XTalks

DECEMBER 20, 2022

While clinical trials are becoming more complex, oncology trials have generally had a greater level of complexity than trials in many other disease spaces. Despite this, the number of oncology trials worldwide has increased dramatically over the past two decades. Regulatory Considerations.

Clinical Trials 97

Clinical Trials Clinical Trials Trials Regulation 97

pharmaphorum

SEPTEMBER 14, 2020

AstraZeneca has resumed UK trials for its coronavirus vaccine, after the country’s medicines regulator gave the all-clear following a safety scare. A UK safety committee has concluded its investigations and recommended to the country’s Medicines and Healthcare products Regulatory Agency (MHRA) that trials are safe to resume.

Vaccination 101

Vaccination Vaccine Trials Protein 101

pharmaphorum

AUGUST 23, 2022

France’s BrainVectis, a subsidiary of Bayer’s Asklepios BioPharma (AskBio) unit, has been given the green light by regulators in France to start dosing patients with its gene therapy candidate for devastating neurodegenerative disorder Huntington’s disease.

Gene Therapy 105

Gene Therapy Gene Trials Protein 105

Drug Discovery World

NOVEMBER 8, 2023

Deepika Khedekar , Associate Centralized Clinical Lead at IQVIA, explains how artificial intelligence could make clinical trials more accurate, accessible and standardised. Tapping into the capabilities of AI One reason AI may accelerate clinical trials is its ability to rapidly process and analyse vast amounts of data.

Clinical Trials 72

Clinical Trials Clinical Trials Trials Drugs 72

Drug Discovery World

JULY 6, 2023

The drug candidate, a monoclonal antibody (mAb) targeting the protein Semaphorin-3A (Sema3A), is being developed as a potential first-to-market treatment for Alport syndrome, a rare genetic kidney disease. Semaphorin-3A is an extracellular guidance protein and a well-known regulator of the actin cytoskeleton.

Antibody 52

Antibody Trials Genetics Protein 52

XTalks

JANUARY 29, 2021

This is relevant for clinical trials as more regulators require evidence of efficacy in comparison to the standard of care, which is likely to be one of the blockbuster products. This means that sponsors are having to fork out for these blockbuster products in order to run their trials more often.

Clinical Trials 104

Clinical Trials Clinical Trials Production Trials 104

The Pharma Data

MARCH 23, 2022

Polymerase is a viral protein that directs how Ebola virus replicates its genome as it infects new hosts. The researchers discovered that Ebola virus polymerase hijacks a cellular protein called GSPT1. To treat Ebola virus infections, researchers are taking a close look at a key piece of the virus: polymerase.

Protein 52

Protein Genome Genomics Research 52

BioPharma Reporter

DECEMBER 11, 2020

Sanofi and GSK announced a delay on Friday in their adjuvanted recombinant protein-based COVID-19 vaccine program to improve immune response in the elderly, saying clinical trials showed an insufficient immune response in older people.

Immune Response 105

Immune Response Vaccination Vaccine Trials 105

Pharmaceutical Technology

JUNE 22, 2023

The TARPEYO delayed-release capsule is a corticosteroid indicated for reducing proteinuria to treat primary immunoglobulin A nephropathy (IgAN) in adult patients at risk of quick disease progression, generally having a urine protein-to-creatinine ratio greater than or equal to 1.5g/g.

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Clinical Trials Clinical Trials Branding Protein 130

The Pharma Data

DECEMBER 3, 2020

New Tau Protein is Abnormal in Very Early Alzheimer’s Disease. Investigators with the University of Gothenburg identified new forms of tau protein that become abnormal in the very early stages of Alzheimer’s disease, even before the development of cognitive problems. “The Every week there are numerous scientific studies published.

Protein 52

Protein Research Regulation Gene 52

Drug Discovery World

MARCH 8, 2023

Trop2 (Trophoblast cell-surface antigens 2), also known as TACSTD2, M1S1, GA733-1, EGP-1, is a member of the tumour associated calcium signal transduction protein (TACSTD) family, which is related to the regulation of intracellular calcium concentration.

Trials 52

Trials In-Vivo In-Vitro 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

Advarra

JANUARY 11, 2024

Adoptive T Cell therapies, therapeutic antibodies, and immunomodulatory proteins represent just some of the potentially beneficial treatment strategies for successful mRNA cancer trials. One strategy proposed the use of synthetic mRNA or modified mRNA analogs, which can enhance the stability and protein expression of mRNA.

