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Month: June 2024

Laboratory trade group files lawsuit against FDA to stop regulation of lab-created tests
June 20, 2024 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 […]

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New Monoclonal Antibody Receives Strong Support from Advisory Committee for Early Alzheimer’s Treatment: Exclusive Life Science Analysis
June 19, 2024 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 […]

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Day One Biopharma Expands into Cancer Biotech with Acquisition of ADCs, Investing $55M for Phase 1-Ready Drug
June 19, 2024 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 […]

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June 18, 2024 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 […]

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Study finds insufficient enrollment of women in medical device trials
June 18, 2024 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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