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— Bipartisan leaders of the new Cures bill are pressing to pass it soon, but it’s likely to be sidelined amid big-budget fights.

— Pfizer’s Covid-19 antiviral is poised to be a key tool against early infection, but advocates question why the company is sharing the pill’s patents — and not the vaccine’s.

— The Biden administration could soon greenlight Covid-19 booster shots for all Americans.

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CURES 2.0 CAMPAIGNING BEGINS — The long-awaited legislative text is here, and its architects are jockeying to squeeze the sprawling medical research package into Congress’ packed calendar. While the follow-up to 2016’s 21^st Century Cures Act has bipartisan support and industry buy-in going for it, the road could still be long.

Bill sponsor Rep. Diana DeGette (D-Colo.), was spotted handing out factsheets to her House colleagues today, harkening back to the first Cures Act, signed into law by Barack Obama, as she rallied support.

“We're now going to try to focus on the fast track and work with our Senate colleagues,” her co-sponsor Rep. Fred Upton (R-Mich.) told reporters. “But we may not meet the deadline before the end of the calendar year unless we really put in some long nights, which somehow, I think we're going to be doing even without this bill.”

It could take even longer. Some lobbyists predict the bill will come for vote alongside Food and Drug Administration user fees that need to be reauthorized this summer. But DeGette and Upton are eager to schedule it sooner and steer clear of attaching the proposal — which includes billions for Biden’s biomedical research vision, boosted Medicare coverage for medical devices and telehealth reforms — to the straightforward and deadline-driven user fees.

And industry stands to win — especially device and diagnostic manufacturers. The bill would let device makers with breakthrough designation from the FDA get four years of automatic Medicare coverage, bringing back a Trump-era rule with some tweaks. It would also let Medicare cover test consultations that help providers understand diagnostic results.

Tasks for FDA and drugmakers are embedded, too, including directives to make clinical trials more diverse and include more real-world data in research. Plus, the FDA would need to establish two more centers of excellence — following in the footsteps of their oncology center — with the conditions that one be focused on diseases with a major societal burden and links to Covid-19 risks, while the other be for less common diseases that most impact children. Start brainstorming now.

PFIZER FILES TO USE COVID ANTIVIRAL — The company on Tuesday asked the FDA to authorize its antiviral Covid-19 pill for emergency use, two weeks after reporting the medicine, Paxlovid, slashes severe disease and death risk by nearly 90 percent.

Those results were positive enough that Pfizer ended its trial early and said it would file ASAP, setting up for a key treatment against early infection alongside Merck’s molnupiravir (also under FDA review).

Both medicines could fill a gap in early options to curb Covid-19 infections, especially as relatively inexpensive and easy-to-make drugs compared to hospital infusions. Hours before it completed its FDA submission, Pfizer announced a licensing agreement to let the World Health Organization’s Medicines Patent Pool facilitate the pill’s production with generic drugmakers around the world.

CEO Albert Bourla was questioned on the patent move at Stat News’ summit later that day, particularly because the company hasn’t budged on similar patent licensing for its Covid-19 vaccine. Paxlovid has a “very simple chemistry” that makes it easier to manufacture than vaccines, Bourla said.

Public health organizations aren’t content with that explanation. “Pfizer’s announcement to voluntarily license the COVID treatment Paxlovid is welcome but is far from enough,” The People’s Vaccine Alliance, a coalition of health and advocacy groups, said in a statement. “It is clear that relying on the voluntary actions of pharmaceutical companies alone will not secure urgently needed access to tests, medicines and vaccines for everyone, everywhere.”

COMING SOON: BOOSTERS FOR ALL? — The Biden administration could make Pfizer-BioNTech’s booster shot available to all adults as soon as the end of this week, people with knowledge of the matter told PULSE.

The move would represent a major expansion of access to the third dose, and come as a relief to those administration officials and outside health experts who have long pushed to make everyone eligible for a booster — especially as Covid-19 cases begin to creep up in some pockets of the country.

It could also help simplify the administration’s messaging on boosters, which has come under fire in recent days from governors.

