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

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

Pharmaceutical Technology

AUGUST 17, 2022

These capabilities comprise cell and exosome genetic engineering for expressing therapeutic targets. In order to offer complete process development, quality control and regulatory services, cGMP manufacturing for pre-clinical and Phase I/II clinical trials, AGC will use its worldwide network.

Manufacturing 130

Manufacturing Gene Therapy Genetic Engineering Gene 130

Pharmaceutical Technology

MAY 2, 2023

Chimeric antigen receptor T-cell (CAR-T) therapies are the only genetically modified cell therapies to have received regulatory approval, and they are currently utilised in relapsed/refractory settings. There is currently a rich and diverse IO pipeline that aims to address these unmet needs, with 703 IO products currently in clinical trials.

Genetic Engineering 130

Genetic Engineering Antibody Clinical Trials Clinical Trials 130

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

Velocity Clinical Research

OCTOBER 3, 2024

.” All Velocity sites are fully prepared to support cell and gene therapy (CGT) clinical trials. Read the full press release: [link] The post Nick Spittal Comments on Velocity’s Membership With Advarra’s Gene Therapy Ready Site Network appeared first on Velocity Clinical Research.

Gene Therapy 52

Gene Therapy Gene Genetic Engineering Clinical Research 52

Pharmaceutical Technology

FEBRUARY 15, 2023

Innovation S-curve for the pharmaceutical industry Gene splicing using nucleases is a key innovation area in the pharmaceutical industry Nucleases play a fundamental role in the field of recombinant DNA technology, or genetic engineering. Nucleases are enzymes that hydrolytically cleave the phosphodiester backbone of DNA.

Gene Splicing 130

Gene Splicing Gene DNA Recombinant DNA Technology 130

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. But there is that significant challenge.

Gene Therapy 147

Gene Therapy Gene Engineer Production 147

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

pharmaphorum

JANUARY 26, 2023

More specifically, CAR-T cell therapy engineers a patient’s own immune cells (T-cells) to detect, target, and destroy cancer cells. Part of the therapy involves T-cells being drawn from a patient’s blood and reprogrammed in a lab to create T-cells that are genetically engineered to kill cancer cells.

Genetic Engineering 96

Genetic Engineering Engineer Genetics Drugs 96

Advarra

MARCH 31, 2023

The use of engineered genetic materials in clinical trials is rapidly expanding, with potential applications for genetic vaccines, gene-modified cellular therapies, and gene therapies. Either way, occupational exposure to these gene delivery systems bears potential risks to the research staff.

Engineer 52

Engineer Genetics Clinical Research Research 52

Advarra

JUNE 13, 2023

Research in gene therapies and genetically engineered drugs and vaccines are growing exponentially, and will only continue to become more popular. The result is not knowing if a gene therapy-related clinical trial can even be activated within the activation timeline typically given to a sponsor during site initiation.

Gene Therapy 52

Gene Therapy Gene Research Genetic Engineering 52

WCG Clinical

NOVEMBER 17, 2023

Since then, however, certain genetic engineering technologies (e.g., In the interim, investigators, institutions, and clinical trial sponsors may consider voluntarily requesting IBC review of research that would require it in the future if these changes are adopted.

Genome 52

Genome Genomics Gene Editing Genetic Engineering 52

Advarra

JANUARY 11, 2024

Some of these approaches involve directly isolating the patient’s immune cells and simply expanding their quantity, while other treatments involve genetically engineering their immune cells to enhance cancer-fighting capabilities.

Vaccination 52

Vaccination Vaccine Protein Antibody 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.”. and Australia.

Vaccination 52

Vaccination Vaccine Clinical Trials Clinical Trials 52

Advarra

AUGUST 8, 2023

However, gene therapy studies require additional review to assess the risks associated with the engineered genetic material, especially as the technology frequently utilizes genetically engineered viruses to deliver genetic information into target cells.

Gene Therapy 52

Gene Therapy Gene Research Genetics 52

The Pharma Data

NOVEMBER 30, 2020

In alignment with Novavax’ commitment to transparency, Phase 3 clinical trial protocols are posted to the company’s website at Novavax.com/resources upon finalization. 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

Bioengineer

JULY 21, 2021

Its biotechnology trade magazine, GEN (Genetic Engineering & Biotechnology News), was the first in its field and is today the industry’s most widely read publication worldwide. Mary Ann Liebert, Inc., A complete list of the firm’s 90 journals, books, and newsmagazines is available on the Mary Ann Liebert, Inc.,

Genetic Engineering 52

Genetic Engineering Development Engineer Genetics 52

XTalks

MARCH 28, 2024

Early clinical trials have shown promising results and this therapy could become a valuable addition towards CRC treatment in the future. Gene Editing and CAR T-Cell Therapy Genetic engineering technologies, such as CRISPR-Cas9, are providing newer potential avenues for cancer treatment.

Gene Editing 59

Gene Editing Life Science Clinical Trials Clinical Trials 59

The Pharma Data

DECEMBER 16, 2020

The Company’s proprietary recombinant technology platform combines the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles designed to address urgent global health needs.

Protein 52

Protein Vaccination Vaccine Immune Response 52

The Pharma Data

JANUARY 10, 2021

The new year began with a fairly low level of clinical trial news. Arcturus Therapeutics got the FDA go-ahead for its Phase II trial of its COVID-19 vaccine candidate ARCT-021. The trial will enroll 600 participants, with 450 receiving ARCT-021 and 150 receiving placebo. Here’s a look. COVID-19-Related.

