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Sarepta Therapeutics, Inc.

https://www.sarepta.com/

Latest From Sarepta Therapeutics, Inc.

Lykos’ MDMA NDA Leads Upcoming Tests Of US FDA’s Psychedelics Draft Guidance

Pipeline is concentrated around Phase II, but sponsors have a few chances to see how FDA handles its ‘foundational constructs’ for psychedelic drugs, led by Lykos’ pending NDA for PTSD and Compass Pathways’ Phase III synthetic psilocybin COMP360 for treatment-resistant depression.

Drug Approval Standards Clinical Trials

Biocon Eyes 'Foothold To Stronghold' For (b)Humira In US, Pauses RH-Insulin Program

Biocon sees some wins for biosimilar adalimumab in the US and signals more opportunities amid the slower than anticipated build-out for Humira rivals. Chinese competition looms for glargine, but the Indian company declares it “will be competitive if these folks launch.”

Biosimilars Strategy

New US FDA Genetic Metabolic Adcomm Needs More Candidates

Given the enthusiasm for the new advisory committee within the rare disease community, the need for an extended deadline is somewhat surprising. FDA has not yet determined when the chair and members of the new panel will be named.

Advisory Committees Rare Diseases

Change Of Plan: Medtronic Drops Ventilators, Keeps Monitoring, Forms New Unit

Medtronic will stop producing ventilators and combine the rest of its patient monitoring and respiratory interventions business into a new business called acute care and monitoring. The company had previously announced plans to divest all of the patient monitoring and respiratory intervention business.

Patient Monitoring Respiratory
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Company Information

  • Industry
  • Pharmaceuticals
    • Vaccines
  • Biotechnology
    • Antisense, Oligonucleotides
    • Gene Therapy, Cell Therapy
    • Large Molecule
  • Other Names / Subsidiaries
    • AVI BioPharma, Inc.
    • Ercole Biotech, Inc.
    • Myonexus Therapeutics, Inc.
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