OPEN ACT would provide additional six months of exclusivity when existing drugs are approved for rare diseases; congressional debate over the measure could get bogged down in drug pricing issues.
Rare disease advocates on Capitol Hill will push hard to get a new incentive program for drug repurposing included in the FDA user fee renewal package that must move through Congress in the next few months.
However, congressional debate on the Orphan Product Extensions Now Accelerating Cures and Treatments Act (OPEN ACT) may move beyond the...
FDA employees are concerned that while the budget authority total proposed for fiscal year 2026 meets the user free appropriations' triggers, the FDA could have trouble meeting allocation triggers without cuts to non-review work.
An unintended consequence of a provision framed as an administrative change in the bill could significantly reduce medication adherence among low-income older adults and increase mortality, a study found.
EU authorities must “take advantage” of the upcoming Biotech Act to reassess the bloc’s policies and “offset existing challenges” for small and midsized enterprises, trade association EUCOPE has said.
Companies operating in Argentina may get their medicines to the market more quickly thanks to new updates to the medicines authorization system.
EU authorities must “take advantage” of the upcoming Biotech Act to reassess the bloc’s policies and “offset existing challenges” for small and midsized enterprises, trade association EUCOPE has said.
The whole contract research organization industry is being impacted by the current volatility in the pharmaceutical industry.
The 14 July deadline for the Citeline Japan Awards 2025 in Tokyo is approaching fast, so here's a reminder to take a look at the categories and criteria and be sure to get your submissions in by this date. Sponsorship opportunities and tables for the event are also available.
