AuroBlog - Aurous Healthcare Clinical Trials blog

JANUARY 8, 2025

The Central Drugs Standard Control Organisation (CDSCO) and Indian Council of Medical Research (ICMR) have together released the draft standard evaluation protocols for the purpose of issuing license for in-vitro diagnostics (IVDs) under the Medical Devices Rules (MDR), 2017.

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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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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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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

NOVEMBER 19, 2021

Cardiac biomarkers can not only serve important roles in the diagnosis, management and prognosis of cardiac diseases, but they can also be significant tools in evaluating treatments in cardiovascular (CV) clinical trials. In CV clinical trials, cardiac biomarkers are most commonly included in efficacy and safety endpoints.

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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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The Pharma Data

OCTOBER 16, 2020

As pharma companies search for solutions to avoid cancelling or delaying clinical trials, virtualizing trials are fast becoming commonplace during the Covid-19 pandemic. With many nationwide and regional lockdowns coming into force, virtual clinical trials are proving to be an effective way to monitor patients remotely.

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XTalks

NOVEMBER 7, 2022

Liquid biopsies have demonstrated promising activity in multiple clinical settings, but the great enthusiasm and expectations around them can be harmful if not adequately managed,” said Dr. El Mustapha Bahassi, PhD, Director, Clinical Laboratory Sciences, at the global clinical research organization (CRO) Medpace.

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Worldwide Clinical Trials

JUNE 21, 2024

The 2024 ASCO Annual Meeting from the American Society of Clinical Oncology is a fantastic platform for clinical researchers to discuss the latest advancements and challenges in oncology research. Currently, there are 12 approved ADC drugs, and several hundred more are in the development pipeline.

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ProRelix Research

MAY 22, 2024

The transition of a drug, medical device, or biopharmaceutical from the laboratory bench to bedside involves a long series of steps starting from drug discovery, computational chemistry, in vitro and […] The post Requirements to Conduct First-in-Human (FIH) Clinical Trials for Biopharmaceuticals appeared first on ProRelix Research.

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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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Pharmaceutical Technology

MAY 16, 2023

The approval also includes clearance for a Phase I clinical trial protocol of NXP900. Nuvectis now has two precision oncology, clinical-stage drug candidates, each with several potential opportunities in cancers that represent serious conditions of unmet medical need. “We

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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

FEBRUARY 1, 2023

Ellipses Pharma stated that the dual FLT3 inhibition and Aurora kinase demonstrated to overcome the acquired resistance to selectively inhibit FLT3 in vitro and in vivo. According to the company, approximately one-third of AML patients are diagnosed with FLT3 mutations related to a higher relapse risk and poor clinical outcomes.

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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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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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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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XTalks

DECEMBER 28, 2023

BillionToOne, a company specializing in molecular diagnostics, has partnered with Janssen Research & Development, LLC, a Johnson & Johnson division, to conduct the AZALEA Phase III clinical trial globally. Although recruitment has not started, AZALEA plans to enroll and assess the therapy in 120 participants.

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The Pharma Data

SEPTEMBER 8, 2020

Phase III clinical trial programme initiated for investigational medicine fenebrutinib, designed to be a highly selective and reversible Bruton’s tyrosine kinase (BTK) inhibitor, in relapsing multiple sclerosis (RMS) and primary progressive MS (PPMS). Roche’s Chief Medical Officer and Head of Global Product Development. “We

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Camargo

NOVEMBER 29, 2021

Like with small molecules, clinical trials of biologics are designed to determine pharmacokinetics (PK), pharmacodynamics (PD), safety, and efficacy. PK studies are conducted to confirm that dosimetry remains unchanged, and toxicology studies are needed to confirm that the therapeutic ratio and safety profile remain unchanged.

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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.

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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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The Pharma Data

APRIL 22, 2023

UC Davis Health researchers have dosed the second participant in their clinical trial looking to identify a potential cure for HIV utilizing CAR T-cell therapy. The trial is the first-in-human clinical study investigating the duoCAR T-cell therapy for the treatment of HIV. The novel study uses immunotherapy.

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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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pharmaphorum

FEBRUARY 19, 2021

US biotech Excision BioTherapeutics has raised $60 million to test a potential HIV cure in the clinic, which would use CRISPR technology to snip out the viral code from human cells and tissues. We have proven the technology and candidate programs in vitro and in vivo in both small animal models and primate models.

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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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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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Pharmaceutical Technology

SEPTEMBER 10, 2008

Before the inception of this institute, the facility was oriented towards pre-clinical toxicology and breeding of the laboratory animals. Before the inception of this institute, the facility was oriented towards pre-clinical toxicology and breeding of the laboratory animals. Dr Ivana Surovà: Biotest s.r.o.

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pharmaphorum

OCTOBER 18, 2021

Also worth exploring is the regulatory oversight and approval process for medical devices and in-vitro diagnostics (IVDs). In addition to data obtained in a clinical setting, information from outside of the clinic can contribute to understanding how a medicine works in daily life.”. billion people have been fully vaccinated.

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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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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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pharmaphorum

MARCH 4, 2021

Sunak pledged £28 million towards the UK’s capacity for vaccine testing, support for clinical trials and to improve the ability to acquire samples of new COVID-19 variants. ” BIVDA, the trade association for British in-vitro diagnostic companies, supported the “super-deduction” policy. .”

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pharmaphorum

SEPTEMBER 9, 2020

Oncomfort has created a platform called Sedakit that provides ‘digital sedation’ – clinical hypnotherapy sessions delivered via a virtual reality headset accompanied by scripts and immersive sounds designed to dissociate patients from their symptoms.

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XTalks

JANUARY 21, 2025

From non-invasive cancer diagnostics to life-saving cardiovascular implants, the latest medical devices cleared or approved by the FDA in 2024 reflect the remarkable strides in science and engineering. In this blog, we discuss some of these new medical devices of 2024 that have improved patient outcomes and enhanced quality of life worldwide.

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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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The Pharma Data

JANUARY 13, 2021

Fast Track designation is well-timed, as we anticipate starting our Phase 2 clinical trial in hospitalized COVID-19 patients this month, and should help bring Brilacidin to patients faster in these dire times.”. In a human lung cell line against SARS-CoV-2, Brilacidin achieved a Selectivity Index of 426.

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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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