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FDA clears first oral PCSK9 inhibitor for LDL-C reduction
The FDA approved Merck’s enlicitide (branded Lipfendra), the first oral PCSK9 inhibitor for adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia, under the...
Lilly takes a $2.8B step into psychedelics via AtaiBeckley acquisition
Eli Lilly agreed to acquire AtaiBeckley in a deal valuing the upfront consideration at $2.8 billion, with additional milestone-related contingent value rights that could raise total consideration...
Kalshi launches biotech prediction markets covering trials and FDA decisions
Kalshi unveiled a pilot program in partnership with AppliedXL to launch prediction markets focused on clinical trial outcomes and FDA regulatory decisions. The exchange will publish continuously...
Mirador reveals a slice of pipeline via deal to rival Tavneos
Mirador Therapeutics, an immune-disease biotech with more than $650 million in VC funding, began disclosing pipeline details after reaching a deal tied to a candidate intended to compete with...
Advancell raises $315M Series D to expand radiopharma capacity for Pluvicto-era race
Advancell secured a $315 million oversubscribed Series D to advance ADVC-001, its lead radioligand therapy targeting prostate-specific membrane antigen (PSMA), and to build out late-stage...
Celcuity wins FDA approval for Revtorpyk in HR+/HER2− breast cancer without PIK3CA mutations
The FDA approved Celcuity’s Revtorpyk (gedatolisib), marking the company’s first U.S. commercialization and its entry into a pathway inhibitor class aimed at PAM signaling. The approval covers...
Merck’s PCSK9 race widens as first oral approval lands ahead of AstraZeneca
Merck moved ahead in the race for an oral PCSK9 by securing the first U.S. approval for enlicitide, beating AstraZeneca’s timeline expectations. Analysts framed the result as a milestone for Merck...
Juno Bio expands women’s health testing with $3.8M funding and a CLIA sequencing lab
Juno Bio raised $3.8 million and opened a CLIA-certified sequencing lab in Oakland, California, to scale its vaginal microbiome assay. The test analyzes roughly 10,000 bacteria and fungi plus four...
Genomate Health partners with Inflexa to use multiomics for precision oncology cohorts
Genomate Health partnered with Inflexa to apply multiomics analytics to identify biological factors tied to cancer treatment response. Genomate will define patient cohorts using its computational...
Preclinical gene therapy shows FMRP restoration and symptom recovery in fragile X mouse model
A gene therapy restoring human FMRP via an AAV vector reversed multiple fragile X syndrome deficits in an FXS mouse model, researchers reported in Gene Therapy. Investigators at Cincinnati...
Big pharma psychedelics push via mega-deal
Eli Lilly moved deeper into psychedelic psychiatry, agreeing to acquire AtaiBeckley in a cash-and-contingent-milestone deal valued at $2.8 billion upfront and up to $3.8 billion. AtaiBeckley’s...
First oral PCSK9 approval reshapes US cholesterol competition
Merck won US FDA approval for Lipfendra (enlicitide), marking the first US clearance for an oral PCSK9 cholesterol-lowering drug. The approval comes as Merck’s oral alternative targets PCSK9 to...
Radiopharma funding boosts late-stage isotopes and manufacturing buildout
Advancell raised $315 million in an oversubscribed Series D to accelerate its integrated radiopharmaceutical push, pairing late-stage clinical development with isotope supply and manufacturing...
AI designs CRISPR-like nucleases that work in cells
Researchers reported in Science that AI-guided protein design can produce functional synthetic RNA-guided nucleases with activity matching or exceeding natural enzymes. The work uses a hybrid of...
New CRISPR nuclease engineering strategy targets off-target control
A separate Science report described an AI-driven framework for creating non-natural CRISPR nuclease variants intended to reduce off-target activity. The work, led by Jennifer Doudna at UC...
Healthcare AI bets go public via prediction markets
Kalshi launched a biotech prediction markets pilot focused on clinical trial outcomes and FDA regulatory decisions, working with AppliedXL. The initiative will create publicly available...
Cancer diagnostics M&A tailwind for Abbott’s Exact Sciences integration
Abbott reported a sharp jump in Diagnostics revenue growth tied to its Exact Sciences acquisition, lifting Q2 Diagnostics sales 42% to $3.09 billion and raising full-year 2026 adjusted EPS...
Manufacturing and supply chain: EU/US regulatory and reimbursement pressure intensifies
Germany approved a substantial increase in rebates on patented drugs, raising pressure on pricing models across the biopharma sector. The policy increases rebates from 7% to 15.5% for patented...
Radiopharma manufacturing and system readiness amid isotope scaling needs
AdvanCell’s Series D financing adds to a growing pattern: investors are funding not just candidates but also manufacturing capacity required to deliver radiopharmaceuticals at scale. The $315...
US public policy: oversight proposals target foreign influence in drug supply chains
A bipartisan US Senate bill reintroduced the “Pharmaceutical Investment Oversight and Accountability Act,” aiming to increase transparency around foreign influence across the US drug supply chain....