BIO

Patient advocacy groups suggest US state and federal agencies are trying to exclude them from certain conversations due to drug industry connections and perceived bias. 

With the sheen of inevitability now scuffed off the BIOSECURE Act, diplomatic efforts to reduce US dependence on Chinese APIs are increasing in prominence. And the power of the legislation itself could be determined by litigation about a video app.

The FDA does not appear likely to provide a calculation for sponsors to show clinical trial diversity, but agency officials seem split on how tough to enforce the new regulations intended to ensure all groups are adequately represented.

BIO CEO John Crowley sat down with Pink Sheet at the industry’s annual convention to discuss his vision for a newly restructured BIO, his thoughts on the upcoming US elections and whether he’d ever lead another biotech. 

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. 

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. 

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.   

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. 

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.

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.

FDA commissioner is thinking about how advisory panel interactions might improperly influence meeting outcomes as the agency undertakes a 'stem to stern' review of the process.  

In a Pink Sheet interview, BIO Chief Advocacy Officer Nick Shipley raised concerns that Medicare’s Alzheimer’s coverage decision is indicative of a broader agency view on accelerated approval that could limit drug reimbursement in both the public and private sector. 

Commissioner also talks drug shortages, difficulty getting key agency and industry priorities done in new pandemic legislation, and how legal challenges to FDA authority could impact pharma companies desire to develop new medicines.