Phase 2
Biomarin indicated that the FDA had requested more data from non-clinical studies to evaluate the theoretical cancer risk to human trial participants. This is likely to take several quarters.
The NDA acceptance is based on positive results from the KRYSTAL-1 trial, which looked into the effect of using 600mg BID of adagrasib in patients.
Roivant Sciences launches new subsidiary Hemavant that will develop Eisai-licensed asset for transfusion-dependent anemia in patients with low-risk MDS.
Six months after the one-time treatment, 47% of patients in Cohort 1 demonstrated a promising two-step or greater improvement in their diabetic retinopathy.
ProQR Therapeutics has reported that their drug sepofarsen failed to meet its primary and secondary endpoints in recent Phase II/III clinical trials.
Eli Lilly’s proposed antibody drug bebtelovimab has received EUA from the FDA after demonstrating its potency against SARS-CoV-2’s Omicron variant.
Curevo, a clinical-stage biotechnology company, is developing safe and highly-effective vaccines to fight infectious diseases such as shingles.
The EMA’s safety committee has announced that they are reviewing reports of menstrual disorders after people received COVID-19 vaccinations from Pfizer-BioNTech and Moderna.
The EUA request is based on the Phase II study that showed treatment with ensovibep reduced the viral load from the SARS-CoV-2 virus within eight days of use compared to placebo.
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