XTalks

APRIL 22, 2022

Flow cytometric receptor occupancy assays are being increasingly used in preclinical and clinical studies. Both the areas of drug development and clinical trials are increasingly using in vitro assays to help determine the efficacy of an investigational therapeutic. What is Flow Cytometry?

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Advarra

MARCH 21, 2023

Regulations for research involving devices, in vitro diagnostics (IVDs), and digital therapeutics differ from those governing pharmaceutical development. The greater the risk, the more likely a series of trials for market clearance or approval will be required. In other words, what are the risks and benefits of the product?

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pharmaphorum

NOVEMBER 4, 2020

It may not be appropriate to use the word ‘failure’ when summarising the utility of clinical trials in the search for a curative or preventative treatment for disease. Most of the trials are underpowered to demonstrate efficacy on mortality and long-term consequences of the disease.

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XTalks

APRIL 14, 2022

Conventional in vitro and in vivo studies are used in the drug development pipeline. Take this quiz to test your knowledge about in silico trials! Register for this free, upcoming webinar to learn more about the benefits of implementing in silico clinical trials with mechanistic models for drug development.

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AuroBlog - Aurous Healthcare Clinical Trials blog

NOVEMBER 1, 2023

The Drug Controller General of India (DCGI) has added in-vitro diagnostic (IVD) medical devices including those for diagnosis of Covid-19, ribonucleic acid (RNA) and deoxyribonucleic acid (DNA) extraction kits, among others into the Class C risk category under the Medical Devices Rules (MDR), 2017.

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XTalks

MARCH 27, 2024

In vitro diagnostics, or IVD, is a field where precision, reliability and robust partnerships propel advancement. Dr. Dhiman has 24 years of clinical research experience in the immunogenetics of vaccines and infectious disease diagnostics. She did her clinical microbiology fellowship at Mayo Clinic in Rochester, Minnesota.

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Pharmaceutical Technology

SEPTEMBER 19, 2022

The EMA CHMP positive opinion is based on findings from the double-blind, randomised, placebo-controlled, multicentre Phase III TACKLE clinical trial of IM dose of Evusheld. Additionally, in the trial, the antibody cocktail was found to be well-tolerated. 5 variant, the company noted. 5 variant, the company noted.

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Drug Discovery World

MARCH 8, 2024

Biopharmaceutical company Innovent Biologics has launched the first-in-human (FIH) Phase I clinical trial of IBI3002, a novel bispecific antibody targeting Interleukin 4 receptor α (IL-4Rα) and thymic stromal lymphopoietin (TSLP). In vitro assays have shown superiority over the marketed monoclonal antibodies to respective target.

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Advarra

SEPTEMBER 23, 2022

The FDA requires the data for these assessments to generally come from animal studies and clinical investigations 1 of the investigational product(s) 2. . In other words, the FDA also regulates whether investigational products may be manufactured, shipped, and administered to human subjects who participate in clinical investigations. .

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Clinical Trials Clinical Trials Trials Regulation 52

Drug Discovery World

JANUARY 31, 2024

Breye Therapeutics, a clinical-stage biopharmaceutical company developing novel oral therapies for retinal vascular diseases within ophthalmology, has started a Phase Ib/IIa clinical trial to investigate danegaptide, following oral administration, in patients suffering from diabetic macular oedema (DMO).

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Pharmaceutical Technology

MAY 31, 2023

ZNA-1041 is under clinical development by F. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval. The company also offers in vitro diagnostics, tissue-based cancer diagnostics, and diabetes management solutions. Buy the report here.

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Pharmaceutical Technology

OCTOBER 5, 2022

In 2010, two patients with end-stage refractory chronic lymphocytic leukaemia (CLL) were administered Novartis’ autologous anti-CD19 chimeric antigen receptor T-cell (CAR-T) therapy, Kymriah (tisagenlecleucel), as part of a Phase I trial.

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XTalks

APRIL 27, 2022

As an urgent situation stirred due to the pandemic, along with Veklury drugs such as ribavirin, penciclovir, favipiravir, nafamostat, nitazoxanide and chloroquine were evaluated in vitro for their antiviral efficiency against a clinical isolate of the novel coronavirus. Clinical Trial on Pediatric Patients.

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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.

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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; 95% C.I,

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Drug Discovery World

APRIL 25, 2023

University of California researchers have dosed the second participant in their clinical trial to identify a potential cure for HIV utilising CAR-T cell therapy. The trial is the first-in-human clinical study investigating the duo CAR-T cell therapy for the treatment of HIV. In 2021 there were an estimated 1.5

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Drug Discovery World

AUGUST 22, 2023

The company has already completed three trials in patients, including a positive open label trial in metastatic breast cancer using a prototype capsule formulation. In addition, total blood levels of sulforaphane (SFN) and SFN-metabolites were confirmed in the micromolar range, where efficacy is seen in vitro.

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Gene Expression In-Vitro Gene Trials 52

Advarra

JULY 18, 2023

Clinical trials involving investigational in vitro diagnostic (IVD) devices are subject to the Food and Drug Administration’s (FDA’s) investigational device exemption (IDE) requirements ( 21 CFR 812 ). When an investigational device does not carry this potential for serious risk, the clinical investigation is NSR.

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XTalks

APRIL 2, 2021

Pfizer released new COVID-19 vaccine trial results this week from its ongoing clinical studies, which include data showing that its COVID-19 mRNA vaccine is 100 percent effective in children between the ages of 12 and 15 and has a 91 percent efficacy against variants with protection lasting at least six months.

