Legislation
Republican congressional staffers could bring a wealth of experience and strong contacts with key legislators to the FDA ahead of the next user fee reauthorization process. But will Health and Human Services Department leadership interfere?
Not all companies will be able to access joint scientific consultations under the EU Health Technology Assessment Regulation, but success is still possible for those that engage with national agencies early on, says EUCOPE’s Alexander Natz.
The Clinical Trials Regulation was “supposed to harmonize” requirements in the EU, but instead it is giving some countries the chance to get ahead by offering faster approval timelines, notes Telethon’s head of regulatory affairs.
Industry likely wants Grace Graham to take the FDA’s top policy and legislative role, but she may be passed over for someone more tied to HHS Secretary Robert F. Kennedy Jr.’s interests.
Trial sponsors in Germany should start preparing negotiation strategies to tackle difficult discussions with trial sites over standardized clauses.
Newly proposed legislation for bolstering the EU’s drug manufacturing capacity and reducing its overreliance on foreign manufacturers includes a number of measures, such a requirement for EU countries to prioritize the security of supply over price when procuring drugs.
An enhanced role for patients in the European Medicines Agency was a key proposal within the EU pharmaceutical legislation overhaul – but patient groups warn this provision could be scrapped or weakened due to ongoing negotiations.
Democrats are raising concerns that the continuing resolution intended to fund the government for the remainder of fiscal year 2025 gives Trump too much power, though it is unclear whether the FDA would be as impacted as other agencies.
Congress continues to offer broad support for encouraging alternatives to opioid pain medicine, including proposals to speed coverage of new agents like Vertex’ Journavx.
The European Commission has confirmed that pharmaceutical companies will be able to request access to data for research under the new European Health Data Space Regulation, which has been published in the EU Official Journal and will enter into force on 26 March.
The estimated costs to the pharmaceutical and cosmetics industry of introducing a fourth level of urban wastewater treatment are unclear, with the European Commission’s estimate of €1.2bn in dispute.
Companies that fail to provide patient health data for secondary use when requested under the new European Health Data Space could be fined and also prevented from making access requests from other entities, a European Commission representative says.
Eli Lilly's move is said to be part of broader industry campaign to invest in America and avoid President Trump's tariffs, but the company also said tax reform is necessary to make the investments.
The leader of the House Energy and Commerce Health Subcommittee has a plan for passing pharmacy benefit manager reforms, but Democrats are skeptical.
In the wake of cuts at the FDA, NIH and CMS, rare disease advocates are reminding Capitol Hill that some cuts can hinder progress, rather than eliminate waste.
The EU’s new Product Liability Directive will make it easier for European consumers to seek compensation relating to defective products even if manufacturers are based outside the bloc. Legal experts caution that this could have substantial implications for pharmaceutical companies.
US pharma leadership is painting its mission, particularly its goal to end Medicare price controls, as patriotic and essential to America’s global dominance over China, a move that seems designed to align with President Trump’s priorities.
Some changes to the contentious social security financing bill have been made, but industry and the government remain at odds over a €1.2bn drugs overspend.
Manufacturers should make use of joint scientific consultations under the EU Health Technology Assessment Regulation, but they must pay close attention to the selection criteria as consultation slots are limited, experts say.
Biotech execs and lobbyists try to explain the Trump Administration's policy strategy and how to thrive in it.