Advarra

JUNE 13, 2024

The standard policies and procedures for safe handling of other types of hazards, such as antineoplastic drugs and infectious material, may not accommodate the specific risks posed by recombinant therapeutics. The post The Importance of Hazard Communications in Clinical Trials Involving Genetic Engineering appeared first on Advarra.

Genetic Engineering 52

Genetic Engineering Clinical Trials Clinical Trials Engineer 52

Advarra

JUNE 12, 2023

IBCs, however, seek to protect study personnel, the community, and the environment from exposure to engineered genetic material and other biohazardous agents. IBCs include members who possess expertise in genetic engineering, biological safety, infectious diseases, and environmental protection. What Does an IBC Review?

Genetic Engineering 98

Genetic Engineering Gene Therapy Genetics Engineer 98

Pharmaceutical Technology

MARCH 2, 2023

According to GlobalData, Phase I drugs for Relapsed Acute Myeloid Leukemia have a 71% phase transition success rate (PTSR) indication benchmark for progressing into Phase II. GlobalData’s report assesses how QN-023a’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks.

Gene Editing 100

Gene Editing Genetic Engineering Engineer Clinical Trials 100

Scienmag

DECEMBER 30, 2021

Immunotherapies called chimeric antigen receptor (CAR) T cells use genetically engineered versions of a patient’s own immune cells to fight cancer. These treatments have energized cancer care, especially for people with certain types of blood cancers.

Scientist 61

Scientist Genetic Engineering Engineer Genetics 61

pharmaphorum

DECEMBER 24, 2020

A serotonin sensor designed using Artificial Intelligence (AI) could help scientists study sleep and mental health and potentially find new neurology drugs. The technique could also be used to test the effectiveness of new psychoactive drugs, according to the US-government funded NIH.

Development 77

Development Drugs Protein Genetic Engineering 77

Pharmaceutical Technology

JUNE 4, 2023

Encoded Therapeutics develops gene therapies for the treatment of severe genetic disorders. The company’s drug ETX-101, comprising a recombinant adeno-associated virus (AAV9) vector, is under development for the treatment of Dravet syndrome. The company is headquartered in South San Francisco, California, US.

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Gene Gene Therapy Genetics DNA 262

Pharmaceutical Technology

AUGUST 17, 2022

These capabilities comprise cell and exosome genetic engineering for expressing therapeutic targets. Furthermore, the CDMO provides various customisable development and manufacturing scales according to the requirements of drug developers in various regions globally. .

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Manufacturing Gene Therapy Genetic Engineering Gene 130

Cloudbyz

MARCH 5, 2024

In the intricate dance of drug discovery and development, two protagonists emerge as the cornerstones of modern medicine: biologics and small molecules. Manufacturing Process : Small Molecules: Manufactured through chemical synthesis, small molecule drugs can be consistently reproduced with a high degree of purity and stability.

Development 97

Development Drugs Immune Response Manufacturing 97

Scienmag

DECEMBER 9, 2020

A new genetic approach can accelerate the study of phage-microbe interactions with implications for health, agriculture, and climate Credit: Wikimedia Commons Scientists are continually searching for new and improved ways to deal with bacteria, be it to eliminate disease-causing strains or to modify potentially beneficial strains.

Bacteria 52

Bacteria Genetic Engineering Genetics Engineer 52

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

pharmaphorum

JULY 27, 2021

AstraZeneca has formed a partnership with Regeneron to investigate the potential of treating obesity using drugs directed at GPR75, a protective gene identified by scientists at the Regeneron Genetics Centre. The post Regeneron, AZ team up on drugs for obesity “superpower” gene appeared first on.

Gene 52

Gene Drugs Genetic Engineering Genetics 52

pharmaphorum

JANUARY 10, 2022

There are still licensing deals to be done in the COVID-19 category it seems, after Novartis paid around $163 million to license rights to an antiviral drug developed by Molecular Partners. Ensovibep has the potential to become the first multi-specific antiviral molecule for the treatment of COVID-19, according to Novartis.

Trials 52

Trials Drugs Antibody Genetic Engineering 52

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

FDA Law Blog

DECEMBER 8, 2022

Food and Drug Administration (FDA) issued two guidance documents, one draft and one final, on food allergen labeling requirements. labeling of major food allergens in bulk foods, dietary supplements, protein-free ingredients, and foods produced through genetic engineering); and. By Sophia R. Gaulkin — Last week, the U.S.

