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Gavel and scales

Analytics used to fell med tech CEO in insider trading case

June 24, 2024
By Mark McCarty
The recent conviction of Ontrak Inc. CEO Terren Peizer for insider trading was conspicuous on two counts, including that it was the first time such a conviction had been obtained solely for trading conducted under a government-approved insider trading policy. More worrisome for industry, generally, is the case is another example of federal prosecutors’ ever-growing use of data and analytics to root out violations of SEC law. This is a trend that seems destined to grow with advances in artificial intelligence.
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U.S. flag, stethoscope

MDMA urges US CMS to adopt new inpatient spinal DRGs for 2025

June 24, 2024
By Mark McCarty
The annual U.S. Medicare inpatient rule typically encodes a number of proposed reassignments of procedures between diagnostic-related groups , and the draft rule for fiscal year 2025 proposes several such changes in the area of orthopedic surgeries. The Medical Device Manufacturers Association lauded the proposed changes, arguing that the existing DRG code structure has failed to keep pace with the growing number of procedures for the lumbar spine, not to mention the significant cost differential associated with each.
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FDA Approved stamp with pills, bottle, blister pack
Biopharma regulatory actions and approvals May 2024

Two Eylea biosimilars among 11 FDA drug approvals in May

June 21, 2024
By Amanda Lanier
In May, the U.S. FDA approved 11 new drugs, a significant drop from the 26 approvals in April, which was the sixth-highest monthly total since 2016. This also falls short of March’s record-setting 30 approvals, the highest number recorded by BioWorld.
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US FDA warning letter spells out expanded access duties

June 21, 2024
By Mari Serebrov
Communication missteps, overreliance on a contract research organization and lack of clarity of U.S. FDA expectations for an expanded access protocol for emergency use resulted in a warning letter posted June 18 that highlights potential pitfalls for sponsor/investigators conducting the individualized studies.
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Product recall concept image

Overtwisting the driver of class I recall of Arrow IABPs

June 21, 2024
By Mark McCarty
It appears that the expression no news is good news is especially applicable to intra-aortic balloon pumps (IABPs), thus the class I recall of Arrow International devices was bad news for patients.
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Vial and syringe with DNA

Full FDA clearance for Elevidys in DMD boosts Sarepta shares

June 21, 2024
By Jennifer Boggs and Randy Osborne
Sarepta Therapeutics Inc. CEO Douglas Ingram said he expects “ferocious” demand for gene therapy Elevidys (delandistrogene moxeparvovec), granted full approval by the U.S. FDA for Duchenne muscular dystrophy (DMD). Shares of the Cambridge, Mass.-based firm closed June 21 at $16.72, up $37.22, or about 30% on the news.
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Africa looks to do for itself with vaccine effort

June 20, 2024
By Mari Serebrov
The African Vaccine Manufacturing Accelerator is up and running, with more than $1 billion already pledged to the effort that’s aimed at supporting the sustainable growth of Africa's manufacturing base and contributing to the African Union's goal of producing 60% of the vaccines required by African countries by 2040.
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Informed by experience, FDA updating interchangeability guidance

June 20, 2024
By Mari Serebrov
Now that it has some experience with interchangeable biosimilars under its belt, the U.S. FDA is proposing an update to its interchangeability guidance that could eliminate the need for switching studies in some instances.
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Neural network

On new Huntington’s data, FDA lifts partial hold on PTC phase II

June 20, 2024
By Lee Landenberger
A nearly two-year-old partial clinical hold has been lifted by the U.S. FDA on PTC Therapeutics Inc.’s pivotal phase II study in Huntington’s disease. The agency had paused enrollment in October 2022, saying it wanted more data on PTC-518, an orally bioavailable small-molecule splicing modifier, before enrollment could continue.
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Non-Hodgkin lymphoma cells in the blood flow

China’s NMPA clears Dizal’s golidocitinib in T-cell lymphoma

June 20, 2024
By Tamra Sami
China’s National Medical Products Administration (NMPA) approved Dizal Pharmaceutical Co. Ltd.’s golidocitinib for treating adults with relapsed or refractory peripheral T-cell lymphoma whose disease has progressed or was refractory to at least one prior systemic therapy.
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