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XTalks

APRIL 18, 2024

Conversely, a negative result suggests a low probability of amyloid pathology, guiding healthcare providers in clinical decision-making and potentially ruling out Alzheimer’s disease in symptomatic patients. There are currently no FDA-authorized blood tests for detecting Alzheimer’s disease.

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Pharmaceutical Technology

JUNE 5, 2023

Pralsetinib is under clinical development by F. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval. The company also offers in vitro diagnostics, tissue-based cancer diagnostics, and diabetes management solutions. Buy the report here.

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Bioengineer

JANUARY 16, 2024

Analysis of circulating tumor (ct) DNA at the time of treatment discontinuation or progression showed that 49% of patients in the AURA3 trial lacked the T790M mutation. The presence of the T790M mutation during first or second-generation EGFR-TKI treatments is observed in 50-60% of patients. months vs. 15.2 months, p = 0.01).

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Drug Discovery World

SEPTEMBER 28, 2023

Earlier this year, we explored the microbiome and its role in drug development across various therapeutic areas. This article will focus on one such area of great unmet need and promise: women’s health. This is likely in part because their byproduct, lactic acid, is known to inhibit pathogenic bacteria 25.

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Drug Discovery World

FEBRUARY 6, 2024

In vitro and in silico models are becoming increasingly sophisticated in predicting drug safety profiles and preventing costly and time-consuming clinical trials. In vitro and in silico models are becoming increasingly sophisticated in predicting drug safety profiles and preventing costly and time-consuming clinical trials.

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Drug Discovery World

APRIL 8, 2024

Jakob Nikolas Kather, Professor of clinical artificial intelligence at Technical University Dresden in Germany, then discussed how AI applications can be used to derive prognostic and predictive information from routine pathology slides.

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XTalks

JUNE 26, 2023

Medical device and in vitro diagnostics technologies provider SurModic Inc. SurVeil’s FDA approval was based on 24 months of data from the pivotal, head-to-head TRANSCEND clinical trial that compared it against Medtronic’s IN.PACT. The balloon is designed for the treatment of patients with peripheral artery disease.

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Pharmaceutical Technology

JUNE 6, 2023

According to Globaldata, it is involved in 5 clinical trials, which are ongoing. The rNPV model is a more conservative valuation measure that accounts for the risk of a drug in clinical development failing to progress. Buy the model here. It also develops RNAi candidates for the treatment of retina diseases. over FY2021.

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Drug Discovery World

MAY 9, 2023

Fewer than 5% of oncology drugs that enter clinical trials in the US receive US FDA approval. This abysmal success rate significantly trails the overall approval rate for compounds entering human trials (about 10% of which reach commercialisation). Cancer is far more complex than the sum of its parts.

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Development Drugs In-Vivo Clinical Trials 52

XTalks

JANUARY 9, 2023

Its mechanism of action differs from currently approved antivirals and has thus far shown no cross-resistance in vitro to other drug classes. Sunlenca received New Drug Application (NDA) approval based on the results of the CAPELLA trial, in which it demonstrated high rates of sustained virological suppression. Gilead Sciences, Inc.

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Drug Discovery World

JUNE 30, 2023

Through the use of human induced pluripotent stem cells (iPSCs) derived cells, we can improve translation and reduce risk of clinical failure. Select mature stem cell lines can then be used in small-scale in vitro assays, and proven biochemical and phenotypic screens supporting target validation and deconvolution studies.

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Drug Discovery World

APRIL 5, 2023

A collaborative network The CBC operates as a collaborative network of 19 Institutes with longstanding drug discovery know-how from target identification through to proof-of-concept clinical trials. The post Only non-US company joins cancer drug discovery consortium appeared first on Drug Discovery World (DDW).

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Roots Analysis

AUGUST 18, 2023

Due to this biological mismatch, several toxic drugs are subjected to costly clinical trials, while potentially useful drugs do not get commercialized. In order to fasten the discovery of innovative drugs and personalized medication, improved in vitro simulation of human biology and pathologies is required.

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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. The post Merck will assess Quris’ AI ‘patient-on-a-chip’ drug safety appeared first on.

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XTalks

MARCH 2, 2021

The 66 percent efficacy determined for the J&J vaccine is for the prevention of mild to moderate disease, an average derived from the companies’ global Phase III trials. The knee-jerk reaction among some has been to deem the vaccine inferior to other authorized counterparts that have higher efficacies.

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Drug Discovery World

DECEMBER 13, 2022

Dr Mariko Taniguchi-Ikeda, Associate Professor in the Department of Clinical Genetics at Fujita Health University Hospital, said: “I have seen patients with FCMD for more than 20 years. Japanese researchers propose using RNA interference for correcting a mistake in the genetic code of patients with Fukuyama muscular dystrophy. .

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XTalks

FEBRUARY 1, 2023

The researchers found that factors in the blood can potentially predict the risk of developing the disease years before a clinical diagnosis is made. Among individuals diagnosed with MCI, ten to 15 percent of them progress to Alzheimer’s disease as observed in clinical studies and five to ten percent in population studies.

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Drug Discovery World

FEBRUARY 22, 2024

With no in-house laboratory space, the company works closely with multiple international contract research organisations (CROs), including Axxam, which carry out all of the Libra R&D, from compound screening assays, to in vivo pharmacokinetic/pharmacodynamic and ADME work, as well as in vitro and in vivo pre-clinical safety assessments.

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