Blueprint Medicines Corporation (NASDAQ: BPMC), a US-based global precision therapy company that said it invents life-changing therapies for people with cancer and blood disorders, announced on Tuesday that the US Food and Drug Administration (FDA) has withdrawn a partial clinical hold on the Phase 1/2 VELA trial of BLU-222.
The company announced on 10 February 2023 that the FDA had placed a partial clinical hold on the VELA trial because of reported visual adverse events, which included transient, reversible episodes of light sensitivity and blurred vision, observed in a limited number of patients. Subjects already enrolled in the trial have continued receiving the study drug.
With the removal of the partial clinical hold, the company is working with trial sites to reinitiate patient enrolment.
Palatin presents symptom resolution data from Phase 3 dry eye disease trial
BioArctic expands exidavnemab trial to include Multiple System Atrophy patients
NeuroSense Therapeutics completes PrimeC commercial manufacturing scale-up
SCG releases SCG101 late-breaking clinical data in HBV-related hepatocellular carcinoma
Genprex signs new research agreement with University of Pittsburgh to advance diabetes gene therapy
AstraZeneca and Daiichi Sankyo's Enhertu shows strong results in early-stage breast cancer trial
Adcentrx's ADRX-0706 granted US FDA Fast Track designation to treat advanced cervical cancer
Ajinomoto and RIBOMIC announce successful extension of nucleic acid aptamer pharmacokinetics