Drug Development
In a 6-0 vote, the FDA’s advisory committee Friday affirmed that trial data confirmed the clinical benefit of Eisai and Biogen’s Leqembi (lecanemab) for the treatment of Alzheimer’s disease.
FEATURED STORIES
Mixed headlines have plagued the cell and gene therapy space of late. We believe that a renewed case of optimism is not only warranted but essential if these therapies are to reach their full potential.
Through substantial leadership turnover and workforce cuts, the FDA has continued to support the advanced therapy sector, actively working to remove obstacles to innovation.
With immunology and inflammation blockbusters like AbbVie’s Skyrizi and Rinvoq reeling in nearly $7 billion combined in the third quarter, the pipeline-in-a-product strategy has never been more attractive.
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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.
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.
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.