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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...
FDA Clears Novo Nordisk Oral Wegovy: First GLP‑1 Pill for Obesity
The FDA approved an oral formulation of Novo Nordisk’s obesity drug Wegovy, marking the first GLP‑1 pill cleared for chronic weight management and for reducing cardiovascular risk similar to the...
Samsung Biologics Buys GSK’s US Facility for $280 Million
Samsung Biologics America signed a definitive agreement to acquire Human Genome Sciences’ Rockville, Maryland biologics manufacturing site from GSK for $280 million, with closing expected near the...
Boehringer Ingelheim Joins White House Drug Push; $10B US Investment
Boehringer Ingelheim agreed to participate in the administration’s drug‑pricing initiative and to join the TrumpRx.gov purchasing platform while committing $10 billion to expand U.S. R&D and...
AstraZeneca, Jacobio Strike Multi‑Hundred‑Million KRAS Deal
AstraZeneca secured ex‑China rights to Jacobio Pharmaceuticals’ pan‑KRAS inhibitor JAB‑23E73 in a deal worth up to $1.915 billion, paying $100 million up front. AstraZeneca will lead clinical...
Aktis Oncology Files for IPO to Fund Radiopharmaceutical Pipeline
Aktis Oncology, backed by big‑pharma investors including Eli Lilly, Merck and Bristol Myers Squibb, filed for an IPO to finance its miniprotein radiopharmaceutical programs. The filing noted plans...
Windward Buys Qyuns Bispecific; $700M Deal for Immunology Asset
Windward Bio acquired ex‑China rights to Qyuns Therapeutics’ clinical‑stage bispecific antibody WIN027 (QX027N), targeting TSLP and IL‑13, in a deal valued up to $700 million. Windward said the...
Ipsen Expands ADC Push with Simcere LRRC15 Asset—$1B Deal
Ipsen struck a licensing agreement with Shanghai‑based Simcere Zaiming to acquire ex‑China rights to SIM‑0613, an LRRC15‑targeting antibody‑drug conjugate, in a deal potentially worth $1.06...
FDA Clears Cytokinetics’ Myqorzo in oHCM — Market Rivalry With BMS
The FDA approved Cytokinetics’ aficamten (Myqorzo) tablets for adults with symptomatic obstructive hypertrophic cardiomyopathy (oHCM) to improve functional capacity and symptoms. Myqorzo, an...