The Pharma Data

SEPTEMBER 2, 2020

The decision allows use of the therapy in the EU in children as young as six years of age and weighing at least 17kg, regardless of HCV genotype or liver disease severity. Source link.

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Genotype Clinical Trials Clinical Trials Trials 52

pharmaphorum

JANUARY 18, 2023

Pharmaceutical companies and biotechs are also adapting their approaches, launching patient finding and engagement programmes that can start years before clinical trials begin and allow them to run ‘recontact by genotype’ studies that the Resilience Project would have liked to do. Giving participants something in return.

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Genetic Disease Genetics Research Genome 97

Worldwide Clinical Trials

AUGUST 14, 2024

The analysis of circulating tumor DNA (ctDNA) in a liquid biopsy can also permit genotyping and help monitor the effectiveness of chemotherapy. The post The Role of Oncology Biomarkers in Personalizing Hematology Treatment Plans appeared first on Worldwide Clinical Trials.

Genetics 195

Genetics Protein Gene Genotype 195

BioTech 365

OCTOBER 5, 2020

Nature Medicine Publication Reports that Liquid Biopsy More Than Doubles Clinical Trial Enrollment Rate Compared to Tissue Biopsy REDWOOD CITY, Calif.–(BUSINESS Despite advances in precision oncology, progress is slowed by the limitations of tissue genotyping, … Continue reading → Nasdaq: GH).

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Clinical Trials Clinical Trials Genotype Trials 40

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. Osimertinib, however, can covalently bind to the T790M and cysteine-797 (C797) residue at the protein’s ATP binding site, overcoming resistance mechanisms.

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The Pharma Data

NOVEMBER 2, 2020

(NASDAQ:ADIL; ADILW) , a clinical-stage biopharmaceutical company focused on the development of treatments for addictions, today provided an update on its landmark ONWARD Phase 3 pivotal trial. 40% of expected Trial patient screenings have been completed and the Trial is more than 25% enrolled relative to planned enrollment.

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Trials Genotype Marketing Production 52

XTalks

SEPTEMBER 15, 2020

A vaccine developed by Swedish company Diamyd Medical has demonstrated significant treatment efficacy in a predefined genetic subgroup of individuals with type 1 diabetes in a Phase IIb clinical trial. In the trial, the vaccine was injected directly into the lymph nodes of type 1 diabetic individuals. The DIAGNODE-2 Trial.

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Vaccination Vaccine Insulin Trials 103

BioTech 365

AUGUST 17, 2020

ETD002 is a novel TMEM16A chloride channel potentiator Therapy applicable to all cystic fibrosis patients, independent of genotype BRIGHTON, England–(BUSINESS WIRE)–Enterprise Therapeutics Ltd (Enterprise), a biopharmaceutical company dedicated to the discovery and development of novel therapies to improve the lives … Continue reading (..)

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Pharmaceutical Technology

DECEMBER 15, 2022

BT-524 is currently being studied in a Phase III trial (ADFIRST) in AFD patients undergoing elective spinal and/or abdominal surgery and has high potential to gain approval for both indications. This provides a large advantage over currently marketed products and may allow BT-524 to capture a significant share of the market at launch.

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Marketing Production Genotype Development 130

pharmaphorum

JANUARY 21, 2022

The findings have been submitted to the Genotype-to-Phenotype National Virology Consortium (G2P-UK), the New and Emerging Respiratory Virus Threats Advisory Group (NERVTAG) and the Joint Committee on Vaccination and Immunisation (JCVI). Overall, antibody levels were nearly 2.5

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Antibody Vaccination Vaccine Genotype 115

Scienmag

MAY 16, 2021

The fully human monoclonal antibody produced sustained reductions in triglyceride levels of up to 82 percent, depending on the patient’s genotype, while also lowering the […].

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Antibody Genotype Drugs Clinical Trials 45

pharmaphorum

JANUARY 29, 2019

What are the implications from these changes for clinical trials? How the shift towards cancer as a phenotype/genotype is being applied in clinical trials and how they are run •What are co-clinical trials and why could they hold the key to answering unmet need in cancer treatment and beyond into broader drug development?

