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While tovecimig met the main goal of progression-free survival in a Phase 2/3 trial, it did not improve overall survival.
FEATURED STORIES
As cell and gene therapy leaders gathered in Maryland to discuss accelerating clinical trials in children, one “cutting edge” session focused on the need to expedite more bespoke gene editing treatments like the one that saved young KJ Muldoon.
Neal and Azbee awards have validated our approach to reporting on the industry at a time of unprecedented shifts at the FDA and other federal agencies.
The FDA is signaling change, but actual success depends on more than simply bringing in a new leader at the Center for Biologics Evaluation and Research; it requires accountability, transparency and consistent action.
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Read our takes on the biggest stories happening in the industry.
Doubling survival in pancreatic cancer, a long-fought rare disease approval, a massive IPO and ambitious biotech entrepreneurs have BioSpace Senior Editor Annalee Armstrong feeling upbeat about the biotech scene.
THE LATEST
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.
Once fully operational, the Pennsylvania site will employ more than 500 people and make cell therapies for thousands of patients a year.
Novartis and Unnatural Products did not specify which disease targets they’re going after, only noting that the latter’s macrocyclic platform can generate potentially next-generation therapies that could apply to cardiovascular conditions.
The FDA’s drug review process can often be “unpredictable,” and review teams typically “differ greatly” in what they ask of drug sponsors, Sen. Bill Cassidy said.
Drug sponsors should nevertheless bolster their application with “confirmative evidence,” chief regulators Marty Makary and Vinay Prasad said on Wednesday, including mechanistic data or findings from related indications or animal models.
In a competitive job market, how applicants present themselves in interviews is critical. Asking about promotions and expressing dislike for the work they’d be doing are just a few reasons hiring managers don’t extend job offers.
Looking for a biopharma job in Pennsylvania? Check out the BioSpace list of nine companies hiring life sciences professionals like you.
Muscle Preservation, Tolerability and Alternative Administration Routes Define Obesity’s Drug Future
In the incredibly hot obesity drug space, with more than 700 clinical trials ongoing, Verdiva Bio and MitoRx leaders discuss how next-generation therapies are targeting lean muscle preservation, extended efficacy and better safety profiles to enable lifelong weight management.
Many scientists-turned-CEOs paradoxically abandon scientific principles when it comes to commercializing their innovations. But applying the scientific method to business decisions can help life science entrepreneurs avoid common pitfalls, attract investment and ultimately bring transformative technologies to market.
Jay Bhattacharya will become the latest leader of the CDC on an acting basis, days after Jim O’Neill stepped aside.