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BioWorld - Wednesday, December 31, 2025
Home » Topics » Clinical, BioWorld

Clinical, BioWorld
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Vaccine target

After a successful phase III, Pfizer-Biontech chase an EUA

Nov. 18, 2020
By Lee Landenberger
With the FDA’s required safety milestone notched in their phase III study of COVID-19 vaccine candidate BNT-162b2, Pfizer Inc. and Biontech SE said they will request emergency use authorization “within days.”
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In the clinic for Nov. 18, 2020

Nov. 18, 2020
Clinical updates, including trial initiations, enrollment status and data readouts and publications: ADC, Afimmune, Aztherapies, Bexion, Biolinerx, Biontech, Bioversys, Boehringer, Chiasma, Cogent, Enlivex, Genoscience, Gilead, Greenwich, Helixmith, Hepion, Kazia, Lilly, Milestone, Moderna, Neurosense, Oncosec, Organicell, Pfizer, Pionyr, Puretech, Sanofi, Sernova, VBI.
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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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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.
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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.
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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.
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Illustration of red blood cells traveling in the arteries

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.
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In the clinic for Nov. 16, 2020

Nov. 16, 2020
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Adverum, Akebia, Alligator, Aptevo, Atara, Beyondspring, Bioaegis, Biological E., Calypso, Cerevance, Dynavax, Genenta, Intravacc, Karyopharm, Kodiak, Moderna, Medexus, Obseva, Precigen, PTC, Rapt, Redhill, Revelation, Rhovac.
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Janssen, AGTC report initial 12-month data for gene therapies in X-linked RP

Nov. 13, 2020
By Cormac Sheridan
DUBLIN – The contest to bring a safe and effective gene therapy for X-linked retinitis pigmentosa (XLRP) to market is intensifying. Two of the three contenders with clinical-stage programs reported initial 12-month data from phase I/II trials and are now looking ahead to pivotal trials and beyond.
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In the clinic for Nov. 13, 2020

Nov. 13, 2020
Clinical updates, including trial initiations, enrollment status and data readouts and publications: 89 Bio, Akero, Albireo, Alnylam, Amarin Annexon, Arrowhead, Biocryst, Bridgebio, Durect, Esperion, Gemini, Greenwich, Horizon, Incarda, Ionis, Mirum, Myokardia, Navidea, Neurorx, NGM, Nkarta, Novartis, Surface, Takeda, VBI.
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