Worldwide Clinical Trials

SEPTEMBER 29, 2022

Ensuring a seamless transition from preclinical to clinical stages in large molecule bioanalysis will help you reach crucial trial milestones on time and within budget. Preclinical assays designed to assess drug toxicity and safety must detect total drug. anti-human IgG).

Reagent 130

Reagent Clinical Trials Clinical Trials Antibody 130

Drug Discovery World

JANUARY 6, 2023

It contains multiple long peptides spanning the most immunogenic regions of the PRAME protein. . In the two-part, open label Phase Ib/II trial, ISA103 will be tested in combination with standard of care checkpoint blocker immunotherapies. A total of 90 patients will be enrolled in the trial. .

Trials 52

Trials Containment Protein Clinical Development 52

The Pharma Data

AUGUST 15, 2021

Food and Drug Administration were based on mRNA, more conventional protein-based vaccines have also shown promise in clinical trials. Most train the immune system to recognize the RBD, a peptide that is the portion of the SARS-CoV-2 spike protein that binds to the ACE-2 receptor on host cell surfaces. bioRxiv [Preprint].

Protein 52

Protein Vaccination Vaccine Antibody 52

The Pharma Data

SEPTEMBER 14, 2020

. AstraZeneca has confirmed that clinical trials assessing its Oxford University partnered coronavirus vaccine AZD1222 have resumed in the UK, following a green light by the Medicines Health Regulatory Authority (MHRA). Source link.

Vaccination 52

Vaccination Vaccine Trials Immune Response 52

Drug Discovery World

JANUARY 9, 2024

Thirteen new-to-market therapeutics and drugs poised to launch in 2024 will achieve ‘blockbuster’ status by 2029 or deliver game-changing benefits to patients. The 2024 Drugs to Watch, are: 1. The therapy has shown positive results in Phase III trials in both breast and lung cancer.

Drugs 67

Drugs Antibody Gene Editing Medicine 67

Drug Discovery World

OCTOBER 21, 2022

The first and only oral contraception containing a new, synthetic version of a naturally occurring oestrogen has been launched in the UK. . Cancer drug shows promise in treating incurable lung disease . The post This week in drug discovery (17-21 October) appeared first on Drug Discovery World (DDW).

Drugs 52

Drugs Allergies Clinical Trials Clinical Trials 52

The Pharma Data

MARCH 30, 2021

Basel, March 30, 2021 — Novartis has obtained exclusive worldwide rights to develop and commercialize therapeutic applications for a library of Fibroblast Activation Protein (FAP) targeting agents including FAPI-46 and FAPI-74, through an assignment agreement with iTheranostics, Inc., an affiliate of SOFIE Biosciences, Inc. Disclaimer.

Protein 52

Protein Licensing Licensing Containment 52

pharmaphorum

FEBRUARY 24, 2022

Clinical stage pharmaceutical company Cantex Pharmaceuticals has obtained a global licence from Harvard University’s Office of Technology Development to develop the small-molecule drug azeliragon into a treatment for inflammatory lung diseases, including COVID-19. said Cantex CEO Stephen Marcus.

Licensing 64

Licensing Licensing Development Drugs 64

XTalks

MAY 24, 2022

There has been a lengthy search to find an HIV cure and there have been a few promising trials, including the stem cell transplantation reported at the 2022 Conference on Retroviruses and Opportunistic Infections (CROI-2022). During the early stage, the drug binds itself between two adjacent capsid monomers and stabilizes the capsid shell.

Drugs 98

Drugs Clinical Trials Clinical Trials Trials 98

Drug Discovery World

JANUARY 19, 2023

A pilot Phase IIa clinical trial evaluating Abionyx Pharma’s CER-001 as a treatment for septic patients at high risk of developing acute kidney injury (AKI) has met its primary endpoint. million related deaths globally. “The trial shows promising positive results across a variety of primary and secondary endpoints.

Drugs 52

Drugs Trials Clinical Trials Clinical Trials 52

XTalks

JUNE 28, 2023

Gene therapies for Duchenne muscular dystrophy (DMD) have been an area of intense research and Sarepta’s Elevidys is now the first one to be approved by the US Food and Drug Administration (FDA). DMD is caused by the absence of dystrophin, a protein that helps maintain the integrity of muscle cells.

Gene Therapy 98

Gene Therapy Gene Protein FDA Approval 98

Pfizer

JULY 26, 2022

Pfizer and BioNTech Advance COVID-19 Vaccine Strategy With Study Start of Next-Generation Vaccine Candidate Based on Enhanced Spike Protein Design. Pfizer and BioNTech Advance COVID-19 Vaccine Strategy With Study Start of Next-Generation Vaccine Candidate Based on Enhanced Spike Protein Design. deliesschef. Tue, 07/26/2022 - 17:41.

