BIIE CEO Dr Stephen Wilson outlines rapid growth plans and a multidisciplinary technology stack targeting global clinical translation.
|Articles|April 27, 2023
Organ on a Chip Technology: Discussion with Yaakov Nahmias (INTERPHEX 2023)
Yaakov Nahmias, founder and chief scientific officer of Tissue Dynamics, discusses the barriers in implementing organ on a chip technology.
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Yaakov Nahmias, founder and chief scientific officer of Tissue Dynamics, and one of the INTERPHEX Keynote speakers in the
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FDA expands Winrevair’s label with HYPERION data, formalizes the use of non-animal testing methods, and Amgen reports positive Phase 3 results for dazodalibep in Sjögren disease.
The FDA has approved a label update for Merck's Winrevair (sotatercept-csrk) incorporating Phase 3 HYPERION data, showing a 76% reduction in clinical worsening events when added to background therapy in adults diagnosed with pulmonary arterial hypertension within the past year.
FDA's new rule formally recognizes non-animal methods like organoids and AI models as valid ways to support human drug testing.
Dazodalibep hit its phase 3 primary endpoint at week 48, building on phase 2 data showing a 6.3-point ESSDAI reduction versus placebo.
Glycomine's GLM101, an investigational liposomal mannose-1-phosphate substrate replacement therapy, has received FDA Breakthrough Therapy designation for PMM2-CDG, a rare glycosylation disorder with no approved treatments.
How early Phase I decisions can shape or compromise the regulatory and financing outcomes that define a biotech program's future.
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