, Alberta, July 02, 2019 (GLOBE NEWSWIRE) -- Hemostemix Inc. (“Hemostemix” or the “Company”) (TSX VENTURE: HEM; OTCQB: HMTXF), a biotechnology company developing and commercializing...
Q BioMed Files for Orphan Drug Designation with U.S. FDA for Autism Spectrum Disorder Subtype
28 juin 2019 08h32 HE
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Q BioMed Inc.
Currently no effective treatment exists for the 20,000 children in the U.S. and 250,000 born worldwide each year with pediatric minimally verbal autism (PMVA) NEW YORK, June 28, 2019 (GLOBE...
Hemostemix Announces Enrollment Update for the ACP-01 Phase II Critical Limb Ischemia Clinical Trial
27 juin 2019 08h30 HE
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Hemostemix Inc.
CALGARY, Alberta, June 27, 2019 (GLOBE NEWSWIRE) -- Hemostemix Inc. (“Hemostemix” or the “Company”) (TSX VENTURE: HEM; OTCQB: HMTXF) is pleased to announce that it has enrolled a total of forty (40)...
Ritter Pharmaceuticals Provides Phase 3 Liberatus Clinical Trial and Regulatory Update
20 juin 2019 09h15 HE
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Ritter Pharmaceuticals, Inc.
LOS ANGELES, June 20, 2019 (GLOBE NEWSWIRE) -- Ritter Pharmaceuticals, Inc. (Nasdaq: RTTR) (“Ritter Pharmaceuticals” or the “Company”), a developer of innovative therapeutic products that modulate...
Melinta Therapeutics Announces U.S. FDA Acceptance of Supplemental New Drug Application for BAXDELA® (delafloxacin) for the Treatment of Community-Acquired Bacterial Pneumonia
19 juin 2019 07h30 HE
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Melinta Therapeutics
~ Application Seeks to Expand Label to Include an Indication and Phase III Data for the Treatment of Adult Patients with Community-Acquired Bacterial Pneumonia (CABP) ~ ~ PDUFA Date Set for October...
VBI Vaccines Announces Positive Top-Line Results from PROTECT, a Pivotal Phase 3 Study of Sci-B-Vac®
17 juin 2019 06h00 HE
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VBI Vaccines, Inc.
Both co-primary endpoints successfully met – including non-inferiority in all adults age ≥18 years, and superiority in adults age ≥ 45 yearsSeroprotection rates four weeks post-3rd vaccination of...