Communication Labelling White Paper 
Pharmaceutical Technology
JANUARY 24, 2023
The multi-centre, open-label, single-arm clinical trial has been designed to evaluate the efficacy, tolerability, and safety of a single dose of NGN-401 delivered using a one-time ICV procedure. Neurogene stated that the FDA IND clearance allows it to commence a Phase II/II trial of NGN-401 in female paediatric Rett syndrome patients.
pharmaphorum
MARCH 30, 2021
Such interventions take the need for robust value claims to a completely different level, with important implications for the evidence companies need to collect, and how they collect and communicate it. There are a number of drivers behind the need to rethink value evidence and value communication. Changes are afoot – what to look for.
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Pharmaceutical Technology
DECEMBER 16, 2022
This submission comprises preliminary findings from a Phase II open-label, single-arm, single-dose, multicentre clinical trial of CNCT19. By downloading this Whitepaper, you acknowledge that we may share your information with our white paper partners/sponsors who may contact you directly with information on their products and services.
Pharmaceutical Technology
FEBRUARY 21, 2023
Its decision is based on the data obtained from the ongoing, open-label, multinational, single-arm, pivotal Phase III HOPE-B trial. The regulatory approval followed a positive opinion from Committee for Medicinal Products for Human Use (CHMP) in December last year. The trial is designed to evaluate the safety and efficacy of Hemgenix.
Pharmaceutical Technology
FEBRUARY 17, 2023
The data from our recently announced 18-month HOPE-2 open-label extension study showed evidence of disease modification and showed statistically significant differences in the Performance of the Upper Limb (PUL).” “CAP-1002 has shown clinical benefits for cardiac and skeletal muscle myopathy, which few therapies have demonstrated.
The FDA Law Blog
OCTOBER 10, 2022
Certainly we would expect clinical communications, as well as HCP-patient communications, to include discussions of test results over time as these would seem highly relevant to clinical decision making. The final guidance focuses on labeling as a means to effectuate Criterion 4. software or labeling.
ISPE
JULY 19, 2023
and management communication strategy. ™” is becoming an increasingly rhetorical one, particularly in view of the growing momentum in the pharmaceutical industry and in various statements and white papers from key regulatory agencies. And finally, it should be acknowledged that the discussion of “why Pharma 4.0™”
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