XTalks

DECEMBER 13, 2024

The DREAMM-7 Phase III trial has spotlighted the potential of Blenrep (belantamab mafodotin) in combination with bortezomib and dexamethasone (BVd) to improve survival outcomes for relapsed or refractory multiple myeloma. DREAMM-7, an international, open-label trial, enrolled 494 participants with at least one prior multiple myeloma therapy.

Antibody 99

Antibody In-Vivo Trials In-Vitro 99

pharmaphorum

AUGUST 10, 2020

Originally intended as a treatment for Ebola virus, Veklury is a nucleotide analogue with broad-spectrum antiviral activity both in vitro and in vivo in animal models against several emerging viruses. The filing is supported by data from two randomised, open-label, multi-centre phase 3 clinical studies of Veklury conducted by Gilead.

Drugs 99

Drugs In-Vivo In-Vitro Contract Manufacturing 99

pharmaphorum

FEBRUARY 19, 2021

Excision wants to take its lead therapy candidate, EBT-101, into a phase 1/2 clinical trial in patients with chronic HIV infection with the proceeds from this latest financing round. We have proven the technology and candidate programs in vitro and in vivo in both small animal models and primate models.

Gene Editing 105

Gene Editing In-Vivo DNA In-Vitro 105

Pharmaceutical Technology

SEPTEMBER 10, 2008

IS: Our genotoxicity testing includes the core battery of the tests requested by EMEA/ICH including mutagenicity in vitro, chromosomal aberration test in vitro and micronucleus test in vivo. Natalie Coomber: Can you provide a quick background on the history of Biotest and the main work it is currently undertaking?

In-Vitro 100

In-Vitro Genotoxicity In-Vivo Development 100

pharmaphorum

FEBRUARY 13, 2022

Quris’ BioAI safety prediction platform – which is based on human tissue samples on chips, nanosensors and machine learning – will be compared to traditional in vitro and in vivo laboratory techniques for spotting toxicity.

Drugs 98

Drugs In-Vivo In-Vitro Pharma Companies 98

Camargo

FEBRUARY 10, 2021

Drug development is an extremely cumbersome process, requiring the testing of an agent from in vitro studies to in vivo studies to in silico modeling. This blog post will discuss how PK modeling can contribute to sample size estimation, a key aspect of a clinical trial protocol. Approaches to Pharmacokinetic Analysis.

Production 133

Production Bioavailability In-Vivo In-Vitro 133

The Pharma Data

MAY 3, 2021

DARS also greatly expanded its clinical trials operations, running three clinical trials related to streamlining biosimilars development and studying safety questions related to opioids and over-the-counter drugs,” Strauss wrote. Posted 03 May 2021 | By Michael Mezher . 2020 was a challenging year.

In-Vitro 52

In-Vitro Clinical Trials Clinical Trials In-Vivo 52

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

JANUARY 12, 2021

INCHEON, South Korea–( BUSINESS WIRE )– Celltrion Group today announced top-line results from its randomised, double-blind, and placebo controlled global Phase II/III clinical trial of CT-P59, an anti-COVID-19 monoclonal antibody treatment candidate. days quicker compared to placebo. days; 95% C.I, days compared to placebo [5.7

Clinical Trials 40

Clinical Trials Clinical Trials Trials In-Vivo 40

The Pharma Data

MARCH 25, 2022

2-4 Evusheld was generally well-tolerated in the trial.(2-4). 2-4 Evusheld was generally well-tolerated in the trial.(2-4). There is a growing body of evidence from multiple independent in vitro and in vivo (animal model) studies supporting the potential of Evusheld to protect against the BA.1,

Antibody 52

Antibody In-Vivo Medicine Vaccine 52

The Pharma Data

MARCH 29, 2022

Evusheld significantly reduced the risk of developing symptomatic COVID-19 in PROVENT Phase III trial, with protection lasting at least six months Evusheld retains neutralising activity against the Omicron BA.2 1-3 Evusheld was generally well-tolerated in the trial. 1-3 Evusheld was generally well-tolerated in the trial.

Antibody 52

Antibody In-Vivo Vaccination Vaccine 52

FDA Law Blog

FEBRUARY 2, 2023

Since 1962, the FD&C Act has authorized FDA to require that sponsors of clinical trials submit data from “preclinical tests (including tests on animals)” in order to demonstrate that their drug is safe enough to advance to testing in humans. adequate to justify the proposed clinical testing.” 21 U.S.C. § 355(i)(1)(A). FDORA § 3209(a)(1).

Clinical Trials 64

Clinical Trials Clinical Trials In-Vivo In-Vitro 64

The Pharma Data

DECEMBER 9, 2020

OHMX.bio – Belgium-based OHMX.bio and Fujirebio Europe were awarded a €720,000 research grant from Flanders Innovation & Entrepreneurship (VLAIO) to develop a clinical in vitro diagnostics (IVD) platform incorporating third generation sequencing (TGS) technologies. A solution could be at hand with Overland Pharmaceuticals.

In-Vivo 52

In-Vivo In-Vitro Antibody Development 52

The Pharma Data

JUNE 17, 2022

“The broadly neutralizing antibodies we described were more efficient in vitro than many anti–SARS-CoV-2 monoclonals previously approved by the FDA for treatment or prevention. 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

The Pharma Data

JANUARY 19, 2021

a privately-held neuron regeneration therapeutics company, today announced the publication of results of their novel pharmacotherapy: NNI-362 to allosterically stimulate neural regeneration in human cultures and in vivo models of aging and disease. CLARKSVILLE, Md., 20, 2021 (GLOBE NEWSWIRE) — Neuronascent Inc. , About NNI-362.