Gene Therapy 52

Gene Therapy Trials Gene Clinical Trials 52

Bioengineer

JULY 19, 2021

The researchers at the CNIO created two genetically engineered mouse models that lacked KRAS4B and expressed the KRAS4A variant only, both with and without the G12V mutation (KRAS4AG12V). Our results suggest that for therapies to be effective, the two KRAS isoforms should be targeted.” ” KRAS genes in embryonic development.

Research 52

Research Gene Genetic Engineering Genetics 52

Bioengineer

JULY 15, 2021

Its biotechnology trade magazine, GEN (Genetic Engineering & Biotechnology News), was the first in its field and is today the industry’s most widely read publication worldwide. Mary Ann Liebert, Inc., publishers (https:/ / www. liebertpub. com/ ) website.

Nurses 52

Nurses Genetic Engineering Engineer Genetics 52

Advarra

OCTOBER 26, 2023

Controlled Environment and IP Containment The potential for a release, and the risk associated with a genetically engineered IP, are part of the IBC’s assessment purview under National Institutes of Health (NIH) Guidelines. Preparing for unforeseeable release with a small spill kit.

Production 52

Production Containment Biohazard Biohazard 52

WCG Clinical

MAY 28, 2024

CAR-T Cells Target Harmful B Cells in Lupus CAR-T cell technology, which uses genetic engineering to direct white blood cells to attack specific molecular targets, was originally proposed for treatment of HIV infection and hematological malignancies. WCG has many ways to support cell and gene therapy clinical trials for lupus.

In-Vivo 40

In-Vivo Clinical Trials Clinical Trials FDA Approval 40

The Pharma Data

MARCH 29, 2022

In a preprint, the researchers at Cornell University led by Associate Professor Hector Aguilar-Carreno showed that genetically engineered mice infected with the virus causing COVID-19 and given a daily dose of the compound in a nasal spray for four days.

Genetic Engineering 52

Genetic Engineering Research Genetics Drugs 52

pharmaphorum

SEPTEMBER 13, 2022

Although clinical trials proved that chemicals could be used to treat cancer, the results of the study remained a closely guarded military secret until 1946. 1956 – The rise of bone marrow transplants. This research paved the way for the first successful treatment of a patient with acute lymphoblastic leukaemia in 2011.

Genome Project 98

Genome Project Genome Genomics DNA 98

pharmaphorum

NOVEMBER 2, 2021

In 2019, there were 57 bsAb candidates in clinical trials, against both haematological and solid tumours. In the pipeline , Amgen has BiTE molecules targeting seven types of cancer in clinical trials, as well as further structures in the design stage. Engagement of immune cells to the tumour cell.

Antibody 52

Antibody Immune Response Production Engineer 52

The Pharma Data

OCTOBER 26, 2020

These mAbs are already of human origin and functionally optimized for high potency by the donor’s immune system; hence, they technically do not require genetic engineering or further optimization to achieve full functionality.

Antibody 52

Antibody Genetic Engineering Development Clinical Trials 52

The Pharma Data

OCTOBER 27, 2020

He is also a principal investigator and a translational chair on several institutional and cooperative group clinical trials exploring novel immunotherapy combinations in gynecologic cancers and other solid tumors. Dean A.

Antibody 40

Antibody Genetic Engineering Engineer Development 40

Cloudbyz

MARCH 5, 2024

Here are some of the complexities encountered in clinical research for each: Biologics : Immunogenicity: Biologics have a higher risk of inducing immune responses, which can affect efficacy, safety, and pharmacokinetics. Monitoring and managing immunogenicity is a complex aspect of clinical trials for biologics.

Development 97

Development Drugs Immune Response Manufacturing 97

The Pharma Data

SEPTEMBER 8, 2020

More specifically, the agency requires that scientific evidence for regulatory approval must come from large, high quality clinical trials that are randomized and observer-blinded, with an expectation of appropriately designed studies with significant numbers of participants across diverse populations.

Vaccination 52

Vaccination Vaccine Containment Clinical Trials 52

Advarra

AUGUST 10, 2023

The risks associated with the research of engineered genetic materials are why the National Institutes of Health Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines) provide the standard for oversight of research involving genetic engineering and gene therapy.

Gene Therapy 52

Gene Therapy Development Gene Drugs 52

The Pharma Data

SEPTEMBER 8, 2020

More specifically, the agency requires that scientific evidence for regulatory approval must come from large, high quality clinical trials that are randomized and observer-blinded, with an expectation of appropriately designed studies with significant numbers of participants across diverse populations. For more information, visit.

Vaccination 52

Vaccination Vaccine Containment Clinical Trials 52

The Pharma Data

JULY 27, 2021

is a clinical stage biotechnology company developing a new class of biologics, Human Heavy-Chain Antibodies (UniAb®), for the treatments of cancer, autoimmunity, and infectious diseases. Even when clinical trials are successful, regulatory authorities may question the sufficiency for approval of the trial endpoints we have selected.

Production 52

Production Antibody Sales Development 52

XTalks

AUGUST 17, 2020

Cue Biopharma is a Cambridge, Massachusetts-based clinical-stage biotechnology company that is focused on developing injectable immune biologics using its proprietary Immuno-STAT (Selective Targeting and Alteration of T cells) platform. Promising Clinical Results. Cell-Based Immunotherapy vs. Immune Biologics.

Protein 98

Protein Engineer Immune Response In-Vivo 98