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Regulatory
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China accepts NDA of influenza tablet, clears Tepezza biosimilar

March 18, 2025
By Marian (YoonJee) Chu
China’s National Medical Products Administration (NMPA) approved the country’s first injectable teprotumumab biosimilar from Innovent Biologics Inc. under the brand name of Sycume (teprotumumab N-01) to treat thyroid eye disease on March 14. The NMPA on March 15 accepted Simcere Pharmaceutical Group Ltd.’s NDA of deunoxavir marboxil (ADC-189) tablets, a product originally developed by Jiaxing Andicon Biotech Co. Ltd. to treat influenza A and B.
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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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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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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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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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Coronavirus, lungs

Healios posts more upbeat data on Multistem cell therapy for ARDS

March 14, 2025
By Marian (YoonJee) Chu
Latest findings on Healios K.K.’s stem cell therapy to treat acute respiratory distress syndrome (ARDS), coined Multistem (invimestrocel; HLCM-051), found the regenerative medicine effective in reducing the number of patient days on ventilator treatment, as well as mortality benefits.
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Map of Europe, Medical Device Regulation (MDR) text

Team NB proposes conditional CE marks for MDR, IVDR

March 14, 2025
By Mark McCarty
The European Association of Medical Device Notified Bodies, also known as Team NB, has proposed the issuance of a conditional CE certificate for medical devices and in vitro diagnostics, a concept said to have existed in the legacy regulations as well. The question for industry is whether this mechanism can be used to aid in the backlog of devices under the Medical Device Regulation (MDR), a problem that is still front and center in the EU eight years after passage of the index legislation.
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Bhattacharya-Makary

Just one more vote to go for FDA, NIH nominees

March 13, 2025
By Mari Serebrov
As expected, the U.S. Senate Health, Education, Labor and Pensions Committee voted March 13 to send the nominations of Jay Bhattacharya as NIH director and Martin Makary as FDA commissioner to the Senate floor for confirmation. Bhattacharya received a narrow 12-11 party-line vote, but Makary picked up some Democratic support to secure a 14-9 vote.
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