pharmaphorum

MARCH 15, 2022

The TruSight Oncology in vitro diagnostic (IVD) test is being launched first in Europe and according to Illumina’s cancer head Kevin Keegan can match patients with suitable therapies “according to clinical guidelines or clinical trials, based on their tumour profile.”

Gene 52

Gene Genome Genomics Gene Sequencing 52

The Pharma Data

AUGUST 27, 2020

FoundationOne Liquid CDx analyses more than 300 cancer-related genes and multiple genomic signatures to help inform treatment decisions for all solid tumour cancers. FoundationOne Liquid CDx adds to Foundation Medicine’s genomic testing portfolio supporting Roche’s mission to deliver truly personalised healthcare.

FDA Approval 52

FDA Approval Genome Genomics Gene 52

The Pharma Data

DECEMBER 14, 2020

Many drugs fail in clinical trials because of their low blood brain barrier permeability. engine along with algorithms tuned to predict BBB permeability played an important role in helping determine which CNS cancers and which genomically-defined subtypes of CNS cancer should be prioritized for development. . Lantern’s A.I.

Drugs 52

Drugs Genomics Genome DNA 52

The Pharma Data

JANUARY 11, 2021

In clinical trials, it could detect COVID-19 with 90%+ accuracy in about two minutes. . By the end of January, Johnson & Johnson is expected to deliver preliminary trial results for its one-dose COVID-19 vaccine candidate. . DalCor Pharmaceuticals initiated the Phase II dal-COVID trial of dalcetrapib for COVID-19.

Vaccination 52

Vaccination Vaccine Clinical Trials Clinical Trials 52

Cloudbyz

JULY 31, 2024

The landscape of modern medicine is rapidly evolving, driven by groundbreaking advancements in diagnostics. This revolution is enabling the growth of innovative biomarker-based precision medicine and cell and gene therapy, transforming both clinical research and post-market care.

Gene Therapy 52

Gene Therapy Gene Medicine In-Vitro 52

The Pharma Data

JANUARY 24, 2021

With a presidential inauguration and a federal holiday, it wasn’t an enormously busy week for clinical trial news, but there was a fair amount, nonetheless. It inked a deal with the National Institute of Allergy and Infectious Diseases (NIAID) to launch a Phase I trial. Read on to see. COVID-19-Related. Non-COVID-19-Related.

Trials 52

Trials Allergies In-Vitro Antibody 52

The Pharma Data

OCTOBER 9, 2021

This designation is predicated on data showing that gantenerumab significantly reduced brain amyloid pillar, a pathological hallmark of Notice, in the ongoing SCarlet RoAD and Marguerite RoAD open- tag extension trials, as well as other studies. Roche’s Chief Medical Officer and Head of Global Product Development.

Antibody 52

Antibody In-Vitro Trials Development 52

The Pharma Data

NOVEMBER 17, 2021

Streamlined in vitro data, published in bioRxiv, demonstrate that sotrovimab retains exertion against all current variants of concern and interest of the SARS-CoV-2 contagion as defined by the World Health Organization, plus others, including, but not limited to, Delta (B.1.617.2), 1.617.2), Delta Plus (AY.1 2) and Mu (B.1.621).

Antibody 52

Antibody In-Vitro Vaccination Vaccine 52

The Pharma Data

OCTOBER 14, 2021

This designation is based on data showing that gantenerumab significantly reduced brain amyloid plaque, a pathological hallmark of AD, in the ongoing SCarlet RoAD and Marguerite RoAD open-label extension trials, as well as other studies. Roche’s Chief Medical Officer and Head of Global Product Development.

Antibody 52

Antibody Medicine In-Vitro Trials 52

The Pharma Data

MARCH 26, 2021

The FDA EUA submission is based on an interim analysis of efficacy and safety data from the Phase 3 COMET-ICE (COVID-19 Monoclonal antibody Efficacy Trial – Intent to Care Early) trial, which evaluated VIR-7831 as monotherapy for the early treatment of COVID-19 in adults at high risk of hospitalisation.

Antibody 52

Antibody Trials Vaccination Vaccine 52

The Pharma Data

OCTOBER 14, 2021

The trial showed that no patients experienced Grade 3 or higher infusion-related reactions during treatment cycle 2 with short duration infusion Gazyvaro, and no unexpected safety findings were found, supporting its use. The approval is based on a positive opinion from the EMA’s Committee for Medicinal Products for Human Use (CHMP).

