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Bone Therapeutics receives Clinical Trial Application (CTA) approval for next clinical studies of its two lead candidates
Regulatory authorities approve JTA Phase III study in osteoarthritic knee pain and ALLOB Phase IIb study in difficult fractures Gosselies, Belgium, 23 March 2020, 7am CET – BONE THERAPEUTICS (Euronext Brussels and Paris: BOTHE), the bone cell therapy company...
GeNeuro Phase 2 multiple Sclerosis Trial Update
GENEVA--(BUSINESS WIRE)--Regulatory News: “We must put the fight against COVID-19 and the safety of MS patients first. Initiation of the trial will now take place once hospitals have more capacities for clinical research and are able to ensure that MS patients will...
Oramed Receives Positive Feedback From End-of-Phase 2 Oral Insulin CMC Meeting With FDA
NEW YORK, March 19, 2020 /PRNewswire/ -- Oramed Pharmaceuticals Inc. (Nasdaq: ORMP) (TASE: ORMP) (www.oramed.com), a clinical-stage pharmaceutical company focused on the development of oral drug delivery systems, today announced positive feedback from its initial...
Pfizer Announces Top-Line Results from Phase 3 Study of 20-Valent Pneumococcal Conjugate Vaccine in Pneumococcal Vaccine-Naïve Adults Aged 18 Years or Older
20-valent pneumococcal conjugate vaccine demonstrated comparable safety and immunogenicity profile to licensed pneumococcal vaccines March 18, 2020 04:15 PM Eastern Daylight Time NEW YORK--(BUSINESS WIRE)--Pfizer Inc. (NYSE:PFE) today announced top-line results from...
Portola Pharmaceuticals Announces Proactive Steps Supporting Public Health Efforts to Combat Coronavirus (COVID-19)
SOUTH SAN FRANCISCO, Calif., March 18, 2020 /PRNewswire/ -- Portola Pharmaceuticals, Inc.® (NASDAQ: PTLA) today announced proactive steps the Company is taking in support of public heath efforts to prevent furtherspread of coronavirus (or COVID-19) around the globe....
TFF Pharmaceuticals Announces Phase 1 Clinical Trial Progress for Voriconazole Inhalation Powder to Treat Invasive Pulmonary Aspergillosis (IPA)
Successfully completes single ascending dose phase of first clinical study in healthy subjects for a direct-to-lung, Thin Film Freezing (TFF) dry-powder formulation Invasive Pulmonary Aspergillosis is a severe fungal pulmonary disease with a mortality rate that can...
Algernon to Support Planned Phase 2 Trial of Ifenprodil for Coronavirus
VANCOUVER, British Columbia, March 19, 2020 (GLOBE NEWSWIRE) -- Algernon Pharmaceuticals Inc. (CSE: AGN) (FRANKFURT: AGW) (OTCQB: AGNPF) (the “Company” or “Algernon”) a clinical stage pharmaceutical development company is pleased to announce that Novotech, a leading...
Enlivex Announces Positive Final Safety and Efficacy Data From Clinical Trial of Off-The-Shelf Allocetra in Patients with Severe Sepsis
– Final Analysis Comparing 10 AllocetraTM-Treated Patients with 37 Matched Controls Showed Significant Positive Responses in State of Organ Failure, ICU Hospitalization and Mortality in a Highly Fragile and Extremely Difficult to Treat Population with Severe Sepsis –...
Mateon to Develop its OT-101, a Phase 3 Clinical Drug Candidate, Initially Against COVID-19
AGOURA HILLS, Calif., March 18, 2020 (GLOBE NEWSWIRE) -- Mateon Therapeutics, Inc., (OTCQB:MATN) (“Mateon”) dedicated to development OT-101, a TGF-Beta antisense drug candidate, today provided an update on its rapid antiviral response program against coronaviruses,...
