Citing difficulties in conducting randomized trials, industry speakers call for a new way of thinking about the US FDA's substantial evidence standard for antifungal approvals under the LPAD route, as well as revisions to enrollment criteria and study endpoints.

The US election will intensify  the spotlight on drug costs, regulators will have their hands full with advanced therapy filings, and the need to address rising infectious disease threats will mount. Biosimilars, cannabis and Brexit are among other hot topics for 2020.

Executives and analysts predict trends spanning M&A, leadership diversity, curative gene therapy commercialization, biosimilars strategy and more. Expect technology innovation to continue to drive investment and deal making in biopharma.

Bristol-Myers Squibb will partner with the biotech accelerator to fund and launch biotechs, with the pharma getting an option to buy. Novartis signs another agreement with IFM months after buying its IFM Tre affiliate.