Regulatory
The House of Representatives voted on a bill that would give the U.S. Food and Drug Administration more power to ensure biopharma companies run large follow-up trials to confirm accelerated approvals.
Bavarian Nordic announced the U.S. Biomedical Advanced Research and Development Authority has ordered an additional 500,000 doses of its monkeypox vaccine, Jynneos.
Following a marathon session of the FDA’s Cell, Tissue and Gene Therapies Advisory Committee, bluebird bio passed its first critical hurdle in approval for the lentiviral vector gene therapy, eli-cel.
The FDA plans to review changes to Novavax’s manufacturing process before it authorizes its vaccine.
Bluebird bio faces a two-day crucible as the U.S. Food and Drug Administration’s Cell, Tissue and Gene Therapies Advisory Committee will give two lentiviral vector gene therapies a thumbs up or down.
The FDA granted Breakthrough Therapy Designation to Verttex’s candidate inaxaplin (VX-147). for the treatment of APOL1-mediated focal segment glomerulosclerosis.
Calls for a reform of drug prices have become a regular occurrence, particularly in the midst of political campaigns. Yet a new report shows the median price of a new drug launched in 2021 was $180,000.
On Tuesday, the FDA’s Vaccines and Related Biological Products Advisory Committee voted 21-0 with one abstention to recommend authorization of Novavax’s COVID-19 vaccine.
For the first time in half a decade, the FDA will convene to address two therapies developed by bluebird bio that could have ripple effects across the industry regarding lentiviral vectors.
Data presented in bladder and pancreatic cancer at ASCO underscore the company’s vision of using NK cells and T cells to target difficult-to-treat cancers.
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