FDA Clinical Hold Hits Keytruda Multiple Myeloma Studies
Development of the leading immune-oncology agent has hit the buffers for multiple myeloma but failure in this relatively small market should not materially impact the product's prospects.
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Deal Watch: Bayer Teams With Nuvisan On Berlin-Based Small Molecule Research Group
Deal news from Bayer, Nuvisan, Inamed, BioMotiv, Bristol-Myers Squibb, Collegium, Assertio, Merck & Co., KalVista, Atreca, Coda, Attenua, Aimmune, Xencor, EyePoint, Equinox, Allergan, Nestle, Zealand, Valeritas…
Darzalex Solid Tumor And PD-(L)1 Combo Future Dashed
Hopes for Genmab/Janssen's myeloma drug daratumumab in solid tumors have faded after the CALLISTO trial in combination with Roche's Tecentriq in NSCLC was halted for lack of benefit and increased mortality. The future is dim for Darzalex in combination with PD-(L)1 therapies in general.
US FDA Tweaks IND Clinical Hold Policy As Number Of Holds Rises
Clinical holds by the US FDA have risen 36% since 2014.