Drug Development

In this episode of Denatured, you’ll be listening to Jane Hughes, President of R&D and Co-founder of Verdiva Bio, and Jon Rees, CEO and Co-founder of MitoRx Therapeutics. We’ll discuss next-generation obesity solutions tackling GLP-1’s muscle loss and adherence challenges, through innovative muscle preservation, oral administration and combination therapy.
FEATURED STORIES
The FDA’s refusal to review Moderna’s mRNA-based flu vaccine is “part of a disturbing pattern” of moving regulatory goalposts, according to Clay Alspach, executive director of the Alliance for mRNA Medicines. Meanwhile, streamlined communications with regulators in other countries pave the way for rapid uptake of novel modalities.
A rapturous response to data published last year for Pelage’s hair loss candidate overwhelmed the biotech. Now, the company is ready to show the world the science behind the breakthrough.
Pfizer, Eli Lilly, Novartis, Bristol Myers Squibb and AstraZeneca are all ramping up the use of AI, but drug discovery is not the primary success story—yet.
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FDA
Pfizer and BioNTech requested the FDA authorize booster shots for their COVID-19 vaccine for all adults 18 years and older, presenting data not available in September.
The drug for treatment-resistant depression reportedly demonstrated significant improvement in patients at its highest dose of 25 mg. Here’s more about it.
Public Citizen urged NIH director Dr. Francis Collins to clarify the NIH’s role in Moderna’s vaccine publicly and explain what he plans to ensure that federal scientists are credited for their work.
AstraZeneca announced its plans to create a new, separate division for vaccines and antibody therapies, specifically its COVID-19 vaccine developed with the University of Oxford and other COVID-19 antibody treatments.
New studies come out regularly supporting the efficacy and safety of the COVID-19 vaccines. Here’s a look as well as other COVID-19 news.
The study was momentous in that it was the first head-to-head comparison of two modalities. The Aimovig showed significantly good results and aced primary endpoints.
Sungho Han, Ph.D., founder and CEO of Genuv Inc. in Seoul, South Korea, has built her career and her company by thinking outside the box.
Selecta Biosciences, Inc. (NASDAQ: SELB), today announced top-line results from a joint Selecta and AskBio Phase I randomized, placebo controlled, double blind, dose-escalation study to evaluate the potential of its ImmTORTM platform in mitigating the formation of neutralizing antibodies against an adeno-associated viral serotype 8 (AAV8) serotype capsid used in gene therapies.
Regeneron Pharmaceuticals announced more positive findings from its ongoing Phase III trial on the use of REGEN-COV to prevent COVID-19 in uninfected persons who have been exposed to the virus.
Bristol Myers Squibb’s Phase III CheckMate -816 trial hit the primary endpoint in an interim analysis.