Drug Development

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 U.S. Food and Drug Administration (FDA) had several PDUFA dates on their calendar for the last week of July, but in two cases, there were problems with the submissions ahead of time. Here’s a look.
Updated trial data show patients treated with BioMarin Pharmaceutical’s severe hemophilia A gene therapy expressed substantially lower factor VIII levels after five years compared with one year, calling into question the drug’s long-term benefits.
It was another busy week for clinical trial updates. Here’s a look at some including Mesoblast Limited, CytoDyn, Magenta Therapeutics and more.
With COVID-19 resurging in the U.S., particularly in states with the lowest vaccination rates, additional news and research about the vaccines and the virus is coming out. Here’s a look.
Oramed Pharmaceuticals said that its majority-owned firm Oravax Medical would be spearheading the project, first in Israel and later in other international clinical locations.
Shares of Adverum Biotechnologies plunged more than 20% in premarket trading after the company announced it was revising its clinical development plan for investigational gene therapy candidate ADVM-022 based on safety concerns in patients with diabetic macular edema (DME).
The company also issued an open letter to the Alzheimer’s disease community from Alfred Sandrock, which attempts to push back against negative media attention.
FDA
The FDA has now approved AstraZeneca’s convenient once-a-week glucose lowering drug for 10 to 17-year-olds with type 2 diabetes.
Every week there are numerous scientific studies published. Here’s a look at some of the more interesting ones.
For the past year, Abbott Laboratories and Quest Diagnostics saw their revenue driven by COVID-19 diagnostics, but that seems to be changing as more and more vaccinated individuals are seeking medical advice for non-viral related issues.