Cell therapy
As part of the collaboration, Johnson & Johnson will have an exclusive option to acquire Sail Biomedicines for an additional $2.58 billion.
ElevateBio will be the primary source of Kyverna’s autologous CAR T cell therapy for anticipated U.S. and global launches in autoimmune indications.
In briefing documents published Monday ahead of an advisory committee meeting for deramiocel, the FDA disagreed with Capricor’s assertion that a Phase 3 trial met its primary outcome measures.
Safety will be the key determinant of in vivo CAR T therapies, according to H.C. Wainwright’s Mitchel Kapoor, who noted that convenience and efficacy won’t be enough to impress investors in this space. Eli Lilly, AbbVie, AstraZeneca and more are up for the challenge.
Poised to become the first company to achieve a regulatory filing for a cell therapy in autoimmune disease, Kyverna Therapeutics is building a pipeline-in-a-product to change the treatment paradigm.
In this episode of Denatured, you’ll hear from Jack Crawford, CEO of Demeetra, and Magnus Gustavsson, chief commercial officer at NorthX Biologics. We unpack the evolution of cell line development — CHO cells, targeted integration, transposases and the collaboration models speeding biologics from sequence to GMP.
Many of the FDA’s decisions this quarter involve applications that have previously been delayed, declined or outright rejected, including one for an mRNA vaccine that became the center of controversy earlier this year.
Teams at facilities being developed by Eli Lilly, Regeneron and other companies will receive early technical guidance and additional perks from the FDA.
If cell and gene therapy makers are going to achieve their mission to improve patients’ lives, the industry must come together to share information across stakeholders, from regulators to manufacturers to payers.
Be Biopharma’s terminated trial is the latest setback in the hemophilia space, where companies like Pfizer and BioMarin have opted to pull their respective products from the market after weak traction.
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