Private Company Edition: Recent venture capital mega-rounds of $100m or more include ADARx and Alltrna, which closed five days after CG Oncology brought in $105m. Also, Tisento launched with assets from Cyclerion and $81m in series A funding and Georgiamune raised a $75m series A round.

In exploratory FDA analyses, PRO data appeared more sensitive at detecting an exposure-toxicity relationship for an oral small molecule cancer drug than clinician-reported data; Project Optimus representative dispels industry concerns that FDA wants firms to find the 'mythical' optimal dose.

Plus deals involving AbbVie/Mitokinin, Roivant/Silicon Therapeutics, CASI/Cleave Therapeutics, Tallac/ALX Oncology, AgeX/LyGenesis, Chinook/Evotec and more.

In a deep-dive sit-down interview with Medtech Insight, ALung Technologies CEO Pete DeComo dishes on US FDA's Breakthrough Devices Program and explains why his firm's novel artificial lung device, Hemolung, is worthy of traveling the expedited pathway to agency approval. DeComo also details two pivotal Hemolung clinical trials in the US and UK, and explains why Hemolung isn't marketing the device for commercial use despite being approved in 36 countries outside the US. He also talks about a future portable version of Hemolung, but noted that's not where ALung is focused right now. "Our first task is that first-generation technology – to get it to market, make it the standard-of-care, and then, if you are successful with all of that, you can do all of those wonderful other things as it relates to portability and wearability," DeComo says.