Drug Development
Sales of Johnson & Johnson’s esketamine-based nasal spray jumped in the fourth quarter last year, priming the pump for a suite of other pharmas, including AbbVie, champing at the bit with their own psychedelics.
FEATURED STORIES
After advancing in lockstep through the pandemic, the fortunes of the biotechs have diverged as their use of COVID-19 windfalls has taken shape.
AstraZeneca’s $15 billion pledge to its China operations highlights the country’s advantages. But other regions are also hoping to host more clinical studies.
With Lykos’ regulatory failure now squarely in the rearview mirror, Compass Pathways and Definium are leading what one analyst suspects will be “a very big year for psychedelics.”
Subscribe to ClinicaSpace
Clinical trial results, research news, the latest in cancer and cell and gene therapy, in your inbox every Monday
THE LATEST
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.
Novavax Chief Executive Officer Stanley Erck believes the U.S. Food and Drug Administration could grant Emergency Use Authorization for its COVID-19 vaccine by May.
What percentage of a population needs to be immune in order to achieve herd immunity is a matter of debate among scientists and public health officials.
To facilitate its goal of building an industry-leading gene therapy company focused on rare CNS diseases, Sio has made it a priority to interact with patient organizations to determine their primary objective, whether that be stability or a cure.
The company has agreed to deliver 100 million doses of the vaccines by the end of June.