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Latest From Dynavax Technologies Corporation
Déjà Vu: CBER Director’s Intervention Saves Sarepta’s Elevidys Again
Failure of the EMBARK confirmatory trial convinced US FDA reviewers the Duchenne muscular dystrophy gene therapy did not show clinical benefit, but biologics center director Peter Marks invoked totality of evidence to grant full approval.
New Promise, Looming Competition For DMD In China
With several new drugs progressing for the estimated 70,000 patients in China with DMD, a recent setback for Nippon Shinyaku's contender and progress for Chinese gene therapy developers are adding both uncertainty and likely competition in an untapped market with pressing medical need.
The Truly Transformational Potential Of AI Relies On The Data
Executives from several AI-focused biotechs emphasize that generating a truly innovative medicine, as opposed to a me-too drug, depends not just on the quantity, but on the quality of data used by the algorithm.
Chinese Firms Up Their Game In Novel Flu Antiviral Development
Joincare Pharmaceutical and partner TaiGen Biotechnology tout preliminary Phase III results in uncomplicated acute influenza for TG-1000, a homegrown follower of Shionogi/Roche’s oral antiviral Xofluza. Novel antivirals for flu were hotly pursued by Chinese developers throughout 2023.
Company Information
- Industry
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Pharmaceuticals
- Drug Delivery
- Vaccines
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Biotechnology
- Antisense, Oligonucleotides
- Drug Discovery Tools
- Large Molecule
- Other Names / Subsidiaries
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- Symphony Dynamo, Inc. (SDI)
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