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Moderna's mRNA Flu Vaccine Just Got a Unanimous FDA Panel Endorsement (After Nearly Getting Killed)
A 9-0 FDA advisory panel vote puts Moderna's mFlusiva on track to become the first licensed mRNA seasonal flu vaccine in the U.S., with an agency decision due August 5. The kicker: the FDA initially refused to even review the application earlier this year amid anti-mRNA political pressure from RFK Jr.'s HHS. The reversal came within a week, and the unanimous vote sent a clear signal that the science outlasted the politics. Against standard egg-based shots, mFlusiva cut hospitalizations and ER visits by nearly 48%.
Why it matters: Beyond flu, this vote validates mRNA as a commercial platform in a $10 billion seasonal market and clears the path for Moderna's combo vaccines covering flu, COVID, and RSV in a single shot.
Read more →Deals and M&A
Merck KGaA Drops $11.3 Billion on the Company That Makes Cell Therapy's Secret Ingredients
The largest life sciences tools deal in over a decade: Merck KGaA is paying $73 per share for Bio-Techne, the company whose cytokines and growth factors are essential to virtually every cell therapy in production. Bio-Techne's GMP reagent business grew over 60% last quarter. The deal signals that owning the supply chain may be just as valuable as owning the drugs themselves.
Read more →A Stealth Biotech Just Signed a $1.6 Billion Deal for a Drug That Hasn't Touched a Human
Boulevard Bio, a Deerfield-backed startup so stealthy its backer's website doesn't list it, licensed an AI-designed trispecific T-cell engager from Hong Kong's METiS TechBio. The $20 million upfront is modest; the $1.6 billion in milestones is not. The molecule targets autoimmune disease, adding to a wave of pharma bets that trispecifics can leapfrog today's bispecific platforms.
Read more →Funding and Financings
A Cancer Biotech You've Never Heard Of Just Broke the Biggest Biotech IPO Record
Parabilis Medicines raised $670 million in its Nasdaq debut, shattering the previous biotech IPO record set by Kailera Therapeutics earlier this year. The Cambridge company's lead drug showed tumor reductions in 100% of response-evaluable patients in early desmoid tumor trials, and a $2.3 billion Regeneron partnership sealed the deal. Shares popped 58% on day one before cooling off, following the 2026 pattern: investors will write massive checks, but only for de-risked stories with real data.
Read more →Regulatory and FDA
The FDA Wants to Inspect Your Drug Factory Before You Finish Building It
Seven companies, including Eli Lilly and Regeneron, were selected for a first-ever FDA pilot that reviews manufacturing facilities while they're still under construction. Late-cycle inspection failures can delay approvals by 6 to 18 months; this program aims to eliminate that bottleneck by front-loading the scrutiny. Lilly's Lebanon, Indiana site (set to become the largest U.S. API plant) is in the inaugural class.
Read more →Praxis Gets a Three-Month FDA Delay, and the Real Story Is Why It Keeps Happening
Praxis Precision Medicine's epilepsy drug relutrigine got bumped from a September to December decision date. The official reason is a data amendment, but the backdrop is an FDA running 3,500 employees lighter since 2025. Denali, Disc Medicine, and Kezar have all seen similar slips. Analysts warn the pattern will only worsen through 2027 as backlogs compound.
Read more →Genentech Scores Fast-Track Review for the First At-Home Shot for Thyroid Eye Disease
The FDA granted Priority Review to Genentech's Enspryng as a self-injectable treatment for thyroid eye disease, with a decision date of October 15. In a market where the only biologic option has been Amgen's $200,000 IV-only Tepezza, a monthly at-home shot could reshape how patients and payers think about TED treatment. The overall market is projected to hit $4 billion by the early 2030s.
Read more →Science and Strategy
BioCryst Is Closing the Lab Where It Was Born 40 Years Ago
BioCryst is shutting down all internal drug discovery and closing its Birmingham, Alabama research center by year-end. The $875 million-revenue company will now source all early-stage programs through licensing and partnerships. Management called the shift "capital-efficient," but the move raises a thorny question: can a biotech that stops discovering drugs still call itself a biotech?
Read more →The Team Behind Pfizer's $10B Metsera Deal Is Building a Biotech Factory Powered by AI
Edison Scientific and Population Health Partners (the crew that built Metsera into a Pfizer acquisition target) are combining an AI "scientist" platform with a proven company-building playbook. Their system, Kosmos, can read 1,500 papers and generate six months of research output in a single 12-hour run. The goal: systematically spin out entire biotech companies, starting with cardiovascular and inflammatory diseases.
Read more →Vistagen's Anxiety Drug Goes 1-for-2 in Phase 3, Stock Craters 80%
Fasedienol, Vistagen's intranasal anxiety spray, failed its latest Phase 3 trial after placebo actually outperformed the drug by 0.4 points. The stock collapsed to under $1, and analysts slashed targets across the board. Vistagen is clinging to a post-hoc subgroup signal in severe patients, but with a mixed Phase 3 record, it joins the long, brutal tradition of CNS drugs that couldn't crack the placebo problem.
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