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HHS Floats Trio of Drug Pricing Models, Some More Ambitious Than Others

February 24th, 2023|Comments Off on HHS Floats Trio of Drug Pricing Models, Some More Ambitious Than Others

AISHealth.com - February 23, 2023    Jeff Myers, Catalyst’s Senior Vice President, Market Access & Reimbursement Strategies, comments on the pricing models recently announced by CMS. Mr. Myers "says cell and gene therapy manufacturers may be skeptical [...]

Former FDA Chief Counsel Elizabeth Dickinson Hailed For Her Expertise, Warmth and Mentorship

October 6th, 2022|Comments Off on Former FDA Chief Counsel Elizabeth Dickinson Hailed For Her Expertise, Warmth and Mentorship

The Pink Sheet - September 27, 2022 In an article on the legacy of retiring FDA Chief Counsel/Deputy Chief Counsel Elizabeth Dickinson, Catalyst’s Nancy Bradish Myers comments that Dickinson’s management style won her internal accolades. [...]

FDAnews Webinar: On Challenges Facing the New FDA Commissioner

January 21st, 2022|Comments Off on FDAnews Webinar: On Challenges Facing the New FDA Commissioner

During her panel for FDAnews, Nancy Myers highlighted impending challenges looming over FDA’s commissioner hopeful, Robert Califf. If confirmed, Califf would enter the FDA at a time crucial to rebuilding public trust in the Agency [...]

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CMS sends roses to Sickle Cell Patients; but will the rest of Cell and Gene Therapy get the thorns?

February 15th, 2023|Comments Off on CMS sends roses to Sickle Cell Patients; but will the rest of Cell and Gene Therapy get the thorns?

By Jeff Myers, Senior Vice President, Reimbursement Strategy and Market Access, Catalyst. On February 14th, CMS released its answer to President Biden’s Executive Order to “do something” to lower drug prices in the public payor programs.  [...]

Catalyst’s Nancy Myers Co-Moderates Alliance for a Stronger FDA Webinar Featuring FDA Deputy Commissioner Andi Fristedt

January 27th, 2023|Comments Off on Catalyst’s Nancy Myers Co-Moderates Alliance for a Stronger FDA Webinar Featuring FDA Deputy Commissioner Andi Fristedt

Catalyst's Nancy Myers participated in an Alliance for a Stronger FDA webinar with FDA's Deputy Commissioner for Policy, Legislation & International Affairs Andi Fristedt on Jan. 13. Ms. Myers co-moderated the session with Emily Holubowich, [...]

FDA User Fee Programs Reauthorized: FDA’s CBER Is A Clear Winner

October 6th, 2022|Comments Off on FDA User Fee Programs Reauthorized: FDA’s CBER Is A Clear Winner

Pharmaceutical Online/Cell & Gene/Bioprocess Online – October 6, 2022 PDUFA VII, CBER and the new gene & cell therapy Super Office: Catalyst’s Nancy Bradish Myers shares her insights on the cleanest user fee reauthorization in [...]