XTalks

AUGUST 19, 2022

XTALKS WEBINAR: How Agile Clinical Trials Unlock Universal Access to Rare Disease Research. Register for this free webinar to learn why the agile clinical trial model is a great fit for many rare disease categories, how to navigate the regulatory landscape for agile clinical trials in rare diseases, how to design studies and more.

Gene Therapy 95

Gene Therapy FDA Approval Gene Clinical Trials 95

pharmaphorum

JANUARY 25, 2022

As the area of bringing a digital therapeutic to market means passing the same level of regulatory scrutiny as a traditional, pharmaceutical therapy, this means “prescription digital therapeutics must undergo extensive clinical trials to demonstrate their safety and effectiveness before they ever reach patients,” said McCann.

Medicine 111

Medicine In-Vivo In-Vitro Development 111

The Pharma Data

NOVEMBER 15, 2020

16, 2020 /PRNewswire/ –: iSTAR Medical , a medtech company developing minimally invasive ophthalmic implants for treatment of patients with glaucoma, today announced positive one-year results from the European STAR-II clinical trial of its micro-invasive glaucoma surgery (MIGS) device, MINIject TM. WAVRE, Belgium , Nov.

Trials 52

Trials In-Vivo Engineer Clinical Trials 52

FDA Law Blog

JANUARY 2, 2022

In Silico Clinical Trials, where “device performance is evaluated using a ‘virtual cohort’ of simulated patients with realistic anatomical and physiological variability representing the indicated patient population.”. Draft Guidance at 4. Draft Guidance at 8. Draft Guidance at 5.

In-Vivo 52

In-Vivo Development Engineer Clinical Trials 52

XTalks

SEPTEMBER 20, 2024

Vittoria Biotherapeutics is a clinical-stage cell therapy company that incorporates the latest advancements in cell therapy and gene editing with a unique approach that potentially overcomes some of the issues with this therapeutic modality. Such challenges highlight a significant unmet need and call for further advancements in the field.

Gene Editing 52

Gene Editing Manufacturing Gene In-Vivo 52

The Pharma Data

DECEMBER 10, 2020

ImmunityBio has engineered the vector to overcome this problem and has shown that its second-generation adenovirus vector can safely and effectively deliver its cargo even in patients with pre-existing adenovirus immunity. This blocking of viral replication was observed in both the lung and nasal passages.

Vaccination 52

Vaccination Vaccine Immune Response Protein 52

FDA Law Blog

JANUARY 2, 2022

In Silico Clinical Trials, where “device performance is evaluated using a ‘virtual cohort’ of simulated patients with realistic anatomical and physiological variability representing the indicated patient population.”. Draft Guidance at 4. Draft Guidance at 8. Draft Guidance at 5.

In-Vivo 40

In-Vivo Regulation Development Engineer 40

XTalks

OCTOBER 1, 2020

Dr. Lin received a medical degree from Shanghai Medical University and specialized in hematology after which she began working in the clinical research unit at the university, treating patients with acute leukemia. 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

pharmaphorum

JANUARY 29, 2021

California-based Sangamo Therapeutics is one such company that believes in the powerful potential of in vivo genome editing and regulation, together known as genome engineering, and has built up a sizable preclinical pipeline of genome regulation treatments for diseases such as Huntington’s disease and Amyotrophic lateral sclerosis (ALS).

Gene Editing 145

Gene Editing Gene Gene Therapy In-Vivo 145

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. However, not all innovations are equal and nor do they follow a constant upward trend.

Gene Splicing 130

Gene Splicing Gene DNA Recombinant DNA Technology 130

pharmaphorum

OCTOBER 8, 2020

Scribe has designed, engineered and tested thousands of evolved CRISPR enzymes to build an advanced platform for creating breakthrough in vivo treatments,” said Oakes. Further back in development are drugs that will be administered to edit genes within the body, but the first of these candidates are now in clinical trials.

Gene Editing 69

Gene Editing Gene In-Vivo Clinical Trials 69

Roots Analysis

SEPTEMBER 18, 2023

While some biobanks ( especially non-clinical ones ) use mechanical freezers for storage, liquid nitrogen is one of the most reliable cryostorage mediums. million people donate blood annually and on a daily basis, approximately 29,000 units of red blood cells are required.

Engineer 52

Engineer Containment In-Vivo Production 52

The Pharma Data

JANUARY 17, 2021

Based in Seattle, Washington, Sana focuses on in vivo and ex vivo cell engineering platforms to develop therapies for cancer, diabetes, cardiovascular disease, CNS disorders, and genetic diseases. Launched in 2019, the company raised $700 million in June 2020 in its initial financing.

In-Vivo 52

In-Vivo Marketing Engineer Genetics 52

XTalks

MAY 19, 2022

In addition, the monitoring done with smart stents may help prevent some clinical complications of conventional stents, which include stent thrombosis (a life-threatening event where the artery is completely blocked due to the formation of a blood clot in the stent) and in-stent restenosis (a slow re-narrowing of the segment with the stent).

Development 72

Development Research In-Vivo Engineer 72

Roots Analysis

AUGUST 31, 2023

Overview of Gene Switch The notion that genes might be turned on and off was discovered several decades ago when studies revealed that E. coli bacteria, as well as lambda bacteriophage, can adapt to the alterations in the composition of their nutrient medium. These genetic switches assist transcription factors in binding to the promoter region.

Gene 40

Gene Gene Therapy Gene Expression Regulation 40

The Pharma Data

JUNE 17, 2022

Previous research has shown that SARS-CoV-2 spike-specific monoclonal antibodies play a key role in providing in vivo protection and have been used in developing COVID-19 vaccines. A modified version of the Cv2.1169 antibody was also effective at treating SARS-CoV-2 infection in mice and hamsters.

Antibody 52

Antibody In-Vivo In-Vitro Immune Response 52

XTalks

FEBRUARY 27, 2024

TIL vs CAR T-Cell Therapies While CAR T-cell therapies involve inserting a CAR engineered to target a specific cancer cell protein into a patient’s T cells, TIL-based T-cell therapies like Amtagvi involve separating TILs from a patient’s tumor (in autologous therapies) and expanding them ex vivo.

FDA Approval 52

FDA Approval Manufacturing In-Vivo Trials 52

The Pharma Data

JANUARY 11, 2021

Our antibody clones in their original IgG format have shown potent neutralization activity in in vitro assays and, in the case of our lead clone, in an in vivo animal model. Headquartered in Mountain View, California, IGM Biosciences is a clinical-stage biotechnology company focused on creating and developing engineered IgM antibodies.

Antibody 52

Antibody Licensing Licensing 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. Cell-Based Immunotherapy vs. Immune Biologics. cells, receptors) to treat disease.

Protein 98

Protein Engineer Immune Response In-Vivo 98

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. The currently approved CD-19 CAR products are autologous, ex vivo cellular therapies.

In-Vivo 40

In-Vivo Clinical Trials Clinical Trials FDA Approval 40

Roots Analysis

AUGUST 23, 2024

Applications of mRNA Vaccine and Therapeutics Recent advances using nucleoside-modified mRNA improved protein expression and diminished activation of innate sensors allowing largely overcoming conventional roadblocks concerning mRNA stability, inefficient in vivo delivery and activation of innate sensors by RNA molecules.

Protein 40

Protein Vaccination Vaccine Immune Response 40