Vaccination 52

Vaccination Vaccine Protein Antibody 52

pharmaphorum

JUNE 30, 2021

Just a few months after starting clinical trials of its nasal spray vaccine for COVID-19, US biotech Altimmune is abandoning the project, saying that it generated weaker than expected immune responses in a phase 1 trial. . The post Altimmune ditches nasal COVID vaccine on weak trial data appeared first on.

Vaccination 98

Vaccination Vaccine Trials Immune Response 98

Drug Discovery World

SEPTEMBER 20, 2023

The collaboration is designed to bolster the company’s offerings in the fields of research, population health, and regulated clinical trials. Olink Explore HT is the company's latest solution for high-throughput proteomics, allowing scientists to accurately measure over 5,300 proteins [.] Not yet a DDW member?

Genome 59

Genome Genomics Research Clinical Trials 59

pharmaphorum

MARCH 3, 2021

Novavax hopes its COVID-19 vaccine could be filed in the US in the second quarter, following a potential approval from the UK regulator in the coming weeks. The timetable for approval from the FDA depends on whether the regulator accepts data from the company’s trial in the UK, which could set up a potential Emergency Use Authorisation.

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Vaccination Vaccine Regulation Immune Response 130

Pharmaceutical Technology

JUNE 9, 2023

Rocket Pharmaceuticals stated that the fast-track designation enables increased communication with the regulator across the development cycle of the gene therapy. In April 2023, the FDA approved the investigational new drug (IND) application for RP-A601 to begin a Phase I clinical trial.

Gene Therapy 147

Gene Therapy Gene FDA Approval Trials 147

Pharmaceutical Technology

JANUARY 25, 2023

Development of PROTACs (PROteolysis TArgeting Chimeras) has advanced fairly rapidly as excitement grows over their potential to selectively degrade proteins that are involved in various diseases, including cancer. PROTACs are a type of heterobifunctional degrader that offers multiple advantages over traditional small molecules.

Protein 130

Protein Bioavailability Development Scientist 130

pharmaphorum

JANUARY 5, 2022

A COVID-19 vaccine that could work against multiple variants of the coronavirus – developed by US biotech Gritstone bio – has generated encouraging immune response data in its first clinical trial. “With new variants – like Omicron and B.1.640.2

Protein 126

Protein Vaccination Vaccine Immune Response 126

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.

Protein 52

Protein Licensing Licensing Containment 52

XTalks

DECEMBER 12, 2023

After receiving US Food and Drug Administration (FDA) approval for Fabhalta (iptacopan) last week for the treatment of the rare blood disorder paroxysmal nocturnal hemoglobinuria (PNH), Novartis presented trial data yesterday showing the drug’s promise in another indication.

FDA Approval 95

FDA Approval Bacteria Trials Protein 95

Pharmaceutical Technology

MAY 8, 2023

The small molecule Bruton’s tyrosine kinase (BTK) inhibitor Brukinsa has been specially designed for delivering sustained BTK protein inhibition by optimising bioavailability, half-life, and selectivity. In April this year, the regulator converted these conditional approvals to regular approvals for R/R WM and R/R CLL/SLL.

Bioavailability 130

Bioavailability Clinical Trials Clinical Trials Protein 130

XTalks

SEPTEMBER 17, 2021

After asking for a placebo-controlled Phase III study for the drug in April that upset the ALS Association, the FDA dialed back on the request this week, agreeing to accept only Phase II trial data for evaluation of Amylyx’s drug application. Accelerated FDA Approval Modeled on Aduhelm. People with ALS and their loved ones cannot wait.”.

Trials 98

Trials Drugs FDA Approval Clinical Trials 98

pharmaphorum

DECEMBER 22, 2021

Pfizer has called a halt to a clinical trial of its gene therapy for Duchenne muscular dystrophy as it investigates the unexpected death of a young male patient. In an update posted today the pharma giant said “we do not yet have complete information and are actively working with the trial site investigator to understand what happened.”

Gene Therapy 58

Gene Therapy Gene Trials Clinical Trials 58

pharmaphorum

APRIL 12, 2022

Gilead Sciences can restart pivotal trials of its cancer antibody magrolimab – the centrepiece of its $4.9 Ongoing pivotal trials in myelodysplastic syndrome (MDS) and acute myeloid leukaemia (AML) can now resume both in the US – where the halt was mandated by the FDA – and overseas where the company opted for a voluntary pause in enrolment.

