Sidley Global Life Sciences

Sidley’s Robert Darwin, a London-based M&A and Private Equity partner, was recently a guest on the BioCentury Show. He discussed the implications of new UK and U.S. administrations, the positive outlook for M&A and private equity in biotech, and the impact of recent policy changes and market trends on the industry as we approach 2025. Listen to or watch the full podcast here. #privatequity #biotech #lifesciences #healthcare

A recent SEC enforcement action against Cassava Sciences over misleading statements made to the FDA about clinical trial (CT) results highlights the importance of life sciences companies exercising care in how they disclose FDA-related information to investors. Lara Shalov Mehraban explains. Read more on "SEC Interest in FDA-Related Disclosures by Life Sciences Companies Highlighted."

On November 1, the Centers for Medicare & Medicaid Services (CMS) issued two Final Rules — the 2025 Physician Fee Schedule Final Rule and the CY 2025 Hospital Outpatient Prospective Payment System Final Rule — that include a number of revisions to payment policies that may significantly impact various stakeholders, including pharmaceutical manufacturers and telehealth providers. Read our insights here, https://bit.ly/4fBxTBv.

The Centers for Medicare & Medicaid Services (CMS) released the final rule for the 2025 Medicare Physician Fee Schedule — which sets forth the regulatory requirements of the Medicare Prescription Drug Inflation Rebate Program and discusses key implementation issues. Read here for our insights on key new program policies, https://bit.ly/4erwkoU. #InflationReductionAct

Sidley represented BigHat Biosciences in a licensing collaboration with Synaffix BV, a Lonza company. The collaboration with Synaffix/Lonza is instrumental to advancing BigHat’s next-gen antibody drug conjugate program, which is at IND-enabling stage and is on track to be BigHat’s first clinical-stage program. The Sidley team was led by partners Alison Lehner and Asher Rubin, and included Robert Darwin and Collin Marshall. Read more here, https://bit.ly/48K5jLZ.

A growing number of healthcare entities, including pharmaceutical manufacturers, are evaluating the use of telemedicine platforms to increase access to healthcare. However, recent congressional inquiries and warnings from the HHS Office of Inspector General highlight the potential risks associated with these models under the federal Anti-Kickback Statute and state prescribing laws. Read our insights below.

As the life sciences sector grapples with complex challenges around sustainability and Environmental and Social Governance (ESG) compliance, Generative AI (GenAI) is emerging as a potentially powerful tool for enhancing efficiency and sustainability. Michele Tagliaferri, Eva von Mühlenen, LL.M., and Anna Melin explain. Read more on "Risks and Benefits of Generative AI for Pharma Supply Chain Management."

Sidley is representing Nektar Therapeutics in the US$90 million sale of its manufacturing facility and reagent supply business to Ampersand Capital Partners. The Sidley team is being led by Daniel Belke, Tommy Tsao, Joshua Hofheimer, and Lauren Grau. Read more here, https://bit.ly/3YS68ik.

Thank you to all who joined Sidley’s Joshua Hofheimer and Chen Yang in Shanghai for the 11th annual BioCentury-BayHelix China Healthcare Summit. Josh shared his insights as a panelist for BioCentury Inc.'s China Summit "Scene Setter" panel and Chen shared her insights as panelist on “How to Harness U.S. and China Policies to Accelerate Product Development.”

Thank you to everyone who joined us in Basel, Switzerland for our recent Women’s Life Sciences Network event, “Combination Therapies – EU Regulatory and Competition Law Headwinds and Strategies.” In a panel discussion featuring insights from Swissmedic’s Dr. Sandra Zaugg Kunz, Takeda’s Elisabeth Leimbacher, and Novartis’ Celine Fang, our guests discussed key considerations related to authority expectations as well as challenges, and potential strategies for EU regulatory and competition law compliance for combination therapies.