Drug Development
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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Together with robust data-driven modeling, rethinking regulation and data use could push forward a notoriously challenging field.
From opening new therapeutic mechanisms to repairing neuronal damage, investigational molecules from Ventyx Therapeutics, AC Immune, Gain Therapeutics and more could shape the future of Parkinson’s disease treatment.
As drug candidates discovered via AI move into later-stage clinical trials, the technology seems to be doing as promised: speeding drug development.
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The Oncologic Drugs Advisory Committee (ODAC), as part of the U.S. Food and Drug Administration (FDA), has voted 13-to-4 against supporting the accelerated approval of Incyte’s PD-1 inhibitor for squamous cell carcinoma.
Roche had a big week, scoring wins but also stepping away from its gene therapy partnership with 4D Molecular Therapeutics.
New data continues to emerge that seems to add to the possibility of COVID-19 originating from a lab leak at China’s Wuhan Institute of Virology.
A new class of compounds currently in development against acute myeloid leukemia has been discovered to block coronavirus reproduction in human lung cells.
The first interim analysis of a three-arm Phase II ARC-7 trial shows Arcus Biosciences’ anti-TIGIT immunotherapy combination features “encouraging clinical activity” as an initial therapy for patients with metastatic non-small cell lung cancer (NSCLC).
The company said it will file a marketing application later this year for the drug under the FDA’s accelerated approval pathway.
The U.S. FDA has had a mix of announcements this week, from drug approvals to the acceptance of NDAs and INDs. Here’s a look.
The analysis showed that the Pfizer and Oxford/AstraZeneca vaccines can protect patients from being hospitalized by as much as 90 percent.
The decision to exercise the option was based on an interim analysis of the ongoing Phase I trial of TNB-383B.
Last summer, claims that the deadly SARS-CoV-2 virus emerged from a virology lab in Wuhan were generally dismissed by the scientific community as right-wing conspiracy theories. A year later, the theory isn’t sounding so far-fetched.