Legislation was also revised to enable manufacturers to justify withdrawing, discontinuing or switching product for follow-on; bills restricting citizen petitions, tribal sovereign immunity also clear committee.
The sponsors of legislation to curtail so-called product hopping and patent thicketing by product innovators cut the section on patent thickets in a manager's amendment that cleared the US Senate Judiciary Committee on 27 June.
The bill, Affordable Prescriptions for Patients Act, S. 1416, would amend the Federal Trade Commission Act to prohibit anticompetitive behaviors...
FDA employees are concerned that while the budget authority total proposed for fiscal year 2026 meets the user fee 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.
Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.
The UK’s research-based pharma industry and medical research charities have set out clear action points to drive greater diversity and inclusion in clinical trials.
Blenrep, GSK’s multiple myeloma therapy, faced a major setback when it was withdrawn from the market in 2022. The drug has since made a return as a second-line therapy, and is on track to being reimbursed in England.
