Events FDA Approval Pharmacokinetics Trials 
Advarra
JUNE 20, 2023
of new cancer drugs tested in Phase I were likely to receive Food and Drug Administration (FDA) approval. Innovation Organizations conducting oncology clinical trials face challenges distinct from the rest of the research community. Typical clinical development timelines for anticancer drugs average an estimated 6.7
The Pharma Data
MAY 5, 2021
It also provided supporting pharmacokinetic data demonstrating the opioid antagonist’s safety and efficacy. . A total of 197 patients in the study arm had at least one of the composite endpoint events, compared with 312 patients in the placebo arm. controlled trial had not received previous systemic therapy for metastatic disease.
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The Pharma Data
SEPTEMBER 7, 2021
The first patients have been enrolled in a phase 1 randomized placebo-controlled clinical trial to study a therapeutic vaccine for opioid use disorder developed by researchers at the University of Minnesota Medical School.
The Pharma Data
OCTOBER 25, 2020
The Company plans to initiate a Phase 2 trial within the next several months. “We An exploratory endpoint of this trial will be to determine the overall clinical improvement after drug administration using the Clinical Global Impression – Improvement Scale (“CGI-I”).
The Pharma Data
AUGUST 19, 2021
The majority of treatment-related adverse events (AEs) were Grade 1-2. FDA for the treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy in May 2021.
Agency IQ
SEPTEMBER 15, 2023
Until recently, the FDA relied on a monograph process through which firms could bring OTC drugs to market without FDA approval so long as it adhered to pre-set terms under the monograph. Finally, the committee came up with a list of recommendations for the structure of additional trials, listed in the meeting minutes.
The Pharma Data
APRIL 11, 2021
” In the Phase 1/2 LIBRETTO-001 trial, 32 adult patients with 12 unique RET fusion-positive advanced cancer types were enrolled by the efficacy cutoff date of September 19, 2020 (with follow-up through March 19, 2021). In this cohort, the most common treatment-emergent adverse events of any grade (?20%) About LIBRETTO-001.
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