[ad_1] FDA commissioner Marty Makary said eased manufacturing requirements for certain cell and gene therapies were “common-sense reforms” to “foster innovation”. Photo by Andrew Harnik/ Getty Images News via Getty Images. The US Food and Drug Administration (FDA) has announced increased flexibility for cell and gene therapy (CGT) manufacturers, loosening quality requirements in an effort…

[ad_1] Shots: J&J has reported longer follow-up results from Cohorts D & E of the P-Ib/II (OrigAMI-1) trial assessing Rybrevant (amivantamab-vmjw; IV) ± FOLFOX/FOLFIRI in pts with RAS/BRAF wild-type mCRC At mFU of 16mos., Rybrevant + FOLFOX (n=20) or FOLFIRI (n=23) achieved a cORR of 51%, with early responses & median time to first response of…

[ad_1] Alembic Pharmaceuticals receives USFDA tentative approval for Bosutinib tablets – Express Pharma Home Latest Updates Alembic Pharmaceuticals receives USFDA tentative approval for Bosutinib tablets [ad_2] Source link

[ad_1] According to Franco Stevanato, CEO of Stevanato Group, tariff policies are beginning to influence how pharmaceutical companies think about manufacturing location and supply chain resilience, but the shift toward localization will take time. While tariffs have created temporary cost pressures for the company, including surcharges passed on to customers, those impacts have largely been…