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Decoding Clinical Trial Costs and Efficiency Roadblocks

Vial

Introduction The biopharma industry is poised to make revolutionary advances in and redefine drug development, and the current climate for innovation appears ideal. According to Rodríguez-Molinero et al., only 5% of molecules in oncology Phase I trials reach the market taking, on average, 7.5

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Massive Bio Launches Industry’s First NASA-Style, Oncology Clinical Trial Command Center to Disrupt and Accelerate Trial Enrollment, Featuring 72-Hour Instant Enrollment from Time of Patient Identification

The Pharma Data

Massive Bio is an AI-driven platform connecting cancer patients and their oncologists to bio-pharmaceutical clinical trials, yielding profound improvement in access and match rates, leading to faster drug development timelines, and creating a novel oncology data ecosystem for improved protocol design and real-world insights.

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Analysis Life Sciences Thank You What We Expect the FDA to do in November 2023

Agency IQ

FDA is proposing to establish the criteria by which it would evaluate drug products and categories of drug products for inclusion on the list of drug products and categories of drug products that present demonstrable difficulties for compounding under section 503A and/or under section 503B.

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Analysis Life Sciences Thank You The FDA and oncology: 2023 year in review

Agency IQ

In 2015, the FDA, along with the American Association for Cancer Research (AACR), held a workshop on dose optimization for small molecules. Pediatric patients: Likewise, reviewers from OCE have persistently voiced the need for pediatric patients to be included earlier in the drug development process as well.

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Analysis Life Sciences Thank You What We Expect the FDA to do in October 2023

Agency IQ

FDA is proposing to establish the criteria by which it would evaluate drug products and categories of drug products for inclusion on the list of drug products and categories of drug products that present demonstrable difficulties for compounding under section 503A and/or under section 503B.

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Analysis Life Sciences Thank You What We Expect the FDA to do in December 2023

Agency IQ

FDA is proposing to establish the criteria by which it would evaluate drug products and categories of drug products for inclusion on the list of drug products and categories of drug products that present demonstrable difficulties for compounding under section 503A and/or under section 503B.

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FDA Approves Inmazeb (atoltivimab, maftivimab and odesivimab-ebgn) Antibody Cocktail for Ebola (Zaire Ebolavirus)

The Pharma Data

“Since 2015, BARDA has partnered with Regeneron to develop a life-saving treatment for Ebola Zaire. Regeneron is actively working with non-governmental organizations and public health agencies to ensure continued access to Inmazeb in low- and middle-income countries.