
Feature|Videos|January 2, 2025
The Future of Regulatory Processes in Cell and Gene Therapy
Transferring knowledge and continuing to work together with regulatory agencies will lead to changes in approval going forward.
Advertisement
Episodes in this series

Regulatory agencies are open to changes within the review process which means the uptake of CAR T-cell therapy will change the landscape itself. This is especially true with large-scale commercialization. Information sharing between global agencies will also be helpful in advancing the science forward.
Advertisement
Related to this article

Novo Nordisk data show real-world weight loss after switching to its oral semaglutide pill, FDA's peptide rulemaking stalls while its enforcement arm targets compounded peptide sellers, and Avi Pardo flags a compliance blind spot in field teams' text messages with doctors.

Dr. Jeremy Levin joins Ken Banta to share why he believes biotech's future demands a new level of leadership and stakeholder education — and why "mission without method" is a wasted effort.

Real-world data from Novo's Octane study show patients who switched from injectable GLP-1 therapy to oral semaglutide lost an average of 4.1% of their body weight within three months.

Numerof's Michael Abrams on why directing employees to the most effective, economical clinicians is digital health's most valuable offering.

Life sciences spends billions on compliance — but WhatsApp, iMessage, and SMS conversations between field teams and HCPs remain invisible to oversight.

New U.S. guidance carves out tariff exemptions for specialty pharmaceuticals, Pharming's Fabrice Chouraqui steps down as CEO amid a board rift, and a dealmaking roundup covers Hengrui Pharma's licensing agreement with Novo Nordisk and AstraZeneca's investment in Summit Therapeutics.

New U.S. guidance exempts orphan drugs, nuclear medicines, cell and gene therapies, and other specialty products from the 100% pharmaceutical tariff when imported from 19 named countries.
Advertisement
Advertisement
Trending on PharmExec
1
New U.S. Guidance Lays Out Exemptions for 100% Tariffs: Report
2
Roundup: Hengrui Pharma and Novo Enter Exclusive License Agreement for HRS-1596, AstraZeneca Enters Collaboartion with Summit Therapeutics
3
Novo Reports Real-World Data Showing Weight Loss After Switch to Oral Semaglutide Pill
4
As Peptide Rulemaking Stalls, FDA Enforcement Moves Forward
5