Vaccination 111

Vaccination Vaccine Protein Immune Response 111

Pfizer

FEBRUARY 16, 2023

These study participants, representing approximately half of the total recruited participants in the trial, are being discontinued following violations of Good Clinical Practice (GCP) at certain clinical trial sites run by a third-party clinical trial site operator.

Clinical Trials 76

Clinical Trials Clinical Trials Vaccination Vaccine 76

Camargo

NOVEMBER 29, 2021

Like with small molecules, clinical trials of biologics are designed to determine pharmacokinetics (PK), pharmacodynamics (PD), safety, and efficacy. Essentially, a biologic is a product that is produced from living organisms or that contains components of living organisms. Recombinant therapeutic proteins. Fusion proteins.

Development 180

Development Protein Production Hormones 180

Drug Discovery World

MARCH 26, 2024

For example, progress made in developing gene mutant-specific inhibitors, antibody-drug conjugates (ADC), or cellular therapies. Results of that Phase I trial are expected to be presented later this year. The post Conversations from ESMO Targeted Anticancer Therapies Congress 2024 appeared first on Drug Discovery World (DDW).

RNA 62

RNA In-Vivo In-Vitro DNA 62

pharmaphorum

JANUARY 19, 2022

Lung cancer drug sugemalimab has delivered positive results following a phase 3 trial. PD-1 inhibitors work against the protein, Programmed Death-Ligand 1 (PD-L1), which is found on the surface of many cells throughout the body. Some cancer cells contain large amounts of PD-L1, which helps them to evade the body’s immune system.

Trials 59

Trials Containment Protein Antibody 59

XTalks

JANUARY 3, 2024

Wainua is the only FDA-approved drug for the treatment of ATTRv-PN that can be self-administered via an auto-injector. In individuals affected by ATTR, which includes both hereditary and wild-type (non-hereditary) variants, the TTR protein forms fibrils that accumulate in various tissues.

FDA Approval 105

FDA Approval Protein RNA Clinical Trials 105

XTalks

JANUARY 31, 2022

COVID-19 vaccine makers Pfizer/BioNTech and Moderna have both commenced trials for their new variant-specific vaccines targeting omicron. The third group will contain unimmunized individuals who will get three doses of the omicron shot. Moderna will be evaluating its omicron targeting booster through extension of an earlier study.

Vaccination 98

Vaccination Vaccine Trials Antibody 98

The Pharma Data

DECEMBER 16, 2020

Currently in Phase 3 clinical testing in the United Kingdom for the prevention of COVID-19, NVX-CoV2373 is a recombinant protein vaccine adjuvanted with Novavax’ proprietary Matrix-M to enhance the immune response. NVX-CoV2373 contains purified protein antigen and can neither replicate, nor can it cause COVID-19. and Australia.

Protein 52

Protein Vaccination Vaccine Immune Response 52

The Pharma Data

JANUARY 13, 2021

Food and Drug Administration (FDA) has granted Orphan Drug Designation for HPN217 for the treatment of multiple myeloma. HPN217, a tri-specific T cell activating recombinant protein construct (TriTAC®) targets B-cell maturation antigen (BCMA), a well-validated antigen expressed on malignant multiple myeloma cells.

Drugs 52

Drugs Clinical Trials Clinical Trials Containment 52

XTalks

DECEMBER 5, 2023

The US Food and Drug Administration (FDA) has granted approval for Bristol Myers Squibb’s (BMS) Augtyro (repotrectinib), marking a significant milestone for the treatment of adult patients with locally advanced or metastatic ROS1 -positive non-small cell lung cancer (NSCLC). criteria and assessed by a blinded independent central review.

Protein 115

Protein FDA Approval Medicine Trials 115

Drug Discovery World

DECEMBER 14, 2023

With leading academic institutions and significant recent investment, Glasgow is shaping up to be an important centre for drug discovery and development in the UK. Discoveries in these areas will identify new treatments which will become the cancer drugs of the future.” DDW’s Diana Spencer explores the city’s unique ecosystem.

Drugs 73

Drugs Life Science Research Scientist 73

Drug Discovery World

SEPTEMBER 4, 2023

In the third and final part of this series of articles focused on plant-based medicines, DDW’s Megan Thomas evaluates therapeutic breakthroughs using plant-based products in drug discovery. In this study, researchers discovered how EGCG breaks apart tangles of the protein tau, a ‘hallmark’ of Alzheimer’s disease.

Medicine 57

Medicine Protein Containment Drugs 57

XTalks

AUGUST 18, 2023

Iveric Bio, a company of Astellas, has secured recent approval from the US Food and Drug Administration (FDA) for its innovative drug, Izervay (avacincaptad pegol intravitreal solution). Izervay contains avacincaptad pegol sodium, an effective complement C5 inhibitor. How Does Izervay Work?

