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Clinical research experts from the CRO Medpace shared insights about the operational and regulatory considerations for neuroscience trials with direct CNS administration. Such therapies may involve small interfering RNA (siRNA) or oligonucleotides in viral transfection platforms, large molecules and antibodies.
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Primary and all key secondary endpoints including itch, interference of itch on sleep and quality of life were met at Week 16 in two pivotal Phase 3 trials in lebrikizumab clinical trial program – Safety profile consistent with prior lebrikizumab studies in atopic dermatitis. 1-4 The U.S. . Almirall S.A.’s
In fact, it has been observed that around 40% of the pharmaceutical drugs approved by regulatory organizations exhibit poor bioavailability / solubility. Further, every year, poor bioavailability is one of the main causes of drug failure in obtaining approval authorization.
Padcev is a first-in-class antibody-drug conjugate (ADC) directed against Nectin-4, a protein. However, now the duo has reported positive primary results from the phase 3 EV-301 trial comparing Padcev to chemotherapy and are positive about receiving FDA affirmation. Maribavir is an orally bioavailable anti-CMV compound.
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