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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...
FDA clears Cytokinetics pill Myqorzo — oHCM gains new oral option
The FDA granted marketing clearance to Cytokinetics’ aficamten, branded Myqorzo, for adults with symptomatic obstructive hypertrophic cardiomyopathy (oHCM). The approval, announced Dec. 19 and...
AstraZeneca lands Jacobio's pan‑KRAS in $1.9B pact
AstraZeneca agreed to outlicense ex‑China rights to Jacobio Pharmaceuticals’ clinical‑stage pan‑KRAS inhibitor JAB‑23E73 in a deal worth up to $1.915 billion. Jacobio retains China rights and will...
Ipsen buys Simcere ADC rights — LRRC15 program expands outside China
Ipsen secured global ex‑China rights to Simcere Zaiming’s LRRC15‑targeting antibody‑drug conjugate SIM‑0613, with potential payments up to roughly $1.06 billion. The agreement covers clinical...
CMS proposes two Medicare drug‑pricing demos — mandatory models on the table
The Centers for Medicare & Medicaid Services proposed two mandatory demonstration models intended to lower Medicare drug prices by aligning U.S. payments with international benchmarks and...
Boehringer signs US pact with White House — $10B investment, TrumpRx participation
Boehringer Ingelheim agreed to invest $10 billion in U.S. operations through 2028 and to participate in the TrumpRx.gov direct‑purchase platform under a White House memorandum aimed at lowering...
Aktis files for IPO to fund radiopharma pipeline — big‑pharma backers watch
Aktis Oncology filed for an initial public offering to raise capital for clinical development of its miniprotein radioconjugates, including a Nectin‑4‑targeted lead program in phase 1b. The...
Gilead licenses two HSV candidates from Assembly — $35M upfront grab
Gilead Sciences exercised licensing rights to two helicase‑primase inhibitors for recurrent genital herpes from Assembly Biosciences, paying $35 million up front. Both ABI‑1179 and ABI‑5366 are in...
Guardant360 CDx wins Japanese approval as companion diagnostic for Lilly drug
Japan’s regulatory authorities approved Guardant Health’s Guardant360 CDx as a companion diagnostic to detect ESR1 mutations and guide eligibility for Eli Lilly’s Inluriyo in breast cancer...
MRD testing achieves pivotal readouts and consolidation — Signatera proves clinical value
The minimal residual disease (MRD) testing market registered high‑impact trial readouts and commercial consolidation in 2025, anchored by positive Phase III IMvigor011 results using Natera’s...
CRO M&A cools — 2025 deals skew smaller, strategic
Contract research organization M&A activity decelerated in 2025, with transactions focused on geographic expansion and technology capabilities rather than blockbuster consolidations. Thermo...