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.
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.
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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.
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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.
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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.
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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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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.
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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.
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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.