Scienmag

JANUARY 28, 2021

— In a new study published in Circulation, Mayo Clinic researchers provide the first preclinical, proof-of-concept study for hybrid gene therapy in long QT syndrome, a potentially lethal heart rhythm condition. ROCHESTER, Minn.

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Gene Therapy Gene In-Vitro Clinical Research 74

Pharmaceutical Technology

SEPTEMBER 10, 2008

was established in 1999 in the process of privatisation of the State Research Institute for Pharmacy and Biochemistry in the Czech Republic. 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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In-Vitro Genotoxicity In-Vivo Development 100

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.

Manufacturing 108

Manufacturing Clinical Trials Clinical Trials In-Vitro 108

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.

Clinical Trials 52

Clinical Trials Clinical Trials In-Vitro Trials 52

pharmaphorum

DECEMBER 16, 2020

Soon the ABPI and the entire industry were facing the ripple effects of COVID-19, including a significant slowdown in non-COVID clinical research, which Torbett says was challenging for the industry to deal with. “We’ve We’ve also seen a very mixed picture in the market for pharmaceuticals,” he says.

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Vaccination Vaccine Life Science In-Vitro 122

XTalks

DECEMBER 13, 2024

XTALKS WEBINAR: Enhance Early Biomarker Discovery: Translating In Vitro and In Vivo Multi-Omics Oncology Data Live and On-Demand: Thursday, January 16, 2025, at 11am EST (4pm GMT/UK) Register for this free webinar to learn how to harness the full potential of multi-omics data and advanced patient models to drive early biomarker discovery.

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Antibody In-Vivo Trials In-Vitro 99

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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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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Trials Clinical Trials Clinical Trials Antibody 97

pharmaphorum

JANUARY 25, 2022

For example, there is no need for in vivo animal or in vitro pre-clinical or non-clinical studies. The area of digital therapeutics is growing rapidly, and in this piece Ben Hargreaves examines why this is the case, how broadly these therapies can be applied and why investment in the area is mounting. This equated to $21.3

Medicine 111

Medicine In-Vivo In-Vitro Development 111

pharmaphorum

OCTOBER 27, 2022

These risks have resulted in many companies being found in breach of self-regulatory codes, and a view that an increasingly narrow interpretation was being taken by authorities. What is the scope of the Guidance? Companies should ensure key words are appropriate and do not constitute unauthorised promotion to the public.

Life Science 98

Life Science Medicine Regulation Compliance 98

Cloudbyz

JULY 31, 2024

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. The landscape of modern medicine is rapidly evolving, driven by groundbreaking advancements in diagnostics.

Gene Therapy 52

Gene Therapy Gene Medicine In-Vitro 52

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

The Pharma Data

DECEMBER 29, 2020

The academic partners of the consortium have been awarded €350,000 from Health Holland under the Eureka Program to develop a SARS-CoV-2-specific therapeutic nanomedicine that is administered via nasal inhalation and that can also be used for in vitro diagnostics. About Radboudumc.

Antibody 52

Antibody In-Vitro Engineer Development 52

Advarra

APRIL 19, 2023

In vitro diagnostic (IVD) devices are tests used on human biospecimens (e.g., IVDs are used in almost all clinical research. IVDs are used in almost all clinical research. However, the testing itself often occurs in laboratories or some other healthcare setting away from research participants.

Research 52

Research Regulation Clinical Trials Clinical Trials 52

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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Clinical Trials Clinical Trials Trials FDA Approval 98

The Pharma Data

JANUARY 24, 2021

It will be run through the NIAID-supported Infectious Diseases Clinical Research Consortium (IDCRC), with support from the Bill & Melinda Gates Foundation. It will be run through the NIAID-supported Infectious Diseases Clinical Research Consortium (IDCRC), with support from the Bill & Melinda Gates Foundation.

