Drug Development
Infigratinib topped “even the most optimistic expectations” for efficacy and safety in the late-stage PROPEL 3 study in achondroplasia, Truist Securities analysts said Thursday.
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Analysts, investors and scientists are eager for Biogen’s 2026 BIIB080 readout. Even if successful, executives warn that there are many more steps before the Alzheimer’s therapy could reach the market.
With a clutch of key data and planned regulatory applications this year from Avidity Biosciences, REGENXBIO and Capricor Therapeutics, CureDuchenne CSO Michael Kelly sees “momentum” in the Duchenne muscular dystrophy pipeline, as Sarepta’s Elevidys leaves the door open.
After advancing in lockstep through the pandemic, the fortunes of the biotechs have diverged as their use of COVID-19 windfalls has taken shape.
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Distribution and administration of the Johnson & Johnson vaccine began this week. There is also additional COVID-19 news. Here’s a look.
Another study is adding to a growing body of literature that suggests convalescent plasma from recovered patients with COVID-19 doesn’t prevent further COVID-19 progression in at-risk people who visit the emergency room.
Gastrointestinal and autoimmune company Arena Pharmaceuticals announced mixed topline results for the Phase IIb trial of its oral cannabinoid receptor type 2 (CB2) agonist olorinab.
The topline data from the BRAVE-AA2 study in 546 adults showed both 2 mg and 4 mg doses of Olumiant regrew hair in adult patients with more than 50% scalp hair loss, compared with placebo.
The study of VIR-7831, which is a dual-action SARS-CoV-2 monoclonal antibody, was recommended to be closed to enrollment by an independent data monitoring board, stating that “there were no reported safety signals, sensitivity analyses of the available data raised concerns about the magnitude of potential benefit.”
STI-2099 is a formulation of its antibody against COVID-19 that can be taken in a nasal spray. It is also evaluating the antibody in an intravenous form (STI-2020) in a Phase I trial.
Eye disease company Oyster Point announced the New Drug Application for its dry eye disease therapy OC-01, submitted in December, has been accepted for regulatory review on the back of positive Phase III data.
Cancer therapy company Athenex suffered a regulatory setback with the receipt of a complete response letter from the U.S. Food and Drug Administration.
In a fourth quarter 2020 financial results announcement made on Monday, Inovio Pharmaceuticals said it has completed enrollment of 400 participants in its Phase II segment of the INNOVATE (INOVIO INO-4800 Vaccine Trial for Efficacy) Phase II/III trial.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for March 2, 2021.