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BioWorld - Sunday, March 22, 2026
Home » Topics » Regulatory » Policy

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Light bulb shines next to extinguished ones

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

March 20, 2026
By Tamra Sami
No Comments
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.
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Gavel, stethoscope, vial and syringe

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

March 17, 2026
By Mari Serebrov
No Comments
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.
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ACIP grows by two ahead of next meeting

March 2, 2026
By Mari Serebrov
No Comments
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.
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Tablets form silhouette of world map

Changing US FDA trial default a global matter

Feb. 27, 2026
By Mari Serebrov
No Comments
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.
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Another lawsuit challenges changes to ACIP, US vaccine schedule

Feb. 25, 2026
By Mari Serebrov
No Comments
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.
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One dice with a green checkmark, red X and gray question mark.

State of the biopharma industry filled with uncertainty

Feb. 25, 2026
By Mari Serebrov
No Comments
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.
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US flag, money, global currency symbols, tariff arrow

Supreme Court ruling not a death knell for US tariffs

Feb. 23, 2026
By Mari Serebrov
No Comments
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.
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February ACIP meeting not happening

Feb. 23, 2026
By Mari Serebrov
No Comments
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.
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US flag, gavel, book

Tariffs nixed by Supreme Court, Trump still has options

Feb. 20, 2026
By Randy Osborne
No Comments
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.
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Prescription drug bottles and pills

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

Feb. 19, 2026
By Mari Serebrov
No Comments
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.
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