BioSpace

APRIL 25, 2024

The genetic engineering startup, recently honored by BioSpace readers for its work environment, is downsizing as it seeks to launch its first clinical trials.

Genetic Engineering 92

Genetic Engineering Engineer Clinical Trials Clinical Trials 92

Pharmaceutical Technology

APRIL 26, 2023

This marks the first-ever designation for genetically modified gamma-delta T cell therapies. INB-400, an autologous, genetically engineered gamma-delta T cell therapy, is the company’s DeltEx chemotherapy-resistant autologous and allogeneic drug-resistant immunotherapy (DRI) technology.

Genetic Engineering 130

Genetic Engineering Drugs Genetics Engineer 130

Clinical Trial Podcast

FEBRUARY 3, 2024

To learn more about clinical trials in diabetes, I invited Dr. Stayce Beck, Global Vice President of Clinical Affairs at Dexcom Inc. in Chemical Engineering from the University of Texas at Austin. The post Diabetes Clinical Trials with Dr. Stayce Beck appeared first on Clinical Trial Podcast & Blog.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Engineer 52

pharmaphorum

MARCH 24, 2022

LifeMine has developed an industrialised, genomics-based discovery engine that it hopes will take a broad, systematic approach to identifying new compounds from fungi and screening them for activity against disease targets. Greg Verdine – LifeMine.

Medicine 105

Medicine Genome Genomics Engineer 105

Pharmaceutical Technology

NOVEMBER 29, 2022

These viruses are engineered genetically for killing cancer. The researchers plan to seek the US Food and Drug Administration approval to commence clinical trials of the viral platform comprising chemokines and cetuximab, in humans. GBMs are called “cold” tumours as they lack helpful immune cells.

Development 130

Development Research Antibody Engineer 130

Pharmaceutical Technology

MARCH 2, 2023

Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval. The therapeutic candidate comprises allogeneic NK cells genetically engineered to express chimeric antigen receptors (CAR-NK) targeting cells CD33.

Gene Editing 100

Gene Editing Genetic Engineering Engineer Clinical Trials 100

pharmaphorum

NOVEMBER 1, 2021

Delytact (teserpaturev) is a genetically engineered oncolytic herpes simplex virus type 1 (HSV-1) that was approved for marketing in Japan earlier this year, and received pricing approval in August at 1.43 million yen (around $12,500) per dose, according to a Pharma Japan report.

Genetic Engineering 122

Genetic Engineering Clinical Trials Clinical Trials Trials 122

XTalks

AUGUST 29, 2022

CRISPR is notable for engineering living cells, allowing scientists to edit, turn off, delete, or replace genes in a cell’s genome. It is difficult to control where the viral vectors insert genes in the genome, and it is difficult to manufacture large quantities of clinical-grade viral vectors. From the Bench to Patient Therapeutics.

Gene Editing 98

Gene Editing DNA Gene Genome 98

Scienmag

JUNE 14, 2021

Investments have catalyzed research, clinical trials and revolutionary treatments across many disciplines UC San Francisco is launching a new initiative to propel the development of living therapeutics – a category of treatments broadly defined as human and microbial living cells that are selected, modified, or engineered to treat or cure disease (..)

Development 75

Development Engineer Clinical Trials Clinical Trials 75

Pharma Marketing Network

NOVEMBER 23, 2024

By leveraging research into specific genetic markers and tailored therapies, campaigns can address niche markets with unparalleled relevance. The Role of Real-World Evidence Real-world evidence (RWE) bridges the gap between clinical trials and everyday use. Authentic, research-backed messaging builds trust and credibility.

Marketing 52

Marketing Research Big Data Medicine 52

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. Clinical trial results for the therapy are expected to be shared in late 2024. The trial showed a 43 percent response rate with 4.5

Engineer 52

Engineer Clinical Trials Clinical Trials FDA Approval 52

pharmaphorum

JUNE 15, 2021

Just over two years later, both of those candidates have failed late-stage clinical trials, leaving Biogen’s $800 million investment in Nightstar looking like a poor deal.

Gene Therapy 105

Gene Therapy Gene Trials Genetics 105

Pharmaceutical Technology

APRIL 5, 2023

And my estimate is that between 25,000 and 30,000 patients have been treated with those therapies globally, which does not include patients treated in clinical trials. We have the emergence of this new pillar of medicine, which is out of the lab and beyond clinical trials now. We must approach this on several fronts.

