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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The DSMB for Ocugen’s Phase I/II trial of OCU400, a gene therapy in development for Retinitis Pigmentosa (RP), recommended the study proceed with enrolling more patients.
Shares of Axsome Therapeutics have fallen more than 20% in trading this morning after the company announced the FDA is unlikely to approve its acute migraine treatment AXS-07 due to unresolved quality control issues.
Final analysis of the Himalaya trial demonstrated safety as well as a statistically relevant 22% improvement of overall survival (OS) without exposing the patient to an increase in liver toxicity.
Eliem Therapeutics could be in trouble following the announcement that its drug candidate ETX-810, intended to treat diabetic peripheral neuropathic pain, did not meet its primary endpoint.
With COVID-19 still very much a threat to the public, researchers are working on developing new treatments. Read on for more updates.
Patient deaths associated with Astellas Pharma’s gene therapy candidate underscore the risks of developing potential one-and-done treatment options for serious diseases.
Nkarta announced that two of its therapies have shown complete remission in patients with blood cancer. These results are the latest development in the treatment of difficult-to-treat blood cancers.
Ardelyx announced the FDA’s OND, CDER, provided an interim response to the company’s second level of appeal for tenapanor. Here’s what you need to know.
Bristol Myers Squibb will hear from the FDA on April 28 about Mavacamten, while Supernus, Axsome, Coherus, Hutchmed and Incyte also await the fate of their respective drug candidates.
Today, Astellas announced that after evaluating its gene therapy for patients with X-linked Myotubular Myopathy, it revised its eligible treatment population and any likely future product label.