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Novartis has failed to reach a reimbursement agreement to keep its first-in-class advanced breast cancer drug on the German market, but it is pressing on with plans to expand market access for the product across Europe. It is also working on securing regulatory approval to use Piqray in a broader patient population that would carve out a more meaningful place in the relevant treatment pathway.
A number of advanced therapies are likely to be approved in the EU this year.
Market Snapshot: GSK's Blenrep and BMS's Abecma are the first of many drugs for the late-line setting. In many cases, the CAR-T may be the first choice, but some patients are unable to handle it or risk progressing while awaiting treatment.
Slated to begin a Phase III later this year of ADVM-022 in wet AMD, Adverum had to scuttle a Phase II study of the gene therapy in DME after a patient suffered ocular hypotension, panuveitis and vision loss in the treated eye.
- Drug Delivery
- Gene Therapy, Cell Therapy
- Large Molecule
- Other Names / Subsidiaries
- Genetix Pharmaceuticals
- Precision Genome Engineering, Inc. (Pregenen)
- Oncology Newco