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Regulatory
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Adcom recommends Lumicell drug even though not a home run

March 5, 2024
By Mari Serebrov
While members of the U.S. FDA’s Imaging Drugs Advisory Committee weren’t blown away March 5 by the trial performance of Lumicell Inc.’s Lumisight (pegulicianine) in helping breast cancer patients avoid second surgeries due to negative margins following a lumpectomy, they voted 16-2, with one abstention, that the benefits of the imaging drug outweigh its risks, even though those benefits are incremental.
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RDS Multisense

RDS receives CE mark for remote monitoring device, plans series A

March 5, 2024
By Shani Alexander
Rhythm Diagnostic Systems SA received CE mark approval from EU authorities for Multisense, a wearable device that continuously monitors patients remotely. The company looks to market the device first in France and Germany.
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Gavel and FTC logo

US agencies propose tighter focus on PBMs and GPOs

March 5, 2024
By Mark McCarty
Three U.S. federal government agencies announced that their focus on consolidation in health care markets may soon ramp up, given concerns that consolidation may be affecting the cost and quality of patient care.
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Chinese flag and pills

China NMPA approves 40 innovative new drugs in 2023

March 5, 2024
By Marian (YoonJee) Chu
China’s National Medical Products Administration (NMPA) cleared 40 novel innovative drugs in 2023, of which nearly half were cancer therapies, marking a significant increase from the 21 new class 1 drugs approved in 2022.
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EMA validates two filings for Daiichi-Astrazeneca’s ADC

March 4, 2024
By Marian (YoonJee) Chu
The EMA validated two marketing approval applications of Daiichi Sankyo Co. Ltd. and Astrazeneca plc’s antibody-drug conjugate (ADC) datopotamab deruxtecan (dato-dxd) on Mar. 4, for two types of lung and breast cancer.
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US FDA seeks adcom illumination on Lumicell imaging drug

March 4, 2024
By Mari Serebrov
The March 5 meeting of the U.S. FDA’s Medical Imaging Drugs Advisory Committee could be the gateway to the first approved intraoperative technology for use in breast cancer that directly examines the lumpectomy cavity for residual cancer.
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US price negotiation update: Counteroffers in, another challenge dismissed

March 4, 2024
By Mari Serebrov
With two U.S. courts rejecting constitutional challenges to Medicare drug price negotiations, every company that had a drug selected for the first round of negotiations countered Medicare’s initial offer of what it considered a maximum fair price by the March 2 deadline, according to the Biden administration.
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Global market charts

FDA’s small business registration fee waiver hinges on bankruptcy

March 4, 2024
By Mark McCarty
The U.S. FDA has proposed an update to an existing program for user fee reductions for companies grossing less than $100 million, although this latest update is much stingier than that. The update would provide registration fee relief for entities with revenues of $1 million or less, but only if that business is in bankruptcy proceedings, a meager bit of relief considering that registration fees in fiscal 2024 run to less than $7,700.
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Multiple myeloma illustration

NMPA clears Carsgen’s BCMA CAR T for refractory multiple myeloma

March 1, 2024
By Tamra Sami

China’s NMPA has approved Carsgen Therapeutics Holdings Ltd.’s NDA for its B-cell maturation antigen (BCMA)-targeted CAR T-cell therapy, zevorcabtagene autoleucel (CT-053, zevor-cel), for treating adults with relapsed or refractory (r/r) multiple myeloma (MM) who have progressed after at least three prior lines of therapy, including a proteasome inhibitor and immunomodulatory agent.


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H3 ankle

FDA sees unexpected rates of failure in Hintermann ankle device

March 1, 2024
By Mark McCarty
The U.S. FDA reported Feb. 29 that data on the Hintermann series H3 total ankle system suggest a significantly higher rate of device failure than seen in premarket clinical studies, a problem that has arisen even though only five years have passed since the agency approved the device.
Read More
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