FDA Opens the Door to Broader Use of Real-World Evidence in Regulatory Reviews
Summary:
The FDA has removed a major barrier to using real-world evidence (RWE) by allowing certain drug and medical device applications to rely on de-identified, aggregate data rather than always requiring individual patient-level information. This policy shift enables regulators to leverage large real-world datasets – such as registries, claims data, and electronic health records – to accelerate reviews and better reflect how treatments perform in real-world settings.
J&J-Backed Link Cell Therapies Debuts With $60M to Advance Precision CAR-T Treatments
Summary:
Link Cell Therapies has launched with a $60 million Series A led by Johnson & Johnson’s venture arm to develop next-generation CAR-T therapies that precisely target tumors while sparing healthy tissue. Built on Stanford-derived logic-gating technology, the platform enables CAR-T cells to activate only when multiple tumor antigens are present, with a lead renal cell carcinoma program entering Phase 1 next year and additional solid and liquid cancer programs in the pipeline.
FDA Clears Enhertu Combination as Frontline Therapy for HER2-Positive Metastatic Breast Cancer
Summary:
The FDA has approved AstraZeneca and Daiichi Sankyo’s Enhertu in combination with Roche’s Perjeta as an initial treatment for HER2-positive metastatic breast cancer, based on Phase 3 data showing a 44% reduction in the risk of disease progression or death compared with the long-standing THP regimen. The decision moves the multibillion-dollar antibody-drug conjugate into first-line use, with strong efficacy gains and a safety profile consistent with existing warnings, potentially reshaping standard care for about 10,000 U.S. patients each year.
Xoma to Acquire Generation Bio in Latest ‘Zombie’ Biotech Takeover
Summary:
Xoma Royalty has agreed to acquire struggling gene therapy developer Generation Bio for about $4.29 per share, plus contingent value rights tied to cash on hand, cost savings, future milestones, and potential asset sales. The deal marks another example of Xoma’s strategy of buying underperforming biotechs – like Generation, whose lipid nanoparticle gene delivery platform faces a long path to the clinic – to return remaining value to shareholders.
Sanofi Strikes $1B+ Alzheimer’s Deal With Korea’s ADEL to Advance Selective Tau Antibody
Summary:
Sanofi has agreed to a potential $1.04 billion partnership with South Korea – based ADEL to develop ADEL-Y01, a next-generation monoclonal antibody that selectively targets toxic tau proteins implicated in Alzheimer’s disease while preserving healthy tau function. The deal, which includes $80 million upfront and milestone-based payments plus royalties, underscores Sanofi’s accelerating push into neuroscience and disease-modifying Alzheimer’s therapies.
