Policy

Multiple appearances on Priority Watch List leading to action?

Wed, 06 May 2026 12:00:00 -0400

It’s a sure bet when the U.S. Trade Representative releases its annual Special 301 Report that Chile, China, India, Indonesia, Russia and Venezuela will be on the Priority Watch List. The 2026 report was no exception.

Bio Korea 2026: US policy risks shift to execution framework

Tue, 05 May 2026 12:00:00 -0400

Regulatory uncertainty that dominated the life science sector in 2025 is transitioning into an execution framework for biotechnology companies, provided companies can tailor regulatory strategies early, and across the entire development cycle.

White House looks to expand MFN pricing for $530B-plus in savings

Tue, 05 May 2026 12:00:00 -0400

Amid calls for transparency on the most-favored nation (MFN) pricing deals U.S. President Donald Trump has reached with 17 biopharma companies, the White House Council of Economic Advisers released a report May 5 detailing how the volunteer MFN policy works and touting the $530 billion-plus in savings it’s projected to deliver over the next 10 years.

Bio Korea 2026: US policy risks shift to execution framework

Mon, 04 May 2026 12:00:00 -0400

US legislative reforms needed to make biosimilars competitive

Mon, 27 Apr 2026 12:00:00 -0400

Now that the FDA is on board with doing away with the U.S.’ unique two-tier biosimilar pathway, the biosimilar industry is urging Congress to pass the bipartisan Biosimilar Red Tape Elimination Act, which would recognize that biosimilars and interchangeables are one and the same.

A free gene therapy? Regeneron’s Otarmeni approved for hearing loss

Thu, 23 Apr 2026 12:00:00 -0400

Children and adults with a type of congenital hearing loss now have a free treatment option, with the U.S. FDA’s accelerated approval of Regeneron Pharmaceuticals Inc.’s DB-OTO, an AAV-mediated gene therapy. Branded Otarmeni (lunsotogene parvec), it is cleared specifically for hearing loss caused by variants in the otoferlin gene.

FDA, CMS partner to deliver RAPIDly for innovative devices

Thu, 23 Apr 2026 12:00:00 -0400

The U.S. FDA and CMS are teaming up to give Medicare beneficiaries quicker access to breakthrough medical devices and provide manufacturers with certainty of reimbursement.

CMS to Bridge coverage for obesity drugs as BALANCE teeters

Wed, 22 Apr 2026 12:00:00 -0400

When the U.S. CMS didn’t get takers for its voluntary Better Approaches to Lifestyle and Nutrition for Comprehensive Health (BALANCE) model to cover obesity drugs under Medicare Part D, the agency punted. It announced late April 21 that it will indefinitely delay the BALANCE model in Medicare but extend its temporary Medicare GLP-1 Bridge demonstration model through the end of 2027. (The Medicaid BALANCE model will still kick in this year in states that choose to participate in it.)

Psychedelic space expanding on Trump’s EO

Mon, 20 Apr 2026 12:00:00 -0400

Timothy Leary is dead, but he could be on the outside looking in with a smile on his face as U.S. President Donald Trump’s latest executive order (EO) fuels a surge in investment in companies researching and developing psychedelic drugs to treat mental health issues. The EO, Accelerating medical treatments for serious mental illness, is intended to address the increasing burden of suicide and serious mental illness, which impacts more than 14 million Americans.

New nominee may need a charm at the CDC

Fri, 17 Apr 2026 12:00:00 -0400

As U.S. President Donald Trump’s third nominee for CDC director, Erica Schwartz will soon find out if three times really is a charm. Trump announced the nomination on social media April 16, touting Schwartz’s credentials for the job. Calling her “incredibly talented,” Trump cited her “distinguished career” as a military doctor, in the Navy and Coast Guard, and her service as deputy surgeon general during his first term in office.

HHS budget hearing not so much about budget

Thu, 16 Apr 2026 12:00:00 -0400

U.S. Health and Human Services (HHS) Secretary Robert Kennedy made his first stop April 16 on a congressional tour in support of President Donald Trump’s proposed fiscal 2027 budget, which would reduce discretional spending for HHS and its agencies by about 12%.

Flow of Trump EOs slowing way down

Wed, 15 Apr 2026 12:00:00 -0400

Despite key vacancies, ongoing staffing challenges and policy issues at the U.S. CDC, FDA and NIH, some of the regulatory churn that roiled those agencies in the first year of the second Trump administration is settling a bit, at least in terms of the number of executive orders (EOs) coming out of the Oval Office.

Kennedy expands ACIP function, membership criteria

Fri, 10 Apr 2026 12:00:00 -0400

Amending his previous two-year-renewal of the standard charter for the U.S. CDC’s Advisory Committee on Immunization Practices (ACIP), Health and Human Services Secretary Robert Kennedy made monitoring adverse vaccine events a primary function of the committee and expanded its liaison membership to include organizations that have challenged vaccine safety.>

UK formalizes zero tariffs deal with US, will pay more for drugs

Wed, 08 Apr 2026 12:00:00 -0400

The U.S. confirmed the agreement in principle made last December to exempt U.K. pharmaceuticals from import tariffs, as the U.K government put its commitment to spend more on patented drugs into effect.

Kennedy sidestepping court order sidelining ACIP?

Tue, 07 Apr 2026 12:00:00 -0400

Don’t like a court order? Sidestep it. That seems to be the idea behind U.S. Health and Human Services Secretary Robert Kennedy’s latest changes to his renewal of the charter for the CDC’s Advisory Committee on Immunization Practices (ACIP).

