United States: Food, Drugs, Healthcare, Life Sciences

When a major animal health company refuses to modify advertising claims deemed misleading by industry self-regulators, what happens next? This case explores the rare escalation...

The U.S. Food and Drug Administration faces a leadership transition as Commissioner Marty Makary steps down amid tensions with the White House, with Deputy Commissioner Kyle Diamantas assuming control in an acting capacity. Will this change in leadership accelerate the agency's food safety reform efforts and chemical assessment initiatives?

The New World screwworm (NWS), Cochliomyia hominivorax, is a parasitic fly whose larvae burrow into the flesh of warm-blooded animals, feeding on healthy tissue and causing myiasis that is often fatal if left untreated. NWS can infest livestock, pets, wildlife and, in rare cases, people. Although long eradicated from the United States, NWS has moved northward through Central America and Mexico in recent years, prompting a sweeping multiagency federal response.

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.

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.

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.

When a major animal health company refuses to modify advertising claims deemed misleading by industry self-regulators, what happens next? This case explores the rare escalation...

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.

The Civil Division of the US Department of Justice (DOJ) recently issued a memorandum outlining unprecedented reforms aimed at accelerating the review and pursuit of certain qui tam complaints filed under the False Claims Act (FCA). Among other things, DOJ has announced that it will complete its review of new “benefits fraud” complaints — those alleging fraud against “federally funded, state-administered benefits programs” — within 120 days.