A small number of start-ups are developing novel specilalty-focused diagnostics that capture drug-like revenues and margins without taking drug-like development and regulatory risks. Questions about the business model abound, since most companies need multiple tests to reach profitability and a changing regulatory climate may force these companies to seek FDA approval for their tests, dramatically increasing development risk and cost.
By Ellen Foster Licking and Roger Longman
Diagnostics have had an image problem for decades. That's why, when Ken Conway started up a new diagnostics effort at...
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Leading a field of rival potassium channel modulators, azetukalner will have a pivotal epilepsy readout early next year, with Phase III trials in depression and biopolar disorder also underway.
The Swiss drugmaker’s BAFF-R inhibitor and ADCC-mediated B-cell depletor candidate has chalked up another win in late-stage development, further strengthening its pipeline-in-a-product bid.
The drug, combined with Merck’s Keytruda, was successful among certain chemotherapy-ineligible MIBC patients, with another Phase III readout expected by March 2026.
The company plans to meet with the US FDA prior to submitting a BLA before the end of 2025 for its cancer vaccine as a first-line advanced melanoma treatment in combination with Keytruda.