How it needs to happen: The FDA must first authorize the additional shot for all Americans over 18, a step the agency could take within the next few days. Then the CDC’s outside advisory panel would debate the expanded eligibility. That panel has already scheduled a meeting for Friday, though It has yet to specify its agenda.

Assuming those advisers recommend opening up access, the CDC could officially act within hours.

BIDEN’S VAX RULES HEAD TO APPEALS COURT — A 16-judge federal court dominated by Republican appointees will hear arguments over the Biden administration’s vaccine-or-test mandate, marking the next phase of the legal battle over the new workplace regulations, POLITICO’s Rebecca Rainey reports.

The case landed in front of the 6^th Circuit Court of Appeals by lottery, after nearly three dozen lawsuits across various federal courts were consolidated into a single challenge. The court consists of 11 GOP-appointed judges, including six named to the bench by former President Donald Trump. The other five were appointed by Democratic presidents.

It’s unclear which three of those judges will hear the case, and their decision is unlikely to be final. Any verdict can still be appealed to the full group and could go to the Supreme Court.

TODAY: HHS OFFICIALS WEIGH IN ON GLOBAL VAX CAMPAIGN — A trio of senior HHS officials will testify this morning on the administration’s role in the global vaccination campaign, amid growing scrutiny of vaccine shortages throughout the developing world.

The House Appropriations subcommittee hearing is set to feature HHS Global Affairs chief Loyce Pace, Biomedical Advanced Research and Development Authority Director Gary Disbrow and David Kessler, who serves as the chief science officer for the Covid-19 response.

President Joe Biden has vowed to vaccinate 70 percent of the world’s population by next September. But the campaign is running behind, and poorer countries have so far received a far smaller share of doses compared to wealthier ones.

The Biden officials are still likely to tout recent progress, including a deal to send Johnson & Johnson doses to conflict zones. The administration is also trying to finalize a new commitment from Moderna. Pfizer, meanwhile, just agreed to license its Covid-19 antiviral pill to an international group aiding the developing world.

ABORTION FOES LAUNCH AD CAMPAIGN AHEAD OF SCOTUS ARGUMENTS — Susan B. Anthony List is spending $2.5 million on anti-abortion ads in the run-up to oral arguments over a Mississippi law that would aggressively restrict abortion access.

The law enacted in 2018 would ban most abortions 15 weeks from the first day of a woman’s last menstrual period. The case, slated for oral arguments on Dec. 1, is the first abortion dispute to be heard by the Supreme Court since Justice Amy Coney Barrett cemented a 6–3 conservative majority.

Susan B. Anthony List is airing its television and digital ads in the Washington media market on a series of broadcast and cable networks, including CNN, Fox News and Newsmax.

Jimmy Kolker is returning to government as a part-time senior adviser to Gayle Smith, the State Department’s coordinator for the global Covid response and health security, per an internal email obtained by PULSE. He will focus on global health security issues.

Kolker served as HHS’ assistant secretary for global affairs during the Obama administration, and before that was deputy U.S. global AIDS coordinator during the George W. Bush era. He’s also served as U.S. ambassador to Burkina Faso and Uganda.

Woodberry Associates hired Kimberly Serota as health advocacy director. Serota previously was policy and advocacy director at the American Urological Association.

Miles Lichtman is now deputy for health oversight and policy on the House Committee on Oversight and Reform’s majority staff. He was previously senior health policy advisor for the committee.

Two authors set out to prove that Covid-19 leaked from a lab. But by the end of their investigation, they’re forced to acknowledge “that they have conducted a wild goose chase,” The Los Angeles Times’ Michael Hiltzik writes of the new book “Viral: The Search for the Origin of Covid-19.”

Air ambulances owned by private equity firms or publicly traded companies tend to charge more and account for a greater proportion of surprise bills, compared with their independent, nonprofit or hospital-owned peers, according to a new study from USC-Brookings Schaeffer Initiative for Health Policy.

White House chief medical adviser Anthony Fauci estimated that Covid-19 cases need to fall "well below 10,000" a day for the U.S. to return to pre-pandemic life, CNBC's Robert Towey reports.