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ORIC pill: Effective in some NSCLC settings, abandoned for HER2 mutations
ORIC Pharmaceuticals reported mixed clinical signals for its oral targeted therapy in lung cancer: the agent showed encouraging activity in certain first- and second-line settings for patients...
Hengrui, BeOne top China's pharma innovation index – IDEA/SAI report
IDEA Pharma and SAI MedPartners published a new China Pharmaceutical Innovation and Invention Index ranking the top 50 Chinese companies; Hengrui and BeOne led the list for invention and...
Gilead/Arcellx: next‑gen myeloma CAR‑T posts high remission rates
Gilead Sciences and partner Arcellx reported pivotal‑stage results at ASH showing deep, durable responses for their anti‑BCMA CAR‑T in multiple myeloma. Among 117 evaluable patients the companies...
MRD: biomarker edges closer to surrogate endpoint for AML
Researchers presented pooled, prospective data at ASH suggesting minimal residual disease (MRD) negativity predicts longer overall survival in acute myeloid leukemia and may serve as a surrogate...
exa‑cel in kids: gene therapy data suggest earlier treatment window
Presentations previewed at ASH indicate exagamglogene autotemcel (exa‑cel, Casgevy) could benefit children aged 5–11 with transfusion‑dependent beta‑thalassemia or sickle cell disease. Vertex and...
Breyanzi expands label: first CAR‑T cleared for marginal‑zone lymphoma
Bristol Myers Squibb secured FDA approval to expand Breyanzi’s indication to include third‑line marginal zone lymphoma, making it the first CAR‑T therapy cleared for this rare, indolent...
Freenome SPAC: liquid‑biopsy firm to access public markets with $330M deal
Freenome agreed to go public via a $330 million SPAC merger as it prepares potential commercialization of its colorectal multi‑cancer screening test. The transaction includes a roughly $240...
ACIP flips birth‑dose hepatitis B guidance — panel debate intensifies
A CDC advisory panel voted to drop the long‑standing recommendation for a universal hepatitis B vaccine dose at birth, a move that departs from decades of federal guidance. The decision followed...
Regeneron’s odronextamab: approval path hit by fresh regulatory, manufacturing snags
Regeneron reported renewed regulatory and manufacturing challenges for odronextamab, its anti‑CD20×CD3 bispecific for lymphoma, complicating the company’s efforts to secure U.S. approval. The...
Ginkgo wins $47M DOE contract to automate high‑throughput phenotyping
Ginkgo Bioworks secured a four‑year, $47 million contract to design and integrate an automated phenotyping platform for the Pacific Northwest National Laboratory. The build will automate...
Syntax Bio: CRISPR ‘Cellgorithm’ cuts stem‑cell timelines from months to weeks
Syntax Bio published research in Science Advances describing a CRISPR‑based ‘Cellgorithm’ platform that programs gene activity to accelerate and standardize human stem‑cell differentiation. The...
Financings and M&A: funding normalizes while $1B‑plus takeouts climb
Biopharma financing softened from October but remained above post‑pandemic troughs, with November collecting $9.94 billion across 96 transactions as markets normalized. At the same time,...
ACIP scraps universal hepatitis B birth dose: parents urged to consult clinicians
The Advisory Committee on Immunization Practices (ACIP) voted to remove the longstanding CDC recommendation that all newborns receive the hepatitis B vaccine immediately after birth. The panel...
MRD edges toward regulator acceptance — Natera snaps up Foresight
Researchers presented pooled data at ASH showing minimal residual disease (MRD) negativity correlates with longer overall survival in acute myeloid leukemia (AML), strengthening the case for MRD...
Vertex’s exa‑cel hits pediatric marks — gene therapies push younger
Vertex reported early pediatric results for its CRISPR-based sickle cell therapy Casgevy (exa‑cel) that met key objectives in children, accelerating plans to expand labeling and access. The data...
Praxis trial halted early for efficacy — stock rallies
Praxis Precision Medicines’ registrational trial of relutrigine in developmental and epileptic encephalopathies (DEEs) was stopped early for efficacy after a phase II readout, triggering a sharp...
AstraZeneca’s dual‑target CAR‑T replicates China data in West
AstraZeneca presented first Western patient data for its dual‑targeting CAR‑T therapy at ASH showing response rates comparable to earlier China-only studies. The preliminary dataset suggests...
Bristol Myers’ Breyanzi cleared for marginal zone lymphoma — first CAR‑T in MZL
The FDA expanded Bristol Myers Squibb’s CAR‑T therapy Breyanzi to include third‑line marginal zone lymphoma, making it the first CAR‑T approved for this slow‑growing non‑Hodgkin lymphoma subtype....
Regeneron’s odronextamab hits new snag — approval roller coaster continues
Regeneron signaled fresh regulatory and manufacturing challenges for its lymphoma bispecific antibody odronextamab after a string of prior hurdles. The company said ongoing issues complicate its...
Freenome to go public via $330M SPAC: prepares for 2026 launch
Freenome agreed to merge with Perceptive Capital Solutions Corp. in a $330 million SPAC transaction backed by a $240 million PIPE from investors including Perceptive Advisors and RA Capital. The...