FDA Approval 52

FDA Approval Drugs Clinical Trials Clinical Trials 52

Drug Discovery World

SEPTEMBER 5, 2022

Throughout the continuum of drug development, from target discovery to patient selection, machine learning approaches are being adopted to reliably mine vast amounts of data and make predictions with higher accuracy Anita Ramanathan discusses how machine learning is currently used across different stages of cancer research. .

Development 52

Development Drugs Protein Genome 52

pharmaphorum

OCTOBER 2, 2020

Confirming press reports, the EMA said that large scale clinical trials from the vaccine codenamed AZD1222 involving several thousands of people are ongoing and results will become available over “the coming weeks and months”. AZD1222 was co-invented by the University of Oxford and its spin-out company, Vaccitech.

Regulation 105

Regulation Vaccination Vaccine Protein 105

pharmaphorum

SEPTEMBER 14, 2021

The Cambridge, Massachusetts biotech is focusing specifically on the 60% of DNA sequences that repeat themselves hundreds or thousands of times in the genome, known as the ‘repeatome’, that could contain targets for cancer and autoimmune disorders.

DNA 52

DNA Immune Response Genome Genomics 52

Roots Analysis

AUGUST 24, 2023

Drug discovery has always been a time-consuming process. On an average, it takes 10-15 years and investments worth USD 4-10 billion to commercially launch a drug. Application of Quantum Computing in Drug Discovery Process: Target Identification: This involves developing a new drug for target identification and validation.

Drugs 52

Drugs Development Clinical Trials Clinical Trials 52

The Pharma Data

JULY 8, 2021

Today, access to the world’s largest browsable resource linking rare protein-coding genetic variants to human health and disease was launched through a genetic exome sequence analysis collaboration between AbbVie (NYSE: ABBV), Biogen Inc. PFIZER DISCLOSURE NOTICE: The information contained in this release is as of July 8, 2021.

Genetics 52

Genetics Biobanking Protein Containment 52

XTalks

FEBRUARY 20, 2024

The vaccines received approvals from the US Food and Drug Administration (FDA) in May 2023 for the prevention of RSV infection. Type of Vaccine Arexvy and Abrysvo are both recombinant protein subunit vaccines. Another difference is that Arexvy contains an adjuvant while Abrysvo does not.

Vaccination 105

Vaccination Vaccine Containment Marketing 105

Drug Discovery World

SEPTEMBER 11, 2023

The main objective of the study is to establish a recommended Phase II dose and schedule. ‘Theranostics’ is the approach of using two paired drugs – the first, a diagnostic agent to identify cells which exhibit a particular biomarker; and the second, a therapeutic drug, to act on those cells.

Containment 57

Containment Clinical Trials Clinical Trials Production 57

Drug Discovery World

NOVEMBER 30, 2023

This presentation covered three primary drivers for a protein expression model: speed, cost and sustainability. “It The next presentation attended in this track was the keynote presentation, which was given by Kate Smith, PhD, Head of UK Protein & Cell Sciences at GSK. GSK has developed high-throughput mammalian and E.

Antibody 57

Antibody Protein Engineer In-Vivo 57

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. Dr. Bahassi: There are several factors to consider when designing a trial that involves ctDNA detection.

Clinical Trials 98

Clinical Trials Clinical Trials Trials FDA Approval 98

Camargo

APRIL 28, 2021

The first tasks in striking this balance are dose selection and dosing interval determination, and this blog post offers an overview on how PK modeling and simulation can be applied to optimize the safety and efficacy of a product for pediatric populations in clinical trials. First Steps Toward Initiating Pediatric Clinical Studies.

Clinical Trials 130

Clinical Trials Clinical Trials In-Vivo Drugs 130

The Pharma Data

JANUARY 31, 2021

Clover plans to initiate a global Phase 2/3 efficacy trial of its protein-based S-Trimer COVID-19 vaccine candidate adjuvanted with Dynavax’s CpG 1018 plus alum in the first half of 2021 with an interim analysis for vaccine efficacy potentially in the middle of 2021. EMERYVILLE, Calif. and CHENGDU, China , Feb.

Vaccination 52

Vaccination Vaccine Trials Protein 52

Drug Discovery World

AUGUST 2, 2023

Genoscience Pharma’s Philippe Halfon and Eric Raymond share their expertise on targeting the recycling of unsustainable production of palmitoylated cancer-associated proteins. Palmitoyl transferases are a zinc finger Asp-His-His-Cystype (ZDHHC) family containing 23 distinct mammalian genes (excluding ZDHHC10) that catalyse this reaction 1.

Protein 52

Protein Immune Response In-Vitro Regulation 52

Drug Discovery World

AUGUST 15, 2023

Can potentially lethal arrhythmias induced by novel drugs be better predicted by using more relevant and sophisticated electrophysiological screening methods? Such techniques, if routinely deployed in drug discovery, may enable improved decision making in predicting serious adverse cardiovascular events.

Drugs 52

Drugs In-Vivo Development Research 52