Trials 52

Trials Allergies In-Vitro Antibody 52

Roots Analysis

SEPTEMBER 4, 2023

In the recent years, service industry has become a fast-growing segment in the overall healthcare domain – thanks to the steady increase in demand for contract research organizations (CROs) and contract manufacturing organizations. Further, large players have been involved in the acquisitions of 32% small and 25% mid-sized companies.

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Development Marketing Medicine Contract Manufacturing 52

XTalks

SEPTEMBER 20, 2024

Vittoria Biotherapeutics is a clinical-stage cell therapy company that incorporates the latest advancements in cell therapy and gene editing with a unique approach that potentially overcomes some of the issues with this therapeutic modality. Such challenges highlight a significant unmet need and call for further advancements in the field.

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Gene Editing Manufacturing Gene In-Vivo 52

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.

Clinical Trials 40

Clinical Trials Clinical Trials Trials In-Vitro 40

The Pharma Data

OCTOBER 22, 2020

The Company intends to use the net proceeds from this offering to support its planned New Drug Application submission for oral sulopenem for the treatment of uncomplicated urinary tract infections in patients with quinolone-resistant pathogens, the continued clinical development of sulopenem, and for working capital and general corporate purposes.

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In-Vitro Clinical Trials Clinical Trials Clinical Development 40

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

Clinical Trials 52

Clinical Trials Clinical Trials Trials Medicine 52

The Pharma Data

DECEMBER 13, 2020

Selected Clinical Parameters in Patients with Type 2 Diabetes at 12 Weeks. Selected Clinical Parameters in Patients with Type 2 Diabetes at 12 Weeks. PXL770 is a first-in-class, oral direct adenosine monophosphate-activated protein kinase (AMPK) activator.

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Trials In-Vitro Insulin Protein 40

XTalks

OCTOBER 1, 2020

WeiQi Lin, MD, PhD, executive vice president of research & development and principal scientist, DURECT Corporation. Lin has made several transitions throughout her career, from being a clinician at an academic center, to academic research, to heading business development in industry. Key Moments.

Scientist 52

Scientist In-Vitro Research Life Science 52

XTalks

MAY 12, 2022

Clinical immunosuppression drugs such as ciclosporin, tacrolimus, sirolimus, prednisone and everolimus are administered to the recovering recipients to prevent transplant rejection. This diagnostic assay works on the principle of in vitro nucleic acid amplification using real-time transcription-mediated amplification (TMA) technology.

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In-Vitro DNA Development Genome 52

Pharmaceutical Technology

FEBRUARY 20, 2023

On the other hand, a lack of diversity in clinical trial populations, particularly when the disease population is significantly underrepresented, greatly diminishes the quality of data obtained for drug safety and efficacy profiles. of the clinical trial population globally. of the clinical trial population globally.

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Research Clinical Trials Clinical Trials Trials 130

The Pharma Data

NOVEMBER 17, 2020

Francisco “Paco” Arredondo, MD, MPH, FACOG, recently Chief Medical Officer of the United States largest network of fertility centers, overseeing more than 50 fertility specialists, and currently a partner in a joint venture developing INVOcell clinics in Mexico. . SARASOTA, Fla. ,

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In-Vivo In-Vitro Genetics Doctor 52

ACRP blog

DECEMBER 18, 2024

Five years ago, in recognition of the importance of medical device studies within the overall clinical research enterprise, the Association of Clinical Research Professionals (ACRP) developed the ACRP Medical Device Professional (ACRP-MDP) specialty certification exam. and European Union, as described in another source.

Research 52

Research Clinical Research Clinical Research Coordinator In-Vitro 52

XTalks

SEPTEMBER 14, 2020

By the end of August, the World Health Organization (WHO) counted 33 vaccine candidates in some stage of clinical trial evaluation. Tension is mounting as nations big and small jockey around industry to ensure they are first in line to access a vaccine, should one prove to be successful against COVID-19. Moderna’s COVID-19 Vaccine.

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Vaccination Vaccine Antibody Life Science 92