STAT News

JULY 28, 2022

Using a common cloning technique, researchers removed the genetic material from one female’s eggs and replaced them with nuclear DNA from the skin cells of another. Then with a novel chemical cocktail, they nudged the eggs to lose half their new sets of chromosomes and fertilized them with mouse sperm. Read the rest…

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Pharmaceutical Technology

NOVEMBER 4, 2022

The staff in the US from the acquired business will be retained by Reaction to set up its presence in Hershey, which comprises in vitro and in vivo expertise. The staff in the US from the acquired business will be retained by Reaction to set up its presence in Hershey, which comprises in vitro and in vivo expertise. at closing.

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In-Vivo In-Vitro Genetics Drugs 130

pharmaphorum

JANUARY 22, 2021

According to the US biopharma company, genetic analyses of publicly available sequences for the new variants of SARS-CoV-2 suggest the mutations in the viral spike protein that have made them more transmissible shouldn’t affect the way Veklury (remdesivir) works. The UK strain – known as B.1.1.7

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Scienmag

AUGUST 31, 2020

The project seeks to kickstart the development of an open access “Organoid Cell Atlas” By creating well-characterized in vitro […].

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Worldwide Clinical Trials

JUNE 21, 2024

Unlike CAR T therapies, TILs are produced in vitro by purifying natural infiltrating lymphocytes from the patient’s own tumor microenvironment. The 2024 ASCO Annual Meeting from the American Society of Clinical Oncology is a fantastic platform for clinical researchers to discuss the latest advancements and challenges in oncology research.

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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.

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XTalks

MARCH 27, 2024

In vitro diagnostics, or IVD, is a field where precision, reliability and robust partnerships propel advancement. Each diagnostic evaluation and every lab discovery signify not only technological advancement but also the fruit of integrated teamwork, with decisions made collaboratively. Their significance in the field of IVD is paramount.

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STAT News

FEBRUARY 23, 2023

Ovarian cancer has long been one of the deadliest cancers to strike women. No tests are available to detect it early, so most patients are diagnosed in later stages, when the cancer is more likely to have spread. Fewer than half of women survive 5 years past their diagnosis, and 80 percent have no known risk factors.

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Genetics In-Vitro Research Gene 111

Bioengineer

JANUARY 16, 2024

Another genetic change at the C797 residue in the ATP binding region of EGFR’s exon 20 has emerged as a key mechanism of resistance to osimertinib. The presence of the T790M mutation during first or second-generation EGFR-TKI treatments is observed in 50-60% of patients. months vs. 15.2 months, p = 0.01). months, 95% CI 1.3,

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The Pharma Data

MAY 17, 2021

The European Commission’s Medical Device Coordination Group (MDCG) sent a notice to in vitro diagnostic (IVD) makers and their authorized representatives reminding them of their obligation to assess the impact of COVID-19 variants on the performance of their tests. . © 2021 Regulatory Affairs Professionals Society.

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XTalks

APRIL 6, 2022

The personalized ctDNA blood test uses the RaDaR™ assay, a liquid biopsy platform developed by the company Inivata. Photo source: Inivata. Lung cancer is the most common cancer in men and the third most common cancer in women, according to global lung cancer statistics by the World Cancer Research Fund.

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DNA In-Vitro Doctor Doctors 105

pharmaphorum

JANUARY 18, 2022

Developing Complex, Translatable and Physiologically-Relevant Cellular Models in vitro. Key Benefits of Attending: • Discuss the uses of advanced cell technologies to construct in vitro models of human tissues. Workshop Leader: Wendy Rowan, Scientific Director, Novel Human Genetics, GSK.

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pharmaphorum

NOVEMBER 1, 2022

Investigating the next generation of genetic medicine through RNA based therapies. RNA therapeutics is a rapidly expanding industry with increasingly growing potential for immunotherapy, personalised medicines, and treatment of genetic, infectious, and chronic diseases. Director, Genetic Medicine. Website: [link].

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Roots Analysis

AUGUST 12, 2024

These diagnostic solutions are essential for detecting and monitoring diseases, identifying genetic abnormalities, and guiding personalized treatment plans. Molecular diagnostic solutions are pivotal across various medical fields, including oncological disorders, infectious diseases, genetic testing, and personalized medicine.

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The Pharma Data

APRIL 7, 2021

today announced the launch of the Elecsys Anti-p53 immunoassay for the in vitro quantitative determination of anti-p53 antibodies. A mutation of p53 is present in half of solid tumor cancers and is the most common genetic change identified so far in human cancers. The assay is now available for all markets accepting the CE Mark.

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Roots Analysis

MARCH 16, 2023

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. In the last few years, researchers have become interested in using in vitro transcribed (IVT) mRNA as a drug delivery agent.

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XTalks

JANUARY 6, 2021

Researchers at the National Institutes of Health (NIH) in the US have isolated small antibodies called “nanobodies” from a llama named Cormac that can block the SARS-CoV-2 coronavirus. The study was led by neuroscientists Thomas J. “TJ” TJ” Esparza, BS, and David L. Preliminary results from the study were published in the journal Scientific Reports.

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FDA Law Blog

NOVEMBER 28, 2023

Gibbs — Shortly before the Thanksgiving holiday, FDA announced with no fanfare that it would be holding a Molecular and Clinical Genetics Panel meeting this Wednesday November 29. It is well known in the industry that FDA has been skeptical of multi-cancer (sometimes also referred to as pan-cancer) tests.

