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Latest From Merz Pharmaceuticals GmbH
Deal Watch: Novartis Acquires Gene Therapy Candidate From AvroBio
AvroBio retains rights to its other HSC gene therapy candidates. Alimera Acquires Further Commercial Rights To Eyepoint’s Uveitis Drug.
Japan's NEC Expands Biopharma Presence With AI-Based R&D
Japanese tech major re-structures its teams for artificial intelligence-based drug development and strategies while expanding its presence in Europe. With confidence in the utility of AI for discovery, it is retaining a key focus on oncology while adding infectious diseases to its targets.
iPLEDGE REMS: US FDA Advisory Cmte. Supports Relaxing Restrictions But Wants More Data
Panel favors elimination of 19-day lockout after patients who can become pregnant miss the first prescription pickup and continuation of at-home pregnancy tests. Members call for more data from isotretinoin sponsors on why acne patients are not participating in pregnancy registry and on disparities by race and ethnicity.
iPLEDGE REMS: FDA Panel To Consider Changing Pregnancy Testing, Counseling Requirements
Advisory committee to discuss proposed changes to isotretinoin REMS to minimize burden and treatment delays while preventing risk of fetal exposure. Agency recommends against at-home pregnancy tests.
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