Tumultuous Development of Venetoclax in t(11;14) Multiple Myeloma

Kaiser MF, Cliff ERS - Journal of Clinical Oncology

  • Innovation Incentives and Competition

Summary:

Venetoclax (Venclexta) demonstrated early, biologically coherent activity in t(11;14) myeloma, but an all‑comer phase 3 strategy produced safety concerns and regulatory freezes that ultimately blocked access even for likely responders. Drug development and regulatory pathways must better accommodate strong biological signals in small subgroups to avoid repeating failures that strand effective therapies.

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Recent Work from PORTAL

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The Impact of Semantics in Medicines Regulation

Costa E, Kesselheim AS - Journal of Law, Medicine, & Ethics

  • Innovation Incentives and Competition
  • Regulation and Clinical Evidence
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Delisted Patents on Pharmaceuticals, 1998-2024

Kirby-Rivera L, Feldman WB, Kim M, Kosmopoulou G, Kesselheim AS, Tu SS - Journal of Law, Medicine, & Ethics

  • Innovation Incentives and Competition
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Delays in Access to Generic Semaglutide Point to Key Missing Pieces in Canada’s Drug Approval System

Eisenkraft Klein D, Kesselheim AS - Health Policy

  • Innovation Incentives and Competition
  • Regulation and Clinical Evidence
Canada approved its first generic semaglutide nearly four months after market exclusivity expired, with delays arising from the absence of clear standards for demonstrating equivalence between fully synthetic generics and the brand-name product. Regulators should publish equivalence standards so manufacturers can build the required evidence into their initial submissions, helping lower-cost alternatives reach patients sooner.
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