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Sanofi to buy Dynavax for $2.2B — Heplisav‑B and shingles candidate added
Sanofi agreed to acquire Dynavax Technologies for about $2.2 billion in cash, adding the commercial hepatitis B vaccine Heplisav‑B and a Phase I/II shingles candidate to its vaccine lineup. The...
FDA clears Omeros’ Yartemlea: first therapy for TA‑TMA
The U.S. Food and Drug Administration approved Omeros Corp.’s Yartemlea (narsoplimab), marking the first approved treatment for hematopoietic stem cell transplant‑associated thrombotic...
Medicare to test GLP‑1 coverage — voluntary model could expand access
CMS announced a voluntary test model designed to allow Medicare Part D plans and state Medicaid programs to cover GLP‑1 drugs prescribed for weight management, a threshold event for U.S. obesity...
J&J scraps eczema candidate from $1.25B buy — efficacy shortfall
Johnson & Johnson announced it is discontinuing development of the experimental eczema drug JNJ‑5939 (NM26), an asset it acquired for $1.25 billion in 2024, after the candidate failed to meet...
Biohaven’s potassium‑channel program fails Phase 2 in major depressive disorder
Biohaven reported that its potassium ion‑channel inhibitor missed primary endpoints in a Phase 2 trial in major depressive disorder, representing a second mid‑stage setback for the program. The...
Engineered vesicles boost oral antibiotic uptake — reduce gut dysbiosis
Researchers published in Nature Communications that engineered vesicles can enhance oral antibiotic absorption while protecting the gut microbiome from dysbiosis. The study describes vesicle...
Gene‑therapy commercial pullback — costs, uptake and regulatory friction bite
Analysts and industry observers report a marked commercial slowdown for gene therapies as pricing levels in the millions and lower-than-expected patient uptake squeeze market prospects. Firms are...
SpatialBench benchmark: agents tested on 146 realistic spatial biology tasks
SpatialBench introduced a suite of 146 verifiable problems drawn from real spatial biology workflows to evaluate AI agents on tasks ranging from QC to spatial analysis across platforms including...
Biopharma fundraising snapshot — year‑to‑date totals through Dec. 24, 2025
A year‑end compilation reports total money raised by biopharma companies (public, private and other financings) through Dec. 24, 2025, providing a consolidated view of capital flows for the...
Hanx Bio IPO tumbles 46% on HK debut despite $75M raise
Hanx Biopharmaceuticals raised HK$586 million (about US$75 million) in its Hong Kong IPO but saw its stock plunge roughly 46% on debut, signaling weak investor reception for some clinical‑stage...
Sanofi pays $2.2B for Dynavax – bolsters vaccine pipeline
Sanofi agreed to acquire Dynavax Technologies for approximately $2.2 billion in cash, consolidating a commercial hepatitis B vaccine and a clinical-stage shingles candidate under Sanofi’s vaccines...
FDA approves Yartemlea: first treatment for TA‑TMA
The U.S. Food and Drug Administration approved Omeros Corporation’s Yartemlea (narsoplimab) as the first therapy for hematopoietic stem cell transplant‑associated thrombotic microangiopathy...
Medicare to test GLP‑1 coverage – payer access inflection
CMS announced a voluntary model to test coverage pathways that would enable Medicare Part D plans and state Medicaid programs to cover GLP‑1 drugs prescribed for weight management. The pilot...
HHS proposes rollback of health‑tech rules – AI transparency pared back
HHS published a proposed rule that would roll back several Biden‑era policies, eliminate many health‑tech certification criteria and remove planned transparency requirements for healthcare AI...
Court overturns FDA LDT rule – labs win major regulatory reprieve
A federal court struck down the FDA’s final rule to regulate lab‑developed tests (LDTs), handing a significant regulatory victory to laboratories and diagnostic trade groups. The decision halted...
Engineered vesicles boost oral antibiotics... protect gut microbiome
Researchers published a Nature Communications study describing engineered vesicles that enhance oral antibiotic absorption while reducing gut dysbiosis. The vesicles act as protective carriers...
Gene therapy market cools – costs and regulation bite
Industry analysis shows commercial headwinds for gene therapy: runaway costs, limited patient uptake and regulatory challenges have damped the field’s commercial momentum. Companies report pricing...
Germline DNA‑repair defects tied to early GI cancers – screening signal
A multi‑center genetics study identified germline DNA repair deficiencies as a driver of early‑onset gastrointestinal cancers, linking inherited repair pathway defects to earlier presentation and...
FDA clears Crescom’s MediAI‑BA: AI pediatric bone‑age tool
Crescom Co. Ltd. received U.S. FDA 510(k) clearance for MediAI‑BA, an AI‑powered pediatric and adolescent bone age analysis software. The class II device evaluates hand/wrist X‑rays to estimate...
Biopharma fundraising: year‑end totals and multi‑year flows
Market trackers released year‑to‑date and historical tallies of capital raised by biopharma through Dec. 24, 2025, providing a snapshot of venture, public and other financings across the sector....