Throughout August 2023, the Office of Information and Regulatory Affairs, Office of Management and Budget, Executive Office of the President (“OIRA”) has held stakeholder meetings regarding a proposed rule which, if enacted, would amend the U.S. Food and Drug Administration’s (“FDA’s”) regulations to make explicit that laboratory developed tests (“LDTs”)…
The Inflation Reduction Act’s Medicare Drug Price Negotiation Program has now officially kicked off. Earlier today (August 29, 2023), the White House announced the list of the first 10 selected drugs under the program, prior to the statutory deadline of September 1. The first 10 drugs selected are as follows:…
Goodwin’s Intellectual Property team regularly works on the most important deals in the life sciences and biotech sector. Our close relationship with clients ensures that the best intellectual property strategies are in place to foster company and product growth and minimize risk. We take pride in structuring, negotiating, and executing…
The second quarter saw significant enforcement and dealmaking in the life sciences space. The Federal Trade Commission (FTC) announced its attempt to block Amgen/Horizon, the first such challenge to a life science transaction since 2009, and issued a second request in Pfizer’s proposed $43 billion acquisition of Seagen. In contrast,…
