Witnesses at US Senate hearings debate bill's impact on drug pricing; discuss limiting it to medical diagnostics.
Legislation to expand what inventions may be patented may carve out an exemption for research, one of several potential changes that the US Congress could make to the measure as it seeks to bridge the sharp divide among stakeholders.
The Senate Judiciary's Intellectual Property Subcommittee held hearings June 4 and 5 to get input on the draft bill to...
The European Commission has published two new strategies on stockpiling that will improve the availability of critical medicines in times of crisis and reduce the EU’s dependance on suppliers outside the bloc.
US FDA would receive more funding for fiscal year 2026 in the Senate appropriations bill than its House counterpart, including $10m for unannounced foreign inspections.
A new EU strategy to ensure access to essential medicines will boost the development of critical medical counter measures, including vaccines and therapies, according to one pharmaceutical industry group.
Clarity on what transferable exclusivity vouchers may look like for new antimicrobial drugs could be nearing. Denmark’s new presidency of the Council of the EU has prioritized concluding its negotiations with European Parliament over the legislative overhaul of the EU’s pharmaceutical legislation.
European regulators must work hard to maintain and build vital but fragile trust in science and processes, said speakers at an event celebrating the European Medicines 30th anniversary.
Nonvoting industry representative’s presence at Pediatric Advisory Committee meeting was required by statute, the agency said, a de facto acknowledgement that an April directive precluding industry reps from sitting on advisory committees has had little practical effect.
Akin to the 505(b)(2) NDA, a new biologic pathway could reduce the need for animal testing, FDA toxicologist says. Expanded use of generally accepted scientific knowledge (GASK), which few sponsors have attempted despite a 2023 draft guidance, would also help.
