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CMS proposes mandatory Medicare drug demos — pilots would tie U.S. prices to peer nations
The Centers for Medicare & Medicaid Services proposed two mandatory payment demonstration programs that would test most‑favored‑nation‑style pricing for Medicare Parts B and D drugs by aligning...
Wegovy pill approved — First oral GLP‑1 cleared for obesity
The FDA approved Novo Nordisk’s once‑daily oral formulation of semaglutide (Wegovy) for weight management and cardiovascular risk reduction. The decision formalizes trial results showing up to...
Singlera inks EU pact: Pure Medical to distribute cfDNA cancer assays
Singlera Genomics signed a research and distribution agreement with Pure Medical to commercialize its mTitan and mGuard cell‑free DNA (cfDNA) methylation sequencing assays across several European...
AstraZeneca bets on pan‑KRAS — $1.9B Jacobio pact
Jacobio Pharmaceuticals outlicensed its phase I pan‑KRAS inhibitor JAB‑23E73 to AstraZeneca in a deal worth up to $1.915 billion; AstraZeneca paid $100 million upfront and will handle development...
Pfizer probe after trial death — Hympavzi extension under scrutiny
Pfizer disclosed a participant fatality in a long‑term extension trial of its tissue factor pathway inhibitor antagonist Hympavzi (marstacimab), reporting a cerebellar infarction followed by...
Patient deaths halt lung ADC Phase III recruitment
Daiichi Sankyo placed a partial hold on recruitment and enrollment in the phase III IDeate‑Lung02 study of the antibody‑drug conjugate ifinatamab deruxtecan after an unexpected rise in grade 5...
Harbour Biomed inks BMS multispecifics deal — $90M now, $1B+ later
Harbour Biomed closed a year‑end collaboration with Bristol Myers Squibb to develop multispecific antibodies, receiving roughly $90 million up front and potential milestones that could exceed $1...
Boehringer joins TrumpRx — $10B US investment and pricing pact
Boehringer Ingelheim struck an agreement with the U.S. administration to join the TrumpRx.gov purchasing platform and pledged $10 billion in U.S. investments through 2028 to expand R&D and...
Aktis files for IPO — radiopharma firm seeks capital for Lilly partnership
Aktis Oncology filed for an initial public offering to fund a pipeline of radiopharmaceutical candidates and to expand operations for its Lilly‑partnered programs. The company plans to...
MRD testing reaches inflection — Signatera trial yields randomized evidence
Minimal residual disease (MRD) testing advanced to clinical decision‑making in 2025 as Phase III and other randomized readouts validated ctDNA‑guided treatment strategies. The Phase III IMvigor011...
CMS proposes Medicare pilots — testing most‑favored‑nation pricing for beneficiaries
The Centers for Medicare & Medicaid Services proposed two mandatory Medicare payment models designed to lower prices for branded drugs by benchmarking costs to prices paid in comparable countries....
Wegovy pill cleared: first oral GLP-1 for obesity
The FDA approved Novo Nordisk’s oral semaglutide formulation, marking the first pill version of Wegovy authorized for chronic weight management and cardiovascular risk reduction. The decision...
CMS proposes Medicare demos: Trump administration pushes MFN-style pricing
CMS proposed two mandatory Medicare demonstration programs intended to tie Medicare drug prices to international benchmarks, a policy derived from the administration’s most-favored-nation (MFN)...
Boehringer dealmaking: $10B US investment and CKD pill pact
Boehringer Ingelheim struck an agreement with the U.S. administration to join a government-run purchasing platform and pledged up to $10 billion in U.S. investments through 2028 to expand...
AstraZeneca scales KRAS push: big ex‑China deal with Jacobio
AstraZeneca paid $100 million up front to secure ex‑China rights to Jacobio Pharmaceuticals’ phase I pan‑KRAS inhibitor, in a deal worth up to roughly $1.9 billion in milestones. The agreement...
Aktis eyes public markets: radiopharma IPO to fund alpha programs
Aktis Oncology filed for an IPO to raise capital for its miniprotein radiopharmaceutical pipeline, aiming to fund ongoing US phase 1b trials and further target expansion. The company highlighted...
Patient death clouds Pfizer’s Hympavzi hemophilia program
Pfizer disclosed the death of a participant in a long‑term extension trial of Hympavzi (marstacimab), reporting a cerebellar infarction followed by cerebral hemorrhage. The company communicated...
Phase III halt: Merck‑Daiichi pause lung cancer ADC trial after deaths
Daiichi Sankyo voluntarily placed a partial recruitment and enrollment hold on the phase III IDeate‑Lung02 study of the antibody‑drug conjugate ifinatamab deruxtecan following a...
Shionogi pays $2.5B for edaravone rights: rare‑disease buy expands portfolio
Shionogi agreed to acquire global rights to edaravone from Tanabe Pharma for $2.5 billion, securing an approved amyotrophic lateral sclerosis (ALS) therapy marketed in the U.S. as Radicava (oral...
MRD testing matures: pivotal trial readouts and commercial consolidation
Minimal residual disease (MRD) testing saw multiple high‑profile trial readouts and commercial consolidations in 2025, with the Phase III IMvigor011 trial using Natera’s Signatera test presenting...