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Latest From AbbVie Inc.

Aduhelm’s ‘Complex’ Circumstances Drove Extensive In-House Advice Process Before Accelerated Approval, Cavazzoni Says

Accelerated approval was considered as option in response to the negative advisory committee vote, but it was not a ‘default,’ CDER officials say. ‘It fit like a glove.’

Approvals Review Pathway

Pharma’s 340B Dispute Resolution Arguments May Get Boost From Supreme Court’s Patent Ruling

As stakeholders begin to mull the impact of the Arthrex opinion, HHS withdraws its advisory opinion concluding manufacturers are legally bound to provide 340B discounts to contract pharmacies, and Lilly takes aim at 340b contract pharmacy ‘replenishment’ model.

Legal Issues Pricing Debate

Intellia, Cellex Team Up On New CAR-T Firm, Backed By Blackstone

Blackstone is providing $250m to combine Intellia’s gene editing and Cellex’s cell manufacturing capabilities in a new CAR-T company using Cellex subsidiary GEMoaB’s technology and pipeline as a foundation.

Financing Regenerative Medicine

UniQure Needs Longer-Term Data For Hemophilia B Gene Therapy EtranaDez

The FDA may want longer follow-up data for companies developing treatments for hemophilia A as well as hemophilia B.

Gene Therapy Blood & Coagulation Disorders
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Company Information

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  • Pharmaceuticals
  • Other Names / Subsidiaries
    • Mavupharma
    • Pharmacyclics, Inc.
    • Stemcentrx, Inc.
    • Luminera
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