Welcome back to the PharmTech Weekly Roundup! I’m Susan Haigney, lead editor of PharmTech. There were some strategic investments made by industry this week, and FDA called out misleading claims about ...
AI accelerates biopharma from discovery to production, cutting cycle times by up to 40%.
As sponsors advanced more niche and personalized modalities, manufacturers were pushed to adopt holistic approaches to safety ...
FDA's Plausible Mechanism Framework streamlines individualized therapy approvals for ultra-rare diseases.
Norgine invests £23 million in Wales site to modernize production and boost resilience for UK and European medicine supply chains.
FDA enforcement accelerated, with recent warning-letter volume exceeding the prior decade’s total, signaling a sustained departure from historical, reactive promotional oversight. “Sameness” ...
FDA granted full approval to teclistamab plus daratumumab/hyaluronidase for RRMM after ≥1 prior line, marking first bispecific T-cell engager conversion from ...
US early-phase trial velocity is constrained by hospital contracting, IRB workflows, and IND review timelines, elevating the ...
M capital investment will retrofit a 45‑acre Athlone site for high-volume oral GLP‑1 tableting, with phased completion in 2027–2028 to de-risk CMC supply. Designating Athlone as a primary ex-US ...
FDA expanded zongertinib’s accelerated approval to treatment-naïve HER2-mutant advanced NSCLC, contingent on mutation ...
Innovators are increasingly focused on whether outsourced partners can help them make better decisions earlier, before ...
The rapid pace of digitalization has created a skills gap, necessitating that staff with traditional chemistry or biology degrees upskill in the IT sector . BioVectra addresses this by collaborating ...
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