Pink Sheet Team
Editorial Team
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The policy and regulatory insights advantage for biopharma decision-makers around the globe.
Latest From Pink Sheet Team
Pink Sheet Podcast: US FDA Device Director Retires, PBM Execs On Capitol Hill, Voucher Program Renewal Push
Editors from the Pink Sheet and Medtech Insight discuss the retirement of Jeff Shuren, PBM executives again appear unscathed after another Capitol Hill appearance, and the growing push to ensure the FDA’s rare pediatric disease priority review voucher program is renewed.
Pink Sheet Podcast Special: Why The US Approves Most New Drugs Before The EU
Pink Sheet reporter and editors discuss the impact of a US and EU drug approvals analysis that found the US FDA still clears many novel products first, including most new cell and gene therapies and cancer treatments.
BIO Notebook: Califf On RWE, Industry Execs On Growing Therapeutic Areas, And More
Insights from Day Four of the BIO International Convention include FDA commissioner Califf on the state of real-world evidence and how it impacts IRA negotiations, Roche's interest in cardiovascular/metabolic assets, Merck's plans in immunology, and industry's rising interest in neuropsychiatry.
BIO Notebook: Amgen CEO Blasts IRA, Novo Nordisk Stays Cautious On BD, And More
Insights from Day Three of the BIO International Convention in San Diego include Amgen CEO Bob Bradway taking aim at the "Innovation Reduction Act," Novo Nordisk's business development head talking about spending its semaglutide bounty, Roivant's long view on BD prospects for Immunovant's FcRn inhibitor, and more regulatory concerns around artificial intelligence.
BIO Notebook: US FDA User Fees For AI Regulation, Partnering Strategy Evolves, And More
Insights from Day Two of the BIO International Convention in San Diego include user fees potentially supporting the FDA's AI ambitions, the evolving pros and cons of partnering, and J&J's view on dealmaking in 2024.
BIO Notebook: Dealing With Rejection, Worrying About March-In Rights, And More
Insights from the first day of the international convention in San Diego also includes interviews on Alzheimer’s investments, dealmaking for mid-sized companies and reflections on the virtues of lean thinking.