Positive phase III top-line results for Valneva SA’s chikungunya virus vaccine candidate, VLA-1553, show the study met its primary endpoint of inducing neutralizing antibody titers, setting it up for possible accelerated approval.
Preliminary real-world data showed that Chinese inactivated vaccines are 63% protective against the COVID-19 Delta variant, China’s top epidemiologist Zhong Nanshan said at the 24th Respiratory Disease Academic Conference of Guangdong Medical Association in Guangzhou.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Abcentra, Aimmune, Beyondspring, Cytomx, Effector, Enzyvant, Humanigen, Inovio, Nordic Nanovector, Pfizer, Pharmaxis.
New top-line results from the phase IIb/III Allegro trial of Pfizer Inc.'s once-daily oral JAK3 inhibitor, ritlecitinib, have met the trial's primary efficacy endpoint of improving scalp hair regrowth in patients with alopecia areata vs. placebo. The new data, to be paired with long-term trial results from Pfizer's long-term Allegro-LT study, move the program one step closer to an expected early 2022 NDA filing.
Positive top-line data from Beyondspring Inc.’s phase III study of plinabulin combined with docetaxel to treat second- and third-line non-small-cell lung cancer (NSCLC) compared to docetaxel alone propelled the company value dramatically higher Aug. 4.
Publication this summer of phase II data with Spruce Biosciences Inc.’s CRF1 antagonist, tildacerfont, for classic congenital adrenal hyperplasia (CAH) in the Journal of Clinical Endocrinology and Metabolism (JCEM) highlighted the indication where a handful of players are known to be active.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Allegro, Ambrx, Angion, Antibe, Eli Lilly, Evotec, Fate, Jacobio, Janssen, Kiniksa, Lumosa, Lutris, Rhythm, Springworks.
Outlook Therapeutics Inc. CEO Russell Trenary said positive results from the phase III study called Norse Two represent “the final step we need” to proceed with the BLA in the first quarter of next year for an ophthalmic formulation of the VEGF binder bevacizumab to treat wet age-related macular degeneration (AMD).
Because a safety threshold was exceeded in its study of the company’s lead candidate, otenaproxesul, Antibe Therapeutics Inc. said it has placed testing of the anti-inflammatory drug on a required pause.
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