USA Trends and Developments Contributed by: David McIntosh, Matt Byron, Ryan Kramer, Sabrina Kim and Zoe Dettelbach, Ropes & Gray LLP
2024 as to whether these companies would be able to meet the high demand for their drugs, particularly if the United States Food and Drug Administration chooses to restrict mass com- pounding. Due to manufacturing and supply constraints, Novo Nordisk and Eli Lilly faced challenges meeting the overwhelming demand for GLP-1 drugs during commercial roll-out. FiercePharma reports that contract development and manu- facturing organisations have been crucial for meeting near-term demand by providing imme- diate production solutions (particularly for the final fill-and-finish step of the manufacturing process), while both companies invest in build- ing out their production lines for the long term, including Novo Holdings’ acquisition of Catalent in late 2024. This high demand is not expected to wane in 2025; 36% of respondents to a Jeffer- ies’ poll said that obesity-related drugs will have the biggest impact in biotech and pharma this year. Although the commercial success of this class of drugs is expected to continue in 2025, one thing to keep an eye on is the selection of Ozempic and Wegovy for Inflation Reduction Act (IRA) Medicare price negotiations in 2027, along with 13 additional drugs. This announcement triggered a fall in Novo Nordisk’s share price, but the future of the IRA under the new Trump Two Trump nominees have signalled a new and biotech-friendly era for antitrust under the sec- ond Trump administration. Trump has chosen Andrew Ferguson to take the place of Lina Khan as chair of the Federal Trade Commission (FTC) and Ferguson’s leadership is likely to result in a lighter antitrust enforcement environment than during Khan’s term, according to a Stifel report. administration remains to be seen. Effects of new Trump administration Antitrust and the FTC
President Trump has also chosen Gail Slater to head up the Department of Justice’s antitrust division, which The New York Times notes may mark a poten- tial redirection away from the Biden administra- tion’s vigorous enforcement of antitrust laws that has resulted in significant merger blockages. According to BioPharma Dive, commentators in the industry expect these leadership changes to be good signs for increased biotech M&A activ- ity. HHS, tax cuts and the Biosecure Act Significant uncertainty remains as to how the dif- ferent personalities in the Trump administration will affect health and drug policy, and how that will reverberate through the life sciences indus- try. On one side of the coin, President Trump has chosen prominent tech CEO Elon Musk (an advocate of high innovation and low regulation) to lead the new Department of Government Effi- ciency (DOGE). Musk’s leadership could trend towards decreased oversight. On the other side of the coin, President Trump has picked Robert F Kennedy Jr to head up the United States Depart- ment of Health and Human Services (HHS). Endpoints News highlights the stark distinc- tion between DOGE’s objectives and Kennedy’s perspective on biotech and pharma. Kennedy is well-known for anti-vaccine views and has a skeptical view of the biotech and pharma indus- try, viewing it as under-regulated and corrupt. According to a Stifel report, upon the announce- ment of his nomination, the XBI dropped from 104 to less than 92 – reflecting widespread con- cern in the biotech sector that Kennedy’s term will negatively impact public health infrastructure and policy. Further, shares in vaccine produc- ers such as Pfizer, Moderna, BioNTech, and Novavax also declined after the announcement of Kennedy’s appointment.
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