Drug firms don't have a firm grasp of the development of biomarkers or their potential role in clinical decision-making. Nor have they, with few exceptions, looked to the diagnostics industry for help-they've been unwilling to outsource activities related to highly proprietary drug development projects. Moreover, traditionally, drug and diagnostic company alliances haven't fared well because both parties have different value expectations. Small diagnostic companies want biotech-like prices for their contributions; pharma marketers often see diagnostics as limiting to their sales efforts, and certainly something that can take attention away, in a 30-second detail call, from the main event-the higher-priced drug. But an eight-year-old alliance between British drug maker GlaxoSmithKline PLC (GSK) and diaDexus Inc. seems to address these barriers with some novel approaches now starting to bear fruit.
For drug companies, diagnostics are hot tools that can help
maximize R&D productivity and improve their drugs' safety and
efficacy profiles. The ventures funds at Eli Lilly & Co. and Pfizer Inc. have both made diagnostics investments.
Arguably the lack of the relevant biomarker has forced
AstraZeneca PLC to withdraw its
European marketing application for gefitinib
(Iressa)—which does help some people.
But drug firms don't have a firm grasp of the development of biomarkers or their potential role in clinical decision-making....
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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.
The seventh annual edition of In Vivo’s Rising Leaders features entrepreneurs, academics, lawyers, regulators and innovators from around the globe, representing the forefront of creativity in health care.
