Get the Daily Brief
Latest Biotech News
Wegovy pill clears FDA: Novo Nordisk poised for broad launch
The FDA approved an oral formulation of Novo Nordisk’s weight‑loss drug Wegovy, marking the first pill version of a GLP‑1 therapy cleared for obesity. Regulators cleared the pill for weight...
Myqorzo cleared: Cytokinetics enters direct fight with BMS’ Camzyos
The FDA granted marketing clearance for Cytokinetics’ aficamten (Myqorzo) to treat symptomatic obstructive hypertrophic cardiomyopathy (oHCM), making a daily oral myosin inhibitor available to...
Samsung Biologics buys GSK U.S. plant: $280m expansion into Rockville
Samsung Biologics America signed a definitive agreement to acquire Human Genome Sciences’ Rockville, Maryland, manufacturing site from GSK for $280 million, with closing expected by the end of Q1...
Pfizer reports death in Hympavzi trial: safety review under way
Pfizer disclosed that a participant in a clinical trial of its hemophilia drug Hympavzi died after a cerebellar infarction followed by cerebral hemorrhage. The company notified investigators and...
Ingrezza flunks DCP test: Neurocrine flags Phase 3 miss
Neurocrine Biosciences reported that valbenazine (Ingrezza) failed to meet its primary endpoint in the Phase 3 KINECT‑DCP trial for dyskinetic cerebral palsy. The company issued an update...
AstraZeneca buys ex‑China rights to Jacobio pan‑KRAS—$1.9B deal
Jacobio Pharmaceuticals out‑licensed its clinical‑stage pan‑KRAS inhibitor JAB‑23E73 to AstraZeneca in a deal worth up to $1.915 billion, with AstraZeneca taking development and commercialization...
Aktis files for IPO: radiopharma backers push miniprotein programs
Aktis Oncology filed for an initial public offering to fund clinical development of miniprotein radioconjugates, aiming to advance candidates such as Ac‑AKY‑1189 for Nectin‑4‑expressing tumors....
Boehringer joins TrumpRx: $10B U.S. investment and tariff protections
Boehringer Ingelheim agreed to invest $10 billion in U.S. pharmaceutical R&D and manufacturing through 2028 and to join the TrumpRx.gov direct‑purchase platform, under an arrangement that secures...
White House and CMS push pricing pilots: MFN deals and Medicare demos roll out
The White House expanded most‑favored‑nation (MFN) pricing agreements and CMS proposed two mandatory Medicare payment demonstration models designed to lower drug prices for Medicare beneficiaries....
MRD testing matures: IMvigor011 readout validates Signatera as a treatment selector
Minimal residual disease (MRD) testing advanced toward clinical utility in 2025 after Phase III IMvigor011 used Natera’s Signatera to select muscle‑invasive bladder cancer patients for adjuvant...
FDA clears Wegovy pill: Novo Nordisk eyes broad launch
The FDA approved an oral version of Novo Nordisk’s obesity medicine Wegovy, marking the first regulator-cleared GLP-1 pill for chronic weight management in more than a decade. The approvals signal...
Samsung Biologics to buy U.S. GSK plant: $280M deal secures 60,000 L capacity
Samsung Biologics agreed to acquire Human Genome Sciences’ Rockville, MD biologics manufacturing site from GSK for $280 million, securing 60,000 liters of cGMP drug-substance capacity and the...
FDA approves Myqorzo – Cytokinetics takes on Bristol Myers’ Camzyos
The FDA cleared Cytokinetics’ aficamten (Myqorzo) tablets for adults with symptomatic obstructive hypertrophic cardiomyopathy (oHCM), providing a daily oral therapy to improve functional capacity...
AstraZeneca inks pan‑KRAS pact: up to $1.9B for Jacobio’s clinical asset
AstraZeneca paid Jacobio Pharmaceuticals $100 million upfront for ex-China rights to JAB-23E73, a clinical-stage pan-KRAS inhibitor, in a deal that could reach about $1.9 billion. AstraZeneca will...
Aktis files for IPO: radiopharma startup to fund Lilly‑partnered trials
Aktis Oncology filed for an initial public offering to finance its pipeline of miniprotein-based radiopharmaceuticals, including an Eli Lilly-partnered program. The Boston- and Durham-based...
Boehringer signs drug‑cost pact: $10B US investment and TrumpRx participation
Boehringer Ingelheim agreed to invest $10 billion in U.S. R&D and manufacturing through 2028 and to join the TrumpRx.gov direct purchasing platform under a deal with the Trump administration. As...
CMS proposes two Medicare drug‑pricing demos: most‑favored‑nation model moves forward
The Centers for Medicare & Medicaid Services proposed two mandatory Medicare payment demonstrations designed to lower drug prices by aligning Medicare payments with prices in peer countries. The...
MRD testing gains validation: trial readouts and consolidation accelerate market
Minimal residual disease (MRD) testing moved toward clinical validation in 2025 as randomized trial readouts and commercial consolidations bolstered the biomarker’s utility across oncology...
Robotic synthesis finds metal‑based antibiotic: iridium candidate emerges
Researchers at the University of York used high-throughput robotic synthesis and triazole 'click' chemistry to generate 672 metal complexes and identified an iridium-based compound with...
Guardant360 CDx approved in Japan: companion test cleared for Lilly breast cancer drug
Japan approved Guardant Health’s Guardant360 CDx as a companion diagnostic to identify ESR1 mutations that determine eligibility for Lilly’s Inluriyo in breast cancer. The clearance expands...