Clinical research
The current vaccinations still offer significant protection against severe diseases. Meanwhile, vaccine companies are progressing in designing and testing Omicron-specific booster shots.
The FDA has placed Astellas Pharma’s Phase I/II FORTIS trial on clinical hold after one of its study participants experienced a serious adverse event.
GSK and Ionis released promising trial data showing their investigational antisense oligonucleotide, bepirovirsen, could significantly reduce HBsAg and viral DNA levels in patients with CHB.
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.
Positive news continues for COVID-19 vaccine development and distribution, with Sanofi and GSK announcing the success of their candidate against the Omicron variant.
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.
Sarepta announced that the FDA has put the Phase II trial for its SRP-5051 (vesleteplirsen) for the treatment of patients with DMD on clinical hold following a serious safety signal.
PRESS RELEASES