Drug Development
The disagreement between Moderna and the FDA has reached a resolution just eight days after the biotech received a Refusal-to-File letter in response to its application for mRNA-1010. Moderna will now seek approval of the vaccine based on age.
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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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Venatorx Pharmaceuticals shared that its Phase III trial on the investigational treatment for complicated urinary tract infections in adults delivered positive outcomes.
On Wednesday, Breakthrough Properties announced the launch of StudioLabs, a turnkey, flexible lab and office solution that has been developed for hyper-growth life sciences companies.
Denali initiates dosing in Phase I/II frontotemporal dementia study. Intellia snags Orphan Drug Designation for experimental T cell receptor (TCR)-T cell therapy, NTLA-5001 in AML.
Morningside Ventures launched a new biotech company called Adiso Therapeutics, and thriving startup Scenic Biotech scooped up €28 million ($31 million) in funding.
This target date is the latest development in a long series of setbacks that Acadia - and other pharma companies - have experienced getting Alzheimer’s treatments approved.
Biopharma and life sciences companies from across the globe provide updates on their businesses and pipelines.
Pfizer has launched a Phase II/III study to assess its oral antiviral Paxlovid in non-hospitalized symptomatic pediatric patients who are at risk for progression to serious disease.
Akari announced that votucalis has potential as a treatment for pain and itch associated with conditions such as atopic dermatitis, psoriasis and neuropathic pain.
Biopharma companies are preparing to unveil new data for various oncology programs at the American Association for Cancer Research (AACR) Annual Meeting in New Orleans next month.
BioNTech announced an expansion on its collaboration with Regeneron to continue advancing mRNA technology and develop novel treatments for a variety of cancers.