BIO Notebook: Califf On RWE, Industry Execs On Growing Therapeutic Areas, And More

06 Jun 2024

• By Pink Sheet Team

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.

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.

CMS has said that when they negotiate under the IRA, Medicare is going to take into account real-world evidence, FDA Commissioner Robert Califf said at BIO 2024

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Finance Watch: Deerfield Closes $600m-Plus VC Fund; Gates Speeds Up Health Investments

09 May 2025

• By Mandy Jackson

Private Company Edition: Deerfield’s third innovations fund will back therapeutics and other opportunities, the Gates Foundation – a sometimes funder of biotech firms – will spend $200bn over the next 20 years, and NewLimit raised a $130m series B round, among other financings.

Pipeline Watch: Six Approvals And Thirteen Phase III Readouts

09 May 2025

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.