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

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.

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Trials Clinical Trials Clinical Trials Antibody 97

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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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

JUNE 24, 2022

Fujifilm’s Irvine Scientific unit has licensed rights to an artificial intelligence-powered technology developed to improve the success rate of in vitro fertilisation (IVF) techniques. “Development and testing of applications to support the selection of oocytes, sperm, and genetic assessment are in progress,” he added.

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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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The Pharma Data

MAY 3, 2021

The division served as the rapporteur in the effort to update the International Council for Harmonisation (ICH) E14 and S7B guidelines on the clinical and nonclinical evaluation of QT/QTc interval prolongation and proarrhythmic potential and leads research for the Comprehensive in vitro Proarrhythmia Assay initiative.

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In-Vitro Clinical Trials Clinical Trials In-Vivo 52

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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In-Vitro Antibody Genetics Protein 52

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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Vaccine Vaccination DNA Protein 52

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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The Pharma Data

DECEMBER 22, 2020

A2’s Tmod engineered T cells uniquely combine a potent activating mechanism to kill tumor cells with a blocking mechanism that protects normal cells from harm by exploiting the loss of genetic material in tumors. A2 will also receive from Merck an equity investment and reimbursement of certain expenses. Series B in October.

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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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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

NOVEMBER 17, 2020

Dr. Anderson has been an early adopter in blastocyst embryo transfer, cryopreservation and pioneered blastocyst biopsy with and without laser technology for genetic testing. . SARASOTA, Fla. , 18, 2020 /PRNewswire/ — INVO Bioscience , Inc. Drs. and across the world.

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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

Engineer 52

Engineer Clinical Trials Clinical Trials FDA Approval 52

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

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.

Protein 52

Protein In-Vitro Medicine Development 52

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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FDA Approval Protein In-Vitro Medicine 52

pharmaphorum

NOVEMBER 2, 2021

They are also designed to have a short in vitro half-life, meaning that they will be cleared from a patient’s system within several hours. They are also designed to have a short in vitro half-life, meaning that they will be cleared from a patient’s system within several hours. Engagement of immune cells to the tumour cell.

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Delveinsight

JANUARY 18, 2021

Angelman syndrome (AS) is a complex genetic rare disorder that affects the nervous system. Preclinical studies undertaken to evaluate the drug have shown that GTX-102 activates the paternal copy of the UBE3A gene in neurons in vitro, and can ease certain disease symptoms in a mouse model of Angelman syndrome.

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The Pharma Data

NOVEMBER 4, 2020

Nasdaq: CNTG), a commercial-stage company focused on rare diseases that transforms real-world clinical and genetic data into actionable information for patients, physicians, and pharmaceutical companies, announced today the opening of its walk-in COVID-19 testing facility at the newly opened Berlin Brandenburg Airport (BER). to 7:00 p.m.

Genetics 40

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The Pharma Data

AUGUST 18, 2020

REGN-COV2 is Regeneron’s two-antibody combination currently in late-stage clinical trials for the treatment and prevention of COVID-19 infection. The companies will collaborate on developing and manufacturing REGN-COV2. Regeneron will distribute REGN-COV2 in the U.S. and Roche will be responsible for distribution outside the U.S. Schleifer, M.D.,

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Antibody Clinical Trials Clinical Trials Manufacturing 52

XTalks

MARCH 28, 2024

In the healthcare community, March is recognized globally to be Endometriosis Awareness Month. This year’s theme is “Innovation and Hope.” This growth can occur on the ovaries, fallopian tubes, the outer surface of the uterus or other organs in the pelvis. This condition is known to affect an estimated one in ten women of reproductive age.

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Hormones Life Science In-Vitro Drugs 40

XTalks

SEPTEMBER 30, 2020

The research shows that the activity of the immune messenger type 1 interferon (IFN) protein is diminished, either by genetic mutations or an autoimmune attack by neutralizing antibodies against it, in a subset of COVID-19 patients. Related: Low T Cell Counts Observed in COVID-19 Patients. Mutational Errors in COVID-19 Patients.

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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

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.

Manufacturing 108

Manufacturing Clinical Trials Clinical Trials In-Vitro 108

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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In-Vitro RNA Licensing Licensing 141