Targeted drug development raises a new conflict of interest possibility when a company hoping to market a drug is also trying to win approval for the diagnostic that proves the drug's efficacy. That problem of "self-validation" is one aspect of the even broader drug/diagnostic question: when and how a company should go about validating a biomarker it wants to incorporate onto a drug label.
Targeted drug development raises a new conflict of interest possibility: the company hoping to market a drug may also be trying to win approval for the diagnostic that proves the drug's efficacy.
That's what Pfizer Inc. realized when it decided to participate in the Alzheimer's Disease Neuroimaging Initiative (ADNI), a consortium...
The cell and gene therapy (CGT) clinical trial landscape in general and CAR-T cell clinical trials in particular are a special focus for the FDA, EMA, and other regulatory agencies. The whole industry is thus aware of the recent FDA safety investigation and requirements for labeling CAR therapy products.
Digital clinical trials, a trend sparked by the COVID-19 pandemic that has held the biopharma industry’s interest, are changing the way patients interact with research and improving access, says Medable’s CEO.
INFOGRAPHIC: Deal volume for both M&A and alliances fell in 2023, but average valuations rose appreciably. Antibody-drug conjugates for cancer drove high-value acquisitions and partnerships.
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Launching In Vivo’s oncology therapeutic review series, this first instalment provides a data-led primer on the global cancer landscape. Future instalments will explore market dynamics, pipeline evolution and the innovations set to define oncology therapeutics through 2032.
Launching In Vivo’s oncology therapeutic review series, this first instalment provides a data-led primer on the global cancer landscape. Future instalments will explore market dynamics, pipeline evolution and the innovations set to define oncology therapeutics through 2032.
