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China remakes clinical trials: faster INDs open CRO, sponsor opportunities
Regulatory reforms in China have dramatically sped timelines for clinical trial approvals, shifting the country from one of the slowest to one of the fastest markets for IND review. U.S. analysts...
GSK buys Rapt — $2.2B for long‑acting anti‑IgE
GSK agreed to acquire Rapt Therapeutics for $2.2 billion, taking control of ozureprubart, a mid‑phase anti‑IgE monoclonal antibody designed to prevent food‑allergy reactions. The deal gives GSK...
Merck, Moderna: personalized melanoma vaccine holds at five years
Long‑term data show that adding Merck’s Keytruda to Moderna’s personalized neoantigen cancer vaccine sustained a roughly 49% reduction in risk of recurrence or death at five years, the companies...
CMS clears payment for Illumina test: $2,989 per genomic profile
The Centers for Medicare & Medicaid Services granted reimbursement for Illumina’s TruSight Oncology Comprehensive assay at $2,989 per test, effective Jan. 1, 2026, Illumina announced. The decision...
Congress writes Medicare path for MCED tests into spending bill
Legislative language in the federal appropriations package would create a streamlined Medicare coverage pathway for multi‑cancer early detection (MCED) tests following FDA approval, according to...
Beam may use biomarkers for accelerated approval — FDA nod opens path
Beam Therapeutics and the FDA agreed that biomarker changes assessed over one year could support an accelerated approval pathway for Beam’s BEAM‑302 base‑editing candidate for alpha‑1 antitrypsin...
Boundless wins IND for oral kinesin degrader — KOMODO‑1 to start H1
Boundless Bio announced FDA clearance of an investigational new drug (IND) for BBI‑940, an oral kinesin degrader, enabling a first‑in‑human trial (KOMODO‑1) in metastatic breast cancer slated to...
Insilico splits NLRP3 rights — $66M deal sparks China tie‑ups
Insilico Medicine agreed to a transaction that will split global rights for a brain‑penetrant NLRP3 inhibitor, generating roughly $66 million in total deal value and an upfront payment in the...
Qiagen draws buyout interest — shares jump on sale chatter
Qiagen’s stock jumped as much as 20% after Bloomberg reported the company is exploring a potential sale and is in talks with advisers and suitors. Market commentary named Danaher and Agilent among...
Guardant and Merck partner on companion diagnostics — liquid biopsy tie‑up
Guardant Health and Merck struck a multi‑year collaboration to use Guardant’s portfolio of liquid and tissue biopsy tests to support patient enrollment in Merck’s global clinical studies. The deal...
Novo exits cell therapy bets — Aspect acquires diabetes assets
Novo Nordisk transferred rights to its stem‑cell derived islet and hypoimmune cell engineering technologies to Aspect Biosystems as part of a deal that lets Aspect develop the diabetes...
GSK snaps up Rapt for food-allergy antibody — $2.2B deal
GSK agreed to acquire Rapt Therapeutics for $2.2 billion to gain ozureprubart, a mid‑phase anti‑IgE antibody intended to prevent food-allergy reactions. The British drugmaker will pay $58 per...
Merck‑Moderna vaccine benefit endures — 5‑year melanoma data
Five‑year follow‑up shows the investigational Merck and Moderna therapeutic cancer vaccine maintained a 49% reduction in risk of recurrence or death when added to Merck’s anti‑PD‑1 therapy,...
FDA flexibility helps Beam push base editor toward accelerated path
Beam Therapeutics gained agency agreement to use a biomarker‑based endpoint evaluated over one year to support an accelerated approval filing for BEAM‑302 in alpha‑1 antitrypsin deficiency (AATD)....
Illumina wins CMS reimbursement — broadens access to CGP
The Centers for Medicare & Medicaid Services granted reimbursement for Illumina’s TruSight Oncology Comprehensive assay at $2,989.55 per test under PLA code 0543U, effective Jan. 1, 2026. The CMS...
Congress advances Medicare pathway for multi‑cancer early detection
Language in the federal appropriations bill would allow Medicare coverage of FDA‑approved multi‑cancer early detection (MCED) tests without waiting for U.S. Preventive Services Task Force...
Insilico splits rights on brain‑penetrant NLRP3 inhibitor — $66M accord
Insilico Medicine agreed to a deal that splits rights for a preclinical, brain‑penetrant NLRP3 inhibitor, securing a $10 million upfront from a newly formed Chinese biotech and setting up a...
Guardant and Merck partner on liquid and tissue companion diagnostics
Guardant Health and Merck launched a multi‑year collaboration to use Guardant’s liquid and tissue biopsy assays to support patient enrollment across Merck’s global clinical trials. The deal ties...
Exciva raises €51M to fund Alzheimer’s agitation pivotal program
Exciva GmbH closed a €51 million (US$59.9 million) Series B to finance a Phase II/III trial of Deraphan, a combination therapy for agitation in Alzheimer’s disease. The Heidelberg‑based...
Astellas relaunches XLMTM gene therapy with MyoAAV capsid program
Astellas Gene Therapies licensed KT430 (ASP2957), a MyoAAV capsid‑based gene therapy developed by Kate Therapeutics/Novartis, to re‑enter X‑linked myotubular myopathy (XLMTM) development with a...