Amgen, Inc. CEO Bob Bradway has reiterated his concerns about the Inflation Reduction Act and the damaging effect it will have on biotech innovation.
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.
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The European Medicines Agency’s qualification of the AIM-NASH tool is said to signify a major advancement for clinical trials for metabolic dysfunction-associated steatohepatitis. The market size for MASH treatments is expected to grow substantially in the coming years.
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Cell and gene therapy manufacturers must consider the practicalities of their product within the context of a health care system before it comes onto the market to be successful, experts from Novartis, AstraZeneca and England’s National Health Service say.
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A risk-based approach to human cell therapies and tissue-based products could incentivize development and prevent bad actors from taking advantage of the current FDA system.
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Experts working in the advanced therapy space say the US has less strict criteria for regulatory pathways for cell and gene therapies than the EU, particularly for products in early development.
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The highlights of recent comments and insights from industry executives on the key issues covered in Scrip.
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RemeGen is planning to complete enrolment in the global Phase III RemeMG study with telitacicept in generalized myasthenia gravis by the end of 2025 or early 2026. The Chinese firm has already sidelined two other global Phase III trials with the molecule to prioritize the indication.
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Private Company Edition: The latest group of drug developers to announce venture capital financings is remarkable for its geographic diversity, from Character Biosciences’ $93m series B round in the US to Augustine’s $85m series B in Belgium to a $29.2m series C for Aculys in Japan.