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FDA OKs first blood test to aid Alzheimer’s diagnosis

BioPharma Drive: Drug Pricing

The FDA cleared the test for early detection of amyloid plaques associated with Alzheimer’s in people aged 55 years and older with signs and symptoms of the disease.

FDA
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When is a Confirmatory Trial “Underway” or Conducted with “Due Diligence” Enough for Accelerated Approval? FDA Explains Its New Authorities

FDA Law Blog: Drug Discovery

FDAs withdrawal authority when a confirmatory trial is not conducted with due diligence was expanded to include that FDA could specify the conditions for a postapproval study. Considering FDAs new authority to specify the conditions for such confirmatory trials (e.g.,

FDA
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Biogen strikes RNAi deal with City; Aurion withdraws IPO

BioPharma Drive: Drug Pricing

Elsewhere, Angelini Pharma licensed a rare disease therapy and the FDA refused to review a Savara lung drug. City will receive $46 million from Biogen under the alliance.

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Regulator and Funder? FDA’s Orphan Products Grants Program awards significant funding to help move promising treatments through clinical development

FDA Law Blog: Drug Discovery

Food and Drug Administration (FDA) plays a pivotal role in fostering the development of treatments for rare diseases through its Orphan Products Grants Program. Each year, FDA selects a limited number of clinical trials to fund to help sponsors pursue development of medical products for rare diseases and advance their field.

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The AI model that is changing clinical trial design

Drug Target Review

Placebo arms, in particular, create ethical and logistical hurdles, especially in areas like rare disease and oncology. They are patient-specific outcome predictions, generated using disease-specific machine-learning models trained on large, longitudinal clinical datasets. Digital twins offer a way forward.

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Lilly’s Amyvid Receives FDA Label Revision to Support Alzheimer’s Diagnosis

The Pharma Data

FDA Approves Label Update for Lilly’s Amyvid, Expanding Its Role in Alzheimer’s Disease Diagnosis and Therapy Guidance In a major development for Alzheimer’s diagnostics, Eli Lilly and Company (NYSE: LLY) announced that the U.S.

FDA
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Rilzabrutinib Cuts Flares in IgG4-Related Disease; Fast Track Granted in US

The Pharma Data

The results come from a open-label, proof-of-concept, Phase 2 study (NCT04520451) and highlight rilzabrutinib’s potential as a disease-changing treatment option for a condition that currently has limited and non-specific treatment options and involves substantial patient suffering due to its chronic and progressive course.