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While it was a relatively quiet week for clinical trial announcements overall, BioSpace takes a look at some of the more intriguing ones.
Amryt Pharma is filing a formal dispute resolution request (FDRR) with the FDA after receiving a CRL that delays the production of its drug for a rare skin disorder.
Intellia Therapeutics and Regeneron Pharmaceuticals presented positive interim data from an ongoing Phase I trial of NTLA-2001 for transthyretin (ATTR) amyloidosis.
RedHill announced that it will lay off a third of its U.S. workforce in an effort to save money over the next year and a half.
Positive news continues for COVID-19 vaccine development and distribution, with Sanofi and GSK announcing the success of their candidate against the Omicron variant.
FDA releases new draft guidance that addresses Breakthrough Therapy designation and action plan for rare, neurodegenerative diseases.
Researchers and drug developers have searched for a way to deliver IL-12 to patients. Researchers at the University of Chicago’s Pritzker School of Molecular Engineering may have found one.
A new report by PwC projects that the second half of this year will see a “flurry of deals activity across all areas of the sector.”
The Boston University School of Medicine has unraveled details about a known genetic component for the development of Alzheimer’s disease (AD): the APOE4 gene.
The life science industry is growing rapidly, and many companies have announced expansions and job creation. Still, others have been forced to cut costs and slash jobs. For that and more, continue reading.
With the submission of NDAs and BLAs, multiple companies are bidding for regulatory approval of drug candidates. BioSpace takes a look at several of the latest requests.
Biogen indicated it has terminated an observational study of its approved Alzheimer’s drug Aduhelm after only 29 people signed up for an expected enrollment of 6,000 patients.
PRESS RELEASES
Upcoming Type B Statistical Methods Meeting expected to set stage for FDA to align with EMA and MHRA on use of Fall 2026 3-year overall survival data combined with biomarkers to support early market access
Highlights TempraMed signs non-binding LOI for exclusive distribution in Kuwait with Elegir Trading Kuwait represents a high-value market with significant demand for insulin, GLP-1 therapies, biologics, and other temperature-sensitive medications LOI includes minimum annual purchase commitments in Year 1 Expands TempraMed’s footprint across the Middle East and supports broader regional commercialization strategy Potential future expansion includes VIVI Med™, VIVI Epi™, and VIVI Cap Smart™ products