Gene Therapy 147

Gene Therapy Gene Engineer Production 147

XTalks

NOVEMBER 23, 2020

The global trials are assessing the safety and efficacy of the vaccine in individuals aged 18 years or over from diverse racial and geographic groups who are healthy or have stable underlying medical conditions. Oxford-AstraZeneca COVID-19 Vaccine Induces Immune Responses in Early Clinical Trials.

Vaccination 97

Vaccination Vaccine Clinical Trials Clinical Trials 97

XTalks

DECEMBER 20, 2023

This includes analyzing how drug combinations may impact individual patients or groups of patients before even entering a clinical trial. With a staggering 90 percent of drugs failing in clinical trials, AI has the potential to help improve these statistics.

Life Science 119

Life Science Gene Editing Development Clinical Trials 119

Pharmaceutical Technology

NOVEMBER 29, 2022

The company now plans to move this approach into a Phase III trial. PharmaTher also has an agreement in place with Case Western Reserve University to develop ketamine as a treatment for Rett syndrome, a rare genetic neurological disorder. PharmaTher is not the only player in this space.

Research 275

Research Trials Drugs Generic Drugs 275

pharmaphorum

JANUARY 26, 2023

Yescarta – a CD19-directed genetically modified autologous T-cell immunotherapy investigated in the ZUMA-1 trial – is the first chimeric antigen receptor (CAR) T-cell therapy recommended for routine use on the NHS in England , meaning that for the first time eligible patients will be able to access CAR-T cell therapy in the long-term.

Genetic Engineering 96

Genetic Engineering Engineer Genetics Drugs 96

Scienmag

MAY 28, 2021

These “liquid biopsy” analyses exploit the unique epigenetic landscape of bone tumors and do not depend on any genetic alterations, […]. The scientists analyzed short fragments of tumor DNA that are circulating in the blood.

DNA 96

DNA Genetics Scientist Clinical Trials 96

XTalks

JANUARY 26, 2024

By targeting and identifying specific genetic mutations, this technology could lead to the development of more precise diagnostic tools, enabling early intervention and treatment. By tailoring treatments based on an individual’s genetic makeup, it may allow for more effective and targeted therapies.

Research 118

Research Gene Editing Gene Genetics 118

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. There, plasma is separated, and tumor DNA is identified by detecting genetic mutations, methylation patterns and fragmentation signals.

FDA Approval 105

FDA Approval Manufacturing Development RNA 105

Advarra

AUGUST 8, 2023

Gene therapy involves the transfer of engineered genetic materials to human research subjects. These studies were previously considered to be highly experimental and limited to early phase trials at a handful of highly specialized academic medical centers.

Gene Therapy 52

Gene Therapy Gene Research Genetics 52

XTalks

JUNE 2, 2022

XTALKS WEBINAR: Next-Gen Cell Therapies: Listening and Engaging with Patient Perspectives as an Essential Element in Clinical Trials. CAR-T is a type of immunotherapy in which the patients’ own T-cells are engineered to target and remove cancer cells. Kymriah Clinical Trial Results. x 10 8 CAR-positive viable T.

Trials 98

Trials Clinical Trials Clinical Trials Engineer 98

pharmaphorum

JANUARY 3, 2023

Haemophilia is a rare genetic bleeding disorder that causes the blood to take a long time to clot because of a deficiency in one or several blood clotting factors. SPK-9001 is a novel, investigation vector containing a bio-engineered adeno-associated virus (AAV) capsid (protein shell) and a high-activity human coagulation FIX gene.

Gene Therapy 98

Gene Therapy Gene Medicine Trials 98

The Pharma Data

OCTOBER 22, 2020

Additional details on the INTERLINK-1 clinical trial can be found here. Including the $50 million payment triggered by dosing the first patient in the Phase 3 INTERLINK-1 clinical trial, Innate Pharma has received $400 million to date. . MARSEILLE, France, Oct. months and a median overall survival of 5.8

Clinical Trials 40

Clinical Trials Clinical Trials Trials Antibody 40

XTalks

JULY 31, 2020

The study developed and researched microbe-controlled and genetically-engineered mice to understand the healing response in the intestine when receiving specific signals from bacteria. If we can influence these interactions, we may be able to control many diseases that are impacted by our microbiome or diet,” she says.

Bacteria 98

Bacteria Genetic Engineering Engineer Research 98

WCG Clinical

NOVEMBER 17, 2023

Since then, however, certain genetic engineering technologies (e.g., For example, two trials testing genetically identical genome-edited cell therapies – one engineered with a viral vector, and one without – can differ in their IBC review requirements because of how the cells were modified rather than what they have become.

