Drug Development
Sanofi will take venglustat to regulators for Gaucher disease but an application for Fabry disease is less clear after the failure of a Phase III trial.
FEATURED STORIES
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 data may show the need for one, but vaccine and immunologists are pushing back against Pfizer and BioNTech’s contention that one is necessary now.
Approximately 100 preliminary reports of GBS have been identified out of 12.8 million doses of the J&J vaccine in the U.S., according to the Centers for Disease Control and Prevention.
The company said that it values the FDA’s feedback and is happy that the agency has accepted its request to provide insights on its Hepatitis B development program.
The first nonsteroidal mineralocorticoid receptor antagonist (MRA) is approved for adults with chronic kidney disease associated with type 2 diabetes.
HHS issued their announcement, saying, “Americans who have been fully vaccinated do not need a booster shot at this time.”
Adulhelm’s proposed price tag of $56,000 per patient per year is hardly the most expensive drug on the market, but controversy regarding packaging and pricing continues.
Morgan had determined that adding one dose of the Moderna or Pfizer-BioNTech mRNA vaccine to one of Oxford-AstraZeneca’s viral vector technology would equal stronger immunity.
While the drug showed significant improvement in patients on a 200mg daily dose of filgotinib, it may not be promoted in the states any time soon.
Last week presented a fair number of clinical trial news. Read on for more information.
The two companies said a booster dose given six months after the second dose had a consistent tolerability profile while still creating high immune responses against the Alpha and Beta variant.