FDA Approval Laboratories Pharmacokinetics Therapies 
Drug Discovery World
APRIL 10, 2024
iECURE has been given the go-ahead to begin US trials of its investigational gene editing-based therapy in newborn males with neonatal onset Ornithine Transcarbamylase (OTC) deficiency. Secondary objectives are to assess the pharmacokinetics and efficacy of ECUR-506.
The Pharma Data
MAY 4, 2021
INDIANAPOLIS , May 4, 2021 /PRNewswire/ — Eli Lilly and Company (NYSE: LLY) is donating COVID-19 therapies to Direct Relief, enabling the humanitarian organization to provide COVID-19 therapies at no cost to low- and lower-middle-income countries most heavily impacted by the pandemic.
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Drug Discovery World
AUGUST 10, 2022
But decades of research led to improvements in cancer therapy, centred around the idea that one’s immune system could aid in treatment. Next, the advent of antibody treatments in 1997 created the first targeted cancer therapy 2. Since 2017, five CAR T cell therapies have been approved and have shown incredible success in the clinic.
The Pharma Data
AUGUST 19, 2021
3] While MET inhibitors have recently received accelerated approval in this setting in some regions, the vast majority of patients eventually acquire resistance to these therapies, thus underscoring the need for new treatment options. [4] RYBREVANT TM (amivantamab-vmjw) received accelerated approval by the U.S.
Drug Discovery World
AUGUST 3, 2023
Even still, these approved drug products require a licensed healthcare provider’s prescription. With these exceptions, no other cannabis, cannabis-derived, or cannabidiol (CBD) products are FDA-approved and therefore on the market 1. At UC San Diego Health, there are currently eight cannabis clinical trials in progress 9.
The Pharma Data
APRIL 11, 2021
” In May 2020, Lilly’s first-in-class selective RET inhibitor Retevmo received Accelerated Approval from the U.S. Retevmo was approved based on the Phase 1/2 LIBRETTO-001 trial’s endpoints of ORR and DoR. FDA-approved oral prescription medicine, 120 mg or 160 mg dependent on weight (<50 kg or ?50
The Pharma Data
DECEMBER 5, 2020
” In the trial, the 49 patients evaluated had a median of five prior lines of therapy (range: 2-17) with 100% being triple-refractory and 57% being penta-refractory; all patients were refractory to anti-CD38 therapy. With a median follow up of 2.6 Multiple myeloma is not curable despite treatment advances.
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