Lachman Consultant Services, Inc. / Articles by: April Alexandrow
20
Feb
Diverse group of smiling businesspeople clapping in office training. Team of professional colleagues cheering and celebrating together while learning in workshop. Attending a seminar for marketing

Applause for Biotech Innovation and CAR-T Manufacturing Excellence

By    Feb 20, 2025    Biologics FDA

A recent report in Nature Medicine (published February 17, 2025) highlights the long-term potential of Chimeric Antigen Receptor T Cell products (aka CAR-T cell therapy), showcasing an exceptional 18-year remission in a neuroblastoma patient.  This milestone is particularly significant given the historical challenges that CAR-T therapy has faced in effectively treating solid tumors like neuroblastoma, even while […]

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08
Jan
The Promise of ACNU A New Era in Self-Care and Market Innovation - Lachman Blog image

The Promise of ACNU: A New Era in Self-Care and Market Innovation

By    Jan 08, 2025    FDA NDA OTC Regulatory Affairs

The pharmaceutical industry is entering a transformative era with the Food and Drug Administration’s (FDA) newly established pathway for nonprescription drug products with an Additional Condition for Nonprescription Use (ACNU), with the final rule announced in a December 2024 Federal Register Notice (here). This new rule aims to broaden consumer access to safe and effective […]

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