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Home » Topics » Clinical

Clinical
Clinical RSS Feed RSS

Pfizer-Biontech’s COVID-19 vaccine hits primary efficacy endpoints

Nov. 18, 2020
By Lee Landenberger
Product image
American Heart Association Scientific Sessions

Medtronic cryoablation beats drug therapy in atrial fibrillation

Nov. 17, 2020
By Annette Boyle
Medtronic plc's cryoablation could soon put drug therapy on ice in parts of the atrial fibrillation (AF) market, based on results of studies published in the New England Journal of Medicine (NEJM) and presented at the American Heart Association Scientific Sessions 2020.
Read More

Brainstorm's Nurown falls short in phase III ALS trial

Nov. 17, 2020
By Michael Fitzhugh
Shares of Brainstorm Cell Therapeutics Inc. (NASDAQ:BCLI) fell 66.3% to $4.02 on Nov. 17 following news that its autologous cell therapy candidate, Nurown, missed the primary efficacy endpoint of a phase III amyotrophic lateral sclerosis (ALS) study.
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COVID-19 mRNA vaccine vials, syringe

Dynamic stability: Moderna flies high with storage-friendly COVID-19 vaccine bid

Nov. 17, 2020
By Randy Osborne
Moderna Inc.’s phase III win with its COVID-19 vaccine candidate, mRNA-1273, lifted spirits while validating the Cambridge, Mass.-based firm’s platform, as Wall Street buzzed with comparisons between the prospects that have yielded late-stage data thus far.
Read More
Sputnik V vaccine

Russia’s Sputnik V vaccine shows 92% efficacy in early phase III readout

Nov. 17, 2020
By Nuala Moran
LONDON – A second COVID-19 vaccine has reported positive results in an interim phase III analysis, with Russia’s Sputnik V showing 92% efficacy. The news comes two days after the first readout from a phase III COVID-19 vaccine trial reported 90% efficacy for Pfizer Inc. and Biontech SE’s BNT-162b2.
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Vaccine administration

Anvisa restarts trials for Sinovac’s COVID-19 vaccine

Nov. 17, 2020
By Alfred Romann and Sergio Held
BOGOTA, Colombia and VANCOUVER, Canada – Anvisa, Brazil’s health care surveillance agency, re-started phase III trials for Coronavac, the COVID-19 vaccine candidate developed by China-based Sinovac Biotech Ltd., after a suspension of just two days. “Anvisa understands that it has sufficient subsidies to allow the resumption of vaccination,” the regulator said on Nov. 11. Anvisa said it plans to continue monitoring “the possible relationship of causality” between an unexpected serious adverse event and the vaccine.
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In the clinic for Nov. 17, 2020

Nov. 17, 2020
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Aivita, Ampio, Avrobio, Bayer, Beigene, Brainstorm, Cerebral, Cymabay, Dicerna, Eicosis, Eiger, Galderma, Jupiter, Kangpu, Kiniksa, Lexicon, Mydecine, Novo, Palladio, Poxel, PTC, Rigel, Trippbio, Urogen.
Read More
COVID-19 mRNA vaccine vials, syringe

Dynamic stability: Moderna flies high with storage-friendly COVID-19 vaccine bid

Nov. 16, 2020
By Randy Osborne
Moderna Inc.’s phase III win with its COVID-19 vaccine candidate, mRNA-1273, lifted spirits while validating the Cambridge, Mass.-based firm’s platform, as Wall Street buzzed with comparisons between the prospects that have yielded late-stage data thus far.
Read More
Janssen’s vaccine candidate

J&J targets U.K. for second study, as early data start flowing from COVID-19 vaccine trials

Nov. 16, 2020
By Nuala Moran
LONDON – A second phase III trial of Johnson & Johnson’s adenoviral-vectored COVID-19 vaccine is starting in the U.K. this week, amid concerns the positive news from the Pfizer Inc./Biontech SE vaccine study will deter volunteers from coming forward to take part.
Read More
Red blood cells, artery

A CRL for sutimlimab is Sanofi’s Friday 13th bad luck charm

Nov. 16, 2020
By Lee Landenberger
The FDA has issued Sanofi SA a complete response letter (CRL) regarding its complement pathway inhibitor sutimlimab, citing deficiencies found during a pre-license inspection of a third-party manufacturing facility.
Read More
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