Sector tariff now more than a threat – for some Rx companies

Tue, 07 Apr 2026 11:00:00 -0400

Sector tariff now more than a threat – for some Rx companies

Mon, 06 Apr 2026 12:00:00 -0400

After nearly a year of threats and promises of a global biopharma tariff of 25% to 500%, U.S. President Donald Trump finally delivered it. In the name of national security, he imposed a 100% sector tariff on prescription drugs and their associated ingredients beginning in about four months for large manufacturers and six months for smaller companies. However, depending on the drug, where it’s made and whether a manufacturer has reached onshoring and pricing agreements with the Department of Health and Human Services, the actual tariff could be as low as 0%.

Drama encases ACIP, CDC amid lawsuit, deadline

Wed, 25 Mar 2026 12:00:00 -0400

Chaos continues at the U.S. CDC and its Advisory Committee on Immunization Practices (ACIP) with the resignation of ACIP member Robert Malone and the impending deadline for the president to nominate a new CDC director following the dramatic exit last year of Susan Monarez and months of acting directors.

Australia’s R&D reset puts biotech translation in focus

Tue, 24 Mar 2026 12:00:00 -0400

Australia is attempting a once-in-a-generation reset of its innovation system, and biotech industry leaders have lauded the federal government’s independent review into Australia's slipping R&D ranks and its proposals to reverse the decline.

China’s pharma rise rattles US policymakers

Tue, 24 Mar 2026 12:00:00 -0400

U.S. lawmakers and industry experts are raising alarm over China’s expanding dominance across the pharmaceutical supply chain, warning that reliance on Chinese inputs poses a growing national security and public health risk.

Australia’s R&D reset puts biotech translation in focus

Fri, 20 Mar 2026 12:00:00 -0400

Judge’s order shuts down new vaccine schedule, ACIP itself

Tue, 17 Mar 2026 12:00:00 -0400

In one fell swoop March 16, a U.S. federal judge stayed the CDC’s January memo revising the childhood vaccine schedule and the Advisory Committee on Immunization Practices (ACIP) as reconstituted by Health and Human Services Secretary Robert Kennedy, along with everything that committee has done since early June.

ACIP grows by two ahead of next meeting

Mon, 02 Mar 2026 12:00:00 -0500

The U.S. CDC’s Advisory Committee on Immunization Practices (ACIP) has two new members, bringing its total membership to 15. As he has done since dismissing the entire ACIP panel last June, Health and Human Services Secretary Robert Kennedy named the new members, Angelina Farella and Sean Downing, barely two weeks before the next ACIP meeting, March 18-19.

Changing US FDA trial default a global matter

Fri, 27 Feb 2026 12:00:00 -0500

The U.S. FDA’s expectations that its new default position of basing marketing authorization of novel drugs on one adequate, well-controlled trial may be overstated. In explaining the policy in a recent article in The New England Journal of Medicine, FDA Commissioner Marty Makary and CBER Director Vinay Prasad said they expect the initiative will create a “surge in drug development,” substantially reduce development costs and will speed drugs to market. While the initiative could reduce the time to the U.S. market, those expectations don’t take into consideration global norms and payer expectations.

Another lawsuit challenges changes to ACIP, US vaccine schedule

Wed, 25 Feb 2026 12:00:00 -0500

U.S. Health and Human Services Secretary Robert Kennedy is facing a second lawsuit challenging his replacement of all the members of the Advisory Committee on Immunization Practices (ACIP) and seeking to undo the CDC’s Jan. 5 revision of its childhood immunization schedule.

State of the biopharma industry filled with uncertainty

Wed, 25 Feb 2026 12:00:00 -0500

While the annual State of the Union address has morphed over the years from a summation of the state of the U.S. government and the president’s legislative agenda into political theater on both sides of the aisle, President Donald Trump did include some recommendations to Congress in his Feb. 24 speech. Among those recommendations was a request for Congress to codify his most-favored-nation pricing policy for prescription drugs.

Supreme Court ruling not a death knell for US tariffs

Mon, 23 Feb 2026 12:00:00 -0500

The ramifications of the U.S. Supreme Court’s decision Feb. 20 that shot down President Donald Trump’s reciprocal tariffs issued under the International Emergency Economic Powers Act are rippling across the world. And Trump’s immediate response to that ruling – a proclamation imposing a temporary 10% import duty on most goods brought into the country beginning Feb. 24 – isn’t helping.

February ACIP meeting not happening

Mon, 23 Feb 2026 12:00:00 -0500

Amid an ongoing court challenge to the current composition of the CDC’s Advisory Committee on Immunization Practices (ACIP), the committee’s Feb. 25-27 meeting has been removed from its calendar.

Tariffs nixed by Supreme Court, Trump still has options

Fri, 20 Feb 2026 12:00:00 -0500

U.S. President Donald Trump’s foreign-imports tariff policies did not hold up well at the Supreme Court, which ruled unconstitutional his edicts under the International Emergency Economic Powers Act. The sharply worded 6-3 opinion was authored by Chief Justice John Roberts.

US GAO: March-ins not much of a solution for Rx prices

Thu, 19 Feb 2026 12:00:00 -0500

Driven by prescription drug prices and oft-repeated claims that nearly every drug developed in the U.S. owes its origins to taxpayer-funded research, watchdog groups and some lawmakers have led demands over the years for price to be considered a “reasonableness” factor in determining whether the government can march in on patents under the Bayh-Dole Act.