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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
RSS
