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...
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.
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.
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.
Private Company Edition: Scrip spoke with the leaders of Gateway Labs and Cure at the BIO International Convention about their mini ecosystems. Also, radiopharmaceutical firm ITM raised €188m ($201.9m), Santa Ana Bio emerged with $168m and Alzheon’s series E totaled $100m.
AstraZeneca’s NIAGARA trial of perioperative Imfinzi in bladder cancer was positively received at the ESMO meeting but its design did not distinguish the contributions of each treatment portion to the overall effect – something that the US FDA is likely to have a view on.
Persistence has paid off for Incyte’s Zynyz in anal cancer with a Phase III win that should make up for a previous disappointment at the FDA and give a boost to the firm’s pipeline prospects for a post-Jakafi era.
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.
