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<a href="https://www.fiercebiotech.com/biotech/fda-launches-pilot-program-speed-sluggish-phase-1-trials" hreflang="en">FDA launches pilot program to speed up sluggish phase 1 trials</a>

After teasing a new initiative to speed up early-stage clinical trials over the summer, the FDA today opened a pilot program for an expedited investigational new drug (IND) application process that the agency hopes will put U.S. phase 1 trials on par with those in China and Australia.

Fierce BiotechFierce BiotechDarren Incorvaia11h ago

<a href="https://www.fiercebiotech.com/biotech/gsk-doubles-down-chimagen-750m-multiple-myeloma-wager" hreflang="en">GSK doubles down on Chimagen with $750M multiple myeloma wager</a>

GSK has bet up to $750 million on a Chimagen Biosciences trispecific T-cell engager, positioning the Big Pharma to start phase 1 development of the multiple myeloma drug candidate next year. The deal comes two years after GSK paid China’s Chimagen $300 million upfront for a trispecific lupus prospect.

Fierce BiotechFierce BiotechNick Paul Taylor18h ago

<a href="https://www.fiercebiotech.com/biotech/cultural-weight-psychedelic-approval-looms-fda-hearing-focuses-access-and-safety" hreflang="en">As ‘cultural weight’ of a psychedelic approval looms, FDA hearing focuses on access and safety</a>

As the FDA marches toward the likely first approval of a psychedelic medicine, the agency today convened a hearing seeking public input on how these drugs should be used, monitored and continuously studied in the real world.

Fierce BiotechFierce BiotechDarren Incorvaia15 Sept