Drug Development
Moderna may seek the FDA’s accelerated approval for its personalized cancer vaccine, president Stephen Hoge said Monday.
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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ShouTi believes many targets addressed by biologic and peptide therapeutics can be reached by innovative, rationally-designed, best-in-class small molecules that don’t need refrigeration or injection.
Cytokinetics filed with the SEC reporting that the FDA planned to hold an advisory committee meeting to review its New Drug Application (NDA) for omecamtiv mecarbil.
Avrobio presented clinical data on Tuesday at the 25th Annual Meeting of the American Society for Gene and Cell Therapy (ASGCT) from its trial of AVR-RD-04, and preliminary results are promising.
Moderna held its first in-person Science and Technology Day since 2019. Notably, the company shared information about its new inhalable lipid nanoparticles (LNPs).
Vertex Pharmaceuticals dedicated a new site in Boston’s Seaport. But the company seemed to say, “But wait! There’s more!” and announced it plans to build another facility in the area.
RQ Biotechnology has officially launched, with the financial backing of AstraZeneca. The move strategically increases the availability of monoclonal antibodies at a time of ever-increasing demand.
Idera Pharmaceuticals has stopped patient enrollment early for its Phase II trial on a candidate melanoma drug after interim data delivered impressive results.
As Scholar Rock prepares to move forward with its experimental assets for spinal muscular atrophy, it has terminated 25% of its staff and also announced the loss of its chief medical officer.
The ASGCT’s 25th Annual Meeting features the latest scientific research in genetics and cellular therapies. Read on for highlights from the meeting.
Evotec and Sernova partnered to develop an implantable induced pluripotent stem cell (iPSC)-based beta cell replacement therapy that can be used to treat both type 1 and 2 diabetes patients.