News
Under the temporary reign of top food executive Kyle Diamantas, the FDA will sustain programs initiated by former Commissioner Marty Makary, including the Commissioner’s National Priority Voucher initiative.
FEATURED STORIES
Partners Summit Therapeutics and Akeso are expected to steal the show at the American Society of Clinical Oncology’s annual conference with data from their potential Keytruda rival, alongside Revolution Medicine’s groundbreaking pancreatic cancer candidate and other assets that could reshape patient care.
The tragic tale of TIGIT is well known. However, RIPK1, myc, STING and alpha-synuclein have also left a trail of failed clinical trials, canceled partnerships and sunk investments in their wake.
Analysts homed in on Duchenne muscular dystrophy and myotonic dystrophy type 1 assets during first quarter earnings as major players like REGENXBIO and Novartis as well as Dyne, Wave, Solid and Sarepta near the regulatory finish line.
FROM OUR EDITORS
Read our takes on the biggest stories happening in the industry.
The Department of Health and Human Services is spinning its wheels, unable to establish steady leadership at three major divisions—the CDC and the FDA’s two primary review units.
THE LATEST
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FDA releases new draft guidance that addresses Breakthrough Therapy designation and action plan for rare, neurodegenerative diseases.
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.