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iHealthScreen Inc. Announces FDA 510K Submission for iPredict™ AMD tool

Legacy MEDSearch

iHealthScreen conducted a prospective trial in the general population to prospectively assess the product’s accuracy, sensitivity and specificity. These prospective study results were initially presented at the Annual Meeting of the American Academy of Ophthalmology (AAO) and selected for Panel Discussion as outstanding work.

FDA 52
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Oncology Market Trends to Watch Out For in 2023

Medico Reach

The American Cancer Society estimates 1,958,310 new cases of cancer in the United States in 2023. As a result, a global approach to healthcare has emerged continually over the years. This global approach to healthcare is known as precision medicine which has emerged in treatments like immunotherapy. billion by 2028.

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Oncology Market Trends to Watch Out For in 2023

Medico Reach

The American Cancer Society estimates 1,958,310 new cases of cancer in the United States in 2023. As a result, a global approach to healthcare has emerged continually over the years. This global approach to healthcare is known as precision medicine which has emerged in treatments like immunotherapy. billion by 2028.

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Eisai/Biogen could get FDA verdict on new Alzheimer’s drug by 6 Jan

pharmaphorum

The FDA has started an accelerated review of Eisai and Biogen’s a new amyloid-targeting antibody lecanemab for Alzheimer’s disease, with a 6 January deadline that keep them ahead of closest rival Eli Lilly. ” The post Eisai/Biogen could get FDA verdict on new Alzheimer’s drug by 6 Jan appeared first on. .

FDA 52
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Lessons Learned from CMS’ Alzheimer’s Drug Coverage Decision

PM360

Carrillo, PhD, Chief Science Officer of the Alzheimer’s Association, called the benefits of slowing disease progression “real and meaningful, giving people more time to participate in daily life, remain independent, and make future healthcare decisions.” 2 Yet the largest payer in the U.S. has seemingly taken a different point of view.

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CSL closes on EU approval for haemophilia B gene therapy

pharmaphorum

The positive opinion for etranacogene dezaparvovec – which was approved as Hemgenix by the FDA last month – raises the prospect of the first one-time therapy in the EU for the bleeding disorder, which affects around 1 in 50,000 of the population, according to the European Haemophilia Network (EUHANET).

Medicine 116
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Microbiome therapies: a maturing movement

European Pharmaceutical Review

difficile in December 2022, the microbiome therapies space in 2023 has continued to see revolutionary developments and continued research advancement. Notably, gut microbiome was found to linked to cancer CAR T therapy response, based data from the largest prospective study of its kind, published in Nature Medicine in March 2023.