Eli Lilly's Alzheimer’s drug, avian flu funding, and more

Congress heads back to work, and we catch up on news including the FDA’s approval of Eli Lilly’s Alzheimer’s drug and what happened at the U.S.-Mexico-Canada Agreement dispute panel on Mexico’s biotech corn ban. (618 words, 3 minutes, 5 seconds)

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Catch up: Lilly’s Alzheimer’s drug, Moderna’s avian flu R&D, calls for PPRV reauthorization

The July 4 holiday didn’t stop biotech innovation and advocacy—here are a few things you might have missed.

New Alzheimer’s drug: The U.S. Food and Drug Administration (FDA) approved Eli Lilly’s Kisunla (donanemab), which helps patients in the early stages of Alzheimer’s by reducing amyloid brain plaque. The July 2 approval followed an advisory panel’s recommendation in June.

What they’re saying: “Kisunla is the first and only amyloid plaque-targeting therapy with evidence to support stopping therapy when amyloid plaques are removed, which can result in lower treatment costs and fewer infusions,” said Eli Lilly.

New avian flu funding: The U.S. Biomedical Advanced Research and Development Authority (BARDA) is providing $176M to Moderna to develop an mRNA vaccine for the H5 virus that causes avian flu.

What they’re saying: “mRNA vaccine technology offers advantages in efficacy, speed of development, and production scalability and reliability in addressing infectious disease outbreaks, as demonstrated during the COVID-19 pandemic,” said Moderna CEO Stéphane Bancel.

More calls for PPRV reauthorization: Statistics and patient stories show why Congress needs to reauthorize the Pediatric Priority Review Voucher (PPRV) program, Pamela K. Gavin, CEO of the National Organization for Rare Disorders (NORD), explained in STAT News.

Why it matters: A NORD analysis found “53 vouchers have been awarded in the program’s first 12 years, resulting in 39 new rare disease treatments to reduce children’s suffering and, in some instances, save their lives,” and 36 of these diseases previously had no FDA-approved treatments, said Gavin.

The bottom line: “By the end of September, Congress must vote to continue the program,” Gavin writes. “It would be a devastating gut punch to millions of American families affected by rare diseases if Congress lets this successful program lapse.”

What happened at the USMCA panel on Mexico’s corn ban

As U.S. officials questioned Mexico’s claims on a biotech corn ban, Mexico has yet to formally withdraw the ban.

Catch up: A Mexican presidential decree would phase out U.S. biotech corn imports. The U.S. challenged the ban as an unscientific violation of the U.S.-Mexico-Canada Agreement (USMCA) and requested a dispute panel, which held hearings June 26-27.

What the U.S. said: “Mexico did not conduct a risk assessment to support its claims and the documentation they provided was over 20 years old and lacked scientific rigor,” according to the National Corn Growers Association readout.

What Mexico said: While incoming Agriculture Minister Julio Berdegue told Reuters that Mexico will focus on achieving self-sufficiency in producing white corn, in another interview with El Universal, he seemingly doubled down on the ultimate goal of banning GMO corn for human consumption. Mexico has not formally withdrawn the ban.

The reality: Mexico’s imports of U.S. corn have hit daily records, and droughts in Mexico are expected to drive a record season of U.S. sales to Mexico—real-world evidence of how higher yield, drought-proofed biotech corn can enhance food security.

BIO’s view: Besides economic harm to Mexico and the United States, the ban would have a devastating impact on agricultural innovation needed to achieve our climate goals and ensure we can meet the world’s growing demand for food, BIO said in comments to the USMCA panel.

What’s next: The USMCA panel’s initial report is expected in September, and the final report in November, the Congressional Research Service said.

President Biden’s Monday: No official events.

What’s Happening on Capitol Hill: Congress returns to D.C. this week. Tomorrow, Federal Trade Commission (FTC) Chair Lina M. Khan will testify during a House Energy & Commerce Committee hearing on the FTC 2025 budget. On Wednesday, the House Appropriations Committee will mark up three bills, most notably Labor-HHS and Ag-FDA. Thursday, the Senate Appropriations Committee marks up spending legislation in several areas including Ag-FDA.