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Biophytis SA Announces Top Line Results of the SARA-INT Phase 2 Clinical Study with Sarconeos in Sarcopenia

Biophytis SA Announces Top Line Results of the SARA-INT Phase 2 Clinical Study with Sarconeos in Sarcopenia
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Meter Walk Test , Full Analysis Dataset , Appendicular Lean Mass , Body Mass Index , Short Physical Performance Battery , Full Analysis Set , Patient Reported Outcome , மீட்டர் நட சோதனை , உடல் நிறை குறியீட்டு , குறுகிய உடல் செயல்திறன் மின்கலம் , முழு பகுப்பாய்வு அமை ,

F. Hoffmann-La Roche Ltd: Phase III prevention trial showed subcutaneous administration of investigational antibody cocktail casirivimab and imdevimab reduced risk of symptomatic COVID-19 infections by 81%

F. Hoffmann-La Roche Ltd: Phase III prevention trial showed subcutaneous administration of investigational antibody cocktail casirivimab and imdevimab reduced risk of symptomatic COVID-19 infections by 81%
Placebo
Risk reduction
13
1.2
4 copies/mL)
14
0.4

Individuals without any COVID-19 symptoms who lived in the same household as an individual who tested positive to SARS-CoV-2 within the prior four days
. Based on the seronegative modified Full Analysis Set population, which includes all randomized subjects without evidence of current or prior SARS-CoV-2 infection (i.e., a negative RT-qPCR test and a negative antibody test) at randomization.
Adverse events (AEs) occurred in 20% (n=265 out of 1,311) of REGEN-COV participants and 29% (n=379 out of 1,306) of placebo participants, and serious AEs occurred in 1% (n=10) of REGEN-COV participants and 1% (n=15) of placebo participants. There were 0 REGEN-COV participants and 4 placebo pa ....

United Kingdom , United States , Nathalie Meetz , Levi Garraway , Daniel Grotzky , Jon Kaspar Bayard , Karl Mahler , Sabine Borngr , Gerard Tobin , Bruno Eschli , Birgit Masjost , Lisa Tuomi , Actemra Roactemra , Loren Kalm , Patrick Barth , Karsten Kleine , National Institute Of Allergy , Us Department Of Health , Pharmaceuticals Industry , Committee For Medicinal Products Human Use , Biomedical Advanced Research , National Institutes Of Health , Human Services , Drug Administration , Head Of Global Product Development , Development Authority ,

Phase 3 Treatment Trial in Recently Infected Asymptomatic Patients Showed REGEN-COV™ (casirivimab with imdevimab) Significantly Reduced Progression to Symptomatic COVID-19

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TARRYTOWN, N.Y., April 12, 2021 /PRNewswire/
Second Phase 3 trial undertaken in collaboration with NIAID to announce results today, both using subcutaneous administration of REGEN-COV in asymptomatic individuals without prior COVID-19 infection
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced positive data from a Phase 3 trial (2069B) of recently infected asymptomatic COVID-19 patients, evaluating REGEN-COV™ (casirivimab with imdevimab) 1,200 mg administered via subcutaneous (SC) administration. REGEN-COV reduced the overall risk of progressing to symptomatic COVID-19 by 31% (primary endpoint), and by 76% after the third day. The trial also demonstrated that REGEN-COV shortened symptom duration and markedly reduced viral levels.
The Phase 3 trial is the second to report results today, which was jointly run with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH). The ....

United Kingdom , United States , Sarah Cornhill , Georged Yancopoulos , Regeneron Velocimmune , Vesna Tosic , National Institute Of Allergy , Regeneron Velocimmune Technology , Teva Pharmaceutical Industries Ltd , Department Of Health , Hospital Of The University Pennsylvania , Regeneron Pharmaceuticals Inc , Biomedical Advanced Research , National Institutes Of Health , Regeneron Genetics Center , Human Services , Us Department Of Health , Drug Administration , Development Authority , Exchange Commission , Office Of The , National Infusion Center Association , National Institute , Infectious Diseases , National Institutes , Katharine Bar ,

Supernus Announces Positive Results from Phase III Study for SPN-812 in Adults with ADHD – IT Business Net

Met primary endpoint with robust statistical significance
Showed efficacy on both hyperactivity/impulsivity and inattention subscales with statistical significance
Showed statistically significant onset of action as early as week 2
Had a good safety and tolerability profile throughout the study
Topline data confirm positive results from prior Phase IIa study in adults and Phase III studies of SPN-812 in children and adolescents
ROCKVILLE, Md., Dec. 22, 2020 (GLOBE NEWSWIRE) Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a pharmaceutical company focused on developing and commercializing products for the treatment of central nervous system diseases, today announced positive topline results from a Phase III study of SPN-812 in adults (P306) for the treatment of attention deficit hyperactivity disorder (ADHD). ....

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Supernus Announces Positive Results from Phase III Study for SPN-812 in Adults with ADHD

Supernus Announces Positive Results from Phase III Study for SPN-812 in Adults with ADHD
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Jack Khattar , Jacka Khattar , Jim Kelly , Peter Vozzo , Exchange Commission , Securities Exchange , Drug Administration , Supernus Pharmaceuticals Inc , Supernus Pharmaceuticals , Symptom Rating Scale , Clinical Global Impression , Complete Response Letter , New Drug Application , Chief Executive Officer , Mixed Model Repeated Measures , Full Analysis Set , Investor Relations , Prescribing Information , Looking Statements , Private Securities Litigation Reform Act , Securities Exchange Act , Executive Vice President , பலா காட்டார் , ஜாக்கா காட்டார் , ஜிம் கெல்லி , பரிமாற்றம் தரகு ,