United States: Life Sciences, Biotechnology & Nanotechnology

Prior authorization has become one of the most frustrating parts of pharmacy operations. It delays care, burdens prescribers, confuses patients, and places pharmacies in the middle of disputes they often did not create.

Artificial intelligence has evolved from experimental technology to an embedded operational reality across the life sciences value chain, with the global AI market projected to reach $69 billion by 2031.

On June 10, 2026, Organon announced that the U.S. Food and Drug Administration (FDA) approved a supplemental biologics license application (sBLA) for TOFIDENCE ® (tocilizumab-bavi)...

On June 3, 2026, the U.S. Food and Drug Administration issued a new draft guidance titled Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities — Questions and Answers (the 2026 Draft Payor Guidance).

The US Department of Defense has significantly expanded its Section 1260H List of Chinese Military Companies, adding 65 entities spanning technology, electric vehicles, biotechnology, and manufacturing sectors.

The Trump administration has decertified and defunded Hawaii’s Medicaid Fraud Control Unit (MFCU), withholding $3 million in federal funds. As detailed in a previous post, in May, the Office of Inspector General for the Department of Health and Human Services (HHS-OIG) informed every state of its intent to review the activities of its MFCU.

Following some questions we posed about the efficacy and legality of the Commissioner’s National Priority Voucher (“CNPV”) Program (the “CNPV Program” or “the Program”) in our 2026 Top of Mind Publication, it is again time to ponder the Program’s future, now that its purported champion, former U.S. Food & Drug Administration (“FDA” or the “Agency”) Commissioner, Marty Makary, M.D. (“Dr. Makary”) is out of office. When Dr. Makary resigned earlier this month, he left behind an agency in transition, replete with a portfolio of ambitious reform initiatives that now face an uncertain future.

This webinar explores the complex landscape of patent applications for microorganisms and specific strains, examining when biological deposits are necessary and how they impact patent strategy. Attendees will learn practical approaches to drafting applications that support both deposited strain claims and broader microorganism claims, while understanding the scope of protection and potential infringement scenarios.

AlixPartners' survey of 200 healthcare and life sciences executives reveals a critical disconnect between operator and investor expectations amid mounting industry pressures. With regulatory uncertainty, workforce challenges, and eroding pricing power threatening profitability, the research examines whether AI and operational fixes can address the structural distress looming across healthcare, biotech, and pharma sectors.