Genetic Engineering 59

Genetic Engineering Containment Cosmetics Protein 59

The Pharma Data

SEPTEMBER 1, 2021

Louis have genetically engineered cells that, when implanted in mice, will deliver a biologic drug in response to inflammation. The engineered cells reduced inflammation and prevented a type of damage to bone, known as bone erosion, in a mouse model of rheumatoid arthritis. million adults in the United States.

Drugs 52

Drugs Engineer Drug Delivery Gene 52

pharmaphorum

SEPTEMBER 11, 2022

The therapy had an overall response rate of 49%, with 20% compete responses, compared to 21% and 7% respectively with BMS’ drug, and the investigators are now following the patients to see if there is a significant difference between the groups on the more stringent measure of overall survival. months versus 3.1

Trials 105

Trials Genetic Engineering Immune Response Engineer 105

XTalks

SEPTEMBER 27, 2023

Poseida is a clinical-stage biopharmaceutical firm that utilizes its unique non-viral gene engineering methods to develop innovative cell and gene therapies. Yarema discusses Poseida’s two Phase I programs in collaboration with Roche, highlighting the strategic partnership’s significance for Poseida.

Life Science 59

Life Science Genetic Engineering Engineer Gene Therapy 59

Pharmaceutical Technology

MAY 8, 2023

Innovation S-curve for the pharmaceutical industry Zinc-finger nucleases is a key innovation area in pharmaceutical Zinc finger nucleases (ZFNs) are tools used in genetic engineering to cleave a chosen genomic sequence. The company’s R&D is also focused on drugs for central nervous system, infections and genetic disorders.

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Genetics DNA Genetic Engineering Antibody 130

Advarra

AUGUST 10, 2023

Rapid growth in gene therapy is expected to receive additional support as the Food and Drug Administration (FDA) Center for Biologics Evaluation and Research (CBER) prepares to launch Operation Warp Speed for Rare Diseases. The Orphan Drug Act creates incentives for developing orphan drugs to treat such diseases.

Gene Therapy 52

Gene Therapy Development Gene Drugs 52

Pharmaceutical Technology

APRIL 5, 2023

More than a decade after the first patient was treated with a CAR-T therapy, six therapies relying on the same principles have been approved by the US Food and Drug Administration (FDA) and marketed to thousands of patients. Exa-cel is almost certainly going to the first CRISPR engineered product [to be approved].

Gene Therapy 147

Gene Therapy Gene Engineer Production 147

The Pharma Data

JANUARY 17, 2021

a global leader in providing drug discovery animal model solutions, announces an expansion of its immuno-oncology portfolio. . These models are engrafted with mouse tumors derived from the same strain background; this genetic similarity between tumor and host prevents the host from rejecting the tumor. RENSSELAER, N.Y.,

Genetic Engineering 40

Genetic Engineering Genetics Engineer Immune Response 40

Roots Analysis

FEBRUARY 13, 2023

It transfers genetic information form to DNA to ribosomes, a specialized structure, or organelle, which decodes genetic information into a protein. With the help of genetic engineering, synthetic mRNAs can express proteins, as they structurally resemble a natural mRNA.

Manufacturing 52

Manufacturing Drug Delivery Systems Genetic Engineering RNA 52

pharmaphorum

MAY 7, 2021

CRISPR’s deal with Nkarta aims to create genetically engineered NK cells, which are harvested and used to create a bank of “off the shelf” cells that can administered to patients like a drug.

Gene Editing 52

Gene Editing Gene Genetic Engineering DNA 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. Additionally, in some cases, gene therapy treatments make permanent changes to a human’s genetic profile, which is different than typical drug treatments.

Gene Therapy 52

Gene Therapy Gene Research Genetic Engineering 52

pharmaphorum

NOVEMBER 6, 2020

The company is trying to repurpose the drug used in rare inflammatory diseases such as juvenile arthritis for COVID-19, to see if it could relieve the extreme immune reaction that can prove fatal after infection with coronavirus. The post Novartis’ Ilaris fails in late-stage COVID-19 trial appeared first on.