Trials 52

Trials Drugs Antibody Protein 52

pharmaphorum

SEPTEMBER 25, 2020

Novavax has begun a late-stage trial of its experimental COVID-19 vaccine in the UK, which could support filings for a licence in the UK, EU and other countries. The UK government has already signed an agreement with the US biotech to buy 60 million doses of the vaccine in August if trials work out.

Vaccination 85

Vaccination Vaccine Trials Protein 85

XTalks

JUNE 28, 2023

The approval is restricted to ambulatory patients within this narrow age range due to uncertainty around its effectiveness in older children, which Sarepta hopes to clarify in a confirmatory trial. 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

pharmaphorum

MARCH 10, 2021

bluebird bio is to ask regulators to restart clinical studies of its LentiGlobin for sickle cell disease, after an investigation concluded that a case of acute myeloid leukaemia (AML) was “very unlikely” to be caused by the gene therapy. The post bluebird seeks gene therapy trial restart after cancer scare appeared first on.

Gene Therapy 56

Gene Therapy Gene Trials Gene Expression 56

pharmaphorum

NOVEMBER 4, 2020

It may not be appropriate to use the word ‘failure’ when summarising the utility of clinical trials in the search for a curative or preventative treatment for disease. Most of the trials are underpowered to demonstrate efficacy on mortality and long-term consequences of the disease.

Clinical Trials 105

Clinical Trials Clinical Trials Trials Vaccination 105

pharmaphorum

DECEMBER 4, 2020

Valneva has said it plans to accelerate research into its Lyme disease vaccine candidate VLA15, bringing forward a trial including children into the first quarter of 2021. OspA is one of the most dominant surface proteins expressed by the bacteria when present in the ticks that spread the disease.

Vaccination 118

Vaccination Vaccine Bacterium Protein 118

XTalks

APRIL 3, 2024

The RBCs in circulation are marked by proteins in the complement system for removal by the spleen and liver. Voydeya’s FDA approval was based on positive results from the pivotal ALPHA Phase III trial. In the trial, the most common adverse events were headache, nausea, arthralgia (joint stiffness) and diarrhea.

FDA Approval 102

FDA Approval Sales Trials Development 102

pharmaphorum

NOVEMBER 23, 2020

AstraZeneca is preparing to file its COVID-19 vaccine with regulators after phase 3 trial results showed it is up to 90% effective. AZ made the announcemen t as the UK regulator reportedly gears up to make a decision on the rival vaccine from Pfizer and BioNTech, ahead of counterparts in the US and Europe.

Vaccination 105

Vaccination Vaccine Regulation Protein 105

Drug Discovery World

JULY 19, 2023

Lilly will work with the FDA and other global regulators to achieve the fastest path to traditional approvals. Participants in TRAILBLAZER-ALZ 2 were stratified by their level of the brain protein tau, a predictive biomarker for Alzheimer’s disease progression.

Trials 52

Trials Clinical Trials Clinical Trials Research 52

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. Regulators may ask at some point to provide that documentation, so it’s important to track that across the study.

Clinical Trials 98

Clinical Trials Clinical Trials Trials FDA Approval 98

XTalks

SEPTEMBER 17, 2020

In rare disease trials, it’s not always feasible to choose clinically-relevant endpoints to measure the efficacy of a new therapeutic. Surrogate endpoints were used as the basis for approval of 45 percent of new drugs reviewed by the FDA between 2010 and 2012.

Trials 98

Trials Gene Hormones Clinical Trials 98

Drug Discovery World

NOVEMBER 15, 2023

The small molecule, which binds to an inner region of a calcium channel to indirectly regulate it, outperformed gabapentin without troublesome side effects, providing a promising candidate for treating pain. A first-in-class small molecule Protein CRMP2 is a key regulator of the Cav2.2

Scientist 52

Scientist Protein Regulation Clinical Trials 52

Drug Discovery World

NOVEMBER 27, 2023

The European Commission has extended use of the therapy to include children with CF aged two through five years old who have at least one F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. “As The combined actions of ivacaftor, tezacaftor and elexacaftor help hydrate and clear mucus from the airways.

Protein 52

Protein Gene Medicine Gene Therapy 52