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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...
Diagnostics regulatory moves: Guardant360 CDx Japan OK and Applied BioCode FDA submission
Guardant Health received Japanese approval for its Guardant360 CDx as a companion diagnostic to identify ESR1 mutations and assess eligibility for Lilly’s Inluriyo in breast cancer patients. The...
MRD Testing Gains Ground: Trial Readouts, M&A and Reimbursement Momentum in 2025
The minimal residual disease (MRD) testing market reached a turning point in 2025 as pivotal trial readouts, commercial alliances and consolidation advanced clinical validation. The Phase III...
FDA approves oral Wegovy — first GLP‑1 pill clears U.S. regulator
The FDA approved the oral formulation of Novo Nordisk’s weight‑loss drug Wegovy, marking the first regulatory clearance of an oral GLP‑1 for obesity in years. The approval covers treatment for...
Samsung Biologics buys GSK U.S. plant — $280M deal, 500 staff retained
Samsung Biologics America signed a definitive agreement to acquire Human Genome Sciences’ Rockville, MD manufacturing site from GSK for $280 million, with closing expected by the end of Q1 2026....
AstraZeneca takes pan‑KRAS asset: $100M upfront, up to $1.9B in milestones
AstraZeneca secured ex‑China rights to Jacobio Pharmaceuticals’ clinical pan‑KRAS inhibitor JAB‑23E73 in a deal worth up to $1.915 billion, paying $100 million up front and agreeing to joint...
Aktis files for IPO — funding radiopharma trials backed by big pharma
Aktis Oncology filed to go public to finance its miniprotein radiopharmaceutical pipeline, including a Lilly‑partnered program. The company, which has raised roughly $346 million in private...
FDA clears Myqorzo — Cytokinetics enters oHCM market vs. BMS
The FDA granted marketing approval for Cytokinetics’ aficamten (Myqorzo) for symptomatic obstructive hypertrophic cardiomyopathy in adults, clearing multiple tablet strengths. The approval...
Boehringer inks $10B U.S. investment — joins TrumpRx to cut medicine prices
Boehringer Ingelheim agreed with the U.S. administration to invest $10 billion in U.S. R&D, manufacturing and operations through 2028 and to participate in the TrumpRx.gov direct‑purchase platform...
White House seals most‑favored‑nation drug deals — three companies remain holdouts
The White House announced most‑favored‑nation (MFN) pricing agreements with nine biopharmas as part of a broader push to align U.S. drug prices more closely with international levels. The...
Lipid‑free self‑amplifying platform boosts vaccines — bypasses LNPs
Researchers published a binary self‑amplifying expression platform in Nature Communications that produces vaccines and nanomedicines without lipid nanoparticles (LNPs). The platform generates...
MRD testing wins randomized trial backing — Signatera readout fuels consolidation
The minimal residual disease (MRD) testing market saw landmark trial readouts and commercial consolidation in 2025, led by the Phase III IMvigor011 study that used Natera’s tumor‑informed...
Guardant360 CDx approved in Japan — companion for Lilly’s Inluriyo on ESR1 mutations
Guardant Health won Japanese regulatory approval for its Guardant360 CDx as a companion diagnostic to identify ESR1 mutations in breast cancer patients eligible for Eli Lilly’s Inluriyo. The...