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Trials Genetic Engineering Licensing Licensing 40

The Pharma Data

JANUARY 4, 2021

Improper disposal of antibiotics also releases these drugs into the environment, and researchers working with these drugs in the lab also have concern over their ultimate effects on study results.

Engineer 52

Engineer Bacteria Genetics Genetic Engineering 52

Roots Analysis

MARCH 16, 2023

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

Vaccination 52

Vaccination Vaccine DNA Protein 52

Advarra

JANUARY 11, 2024

Additionally, personalized medicine tends to be more difficult to manufacture because of regulatory requirements beyond traditional drug manufacturing requirements. For example, not all patients respond to immunotherapies; only an estimated 20-40% of patients respond to current immunotherapies.

Vaccination 52

Vaccination Vaccine Protein Antibody 52

The Pharma Data

NOVEMBER 9, 2020

Food and Drug Administration (FDA) has granted Fast Track Designation for NVX-CoV2373, the Company’s COVID-19 vaccine candidate. GAITHERSBURG, Md., 09, 2020 (GLOBE NEWSWIRE) — Novavax, Inc. Nasdaq: NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced that the U.S.

Vaccination 52

Vaccination Vaccine Clinical Trials Clinical Trials 52

The Pharma Data

JANUARY 24, 2021

25, 2021 /PRNewswire/ — Elasmogen Ltd , the pioneering biopharmaceutical company leading the development of VNAR and soloMER biologics, today announces a significant breakthrough in the identification of next-generation protein-based drugs potentially capable of stopping COVID-19 infections. ABERDEEN, Scotland , Jan.

Antibody 40

Antibody Protein Research Genetic Engineering 40

XTalks

MARCH 6, 2024

This includes discussions on cutting-edge technologies and methodologies in brain research, such as neuroimaging, genetic engineering and artificial intelligence. It granted the application priority review status, setting a Prescription Drug User Fee Act (PDUFA) target action date of August 11, 2024. percent.

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FDA Approval In-Vitro Research Marketing 69

The Pharma Data

DECEMBER 16, 2020

Food and Drug Administration, European Medicines Agency and/or Medicines and Healthcare products Regulatory Authority in the United Kingdom. Given the urgency of timely approval and delivery of vaccine during the pandemic, the regulatory review process may leverage review by prioritized regulatory bodies such as the U.S.

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Protein Vaccination Vaccine Immune Response 52

XTalks

AUGUST 17, 2020

Immune checkpoint inhibitors : these are drugs that block immune checkpoints, allowing immune cells to elicit enhanced responses to cancer cells. A growing area in the immunotherapy space is the development of biological modulators, which are genetically engineered proteins that target specific components of the immune system.

Protein 98

Protein Engineer Immune Response In-Vivo 98

The Pharma Data

OCTOBER 27, 2020

The SAB consists of a group of world-renowned experts in immuno-oncology research and drug development carefully selected to act as advisors to guide the Targovax R&D strategy. In their capacity as world-leading experts in immuno-oncology drug development, oncolytic viruses and mesothelioma, Dr. Clynes, Dr. Zamarin and Prof.

Antibody 40

Antibody Genetic Engineering Engineer Development 40

The Pharma Data

JANUARY 10, 2021

ILP100 is a genetically engineered Lactobacillus that acts as a small bioreactor on site in the wound, continuously introducing a chemokine, CXCL12, into the wound tissue. The drug is an RNA interference (RNAi) therapeutic. The company also received an ok to launch a Phase I trial of TH1902, its lead peptide-drug conjugate.

Gene Therapy 52

Gene Therapy Trials Gene Clinical Trials 52

pharmaphorum

SEPTEMBER 13, 2022

Just over a decade after it was developed by biochemist Nicholas Lyndon, Imatinib received US Food and Drug Administration (FDA) approval in 2001. Since then, it has transformed the treatment of chronic myeloid leukaemia and non-Hodgkin’s lymphoma. 2002 – Emergence of CAR-T therapy. 2012 – The 100,000 Genomics Project begins.

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Genome Project Genome Genomics DNA 98

Roots Analysis

SEPTEMBER 9, 2024

It is worth highlighting that in 2023 alone, close to 20 protein-based drugs were approved for the treatment of myriad of disease indications including oncological and metabolic disorders. Algal Expression System: This expression system is used in genetic engineering, biofuel production, botany.

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Protein Gene Production DNA 40