Regulatory

Ireland’s current voluntary system for disclosing pharmaceutical company payments to health care professionals and organizations is flawed and does not adequately deal with conflicts of interests, according to an Irish law maker.

FTC decision, says Bureau of Competition director Daniel Guarnera, influenced by both companies marketing different lines in different countries, limiting the number of similar products in the same categories the combined firm would offer.

Green light follows a recent rejection by the US FDA to partner Regeneron's request for an extension to the dosing interval.

Expanded confidential pricing for pharmaceuticals is intended to help manage medicines expenditure, according to Amgros, the procurement agency that will negotiate the prices.

Legal experts warn, however, that new Mexican procurement rules are discriminatory and could be challenged in the courts.

The 1,383 entries on OMUFA arrears list for facility registrations from FY2021 through FY2025 on FDA’s list exceeds its estimate of 1,134 entities subject to the fee for FY2025.

Legal experts warn, however, that new Mexican procurement rules are discriminatory and could be challenged in the courts.

There is a place for using external reference pricing to set prices of advanced therapies, but any such mechanism must take into account the specificities of the Brazilian market and health system.

Generics Bulletin reviews global regulatory developments across the world.

Companies operating in Argentina may get their medicines to the market more quickly thanks to new updates to the medicines authorization system.

European health systems already pay far too much for new medicines and payers will not accept higher prices to compensate for lower US prices, according to Anja Schiel, from NOMA, the Norwegian health technology assessment body.

The French company will start shipping its blockbuster shortly to meet expected strong demand in the 2025–26 RSV season.