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

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.

Trials 97

Trials Clinical Trials Clinical Trials Antibody 97

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

pharmaphorum

JANUARY 25, 2022

As the area of bringing a digital therapeutic to market means passing the same level of regulatory scrutiny as a traditional, pharmaceutical therapy, this means “prescription digital therapeutics must undergo extensive clinical trials to demonstrate their safety and effectiveness before they ever reach patients,” said McCann.

Medicine 111

Medicine In-Vivo In-Vitro Development 111

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

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

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.

Gene Editing 52

Gene Editing Manufacturing Gene In-Vivo 52

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.

In-Vitro 40

In-Vitro Clinical Trials Clinical Trials Clinical Development 40

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.

Clinical Trials 98

Clinical Trials Clinical Trials Trials In-Vitro 98

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.

Clinical Trials 98

Clinical Trials Clinical Trials Trials FDA Approval 98

The Pharma Data

DECEMBER 13, 2020

The STAMP-NAFLD trial was a 12-week, randomized, parallel group study in 120 presumed NASH patients with or without type 2 diabetes (T2DM). The Company additionally announced new preclinical results and plans for a Phase 2b trial focused on patients with noncirrhotic biopsy-proven NASH and coexisting prediabetes or T2DM.

Trials 40

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

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

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.

Antibody 99

Antibody In-Vivo Trials In-Vitro 99

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

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.

In-Vitro 100

In-Vitro Genotoxicity In-Vivo Development 100

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.

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

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.

Vaccination 143

Vaccination Vaccine Regulation Medicine 143

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

ACRP blog

DECEMBER 18, 2024

Medical device trials, however, are typically smaller in scale and require fewer phases [than drug trials]. Stay tuned at the ACRP 2025 conference in New Orleans next April for details on how the ACRP-MDP program is evolving to meet current demands in the research workforce. 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. As of July, the company and its federal partner stated that it is on track to supply between 500 million to 1 billion doses a year at a dose of 100 µg now selected for their Phase III trial.

Vaccination 92

Vaccination Vaccine Antibody Life Science 92