As talks continue on the EU pharmaceutical legislative reform proposals, drug firms may have to wait some time before they find out what the future periods of regulatory data protection and orphan market exclusivity will be.
The EU regulatory data protection regime is facing one of the biggest shake-ups in 20 years, with proposals by the European Commission to reduce the baseline period of RDP and introduce a system under which a set of top-up protection periods could be granted under certain conditions.
While the move to cut RDP is controversial in itself, companies that will be affected by this change – R&D-based...
Create an account to read this article
Already a subscriber?
The financial macroenvironment may be looking more favorable for 2025 but will pharma growth be muted by elements beyond its control? In Vivo discusses the headwinds and drivers for pharma in the coming 12 months.
Despite the stellar success of the class so far, biotech is now looking past GLP-1s to more tolerable, sustainable approaches to obesity.
Former Roche CEO Bill Burns reflects on transforming Roche into a global leader in specialty care and oncology. Now, as he spearheads efforts to combat antibiotic resistance, Burns shares insights on industry evolution, the power of cultural change, and the urgent need for a new business model in antibiotics development.
The Top 100 ranking of global medtechs by revenues for 2023 illustrated how the leaders continue to tailor innovation to users and patients according to market trends while driving portfolio management for growth.
The Chinese appetite for GLP-1s is noticeable. While the market opportunity for western pharma is huge, so are the strategic market access challenges, though not unsurmountable, L.E.K. Consulting told In Vivo.
Despite recent political turmoil, outside investor and corporate interest in South Korean biopharma innovation appears robust or even increasing.
A discussion with Karen Harris, CFO of the Alzheimer's Drug Discovery Foundation, about the foundation's investment strategy, biotech and investor sentiment at the recent BIO conference and what innovations give her hope for Alzheimer's patients.