Genome 52

Genome Genomics Gene Editing Genetic Engineering 52

XTalks

JANUARY 2, 2024

The clinical study also highlighted the favorable tolerability profile of Filsuvez. The most commonly reported adverse reactions in the clinical trial were pruritus (itching) and pain at the wound application site, occurring in 7.3 Specifically, 41.3 percent observed in the control gel arm. percent of cases.

FDA Approval 111

FDA Approval Gene Therapy Gene Trials 111

Bioengineer

JULY 23, 2021

Credit: Texas A&M Engineering. The team has recently submitted a patent disclosure with the Texas A&M Engineering Experiment Station. Video credit: Dr. Abhishek Jain/Texas A&M Engineering. Team identifies crucial interaction between platelets and tumors for the first time. ” ###. Original Source.

Engineer 52

Engineer Gene Editing Clinical Trials Clinical Trials 52

The Pharma Data

NOVEMBER 27, 2020

Nasdaq:RYTM), a biopharmaceutical company aimed at developing and commercializing therapies for the treatment of rare genetic diseases of obesity, announced today that the U.S. With this approval, Imcivree becomes the first-ever FDA approved therapy for these rare genetic diseases of obesity. BOSTON, Nov.

FDA Approval 52

FDA Approval Genetic Disease Genetics Clinical Trials 52

The Pharma Data

NOVEMBER 9, 2020

“While the regulatory review of this clinical program will be expedited, Novavax remains committed to a data-driven and scientifically rigorous approach in demonstrating safety and efficacy, which we believe will support confidence in the vaccine in the U.S. and globally.”. About NVX-CoV2373. and Australia.

Vaccination 52

Vaccination Vaccine Clinical Trials Clinical Trials 52

XTalks

FEBRUARY 9, 2024

Epilepsy has diverse etiologies, which are categorized into structural, genetic, infectious, metabolic, immune and unknown causes. Results from the Phase III clinical trial that led to the approval demonstrated that Ztalmy elicited a median 30.7 However, seizures can often be managed effectively.

FDA Approval 64

FDA Approval Clinical Trials Clinical Trials Genetics 64

The Pharma Data

NOVEMBER 30, 2020

CoV2373 is a stable, prefusion protein antigen derived from the genetic sequence of the SARS-CoV-2 coronavirus spike (S) protein and adjuvanted with Novavax’ proprietary Matrix?M. pivotal Phase 3 trial update. Novavax completed enrollment of 15,000 participants in a pivotal Phase 3 clinical trial being conducted in the U.K.

Clinical Development 52

Clinical Development Vaccination Vaccine Development 52

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.,

Gene Therapy 52

Gene Therapy Gene Medicine In-Vitro 52

XTalks

MAY 20, 2022

A Clinical Scientist will perform a wide range of duties depending on the focus of their research. Here is a summary of the kind of work you can expect to do: Design and implement clinical trials for human diseases and treatment. Clinical Pharmaceutical Science. Rehabilitation Engineering. Genetic Science.

Scientist 105

Scientist Life Science Clinical Research Doctors 105

The Pharma Data

DECEMBER 16, 2020

NVX-CoV2373 is a protein-based vaccine candidate engineered from the genetic sequence of SARS-CoV-2, the virus that causes COVID-19 disease. is conducting late-stage clinical trials for NVX-CoV2373, its vaccine candidate against SARS-CoV-2, the virus that causes COVID-19. About NVX-CoV2373.

Protein 52

Protein Vaccination Vaccine Immune Response 52

The Pharma Data

OCTOBER 19, 2020

With over 300 active clinical trials, Winship researchers are dedicated to taking new cancer treatments from bench to bedside. cancer centers selected as a Lead Academic Participating Site for the NCI’s National Clinical Trials Network (NCTN). Winship is one of 32 U.S. Brille , Vice Chairman of Caris Life Sciences.

Life Science 52

Life Science Clinical Trials Clinical Trials RNA 52

The Pharma Data

JANUARY 17, 2021

n-Lorem selects patients based on their genetic mutation and the organ affected rather than their specific diseases. “We They’re basically the same,” but each one uses a particular nucleotide to bind to specific genetic sequence. Safety is critical in all clinical trials, but with ultra-rare diseases, even greater care is taken.

Genetics 52

Genetics Clinical Trials Clinical Trials Drugs 52