Policy

An FDA “expert roundtable” on talc produced a new talking point on a potential drug safety risk, but the basis of that claim is difficult to determine.

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.

ZIN, the Dutch health technology assessment body, estimates that the number of patients eligible for treatment with a PARP inhibitor will be halved following a reassessment of drugs in the class.

The agency says items on its Human Foods Program’s proposed agenda for guidance “to complete during 2025” include identity and safety information for NDI notifications. Its announcement also links to document about a separate key industry question, a rulemaking which would recognize NAC as a lawful

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.

Incentives for repurposed drugs proposed as part of the EU pharma reform package are a “great step forward,” but more recognition is needed from payers and regulators to leverage the benefits of these medicines, experts say.

Dietary Supplement Caucus e-launched the 119th Congress with Utah Republican House member Mike Kennedy and Texas Democrat member Marc Veasey as co-chairs and with a total of nine senators and 20 House members spanning both parties.

Healthcare product industries await publication of the NHS 10-Year Plan, due out the coming days, which will focus on health generally not just the NHS, UK health secretary Wes Streeting said during a final prelaunch event on 24 June.

Celltrion has reinforced its commitment to the UK by opening a new central operations hub in Uxbridge, while acknowledging that “major questions over the attractiveness of the market” need to be addressed to encourage development and ensure a sustainable environment for UK biosimilars.

The China Securities Regulatory Commission has proposed a new “growth tier” for the STAR Market of the Shanghai Stock Exchange, to reinstate the market’s listing standards for unprofitable firms.

Complaint filed Utah federal court says “Supreme Court explicitly rejected Chevron deference to agency interpretations” in the Loper decision, compelling rejection of “an agency’s statutory interpretation unless the court, ‘after applying all relevant interpretive tools, concludes’ the interpretatio

A differentiated profit-sharing model to accelerate the use of AI in drug development using clinical and patient data is being proposed in South Korea, but the idea faces multiple practical challenges