Genome 52

Genome Genomics Medicine Clinical Trials 52

Pharmaceutical Technology

JUNE 6, 2023

According to Globaldata, it is involved in 5 clinical trials, which are ongoing. Pharma Mar offers in vitro diagnostic products used for detection of virus and bacteria in respiratory infections and human papilloma virus genotypes, among others. Buy the model here.

Hormones 100

Hormones In-Vitro Genotype Bacteria 100

Delveinsight

DECEMBER 13, 2020

Even though clinical trial results were promising, adverse events and serious complications were observed. Hepatitis C treatment options, without a doubt, have improved significantly, including pan-genotypic medications that are used to treat all genotypes and subtypes. Both drugs resulted in inhibition of HCV replication.

Genotype 52

Genotype FDA Approval DNA Drugs 52

XTalks

SEPTEMBER 28, 2020

Related: Liquid Biopsies Help Match Cancer Patients to Phase I Trials. The test is based on the detection of actionable genes – genes with known driver mutations that can be targeted by an approved therapy (or investigational therapies in clinical trials).

Gene 105

Gene DNA Life Science Genotype 105

XTalks

APRIL 15, 2021

Late-stage clinical trial failures are largely to blame for the lack of effective treatment options for patients with HFpEF, and poor five-year survival rates make this an area of great unmet need. A lack of efficacy is the greatest reason for clinical trial failures, especially in Phase II and Phase III,” says Dr. Tyl.

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Development Drugs Genome Genomics 98

pharmaphorum

JANUARY 29, 2023

The EMA’s human medicines committee has started a review of Novartis’ sickle cell disease (SCD) therapy Adakveo, shortly after the company reported that it failed to show efficacy in a phase 3 trial. STAND found no benefit over placebo on VOC rates for both doses of Adakveo on test – 5 mg/kg and 7.5 compared to 2.98

Genotype 52

Genotype Trials Antibody Regulation 52

pharmaphorum

AUGUST 11, 2022

Pharmacogenomics is ushering in an era where we can eliminate those struggling with a trial-and-error system that leaves many getting sicker even when effective treatments exist for them. With this promise beginning to be realised, it’s on drug makers to use genomic testing to steer their development process.

Genome 98

Genome Genomics Drugs Genetics 98

XTalks

FEBRUARY 4, 2021

Through these collaborations, cohort research dataset sharing programs allow for whole-genome sequence and genotype data to be made available for independent research. Now, if all you’ve already got is a bioresource of 20,000 people that have already been genotyped, you can choose those from that sample and focus your effort.”.

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Research Biobanking Drugs Genome 98

XTalks

JANUARY 21, 2025

In a clinical trial, participants demonstrated a 98% success rate after six months post implantation, with arteries widened successfully and no stent fractures observed. In a trial with 100 patients , the device demonstrated no major complications, an average bleeding stop time of 2 minutes, with patients walking within approximately 2.5

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The Pharma Data

NOVEMBER 10, 2020

Although a few are out there, phosphorylated tau (P-tau) may enable even earlier and more accurate detection, according to Eli Lilly-associated researchers speaking at the Clinical Trials on Alzheimer’s Disease (CTAD) virtual conference in early November. This is encouraging as a pharmacodynamic biomarker in larger trials,” Dage said.

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Clinical Trials Clinical Trials Trials Antibody 52

The Pharma Data

OCTOBER 9, 2021

Food and Drug Administration (FDA) Antimicrobial Drugs Advisory Committee (AMDAC) voted unanimously to recommend use of maribavir (TAK-620) for the treatment of refractory cytomegalovirus (CMV) infection and disease with genotypic resistance to ganciclovir, valganciclovir, foscarnet or cidofovir in transplant recipients.

Drugs 52

Drugs Genotype Medicine Bioavailability 52

The Pharma Data

JANUARY 26, 2021

Eli Lilly expanded its ongoing BLAZE-4 study to include Vir’s monoclonal antibody in the trial. Data published last week showed that bamlanivimab significantly reduced COVID-19 risk for nursing home residents in a Phase III trial. . Food and Drug Administration to treat mild-to-moderate COVID-19 patients.

