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 2024 Day 4
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The US Food and Drug Administration is advising the Centers for Medicare and Medicaid Services on the types of real-world evidence research Medicare might want to look at as CMS works to come up with a maximum fair price for the drugs selected for negotiation under the Inflation Reduction Act.

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Cash-Strapped Chinese Biotechs A Growing Draw For Western Pharma Partnering

 

Nauman Shah, head of business development for J&J Innovation, sat down at the BIO CEO & Investor Conference to talk about his trip to China and the state of the biotech scene there.

Sutro Works Toward A Better Ovarian Cancer ADC

 
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Sutro Biopharma CEO Bill Newell spoke with Scrip about the company’s novel platform, its goal of improving folate receptor alpha-driven ovarian cancer and its business development strategy.

Amgen’s Ian Thompson On Payer Shifts, Obesity Opportunity And The Future Of Blockbusters

 
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Scrip spoke with Amgen’s senior VP of US business operations about the impact of drug pricing and reimbursement pressures coming from government policy changes and commercial payers.

Competitive Dealmaking Market Shifts To Smaller M&A, Partnering

 
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Dollars spent on biopharma M&A so far in 2024 may not be as high as in 2023, but dealmakers say deal volume is robust with many factors influencing the overall value of transactions this year.

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Global Pilot Reduces Drug Manufacturing Inspections With Hybrid Approach

 
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A global collaborative inspections pilot reduced the number of individual inspections for participating manufacturing facilities, demonstrating that multiple regulatory authorities can carry out joint inspections using a mix of on-site and remote approaches.

EMA Considers Whether Intrathecal Zolgensma Deserves Fast Tracking

 

Novartis is planning to file EU and US marketing applications for an intrathecal formulation of its spinal muscular atrophy gene therapy, Zolgensma, in H1 2025.

China Approvals Rise But Conditional-To-Full Conversion Slips

 
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A new annual report from China's CDE shows a rise in overall product approvals but a fall in the transition rate for conditional to full approvals, possibly signalling more stringent requirements.