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Medera and Novoheart collaborate on mini-heart models for HLHS

Pharmaceutical Technology

Medera and its subsidiary Novoheart have collaborated with scientists at the University of California San Diego School of Medicine and Mayo Clinic to develop mini-heart models for hypoplastic left heart syndrome (HLHS). Credit: shisu_ka/Shutterstock. Don’t let policy changes catch you off guard.

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Understanding Recent Changes to 505(b)(2) Drugs and Reimbursement

Pharmacy Times

CMS is issuing unique J-codes for 505(b)(2) drugs, classifying them as sole-source products if not therapeutically equivalent. This pathway reduces submission denial risk, accelerates drug development, and offers potential market exclusivity for up to 7 years.

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NHC Comments on Key Information and Facilitating Understanding in Informed Consent

Putting Patients First Blog

Mayo Clinic Proceedings, 96(8) , 2095-2101. A blueprint for developing patient-centered core impact sets (PC-CIS). Re: Patient-Focused Drug Development: Collecting Comprehensive and Representative Input; Draft Guidance for Industry, Food and Drug Administration Staff, and Other Stakeholders (Docket No.

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STAT+: Former NCI chief and serial biotech entrepreneur raise $70 million to start companies that fail fast

STAT

Jupiter has raised $70 million from investors including Mission BioCapital and the Mayo Clinic to start small biotechs that might eventually be sold off at much higher valuations.