Antibody 52

Antibody Genotype Trials Nurses 52

XTalks

MARCH 3, 2021

Nulibry Trial Results. The efficacy of Nulibry in the treatment of MoCD Type A was demonstrated in data from three different clinical trials that was compared to data from a natural history study. It is administered as an intravenous medication, delivering the enzyme to allow for the formation of the molybdenum cofactors.

FDA Approval 64

FDA Approval Genotype Clinical Trials Clinical Trials 64

pharmaphorum

NOVEMBER 10, 2021

This database should support automatic importation from hospitals, laboratories and surveillance networks and link to genotypic data when available.”. HHS should then support trials to establish the additional clinical benefit and optimal use of these drugs,” recommended the consensus report. One health.

Medicine 105

Medicine Genome Genomics Genotype 105

The Pharma Data

SEPTEMBER 2, 2021

Multiple trials reinforce the efficacy of Imfinzi combinations, including with novel immunotherapies, for lung cancer patients across settings. DESTINY-Breast03 is the first global Phase III trial of Enhertu against an active control.

Trials 52

Trials Medicine Antibody Clinical Trials 52

The Pharma Data

APRIL 14, 2021

Continued approval is contingent upon verification and description of clinical benefit in a confirmatory trial. A global, randomized Phase 3 confirmatory clinical trial TROPiCS-04 (NCT04527991) is underway and is also intended to support global registrations. More information on TROPiCS-04 is available at [link]. About Trodelvy.

Genotype 52

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The Pharma Data

APRIL 7, 2021

The Phase 3 ASCENT study, an open-label, active-controlled, randomized confirmatory trial, enrolled more than 500 patients with relapsed/refractory metastatic triple-negative breast cancer (TNBC) who had received two or more prior systemic therapies (including a taxane), at least one of them for metastatic disease. About the ASCENT Study.

HR 52

HR Genotype FDA Approval Genotoxicity 52

Delveinsight

AUGUST 25, 2021

Apart from these, Xarelto (for PAD) and Darzalex (for Amyloidosis and Refractory Multiple Myeloma) are in Phase III of clinical trials, while Tremfya (for Crohn’s Disease), Seltorexant (for insomnia), and Ciltacabtagene Autoleucei (BCMA CAR-T) (for multiple myeloma) are in Phase II of development. Imbruvica contributed USD 5.3

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Vaccination Vaccine Drugs Sales 98

The Pharma Data

MARCH 25, 2021

Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. Food and Drug Administration (FDA) to treat adult patients with metastatic TNBC who have received at least two prior therapies for metastatic disease. About the ASCENT Study.

Genotoxicity 52

Genotoxicity Genotype Containment Protein 52

The Pharma Data

DECEMBER 9, 2020

The aim of the research will be to create a TGS IVD platform by optimizing a multi-layer approach encompassing the initial sample and library preparation, state-of-the-art sequencing technologies and improved genotyping procedures. osteolabs – Germany’s osteolabs GmbH raised €1.6 million in a second financing round.

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In-Vivo In-Vitro Antibody Development 52

The Pharma Data

NOVEMBER 24, 2020

Professor and Chief, Pediatric Nephrology and Hypertension, Jack and Lucy Clark Department of Pediatrics, Mount Sinai Kravis Children’s Hospital, New York City and Investigator on the ILLUMINATE-A trial. Saland, M.D.,

FDA Approval 52

FDA Approval Production RNA Medicine 52

XTalks

MARCH 1, 2024

Related: Abbott’s HPV Test Gets FDA Approval for High-Risk HPV Detection and Cervical Cancer Screening Next-Generation Sequencing Next-generation sequencing (NGS) technologies are being considered for HPV detection and genotyping.

Vaccination 52

Vaccination Vaccine Life Science FDA Approval 52

XTalks

MARCH 26, 2025

South San Francisco-based biotech Kezar Life Sciences (NASDAQ: KZR) announced topline results from its Phase IIa PORTOLA trial evaluating zetomipzomib for the treatment of autoimmune hepatitis (AIH). Attendees will learn how clinical trial assays and genotyping kits can enhance research and clinical insight. million and $94.2

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Trials Life Science Clinical Trials Clinical Trials 66