Legislation
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.
The European Commission has released three exercises to help pharma companies prepare for joint clinical assessments under the new EU Health Technology Assessment Regulation. Experts explain how manufacturers should interpret these and what their limitations are.
Robert F. Kennedy Jr. will become HHS secretary while retaining his anti-vaccine positions. His first action likely will be creating a new safety commission, which industry must hope holds off more drastic action.
Company dossiers submitted for EU-level joint clinical assessments under the Health Technology Assessment Regulation will be made public. This could conflict with other strategic business decisions and should be planned for in advance, experts say.
Trump’s former FDA commissioner sees ‘nothing good’ coming from negotiating a new user fee agreement in the ‘current political environment.’
At a lively AAM Access! conference in Florida, AAM President and CEO John Murphy acknowledged the negative effects of potential tariffs, but also suggested that the second Trump Administration could be an opportunity for the generics and biosimilars sectors to advance market reforms.
Pink Sheet reporter and editors discuss what pushed a crucial Senate Finance Committee swing vote to support Robert F. Kennedy Jr. as HHS Secretary and the FDA slowly expanding its communications with the public amid the Trump Administration freeze.
Pharmaceutical companies in the EU have until August to ensure their staff have an adequate level of artificial intelligence literacy in line with new obligations set by the AI Act this month.
The FDA's recent communications freeze has blocked participation in international standards development groups, which could impact the alignment of US and international requirements.
Momentum is building around the European Commission’s race to propose a Critical Medicines Act, which aims to tackle drug shortages and create a better framework for establishing manufacturing facilities of essential medicines in the EU.
The Trump transition so far has all the hallmarks of the tech industry’s favorite management slogan, but that might not work well for biopharma companies if the FDA is one of the agencies that gets broken.
CDER and CBER once again posted net employee gains, even during the quarter that included the presidential election, despite fears that many would leave rather than endure the changes to be imposed by President Trump.
Competition to win a coveted joint scientific advice slot will be fierce due to the limited number available.
The chair of the Senate Health, Education, Labor and Pensions Committee questioned whether Kennedy could reject anti-vaccine views in the face of data affirming their safety and efficacy.
The Belgian health technology assessment agency will also lead on joint scientific consultations, which will be instrumental in helping companies submit appropriate dossiers for joint clinical assessments.
The Council of the EU has formally adopted the European Health Data Space regulation, meaning that it will soon enter into force in the EU. Experts explain what this means for the pharmaceutical industry.
The FDA's interim leadership takes shape, but the sense of transition chaos still lingers.
Pink Sheet reporter and editors discuss the uncertainty created by the Trump Administration freezing most communications at the Health and Human Services Department, new travel and telework bans, as well as the delay in announcing an acting FDA leader and the impact of new executive orders on the FDA and CMS.
The cell and gene therapy field has reached an inflection point in the US as the second Trump Administration begins and advocates argue the sector could fit well with the “MAHA” agenda.