A new gene therapy, a procurement process gone wrong, and backing away from a biosimilar… What’s new for pharma in business?
Stephanie Sutton |
- The FDA has cleared 23andMe’s Personal Genome Service Pharmacogenetic Reports for the inclusion of information about genetic variants that may impact a patient’s ability to metabolize some medicines. The test does not describe an association between the detected variants and any specific drug, nor whether a person will or will not respond to a particular drug. It is intended to help inform discussions with healthcare providers.
- A new gene therapy has been recommended for approval in Europe. Luxturna can be used in adults and children suffering from retinal dystrophy – an inherited disorder caused by RPE65 gene mutations, which usually leads to blindness. Novartis will be required to conduct follow ups on patients to ensure long-term safety and efficacy.
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