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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Early data from a combination of Cue Biopharma’s CUE-101 and Keytruda shows the treatment is effective in patients with recurrent/metastatic HPV16+ head and neck cancer.
PACT Pharma shared results of a first-of-its-kind trial using CRISPR technology to swap a gene in a patient’s immune cell to treat solid tumors.
At the FDA’s request, GSK has restricted the use of Zejula, a PARP inhibitor, to a specific population as a second-line maintenance treatment for ovarian cancer following updated data.
Seagen’s Adcetris has been given FDA approval for the treatment of children aged two years and above with high-risk classical Hodgkin lymphoma.
BrainStorm Cell Therapeutics ran into another stumbling block with ALS hopeful NurOwn Thursday as the FDA issued a Refusal to File Letter for its Biologics License Application.
The FDA’s Pulmonary-Allergy Drugs Advisory Committee voted against the potential Emergency Use Authorization of the company’s COVID-19 therapeutic candidate, sabizabulin.
AstraZeneca will give up on seeking approval for its COVID-19 vaccine in the United States. It is also abandoning three early-stage programs.
An anti-CD70 antibody drug conjugate developed by Ambrx, Inc. has been administered to the first patient in a Phase I study in China. It marks the first ADC in active development that targets CD70.
Oncolytics Biotech released data Thursday from a Phase I/II study in pancreatic ductal adenocarcinoma that support plans to advance the program into Phase III.
With a fresh $18 million in the bank, NRG Therapeutics is ready to put its novel mitochondrial approach to the test for devastating neurodegenerative disorders—Parkinson’s and ALS.