Sarepta, Eli Lilly, SSRI, NIH, Bristol effects

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Morning. Today, we are discussing how Duchenne patients and their families react to the shelves of Sarepta Therapeutics gene therapy, see a panel of the FDA composed largely of SSRI skeptical castigated during pregnancy, and more.

The need to know this morning

• European regulators have said Sarepta therapeutics’ Duchenne’s muscular dystrophy of muscular dystrophy should not be approved, more implementing the future of treatment, which is also faced with in-depth examination in the United States, Roche has commercial rights on gene therapy, called Elecidys, Europe and other countries.
• European regulators have said Eli Lilly’s The treatment of Alzheimer Kisunla should be approved for a limited group of patients, modifying the course of an initial recommendation to reject the medication.
• Bristol Myers Squibb Appointed Cristian Massacesi as his new chief chief doctor. Massacesi is a Phyisican and was recently a chief doctor in Astrazeneca and its Alexion unit. He replaces Samit Hiray, which has been the CMO of Bristol in the past six years.

Devasted families after the FDA interrupt Sarepta gene therapy

Families of boys with Duchenne muscular dystrophy were devastated when Food and Drug Administration asked Sarepta Therapeutics to end the expeditions of its gene therapy, Elenidys, citing security problems – and society then agreed this week. Parents who had fought for months to obtain access are now stuck in the limbo, with suddenly canceled appointments and little communication from regulators, reports Jason Mast of Stat.