Happy Monday! Congress is still stuck on subsidies and the shutdown while agencies push ahead on key rules. States are bracing for premium shocks and fresh legal fights. Industry is moving fast on obesity pills and dealmaking. Here is what you need to know going into the week.

In this week’s Nimitz Health:

• Federal News: Shutdown day 34, CMS opens window shopping, and FDA issues biosimilar guidance

• State News: Texas sues Tylenol, New Jersey warns of premium spikes, and other states explore relief.

• Industry News: COVAX tell all, Pfizer challenges Novo’s Metsera deal, and oral obesity pill race heats up.

WHO’S HAVING EVENTS THIS WEEK?

Wednesday, November 5th

• *Senate Aging: “Renewing Our Commitment: How the Older Americans Act Uplifts Families Living with Aging-Related Diseases” at 3:30pm. Watch here.

*Will be covered by Nimitz Health. Please email [email protected] if you would like a readout of any other hearings.

NEWS DRIVING THE WEEK

Federal News

Congress remains stuck over how to handle the expiring enhanced Affordable Care Act subsidies and that fight is driving the shutdown. Vulnerable House Republicans are signaling some openness to talks while resisting a quick renewal, and several want the government reopened first. Democrats argue renewal would blunt premium spikes and they continue to press for a deal. Live government shutdown updates are here.

The Senate HELP Committee delayed the hearing for Surgeon General nominee Casey Means after she went into labor. When the hearing is rescheduled, she is likely to face questions on vaccines and on her medical and public health credentials.

The Department of Health and Human Services brought back furloughed staff to move Rural Health Transformation Fund applications. Submissions are due next week and awards are expected by the end of December. The money aims to modernize rural care with telehealth and with artificial intelligence and will be distributed over five years starting in 2026.

The Centers for Medicare and Medicaid Services opened window shopping for 2026 marketplace plans after a late start. The agency recalled some furloughed staff and is under pressure from Senate Democrats over the delay. The Kaiser Family Foundation estimates average premiums will climb and the uncertainty over subsidies is adding fuel.

FDA issued draft guidance aimed at accelerating biosimilar approvals and expanding interchangeability. The agency signaled that comparative switching studies would no longer be expected in many cases and said it plans to consolidate older guidance into a streamlined rulebook to ease development. Leaders said the shift could shave years off timelines and that biosimilars made in the United States would get priority in review.

State News

Texas Attorney General Ken Paxton sued the maker of Tylenol and alleged deceptive marketing to pregnant women while national figures amplified unproven links to autism and ADHD. The companies defended acetaminophen when used as directed and industry counsel expect copycat actions and pressure on retailers and ad platforms in discovery.

New Jersey regulators warned of severe premium hikes on the state exchange if enhanced Affordable Care Act subsidies lapse, with increases that could approach one hundred seventy five percent. State officials say roughly sixty thousand people could lose financial help and the average enrollee could pay about two thousand seven hundred eighty dollars more next year without federal action.

Premium shocks vary widely across states. Analyses flag sharper increases in HealthCare.gov states than in those with their own exchanges and some states are weighing stopgaps such as reinsurance and wraparound aid while they wait on Congress. Colorado is preparing for outsized increases among unsubsidized enrollees if federal support expires.

Industry News

The former head of Gavi published a tell-all on the Covid vaccine rollout. He recounts how limited early deliveries, tough contract terms, and national export limits throttled supply through Covax, while crediting Operation Warp Speed for accelerating mRNA development. The account is reigniting debate over indemnity, supply chain resilience, and how to structure public private partnerships before the next pandemic.

Pfizer filed a second lawsuit to block Novo Nordisk’s plan to buy Metsera in a deal valued up to nine billion dollars. Pfizer argues the structure would entrench Novo’s dominance in GLP one medicines by sidelining a rising competitor and by freezing potential support from Pfizer. The complaint targets Metsera’s controlling investors and highlights a rapid antitrust backdrop with the Federal Trade Commission fast tracking approvals for Pfizer’s separate Metsera agreement. Eli Lilly said it will not bid and will let the rivals fight over the asset.

The race to launch an obesity pill is accelerating as Novo Nordisk and Eli Lilly report positive results and prepare filings. Pills could open the market to people who avoid injections and could enable fixed dose combinations for heart and kidney disease. Capacity and dosing needs remain hurdles for peptide based tablets, while small molecule approaches may scale faster. Analysts expect orals to become a substantial segment even as injectables remain the workhorse. Pricing and manufacturing will shape how quickly access expands over the next several years.

FOR FUN

Florida State Football is back on track, and Emily got to cheer in person this time! Check out highlights from FSU’s 42-7 win over Wake Forest here.

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