Medicine 52

Medicine In-Vitro Antibody Genome 52

The Pharma Data

NOVEMBER 23, 2021

Roche moment blazoned that new data from its expansive haematology portfolio will be presented at the American Society of Hematology (ASH) Annual Meeting and Exposition from 11-14 December 2021. The safety profile was similar for Polivy plus R-CHP versus R-CHOP.1 Roche’s Chief Medical Officer and Head of Global Product Development. “

Antibody 52

Antibody In-Vitro Development Genome 52

The Pharma Data

SEPTEMBER 16, 2020

Blueprint Medicines will present new data from the registrational phase I/II ARROW trial, investigating Gavreto TM (pralsetinib) for the treatment of people with RET-mutant medullary thyroid cancer. New and updated data from across our broad cancer portfolio including phase III results in breast, lung and prostate cancers.

HR 52

HR Medicine Hormones Trials 52

The Pharma Data

MARCH 16, 2021

1 lineage gained prominence in late 2020, with each carrying a number of genomic mutations. The cobas SARS-CoV-2 Variant Set 1 Test is designed to detect key spike mutations in virus variants associated with increased human-to-human transmission. 1.1.7), South Africa (B.1.351), 1.351), and Brazil (P.1). Variants of B.1.1.7, 1.351 and P.1

Antibody 52

Antibody Clinical Trials Clinical Trials Vaccination 52

The Pharma Data

JULY 23, 2021

In addition to the REGN-COV 2067 trial in non-hospitalised patients, Ronapreve is currently being assessed in a phase II/III clinical trial for the treatment of COVID-19 in hospitalised patients (REGN-COV 2066). Roche’s Chief Medical Officer and Head of Global Product Development.

Antibody 52

Antibody Medicine Production In-Vitro 52

The Pharma Data

SEPTEMBER 6, 2020

FDA also granted Priority Review to Gavreto for the treatment of people with advanced or metastatic RET-mutant medullary thyroid cancer and RET fusion-positive thyroid cancer. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

FDA Approval 52

FDA Approval Medicine In-Vitro Genetics 52

The Pharma Data

NOVEMBER 12, 2021

About Ronapreve (casirivimab and imdevimab) The efficacity and safety of Ronapreve (casirivimab and imdevimab, known as REGEN-COV ® in the United States) have been studied across multiple phase III clinical trials innon-hospitalised and hospitalised COVID-19 cases, and in the preventative setting.

In-Vitro 40

In-Vitro Medicine Development Marketing 40

The Pharma Data

NOVEMBER 11, 2021

A final decision regarding the blessing of Ronapreve is anticipated from the European Commission in the near future. Roche’s Chief Medical Officer and Head of Global Product Development.”People It has also been conditionally recommended by WHO.

In-Vitro 40

In-Vitro Antibody Medicine Development 40

The Pharma Data

JULY 21, 2021

Group sales up 8% 1 at constant exchange rates (CER); 5% in Swiss francs. Pharmaceuticals Division sales decline 3%; sales grow 4% in the second quarter, following a first-quarter decrease of 9%; newly launched medicines (+30%) compensate for the continued impact from biosimilars. Outlook for 2021 confirmed. Group results.

Sales 52

Sales Medicine Antibody In-Vitro 52

The Pharma Data

JUNE 26, 2021

Roche-sponsored global trials included the placebo-controlled EMPACTA, COVACTA and REMDACTA studies. Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S. The EUA is based on results from four randomised, controlled studies that evaluated Actemra/RoActemra for the treatment of COVID-19 in more than 5,500 hospitalised patients.

Clinical Trials 40

Clinical Trials Clinical Trials In-Vitro Antibody 40

XTalks

MAY 12, 2022

This diagnostic assay works on the principle of in vitro nucleic acid amplification using real-time transcription-mediated amplification (TMA) technology. The Aptima CMV Quant Assay helps to detect changes in the viral load of the transplant patient to understand the response of the individual to anti-CMV treatment.

In-Vitro 52

In-Vitro DNA Development Genome 52

Pharmaceutical Technology

FEBRUARY 20, 2023

If clinical trial participants are representative of the wider disease population, they can help sponsors assess the effectiveness of new and existing therapeutics. of the clinical trial population globally. This may sound obvious, but it is still a major hurdle in drug development. participation of white subjects.

Research 130

Research Clinical Trials Clinical Trials Trials 130

XTalks

JANUARY 6, 2025

For example, antisense oligonucleotide (ASO)-based therapies have gained traction, with 100 Phase I clinical trials initiated and around 25 percent of these advancing to Phase II or Phase III trials in recent years. Related: Biotech IPOs in 2024: Navigating the New Wave of Innovation 1.

Gene Therapy 111

Gene Therapy RNA Gene Editing Gene 111

FDA Law Blog

DECEMBER 6, 2024

There is even a tip of the hat to alternative (non-animal) test methods, which have become powerful methods for the assessment of the potential for off-target toxicity and unintended genome editing. Section #1: FDA Interactions Given the wide range of sponsors (i.e., CBER will not commit to reviewing packages greater than 250 pages.

Gene Therapy 59

Gene Therapy Gene Production In-Vivo 59