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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Licensing Licensing In-Vitro Regulation 180

Pharmaceutical Technology

APRIL 27, 2023

The treatment is now indicated for CF patients with a minimum of one F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene, or with a mutation in the CFTR gene that responds to Trikafta based on in vitro data. It was previously approved to treat CF in children aged between six and 11 years.

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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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RNA DNA In-Vitro Drugs 189

Pharmaceutical Technology

MAY 4, 2023

The approval allows KALYDECO to be used in infants who have at least one mutation in their cystic fibrosis transmembrane conductance regulator (CFTR) gene that is responsive to the therapy, on the basis of clinical and/or in vitro assay results. This cohort showed a safety profile identical to that found in older children and adults.

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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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In-Vitro In-Vivo Sales Clinical Trials 279

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. Want to learn more?

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Trials In-Vivo In-Vitro Clinical Trials 98

Scienmag

NOVEMBER 17, 2020

Researchers at Karolinska Institutet in Sweden report promising results from an in vitro combination therapy against COVID-19.

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In-Vitro Medicine Trials Research 59

World of DTC Marketing

JULY 12, 2021

Pfizer and Moderna both have reported six-month follow up data from their phase 3 trials. And both companies have performed in vitro tests that demonstrate satisfactory vaccine efficacy against variants of concern. SUMMARY: Pfizer says it has data on waning immunity from their COVID vaccine. The FDA and CDC say “not so fast.”

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Vaccination Vaccine In-Vitro Doctors 292

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. The trial is set to occur across the US, the European Union (EU) and selected global locations.

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Trials Clinical Trials Clinical Trials Antibody 97

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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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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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. The FDA IND clearance allows the company to expand its ongoing first-in-human Phase I/II clinical trial of EP0042.

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FDA Approval In-Vivo In-Vitro Trials 130

Worldwide Clinical Trials

JUNE 21, 2024

Worldwide Clinical Trials attends each year to hear from the research community, connect with our sponsors and sites, and explore potential partnerships to drive forward novel treatments. Unlike CAR T therapies, TILs are produced in vitro by purifying natural infiltrating lymphocytes from the patient’s own tumor microenvironment.

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XTalks

APRIL 22, 2022

Both the areas of drug development and clinical trials are increasingly using in vitro assays to help determine the efficacy of an investigational therapeutic. In a recent webinar, Dr. Olsson described the benefits of flow cytometric receptor occupancy assays in clinical trials. What is Flow Cytometry?

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Clinical Trials Clinical Trials Trials Antibody 98

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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Clinical Trials Clinical Trials Trials In-Vitro 98

Pharmaceutical Technology

MAY 16, 2023

The approval also includes clearance for a Phase I clinical trial protocol of NXP900. NXP900 plus Osimertinib in vitro showed a possible ability to reverse acquired resistance to these drugs in non-small cell lung cancers. Nuvectis has licensed the exclusive global rights to NXP900 from the University of Edinburgh in Scotland, UK.

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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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Clinical Trials Clinical Trials In-Vitro Trials 52

Pharmaceutical Technology

APRIL 12, 2023

FoundationOne CDx is a sequencing-based in vitro diagnostic device that can identify alterations in 324 genes from tumour samples. Foundation Medicine has announced it will supply a tissue-based test as a companion diagnostic for Bristol Myers Squibb’s (BMS) recently acquired ROS1/TRK inhibitor repotrectinib.

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Genome Genomics In-Vitro Gene 130

Pharmaceutical Technology

MAY 31, 2023

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. ZNA-1041 is under clinical development by F. Buy the report here.

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XTalks

NOVEMBER 7, 2022

Gleich, MD, FACS, Senior Vice President, Medical Department, and Dr. Christopher Huth, PhD, Senior Clinical Trial Manager, Clinical Trial Management. Liquid Biopsy Use in Oncology Clinical Trials. These tumor-derived entities are used to derive genomic and proteomic data. Concentration of CTCs in Cancer Patients.

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Clinical Trials Clinical Trials Trials FDA Approval 98

XTalks

MARCH 27, 2024

In vitro diagnostics, or IVD, is a field where precision, reliability and robust partnerships propel advancement. Dr. Dhiman is a scientific expert in molecular infectious disease and women’s health and is actively engaged in multiple clinical trials with a special interest in rapid molecular diagnostics for sepsis.

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Manufacturing Clinical Trials Clinical Trials In-Vitro 108

Pharmaceutical Technology

MAY 10, 2023

The research teams will examine the use of CytoMed’s allogeneic gdTc on multiple AML and breast cancer subtypes in vitro and in vivo. Under the two-year deal, both parties expect to develop new treatment methods for patients’ unmet AML and breast cancer needs at a reasonable price.

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Gene Therapy In-Vivo In-Vitro Gene 147

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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Antibody In-Vivo Trials In-Vitro 99

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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FDA Approval In-Vitro Clinical Trials Clinical Trials 98

Pharmaceutical Technology

MAY 24, 2023

is expected to enter Phase II/III registration trial as the first-line treatment for advanced Merkel cell carcinoma (MCC) early next year. to investigational new drug-enabling trials, expected in 2024, to treat aggressive diffuse large B-cell lymphomas (DLBCLs). Morphogenesis’ lead personalised cancer vaccine, IFx-Hu2.0,

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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.

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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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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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Vaccine Vaccination Trials Clinical Trials 59

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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BioTech 365

OCTOBER 7, 2020

– Antiviral Activity Confirmed by Early Stage Studies Conducted through the National Institute of Allergy and Infectious Diseases Preclinical Services Program and Texas Biomedical Research Institute – Patient Enrollment for Phase 2 Trial Ongoing DALLAS, Texas, Oct. 07, 2020 (GLOBE … Continue reading →

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In-Vitro Allergies Trials Research 40

XTalks

MARCH 1, 2021

NYSE: PFE ) and BioNTech SE (Nasdaq: BNTX ) have announced that they are beginning a trial to evaluate the safety and efficacy of a third booster dose for their COVID-19 vaccine (BNT162b2), as well as new vaccine variants. The study will be a part of current Phase I, II and III trials. Pfizer Inc.

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pharmaphorum

SEPTEMBER 22, 2021

. “The authorization of this AI-based software can help increase the number of identified prostate biopsy samples with cancerous tissue, which can ultimately save lives,” said Tim Stenzel, director of the FDA’s office of in vitro diagnostics and radiological health. That compared to 90.9%

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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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Clinical Trials Clinical Trials Trials Production 52

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?

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In-Vitro Genotoxicity In-Vivo Development 100

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.

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Gene Editing In-Vivo DNA In-Vitro 105

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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FDA Approval Drugs Sales In-Vitro 96

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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