Saniona completes its six months double blind Phase 2a trial of Tesomet in hypothalamic obesity
·Last patient completes last visit in the six-month, placebo-controlled part of study ·18 patients have continued into open-label extension ·Top-line results from placebo-controlled part of study still expected in Q2 2020 Saniona (SANION.ST), a clinical stage...
Roche initiates Phase III clinical trial of Actemra/RoActemra in hospitalised patients with severe COVID-19 pneumonia
Basel, 19 March 2020- Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced we are working with the Food & Drug Administration (FDA) to initiate a randomised, double-blind, placebo-controlled Phase III clinical trial in collaboration with the Biomedical Advanced...
Genentech Initiates Phase III Clinical Trial of Actemra in Hospitalized Patients With Severe COVID-19 Pneumonia
SOUTH SAN FRANCISCO, Calif.--(Business Wire)--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the company is working with the U.S. Food & Drug Administration (FDA) to initiate a randomized, double-blind,...
Genentech Initiates Phase III Clinical Trial of Actemra in Hospitalized Patients With Severe COVID-19 Pneumonia
SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the company is working with the U.S. Food & Drug Administration (FDA) to initiate a randomized, double-blind, placebo-controlled...
Roche initiates Phase III clinical trial of Actemra/RoActemra in hospitalised patients with severe COVID-19 pneumonia
Basel, 19 March 2020- Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced we are working with the Food & Drug Administration (FDA) to initiate a randomised, double-blind, placebo-controlled Phase III clinical trial in collaboration with the Biomedical Advanced...
US Clinical Trial Site Concerns Over COVID-19 Impact on Enrollment Jumps by 88% in Just 4 Days
European site enrollment concerns near 80% An ongoing quantitative survey conducted by Continuum Clinical shows clinical research study sites are rapidly becoming more concerned about COVID-19-related interruptions to clinical trial recruitment and retention, with US...
Roche to start Phase III trial of Actemra in Covid-19 patients
Roche has collaborated with the US Food and Drug Administration (FDA) to conduct a Phase III clinical trial of Actemra/RoActemra (tocilizumab) in hospitalised adults with severe Covid-19 pneumonia. Actemra/RoActemra is an anti-IL-6 receptor biologic approved to treat...
NIH Begins Clinical Trial of Investigational Vaccine For COVID-19
A Phase 1 clinical trial evaluating an investigational vaccine designed to protect against coronavirus disease 2019 (COVID-19) has begun at Kaiser Permanente Washington Health Research Institute (KPWHRI) in Seattle, WA, the United States National Institutes of Health...
Provention Bio Provides Update on the Status of Its Phase 3 PROTECT Study for the Treatment of Newly Diagnosed Type 1 Diabetes
- PROTECT Study Randomization to be Paused Temporarily in Response to the Ongoing Public Health Crisis - Company Reaffirms it is on Schedule to Complete PRV-031 (teplizumab) Rolling BLA Submission for Prevention or Delay of T1D in At-risk Individuals OLDWICK,...
Arcutis Announces Inclusion of Children in On-going Pivotal Phase 3 Clinical Trials Evaluating Topical Roflumilast (ARQ-151) as a Potential Once Daily Topical Treatment for Plaque Psoriasis
WESTLAKE VILLAGE, Calif., March 16, 2020 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (NASDAQ:ARQT), a late-stage biopharmaceutical company focused on developing and commercializing treatments for unmet needs in immune-mediated dermatological diseases and...
XORTX Launches XRx-101 Following the Filing of a Provisional Patent to Potentially Treat Respiratory and Kidney Disease Injury Due to Coronavirus Infection XRx-101 – a triple action approach to suppressing COVID-19 Injury
CALGARY, Alberta, March 16, 2020 (GLOBE NEWSWIRE) -- XORTX Therapeutics Inc. ("XORTX" or the “Company”) (CSE: XRX; OTCQB: XRTXF), a biopharmaceutical company focused on developing innovative therapies to treat progressive kidney disease, with late stage clinical...