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BioWorld - Tuesday, December 30, 2025
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Prescription pad

Legislation would authorize AI to write prescriptions

March 18, 2025
By Mark McCarty
The unrelenting pressure on medical practice in the U.S. has sparked some innovations, but a legislative innovation is now in the works that would fundamentally shift how at least some drugs are prescribed. The Healthy Technology Act of 2025 (H.R. 238) would allow AI and machine learning algorithms to write prescriptions for pharmaceuticals, although the lack of co-sponsors for H.R. 238 suggests that this bill is not ready for prime time just yet.
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Architectural pillars

Qui tam provisions of US False Claims Act under increasing pressure

March 18, 2025
By Mark McCarty
U.S. law allows whistleblowers to file suit for violations the False Claims Act, but the legality of these qui tam relators under the Appointments Clause is under intense scrutiny thanks to a case heard in Florida district court.
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Rendering of Alteogen’s ALT-B4

Alteogen in $1.35B Medimmune deal; Astrazeneca bids $1B for Esobiotec

March 18, 2025
By Marian (YoonJee) Chu
Alteogen Inc. signed its first billion-dollar partnership this year for ALT-B4 technology through two separate contracts with Astrazeneca plc’s U.K.- and U.S.-based Medimmune subsidiaries worth up to $1.35 billion combined.
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Look, Ma, no adcom

March 17, 2025
By Mari Serebrov
Breaking with a 30-year tradition, the U.S. FDA selected the strains for the next flu vaccine March 13 without convening its independent vaccine advisory committee. Instead, the agency brought together 15 scientific and public health experts from within the FDA, the CDC and the Department of Defense to make the recommendations for the next flu season. That group met the same day that the agency’s Vaccines and Related Biological Products Advisory Committee had been scheduled to make the selection.
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Gavel and scales

Former Magellan officials enter guilty pleas in lead test prosecution

March 17, 2025
By Mark McCarty
Three former officials with Magellan Diagnostics Inc., have entered guilty pleas in connection with faulty tests for lead poisoning that were widely used across the U.S. between 2013 and 2017. While former CEO Amy Winslow and two others will not be sentenced until later this year, all three face possible prison terms of three years or more and fines of as much as $250,000, highlighting the hazards of a lack of scruples with regard to compliance with U.S. FDA regulations.
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AltiX AI.i_ComboLab

GE Healthcare Altix AI.i upgrades EP and cath lab capabilities

March 17, 2025
By Annette Boyle
With its Altix AI.i launch, GE Healthcare Technologies Inc. aims to upgrade the user experience and efficiency of its catheterization lab and electrophysiology procedures. The new capabilities apply to the Cardiolab, Mac-Lab and Combolab products. The Alitx Ai.i software upgrades received U.S. FDA clearance in December. CE mark is pending.
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Telehealth illustration

Medicare telehealth provisions survive in latest continuing resolution

March 17, 2025
By Mark McCarty
The latest continuing resolution (CR) for the U.S. budget funds government operations through the end of the fiscal year, which in modern times may come across as an achievement. However, Medicare telehealth also won in the CR, which extends some temporary measures for telehealth as Congress continues to mull over the question of a permanent expansion of Medicare telehealth benefits.
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Rendering of Alteogen’s ALT-B4

Alteogen in $1.35B Medimmune deal; Astrazeneca bids $1B for Esobiotec

March 17, 2025
By Marian (YoonJee) Chu
Alteogen Inc. signed its first billion-dollar partnership this year for ALT-B4 technology through two separate contracts with Astrazeneca plc’s U.K.- and U.S.-based Medimmune subsidiaries worth up to $1.35 billion combined.
Read More

Lost in trans-lation? Trump’s mouse charge doesn’t click

March 14, 2025
By Randy Osborne
U.S. President Donald Trump touched off a not-uncommon flurry of puzzlement and outrage when, during his speech to Congress on March 4, he referred to an example of government waste as spending $8 million on “making mice transgender. This is real.” Skeptical media outlets jumped on the case right away.
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Mehmet Oz, nominee for administrator of the Centers for Medicare & Medicaid Services

Oz promises AI, innovation, lower drug prices if confirmed to lead CMS

March 14, 2025
By Karen Carey
Cardiothoracic surgeon and television personality Mehmet Oz, President Donald Trump’s nominee for administrator of the Centers for Medicare & Medicaid Services (CMS), faced the U.S. Senate’s finance committee on March 14, suggesting the implementation of artificial intelligence (AI) technologies and the reduction of drug prices would be among his top priorities, if confirmed.
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