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Latest From Biogen, Inc.
Private Company Edition: The global accelerator has new commitments from HHS and the Wellcome Trust. Also, Apollo buys into Sofinnova Partners with an up to €1bn investment, Castle Creek raised $124.6m in private funding this year in lieu of an IPO and Remix closed a $70m series B round.
The FDA’s principal deputy commissioner wonders how the agency will work with ARPA-H to help get its projects to patients and the health care system given its other responsibilities.
Accelerated Approvals Need Earlier Planning On Surrogate Endpoints, Postmarketing Trials – FDA’s Marks
Current accelerated approval provisions are the ‘sweet spot’ for balancing access and efficacy, but more attention needs to be paid by sponsors and the agency to working out regulatory pain points earlier in the development process, CBER director tells gene/cell therapy conference.
Regulators want to help smooth the process of bringing a gene therapy to market, hoping to iron out ‘surprises’ and even address reimbursement issues for the sake of patients.
- Drug Delivery
- Gene Therapy, Cell Therapy
- Large Molecule
- Other Names / Subsidiaries
- Biogen Idec
- Convergence Pharmaceuticals Ltd
- Nightstar Therapeutics plc
- Stromedix, Inc.
- Syntonix Pharmaceuticals