Torrey Cope

Feb 27, 2024 | lexology.com | Sharon Flanagan |Stephen Abreu |Robert Darwin |Carlton Fleming |Frank Rahmani |Meenakshi Datta | +3 more

Our lawyers share the top investment and regulatory trends from last month’s agenda-setting JP Morgan Health Care Conference. We expect an abundance of novel financing structures, investment focus on new disease states, and important new U.S. Food and Drug Administration (FDA) guidance. Regulatory developments in the U.S.: The FDA has issued several new policy documents on issues such as clinical trial design and conduct, affirming the agency’s high bar for approvals.

Nov 8, 2023 | datamatters.sidley.com | Meenakshi Datta |Elizabeth Hardcastle |Deeona Gaskin |Torrey Cope

The Biden administration’s executive order issued on October 30, 2023, includes a number of initiatives relating to the development and use of artificial intelligence (AI), including in healthcare.

Nov 7, 2023 | lexology.com | Meenakshi Datta |Elizabeth Hardcastle |Deeona Gaskin |Torrey Cope |Sama Kahook

The Biden administration’s executive order issued on October 30, 2023, includes a number of initiatives relating to the development and use of artificial intelligence (AI), including in healthcare.

Mar 15, 2023 | lexology.com | Torrey Cope

In the first of a series on surviving the current financial and regulatory environment, Torrey Cope looks at how life sciences companies can reduce difficulties in getting new products approved by the U.S. Food and Drug Administration through effective written submissions. Life sciences companies currently face numerous challenges when seeking approval for new drugs and biological products.

Feb 23, 2023 | lexology.com | Elizabeth Hardcastle |Meenakshi Datta |Stephanie P. Hales |Donielle McCutcheon |William A. Sarraille |Catherine Y. Starks | +2 more

On February 14, the U.S. Department of Health and Human Services (HHS)  that the HHS Secretary had selected three new payment and service delivery models for testing by the Center for Medicare & Medicaid Innovation (CMS Innovation Center). HHS has directed the CMS Innovation Center to test whether these new models result in lower prescription drug costs, promote accessibility to therapies, and/or improve quality of care.