XTalks

JANUARY 21, 2025

From non-invasive cancer diagnostics to life-saving cardiovascular implants, the latest medical devices cleared or approved by the FDA in 2024 reflect the remarkable strides in science and engineering. In this blog, we discuss some of these new medical devices of 2024 that have improved patient outcomes and enhanced quality of life worldwide.

FDA Approval 105

FDA Approval Manufacturing Development RNA 105

XTalks

APRIL 6, 2022

Cancerous cells and tumors release small fragments of DNA into the bloodstream called circulating tumour DNA (ctDNA). The researchers at the Cancer Research UK Cambridge Institute published this data from the LUng cancer CIrculating tumour DNA (LUCID) study in the journal Annals of Oncology. Photo source: Inivata.

DNA 105

DNA In-Vitro Doctors Doctor 105

BioTech 365

MARCH 9, 2021

an important non-canonical DNA secondary structure in vivo and in vitro, G-quadruplexes (GQs) have been widely investigated in many fields including biology, … Continue reading →

Scientist 40

Scientist In-Vivo In-Vitro DNA 40

BioTech 365

SEPTEMBER 20, 2020

SEVILLE, Spain–(BUSINESS WIRE)–Universal Diagnostics (UDX), an in-vitro diagnostics company developing minimally-invasive, blood-based solutions for detecting cancer early, announced today that promising new data for its investigational advanced adenoma (precursor lesions of colorectal cancer) detection blood test and multi-cancer detection (..)

In-Vitro 40

In-Vitro DNA Development 40

XTalks

DECEMBER 28, 2023

XTALKS WEBINAR: Impacts of the New IVD Regulation (IVDR) for Manufacturers and Users Live and On-Demand: Tuesday, January 9, 2024, at 10am EST (4pm CET/EU-Central) Register for this free webinar to learn how the new In Vitro Diagnostic Regulation (IVDR) impacts manufacturers and users of diagnostic devices.

Trials 97

Trials Clinical Trials Clinical Trials Antibody 97

Bioengineer

JANUARY 16, 2024

Analysis of circulating tumor (ct) DNA at the time of treatment discontinuation or progression showed that 49% of patients in the AURA3 trial lacked the T790M mutation. Analysis of circulating tumor (ct) DNA at the time of treatment discontinuation or progression showed that 49% of patients in the AURA3 trial lacked the T790M mutation.

Genomics 119

Genomics Genome Protein In-Vitro 119

pharmaphorum

OCTOBER 29, 2020

The platform applies machine learning, human genetics, and functional genomics to generate predictive in vitro models that provide insights into disease progression. The platform applies machine learning, human genetics, and functional genomics to generate predictive in vitro models that provide insights into disease progression.

Development 45

Development DNA In-Vitro Genome 45

Roots Analysis

MARCH 16, 2023

Messenger ribonucleic acid (mRNA) is a single-stranded molecule that is complementary to a gene’s DNA. It is important in the process of protein synthesis because mRNA is responsible for transferring genetic information from DNA to ribosomes, which then decodes the genetic information into a protein.

Vaccination 52

Vaccination Vaccine DNA Protein 52

Roots Analysis

AUGUST 12, 2024

Molecular diagnostic tests refer to tests intended to detect specific sequences in human genomic samples, such as DNA or RNA, in order to diagnose a particular disease. It is worth mentioning that molecular diagnostics is a subset of the broader in vitro diagnostics market.

Genetics 40

Genetics Gene Expression RNA DNA 40

The Pharma Data

AUGUST 27, 2020

Cancer is a disease of the genome, driven by genetic mutations within a tumour’s DNA. FoundationOne Liquid CDx analyses circulating cell-free DNA from a patient’s blood sample and uses massively parallel sequencing to detect the four main classes of genomic alterations.

FDA Approval 52

FDA Approval Genome Genomics Gene 52

The Pharma Data

OCTOBER 26, 2021

About the AVENIO Tumor Tissue CGP Kit The AVENIO Tumor Tissue CGP Kit is a Research Use Only next-generation sequencing test that provides an end-to-end workflow from DNA extraction and library preparation to generation of variant results by the FoundationOne Analysis Platform via AVENIO Connect.

Genome 52

Genome Genomics Research Medicine 52

The Pharma Data

DECEMBER 14, 2020

The current standard of care for GBM consists of de-bulking surgery followed by combined treatments with fractionated ionizing radiation (IR) and the DNA alkylating agent temozolomide (TMZ). . Many drugs fail in clinical trials because of their low blood brain barrier permeability. Lantern’s A.I.

Drugs 52

Drugs Genomics Genome DNA 52

The Pharma Data

DECEMBER 22, 2020

Available since 2017 as an in vitro diagnostic assay (IVD) in Europe and the United States, Japanese clinical geneticists can now have access to this assay to help identify a definitive genetic diagnosis for their patients. SANTA CLARA, Calif.–( –( BUSINESS WIRE )– Agilent Technologies Inc.

