The U.S. FDA’s effort to push companies toward more and better randomized, controlled trials ahead of accelerated approvals – apparently driven by the lack of confirmatory studies done afterward – is “an important and meaningful move by the agency,” said Day One Pharmaceuticals Inc. CEO Jeremy Bender. “The industry’s history in that space has been a little mixed.” Bender’s remarks came Aug. 9 as part of a wide-ranging panel discussion hosted by analyst Robert Driscoll during the Wedbush Pacgrow Healthcare Conference.
Beigene Ltd.’s tislelizumab met its primary endpoint of noninferior overall survival vs. sorafenib as a first-line treatment in hepatocellular carcinoma (HCC), marking the eighth positive phase III trial readout for the anti-PD-1 drug across multiple cancer types and lines of therapy.
Neither the primary endpoint of overall response rate nor the key secondary endpoint of progression free survival achieved statistical significance in Isofol Medical AB’s phase III Agent study of arfolitixorin in combination with 5 fluorouracil, oxaliplatin and bevacizumab in metastatic colorectal cancer (mCRC), licensee Solasia Pharma KK reported.
Prometheus Biosciences Inc.’s stock-boosting news July 26 put more investor eyes on inflammatory bowel disease (IBD), where the company during its R&D Day revealed the target of PRA-052, the clinical candidate that emerged from the program known as PR-600. PRA-052 takes aim at the CD30 ligand, which acts as a co-stimulatory molecule to drive T-cell proliferation and differentiation.
The largest study to date assessing the use of cell-free DNA (cfDNA) analysis to detect cancer in advance of symptoms has completed enrollment of 140,000 healthy volunteers. The study, being run in the U.K. National Health Service (NHS) by the charity Cancer Research UK (CRUK) and cfDNA diagnostics specialist Grail Inc., is using Grail’s Galleri test to look for cancer-specific methylation patterns in blood.
Top-line data from Verona Pharma plc’s phase III ENHANCE-2 study show its inhaled ensifentrine hit the primary and secondary endpoints in treating chronic obstructive pulmonary disease (COPD). Next up: data from the companion phase III, ENHANCE-1, which is expected by the end of 2022.
It’s an august August for Hutchmed Ltd. as it reported positive business results and a number of trial developments, including results from its pivotal global phase III FRESCO-2 trial evaluating the investigational use of fruquintinib in patients with advanced, refractory metastatic colorectal cancer, which met its primary endpoint of overall survival.
Following the readout of a phase II trial evaluating its COVID-19 oral antiviral Pentarlandir (SNB-01), Taiwan’s Syneurx International Corp. said it expects to launch a phase III test of the candidate in the next few months.
Data on C2N Diagnostic LLC’s new blood test combining a proprietary p-tau217 measurement with the amyloid beta (a-beta) 42/40 ratio, a component of C2N’s commercially available PrecivityAD blood test, could help to predict people at risk for Alzheimer’s disease (AD) – even at the earliest stages.
Epigenetic test company Volitionrx Ltd. appointed contract research organization (CRO) Diagnostic Oncology CRO LLC (DXOCRO) to conduct development and clinical validation studies for its Nu.Q product portfolio in the U.S. DXOCRO will carry out large-scale finding studies across the U.S. using Henderson, Nev.-based Volition's cancer tests to determine clinical utility in sepsis and cancer. The trials are aimed at U.S. FDA approval of the products.
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