Lab group urges lawmakers to rescind FDA final rule on LDTs
A survey found 48% of labs will discontinue LDTs if they do not qualify for an exception under the FDA final rule.
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Many FDA-authorized AI devices lack validation data
About 43% of all AI-enabled devices cleared or approved by the FDA through 2022 were missing validation data, and only 28% were tested prospectively, according to a Nature Medicine study.
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Elevance expands ACA plans in Florida, Texas, Maryland
The insurer’s Wellpoint subsidiary is expanding its ACA footprint for the 2025 coverage year, likely in a bid to capture enrollees who recently lost Medicaid coverage.
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Terns Shares Climb as Investigational GLP-1 Pill Spurs 5% Weight Loss After 28 Days
Terns Pharmaceuticals will advance TERN-601 into Phase II after early-stage data showed the oral therapy led to weight loss of 4.9%, comparable with weight loss pills Lilly and Pfizer are developing, according to analysts.
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Illumina court ruling limits EU regulators’ merger review power
The European Commission lacked oversight authority to examine the proposed sale of a cancer-detection company to biotech company Illumina, the court found.
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Relay Scores Early Breast Cancer Win, Plans Pivotal Trial Against AstraZeneca’s Truqap
Set to start in 2025, Relay Therapeutics is moving toward a pivotal study of experimental treatment RLY-2608 in heavily pretreated locally advanced or metastatic breast cancer.
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Inteligencia Artificial revoluciona los algoritmos de predicción en juegos de casino online
La inteligencia artificial (IA) está transformando rápidamente la industria del juego en línea. Los algoritmos de predicción mejorados están cambiando la manera en que los jugadores interactúan con los juegos de casino online. Este avance tecnol&oa …
GSK to Approach FDA With Positive Phase III Data For Long-Acting Asthma Med
GSK’s twice-yearly depemokimab reduced asthma attacks by half and cut clinic visits by nearly three-quarters, positioning it for an estimated $4 billion in peak sales if approved.
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AstraZeneca, Daiichi Sankyo Turn to AI to Explain Phase III NSCLC Miss for Dato-DXd
Using a computational biomarker, the companies say they can identify which patients would derive significant clinical benefit from their experimental antibody-drug conjugate. AstraZeneca and Roche are co-developing and commercializing a companion diagnostic for the biomarker.
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Summit Declares NSCLC Victory Over Keytruda, Analysts Advise Caution With China-Only Data
In advanced non-small cell lung cancer, Summit Therapeutics’ ivonescimab appears to be 49% more effective at reducing the risk of disease progression or death versus Merck’s Keytruda in a late-stage study. However, analysts contend the caveat is that the trial was conducted in an entirely Chinese patient population.