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Latest From bluebird bio
Pfizer In Pole Position To Benefit From Novartis Sickle Cell Drug Setback
Pfizer joined Novartis as the market leader in sickle cell disease when it acquired Global Blood Therapeutics last year. The US giant's Oxbryta may now move ahead following a clinical and regulatory setback for the Swiss major's Adakveo.
US FDA Has History Of Pushing Sponsors On Confirmatory Trials … Sometimes
Even before a new law granted FDA authority to require studies be underway before accelerated approval, review divisions have, in some cases, given sponsors years of advance notice on expectations around study timing, according to a Pink Sheet review of NME accelerated approvals.
Finance Watch: Fundraising Shows Preference For Later-Stage Companies
Recent financings, including the $150m launch of Pathalys and a planned $100m IPO for Mineralys, illustrate the reality of biopharma funding in 2023 – that having near-term clinical trial milestones are key to fundraising this year. Companies with dwindling cash are conserving the funds they have left.
Califf: Decades Of Follow-Up Necessary For Gene Therapy
FDA Commissioner Califf acknowledges that regulatory pathways for gene therapies are still being developed and that many factors outside of the modality impact agency requirements as he emphasized the need for long-term follow up due to the unknowns of gene modification.
Company Information
- Industry
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Pharmaceuticals
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Drug Delivery
- Macromolecule
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Drug Delivery
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Biotechnology
- Gene Therapy, Cell Therapy
- Large Molecule
- Other Names / Subsidiaries
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- Genetix Pharmaceuticals
- Precision Genome Engineering, Inc. (Pregenen)
- Oncology Newco
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