In-Vivo 40

In-Vivo Clinical Trials Clinical Trials In-Vitro 40

FDA Law Blog

OCTOBER 11, 2022

In prevalent conditions, FDA nearly universally requires that substantial evidence be demonstrated via two adequate and well-controlled clinical investigations, for example, two Phase 2 or 3 trials (as long as they have the characteristics delineated at 21 CFR § 314.126).

Clinical Trials 61

Clinical Trials Clinical Trials Drugs Trials 61

Delveinsight

JANUARY 18, 2021

The company was running Phase III trials of the therapy for AS; however, the therapy flunked in the trial failing to meet its primary endpoint. The companies had to pause the trials of GTX-102 after the patients temporarily lost the ability to walk. GeneTx and Ultragenyx are co-developing the therapy.

Marketing 52

Marketing Gene Drugs Protein 52

Delveinsight

DECEMBER 21, 2020

The expressions of these receptors were detected in GBM cell lines – in ex-vivo primary cancer cells extracted and in-situ GBM tissue biopsies. Thus, there can be a possibility that Cannabis may have the potential to cure Glioblastoma, however, further research, clinical trials are required and underway for a clearer picture.

In-Vivo 52

In-Vivo Clinical Trials Clinical Trials In-Vitro 52

XTalks

SEPTEMBER 20, 2024

XTALKS CLINICAL EDGE: Issue 3 — Interview with CTTI Xtalks Clinical Edge is a magazine for clinical research professionals and all who want to be informed about the latest trends and happenings in clinical trials. 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

Delveinsight

JANUARY 12, 2021

million after Birinapant successfully becomes a part of the Phase I trials. The companies believe that their candidate in its original IgG format has shown potent neutralization activity in in vitro assays and in an in vivo animal model. The duo will jointly develop the therapy, conducting clinical trials globally.

Licensing 52

Licensing Licensing Antibody Gene Therapy 52

The Pharma Data

OCTOBER 22, 2020

reflect the shared commitment of Gilead, government agencies and clinical trial investigators to advance well-tolerated, effective treatment options for the fight against COVID-19. Previously authorized by the FDA for emergency use to treat COVID-19, Veklury is now the first and only approved COVID-19 treatment in the United States.

FDA Approval 52

FDA Approval Trials Clinical Trials Clinical 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. Upon binding, the antibodies block the spike protein from interacting with ACE2 and thereby prevent virus-induced cell-killing, also known as cytopathic effect.

Antibody 52

Antibody Licensing Licensing Development 52

The Pharma Data

OCTOBER 21, 2020

Company is on t rack to s ubmit an IND in the fourth quarter of 2020 and i nitiate a Phase 1 /2 clinical trial for advanced solid tumors in 2021. Research s howed KB-0742 i nhibited a ndrogen r eceptor -d ependent a ctivity and r educed t umor g rowth in c astration -r esistant p rostate c ancer. SAN MATEO, Calif., and CAMBRIDGE, Mass.,

In-Vivo 40

In-Vivo In-Vitro Bioavailability Clinical Trials 40

XTalks

OCTOBER 1, 2020

The drug is currently in clinical trials for alcoholic hepatitis (AH), nonalcoholic steatohepatitis (NASH), as well as in COVID-19 patients with acute liver or kidney injury. However, this has since changed, and now, transitioning between academia and industry has become more commonplace. Key Moments. A life-changing moment came for Dr.

Scientist 52

Scientist In-Vitro Research Life Science 52

Pharmaceutical Technology

FEBRUARY 23, 2023

Many compounds present sub-optimal pharmacokinetic (PK) data (either predicted from in-vitro and pre-clinical data or measured in the clinic), such as poor exposure (leading to high doses), large variability, short half-life requiring more than once-a-day dosing, or C max -related adverse events (AEs).

Development 246

Development Drugs Bioavailability In-Vivo 246

Pharmaceutical Technology

FEBRUARY 28, 2023

The bispecific antibody was found to conditionally activate the immune pathway in the tumour microenvironment in vitro and in vivo trials. It also activated tumour-infiltrating DCs and T cells in vivo pharmacodynamic studies. Early R&D projects coverage on Pharmaceutical Technology is supported by Mimotopes.

In-Vivo 130

In-Vivo Antibody In-Vitro Licensing 130

XTalks

DECEMBER 6, 2024

XTALKS WEBINAR: Enhance Early Biomarker Discovery: Translating In Vitro and In Vivo Multi-Omics Oncology Data Live and On-Demand: Thursday, January 16, 2025 , at 11am EST (4pm GMT / UK) Register for this free webinar to explore the critical role of early biomarker identification in de-risking drug candidates and increasing clinical success rates.

Gene 98

Gene In-Vivo In-Vitro Genetics 98

FDA Law Blog

DECEMBER 6, 2024

Because this guidance covers such a breadth of information, for Part 1 of our coverage, we will focus on the non-CMC topics and summarize our top takeaways from each section, something of a Cliffs Notes for the Cliffs Notes. Section #1: FDA Interactions Given the wide range of sponsors (i.e.,

Gene Therapy 59

Gene Therapy Gene Production In-Vivo 59