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XTalks

NOVEMBER 4, 2020

Infants experience allergic responses closely linked with the mother’s allergic response in ways that cannot only be explained by genetics. New research from Duke University-NUS shows that allergen-primed antibodies may be passed to offspring in utero. They reported their findings last week in the journal Science.

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Cloudbyz

JULY 31, 2024

These technologies provide insights into genetic, proteomic, and metabolomic profiles, enabling the discovery of biomarkers associated with diseases like cancer, cardiovascular diseases, and neurological disorders. For instance, in oncology, patients with specific genetic mutations (e.g.,

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The Pharma Data

DECEMBER 22, 2020

This assay enables clinical geneticists to detect genetic aberrations associated with developmental delay, intellectual disabilities, congenital anomalies, and unexplained dysmorphic features. “We are truly excited and humbled to bring the power of diagnostic microarray testing to the Japanese market. About Agilent Technologies.

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pharmaphorum

JANUARY 17, 2023

Ben Hargreaves speaks to Liberate Bio, a company that is hoping to address the delivery issues that could prevent mRNA, as well as siRNA and ASO therapeutics, from reaching their full potential. The pandemic proved that mRNA technology could provide effective protection against infectious disease, at least in the case of COVID-19.

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FDA Law Blog

JULY 8, 2021

Javitt — For many years, one of the most controversial topics in device regulation has been the dual-track oversight of in vitro diagnostics (IVDs) and laboratory developed tests (LDTs). According to Concert Genetics there are currently an estimated 160,000 genetic tests – which is only one type of LDT.

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FDA Law Blog

MAY 25, 2022

Javitt — On April 19, FDA issued a safety communication regarding genetic non-invasive prenatal screening, commonly referred to as non-invasive prenatal tests or NIPT ( here ). NIPT are intended to screen for genetic abnormalities in a fetus. Nor is this the first time that FDA has raised concerns with NIPT.

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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.

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FDA Law Blog

DECEMBER 11, 2023

Mullen — With comments due on the proposed LDT rule last week, FDA wasted no time updating the Unified Agenda to indicate that a final rule may be published in April ( here ). We take this date with a grain of salt given the frequency with which these dates are missed and given the volume of comments filed. (It

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FDA Law Blog

DECEMBER 6, 2023

For example, one of the primary articles cited by FDA to show poor laboratory performance of LDTs has been the subject of a reanalysis by the College of American Pathologists that found “excellent laboratory performance” of molecular oncology proficiency testing for cancer-associated genetic variants. FDA seems unconcerned by this prospect.

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The Pharma Data

SEPTEMBER 28, 2021

Real-time PCR technology allows a rapid and specific measurement of the presence of genes from microorganisms related to infectious diseases, cancer, and genetic abnormalities. Roche is additionally the planet leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management.

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The Pharma Data

DECEMBER 20, 2020

On May 14, the company presented data from the vibegron EMPOWUR 52-week extension study and data by age groups from the 12-week placebo-controlled EMPOUR study at the 2020 American Urological Association Annual Meeting. The drug is a once-daily, beta-3 adrenergic agonist. David Staskin, principal investigator of EMPOWUR and a urologist with St.

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Roots Analysis

OCTOBER 16, 2023

These clones can be manipulated and mutated in vitro to alter the expression and function of a protein. This has enabled several researchers to study genetic disorders more precisely and closely. The freedom to manipulate the genetic material and adulterate human species may lead to adaptive malfunctions.

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XTalks

AUGUST 8, 2024

Tecelra is the first cell therapy engineered for a solid tumor cancer in the US, offering a new option for patients with specific genetic markers who have previously undergone chemotherapy. It is also the first new treatment for adults with synovial sarcoma in over a decade. The trial showed a 43 percent response rate with 4.5

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Engineer Clinical Trials Clinical Trials FDA Approval 52

Roots Analysis

OCTOBER 22, 2023

RNA therapeutics are a novel class of biopharmaceuticals that harness the power of RNA molecules for the treatment and prevention of a wide range of disorders, including oncological, and genetic disorders as well as infectious diseases. These therapeutics are broadly classified into two categories, namely coding RNAs and non-coding RNAs.

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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 is a comprehensive genomic profiling (CGP) test that analyses more than 300 cancer-related genes and multiple genomic signatures to optimise patient care.

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The Pharma Data

DECEMBER 9, 2020

Vigil’s pipeline strategy is to target these diseases by combining a high-level understanding of microglia physiology, disease genotyping, and patient phenotyping to identify specific genetic variations associated with microglial dysfunction. which will remain a key shareholder. in a statement. . Libra Therapeutics.

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The Pharma Data

APRIL 29, 2022

91% of infants treated with Evrysdi in the FIREFISH study were still alive at three years Infants treated with Evrysdi maintained or continued to improve in measures of motor function, including their ability to sit without support for 5 and 30 seconds Evrysdi has proven efficacy in infants and adults, with over 5,000 patients treated to date.

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The Pharma Data

MAY 31, 2022

The approval is based on interim efficacy and safety data from the RAINBOWFISH study in newborns, which showed that the majority of pre-symptomatic babies treated with Evrysdi achieved key milestones such as sitting and standing with half walking after 12 months of treatment. Jude Children’s Research Hospital.

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The Pharma Data

SEPTEMBER 6, 2020

RET-activating fusions and mutations are key disease drivers in many cancer types, including NSCLC and medullary thyroid cancer (MTC), and treatment options that selectively target these genetic alterations are limited. Gavreto is a once-daily, oral precision therapy that selectively inhibits RET-altered cancers. months, not reached).

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