Genome 40

Genome Genomics Genetics In-Vitro 40

Cloudbyz

JULY 31, 2024

Liquid biopsies, for example, allow non-invasive monitoring of cancer progression and response to treatment by analyzing circulating tumor DNA (ctDNA) in blood samples. The landscape of modern medicine is rapidly evolving, driven by groundbreaking advancements in diagnostics.

Gene Therapy 52

Gene Therapy Gene Medicine In-Vitro 52

The Pharma Data

SEPTEMBER 1, 2020

Antigen test reliably and quickly triages people suspected of SARS-CoV-2, with results ready in 15 minutes, allowing informed treatment decisions. Antigen test accurately screens individuals with known exposure to infected SARS-CoV-2 patients, providing fast answers regarding their infection status. Food and Drug Administration (FDA).

In-Vitro 52

In-Vitro Antibody Medicine Clinical Trials 52

Pharmaceutical Technology

MAY 26, 2023

Enzymatic DNA production company Touchlight have augmented its DNA production capabilities with a newly announced expansion to its London facilities. Tripling its production capacity, Touchlight can now manufacture 8kg plasmid DNA, a key component for mRNA gene therapies and vaccines.

DNA 130

DNA Manufacturing Gene Gene Therapy 130

XTalks

OCTOBER 1, 2020

Leaving academia for industry is a route that academic scientists and professors did not traditionally pursue in the past due to perceived differences in skillsets, experiences and even associated stigmas. However, this has since changed, and now, transitioning between academia and industry has become more commonplace. Key Moments.

Scientist 52

Scientist In-Vitro Research Life Science 52

Roots Analysis

OCTOBER 16, 2023

DNA cloning refers to the process of generating multiple copies of a particular DNA segment. DNA and Gene Cloning involves the isolation of a DNA sequence of any species ( often a gene ) and its insertion into a vector to enable growth without any alteration in the original DNA sequence.

DNA 40

DNA Gene Protein In-Vitro 40

XTalks

SEPTEMBER 30, 2020

The team sequenced DNA from 659 critically ill COVID-19 patients and 534 controls with mild or asymptomatic disease. The two studies were recently published online in the journal Science, both of which were led by Jean-Laurent Casanova, an infectious disease geneticist at Rockefeller University. Mutational Errors in COVID-19 Patients.

Antibody 135

Antibody Genetics Research In-Vitro 135

XTalks

OCTOBER 8, 2024

The approval was awarded to Abbott’s Alinity m MPXV assay, the first mpox in vitro diagnostic (IVD) listed under the WHO’s Emergency Use Listing (EUL) procedure. The Alinity m MPXV assay is a real-time PCR test designed to detect mpox virus (clade I/II) DNA from swabs of human skin lesions.

In-Vitro 98

In-Vitro DNA Contamination Manufacturing 98

XTalks

NOVEMBER 7, 2022

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.

Clinical Trials 98

Clinical Trials Clinical Trials Trials FDA Approval 98

Pharma Mirror

APRIL 21, 2024

Messenger RNA (mRNA) is a single-stranded ribonucleic acid transcribed from the DNA chain, carrying the encoding information for protein synthesis. In vitro transcribed (IVT) mRNA has been successfully The post General Design Methods for mRNA Drugs appeared first on Pharma Mirror Magazine.

In-Vitro 130

In-Vitro Drugs Genetic Disease RNA 130

XTalks

MAY 12, 2022

This diagnostic assay works on the principle of in vitro nucleic acid amplification using real-time transcription-mediated amplification (TMA) technology. The Aptima CMV Quant Assay helps to detect changes in the viral load of the transplant patient to understand the response of the individual to anti-CMV treatment.

In-Vitro 52

In-Vitro DNA Development Genome 52

The Pharma Data

SEPTEMBER 28, 2021

About the three new Roche tests for Influenza A/B, RSV; ADV, hMPV, EV/RV; and Parainfluenza 1-4 These tests utilise a real-time PCR macromolecule amplification method to detect specific DNA sequences obtained after extraction or following reverse transcription of RNA.

Marketing 52

Marketing In-Vitro DNA Bacteria 52

XTalks

AUGUST 12, 2020

Despite the effectiveness of anti-retroviral therapy (ART) in significantly improving health, quality of life and reducing mortality among HIV-positive individuals, new research shows that persistent infections may be due to the ability of the virus to take refuge in distinct subsets of immune T cells.

RNA 52

RNA Protein DNA In-Vivo 52

Roots Analysis

OCTOBER 22, 2023

In the last few years, researchers have become interested in using in vitro transcribed (IVT) mRNA as a drug delivery agent. It is important to highlight that IVT mRNAs are structurally similar to natural mRNAs and can be used to express proteins through genetic engineering.

