A panel of CDC vaccine advisors voted to drop a recommendation that all children receive the hepatitis B vaccine at birth, breaking with decades of standard practice. The Advisory Committee on Immunization Practices voted 8-3 on Friday that pregnant women who test negative for hepatitis B should consult a healthcare provider before giving their newborn a shot. If parents choose not to give the vaccine at birth, the committee suggests waiting until at least 2 months of age. 

What changes? If adopted by acting CDC Director Jim O’Neil, the vote would undo longstanding vaccine policy. For years, the CDC has recommended that all newborns receive the hepatitis B vaccine within the first day of being born. In response, Sen. Bill Cassidy (R-LA) urged O’Neil not to endorse the recommendation. Cassidy wrote in a social media post that “ending the recommendation for newborns makes it more likely the number of cases will begin to increase again. This makes America sicker.” Endpoints’ Max Bayer has more details here on how the ACIP meeting played out.

Meanwhile, pressure continues to build at the FDA. Tracy Beth Høeg was appointed this week as acting CDER director, replacing Rick Pazdur, who was in the role for less than a month. Høeg, who has been a skeptic of Covid-19 vaccines, trained as a sports medicine physician and epidemiologist. In a statement given before Høeg was appointed, BIO chief John Crowley said Pazdur’s departure “raises serious concerns about the repeated turnover in key leadership occurring at the FDA,” adding that “we need organizational strength and stability.” The agency was also subject to criticism this week in an editorial by a dozen former permanent and former acting FDA commissioners, who wrote that they were “deeply concerned” about its stance on vaccine safety following an internal memo. Read more here. 

🚨 This week, we launched our new intelligence platform called Endpoints Signal. Tom Randall, who spent nearly two decades at Bloomberg, is running the Signal ship, having produced award-winning work on the future of transportation and energy. Tom’s steering of Signal is a return to the biopharma beat for him, where he first started his career. Read more about why Endpoints is launching Signal in a note from founder Arsalan Arif. 

Signal’s flagship product is the Biopharma Sentiment Index, or BPSI. The BPSI (pronounced BIP-see) attempts to boil down industry sentiment into a single number, similar to the University of Michigan’s consumer confidence index. A “neutral” sentiment is represented by a 100. Numbers above 100 are positive, and those below 100 are negative. In the inaugural BPSI, which will be reported quarterly, sentiment came in at a 78. Read more about it from Tom here. 

As part of Signal, we also include rotating “Pulse” questions every quarter that measure confidence around timely issues. The first Pulse Report focused on how AI is showing up in biopharma. What stuck out first: 48% of respondents now describe themselves as heavy AI users in the workplace. Read more from Tom here.

The plans for a secretive startup are coming into view, biotech correspondent Kyle LaHucik reported exclusively this week. ARCH Venture Partners and the Parker Institute for Cancer Immunotherapy (PICI) are finalizing their investment plans in the startup, called Medici Therapeutics. Its existence has been briefly mentioned in a handful of regulatory and scientific documents, but the scope of its actions and ambitions hasn’t been reported previously. 

Though Medici won’t say how much money it's raised, two sources indicate Medici recently acquired Nutcracker Therapeutics, in which ARCH had invested more than $200 million. Some of Medici’s ambitions include personalized cancer vaccines, tumor-infiltrating lymphocyte (TIL) therapies, in vivo TCR therapies, cellular rejuvenation approaches and mRNA manufacturing capabilities. 

🥼 Generate:Biomedicines is launching two large studies for its lead drug candidate, which is an anti-TSLP antibody called GB-0895, in severe asthma. It appears set to be the first Phase 3 start for an AI-focused biotech, a sign that the field is maturing beyond not just building models but advancing drug programs.