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The Utility of Liquid Biopsy in Oncology Clinical Trials

XTalks

Liquid biopsy tests in oncology involve isolating entities such as circulating tumor cells (CTC), circulating tumor DNA (ctDNA) and tumor-derived exosomes. These tumor-derived entities are used to derive genomic and proteomic data. The same webinar held a Q&A session with Dr. Bahassi and two other experts from Medpace, Dr. Lyon L.

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US FDA Advisory Committee votes in favour of maintaining accelerated approval of Roche’s Tecentriq for previously untreated metastatic bladder cancer

The Pharma Data

5 percent of the tumour area) as determined by an FDA-approved test or are not eligible for any platinum-containing chemotherapy regardless of PD-L1 status. The advisory committee provides the FDA with independent opinions and recommendations from outside medical experts though the recommendations are not binding.

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Lab to jab in 100 days: manufacturing flexibility for future rapid responses

Pharmaceutical Technology

The live attenuated vaccine was authorized by the EMA and FDA five years later in 2019 — half the time than normal. The live attenuated vaccine was authorized by the EMA and FDA five years later in 2019 — half the time than normal. Before COVID-19, Merck held the record for the fastest modern vaccine ever developed.

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US FDA Advisory Committee votes in favour of maintaining accelerated approval of Roche’s Tecentriq for PD-L1-positive, metastatic triple-negative breast cancer

The Pharma Data

Today’s ODAC meeting is part of an industry-wide review of accelerated approvals with confirmatory trials that have not met their primary endpoint(s) and have yet to gain regular approvals. The FDA has not announced when it will make its final decision for Tecentriq in this indication.

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Pfizer Responds to Research Claims

Pfizer

Working with collaborators, we have conducted research where the original SARS-CoV-2 virus has been used to express the spike protein from new variants of concern. and global regulatory requirements for our oral treatment, PAXLOVID™, Pfizer undertakes in vitro work (e.g., It is important to note that these studies are required by U.S.

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Innovation Pharmaceuticals’ Brilacidin for the Treatment of COVID-19 Receives FDA Fast Track DesignationPhase 2 clinical trial of Brilacidin for COVID-19 anticipated to commence this month

The Pharma Data

Food and Drug Administration (FDA) has designated as a Fast Track development program the investigation of Brilacidin as a potential treatment for COVID-19. Brilacidin is a first-in-class Host Defense Protein (HDP) mimetic with antiviral, anti-inflammatory and antibacterial properties.

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Using bispecific antibodies to advance cancer immunotherapy

pharmaphorum

Clinical interest in bsAbs gained momentum following the promising data and market success of blinatumomab (BLINCYTO®, Amgen), a fragment-based bispecific T cell engager (BiTE), which first received FDA approval in 2014 and EMA approval in 2015. Simplified schematic overview of the proposed mechanisms of action for bsAbs.