RNA 40

RNA Protein Genetics Gene Expression 40

The Pharma Data

MAY 18, 2021

MMR is a molecular mechanism that functions to correct certain errors that can spontaneously occur during DNA replication. This companion diagnostic (CDx) provides clinicians with a standardised testing option that uses a comprehensive panel of DNA mismatch repair (MMR) biomarkers tested by immunohistochemistry (IHC).

FDA Approval 40

FDA Approval DNA Protein In-Vitro 40

The Pharma Data

AUGUST 4, 2020

Accurate monitoring of Epstein-Barr virus DNA levels is critical, as they are associated with a range of life threatening-diseases including cancer in transplant patients. This is the first quantitative in vitro diagnostic test for Epstein-Barr virus (EBV) DNA in the United States.

DNA 52

DNA In-Vitro Medicine Reagent 52

Roots Analysis

AUGUST 15, 2023

Overview of Cell Free Systems Cell-free systems are ­in-vitro platforms which allow occurrence of biochemical reactions in the absence of living cells. These expression systems utilize bio machinery harvested from the lysate of disrupted cells for the manufacturing of a wide array of macromolecular and small molecule products.

Protein 52

Protein In-Vitro Reagent Production 52

Roots Analysis

JANUARY 14, 2024

It is worth mentioning that in vitro gene expression requires a suitable host for the production of a specific gene product. Notably, biologics have higher success rates than conventional small-molecule drugs owing to lesser off-target toxicity of biologics, which is one of the key reasons of failures in small molecule drugs development.

Contract Manufacturing 40

Contract Manufacturing Protein Manufacturing Production 40

Pharmaceutical Technology

NOVEMBER 22, 2022

mRNA vaccines can be made more quickly than traditional vaccine platforms because they are produced using an in vitro synthetic process that does not require the time-consuming growth or removal of cells and proteins. Before COVID-19, Merck held the record for the fastest modern vaccine ever developed. The UK Government is behind this effort.

Manufacturing 130

Manufacturing Vaccination Vaccine RNA 130

Pfizer

JANUARY 27, 2023

In preclinical studies, nirmatrelvir did not demonstrate evidence of mutagenic DNA interactions. The European Commission (EC) will review the CHMP recommendation and is soon expected to make a final decision. PAXLOVID is currently approved or authorized for conditional or emergency use in more than 70 countries to treat COVID-19.

Marketing 75

Marketing Production Drugs Licensing 75

Pharmaceutical Technology

FEBRUARY 20, 2023

On the other hand, a lack of diversity in clinical trial populations, particularly when the disease population is significantly underrepresented, greatly diminishes the quality of data obtained for drug safety and efficacy profiles. This may sound obvious, but it is still a major hurdle in drug development. of the clinical trial population globally.

Research 130

Research Clinical Trials Clinical Trials Trials 130

Pfizer

DECEMBER 20, 2022

In preclinical studies, nirmatrelvir did not demonstrate evidence of mutagenic DNA interactions. FDA Extends Review of Pfizer’s New Drug Application for PAXLOVID™. Tuesday, December 20, 2022 - 04:30pm. Pfizer oral treatment remains available to eligible U.S. NEW YORK, December 20, 2022 -- Pfizer Inc. NYSE: PFE) announced today that the U.S.

Drugs 69

Drugs Licensing Licensing Containment 69

Pfizer

DECEMBER 13, 2022

In preclinical studies, nirmatrelvir did not demonstrate evidence of mutagenic DNA interactions. Nirmatrelvir has shown consistent in vitro antiviral activity against the following variants: Alpha, Beta, Delta, Gamma, Lambda, Mu, and Omicron BA.1, The additional 3.7 million treatment courses are planned for delivery by early 2023. .

Drugs 110

Drugs Licensing Licensing Production 110

Pfizer

AUGUST 15, 2022

In preclinical studies, nirmatrelvir did not demonstrate evidence of mutagenic DNA interactions. Nirmatrelvir has shown consistent in vitro antiviral activity against the following variants: Alpha, Beta, Delta, Gamma, Lambda, Mu, and Omicron BA.1 FDA Emergency Use Authorization Statement.

Drugs 99

Drugs Vaccine Vaccination In-Vitro 99

The Pharma Data

MARCH 22, 2022

In preclinical studies, nirmatrelvir did not demonstrate evidence of mutagenic DNA interactions. Financial details of the agreement were not disclosed. Pfizer expects supply to be available to support orders in April 2022, and supply will continue throughout 2022, pending regulatory authorization or approval and according to country needs.

In-Vitro 52

In-Vitro Contract Manufacturing Manufacturing Development 52