AI Archives - Page 28 of 35

June 21, 2024 Artificial Intelligence FDAcop

FDA Considers Changing Policy on Study Requirements for Biosimilars Switching

The FDA is considering changes to its biosimilar policy, which could benefit companies that develop complex follow-on biologic drugs, clinicians who prescribe them, and the patients who receive them. Currently, pharmacists cannot substitute lower-cost biosimilars for brand-name products unless they are classified as interchangeable by the FDA. This requires additional clinical trials beyond those needed […]

June 20, 2024 Artificial Intelligence FDAcop

Healthcare Company GE and MediView XR Collaborate to Launch OmnifyXR – an AR Radiology Suite for Clinical Applications

GE HealthCare and MediView XR have successfully implemented their co-developed OmnifyXR Interventional Suite System in a clinical setting. This system combines GE’s imaging technology with MediView’s augmented reality and surgical navigation platform to improve assessment of patient anatomy, enable informed clinical decision-making, and facilitate remote collaboration among care teams. The platform allows for displaying up […]

June 20, 2024 Artificial Intelligence FDAcop

Life Sciences Analysis: A Gratitude Message

Alzheimer’s disease (AD) is a devastating condition that affects millions of people worldwide, causing cognitive decline, behavioral changes, and functional impairment. Currently, the FDA has approved several therapies for AD, including medications like Aricept, Namenda, and Rexulti that target cognitive symptoms. Additionally, disease-modifying therapies like Aduhelm and Leqembi have been approved, with a focus on […]

June 20, 2024 Artificial Intelligence FDAcop

Laboratory trade group files lawsuit against FDA to stop regulation of lab-created tests

The American Clinical Laboratory Association and PCR lab HealthTrackRx have filed a lawsuit against the FDA regarding its plan to regulate lab-developed tests. The FDA’s regulation of these tests has historically been limited, but as tests have become more numerous and complex, unreliable tests have caused harm to patients. The lawsuit argues that the FDA […]

June 19, 2024 Artificial Intelligence FDAcop

New Monoclonal Antibody Receives Strong Support from Advisory Committee for Early Alzheimer’s Treatment: Exclusive Life Science Analysis

The FDA’s Peripheral and Central Nervous System (PCNS) Advisory Committee recently met to discuss Eli Lilly’s donanemab as a potential treatment for early Alzheimer’s disease. The committee looked at the trial design and safety signals of the drug, ultimately voting unanimously in favor of its risk-benefit profile. If donanemab is approved, it could help alleviate […]

June 19, 2024 Artificial Intelligence FDAcop

Day One Biopharma Expands into Cancer Biotech with Acquisition of ADCs, Investing $55M for Phase 1-Ready Drug

Day One Biopharmaceuticals, a recently FDA-approved commercial-stage company, is expanding its pipeline by acquiring rights to a novel drug from MabCare Therapeutics. The drug, now renamed DAY301, targets protein-tyrosine kinase 7 (PTK7), which is found in certain cancer cells and pediatric cancers. This drug candidate could potentially compete with a similar drug from Genmab, acquired […]

June 19, 2024 Artificial Intelligence FDAcop

Exclusive Article | Gratitude

The Supreme Court unanimously ruled that The Alliance for Hippocratic Medicine and the doctors it represented did not have adequate proof of standing to sue the FDA, providing the agency relief from potential endless litigation. Standing is the right of a person or organization to sue another entity and is determined by whether the party […]

June 18, 2024 Artificial Intelligence FDAcop

Supreme Court Unanimously Resolves FDA’s ‘Standing’ Issue: FDA Today Exclusive

In a recent Supreme Court decision, it was unanimously ruled that The Alliance for Hippocratic Medicine and the doctors it represented did not have adequate proof of standing to sue the FDA. The lower courts had previously allowed the lawsuit to proceed based on a theory that not prescribing mifepristone or treating patients who had […]

June 18, 2024 Artificial Intelligence FDAcop

EMA Expresses Gratitude for New MDR/IVDR Standardization Request, Announces Changes to Deadlines

The European Commission recently adopted a new version of the medical device and diagnostics standardization request, adding more standards and extending deadlines by four years. Harmonized standards are published in the European Union’s Official Journal and provide conformity with essential requirements of regulations. European standards organizations, such as CEN and Cenelec, are responsible for developing […]

June 18, 2024 Artificial Intelligence FDAcop

Study finds insufficient enrollment of women in medical device trials

A recent study published in JAMA Internal Medicine reveals that women continue to be underrepresented in medical device trials, particularly in cardiovascular studies. The research found that from 2010 to 2020, the percentage of women participating in high-risk medical device trials did not increase, with women making up just 33% of participants in trials published […]

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