XTalks

MAY 4, 2023

Celiac disease is an autoimmune disorder that is triggered by the consumption of gluten, a protein found in barley, wheat and rye. When a person with celiac disease eats something that contains gluten, their immune system attacks their small intestine, damaging the lining and interfering with the absorption of nutrients from food.

Clinical Trials 98

Clinical Trials Clinical Trials Trials Immune Response 98

Pharmaceutical Technology

JANUARY 24, 2023

Developed with the University of Edinburgh, the EXACT self-contained technology enables MeCP2 protein therapeutic levels while avoiding overexpression-related toxicities. Neurogene stated that the FDA IND clearance allows it to commence a Phase II/II trial of NGN-401 in female paediatric Rett syndrome patients.

Gene Therapy 208

Gene Therapy Gene Gene Expression Regulation 208

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

XTalks

NOVEMBER 6, 2020

Canadian clinical-stage biotech company Symvivo Corporation has developed an oral COVID-19 vaccine that entered clinical trials this week. The first healthy volunteer was dosed with the vaccine in Australia as part of the bacTRL-Spike COVID-19 Phase I clinical trial. COVID-19 Clinical Trials.

Clinical Trials 75

Clinical Trials Clinical Trials Vaccination Vaccine 75

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. For studies of humanized therapeutics (monoclonal antibodies [mAb], fusion protein, antibody-drug conjugates [ADC], bispecific antibodies, etc.), anti-human IgG).

Reagent 130

Reagent Clinical Trials Clinical Trials Antibody 130

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

pharmaphorum

SEPTEMBER 24, 2020

Based on that technology the companies have designed, built and tested a prototype, Microtox BT, which can analyse the breath and detect the spike protein of the coronavirus in real time. If the trial goes well the company said Microtox BT could enable instant real-time testing of people within the community.

Containment 143

Containment Protein Trials Vaccine 143

pharmaphorum

SEPTEMBER 1, 2020

AstraZeneca has expanded development of COVID-19 vaccine AZD1222 into the US, beginning a phase 3 clinical trial across all adult age groups. The UK pharma said that the trial will recruit up to 30,000 adults aged 18 years or over to assess the safety, efficacy and immune response.

Vaccine 69

Vaccine Vaccination Trials Immune Response 69

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 Genomics Genome Research 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.

Vaccine 52

Vaccine Vaccination Trials Immune Response 52

XTalks

AUGUST 22, 2023

It’s a grain-free breakfast cereal that contains only three grams of sugar and eight grams of plant-based protein. Its products are low in sugar, grain-free and enriched with protein. The Unsweetened flavor, for example, features only chickpea, pea protein, tapioca and salt.

Protein 98

Protein Branding Containment Production 98

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 Vaccine Vaccination Antibody 52

XTalks

JUNE 16, 2021

Novavax shared the latest data from its ongoing late-stage COVID-19 vaccine trial, which shows that its yet-to-be authorized shot provides 100 percent protection against moderate and severe disease and has an overall efficacy of 90.4 Related: Latest Data from Novavax COVID-19 Vaccine Trial Involving B.1.351

Vaccination 98

Vaccination Vaccine Protein Trials 98

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

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 Vaccine Vaccination 76

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

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 Vaccine Vaccination Immune Response 52

Pfizer

AUGUST 3, 2022

Decision follows results of interim futility analysis which indicate Phase 3 REALM-DCM trial unlikely to meet primary endpoint. Based on these results, the Phase 3 trial and further development of PF-07265803 will be discontinued. The information contained in this release is as of August 3, 2022. Disclosure Notice.

Development 101

Development Vaccine Vaccination Production 101

XTalks

NOVEMBER 23, 2020

Severe cases of the infection did not occur among trial participants, nor were any hospitalizations reported. The global trials are assessing the safety and efficacy of the vaccine in individuals aged 18 years or over from diverse racial and geographic groups who are healthy or have stable underlying medical conditions.

Vaccination 97

Vaccination Vaccine Clinical Trials Clinical Trials 97

Pharmaceutical Technology

NOVEMBER 22, 2022

According to CEPI: “Achieving the 100 Days Mission would give the world a fighting chance of containing a future outbreak before it spreads to become a global pandemic.”. Messenger RNA vaccines contain nucleic acids that code for a specific protein, or target antigen, related to a virus or disease.

Manufacturing 130

Manufacturing Vaccine Vaccination RNA 130

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. Pediatric Studies for Products with No Adult Clinical Trials.

Clinical Trials 130

Clinical Trials Clinical Trials In-Vivo Drugs 130

The Pharma Data

SEPTEMBER 17, 2020

The illness of one of the participants in the Oxford-AstraZeneca COVID-19 vaccine trial may not have been caused by the treatment itself, according to newly revealed information. . The trials testing the vaccine have resumed in Britain, Brazil and South Africa after they were initially paused on 6 September. Photo by Retha Ferguson.

Vaccine 52

Vaccine Vaccination Trials Containment 52

pharmaphorum

AUGUST 16, 2020

ChAdOx1 – which is in large-scale phase 2/3 trials – was licensed by AZ in April and renamed AZD1222, and should be ready for first deliveries before the end of the year. It will be provided on a no-profit basis while the pandemic is ongoing. Those deals cover 200 million doses of J&J’s Ad26.COV2.S

Vaccine 111

Vaccine Vaccination Immune Response Trials 111

XTalks

AUGUST 17, 2020

With several biologics in the pipeline, including one in early stage clinical trials for head and neck cancer, the company is positioned to engineer highly specific biologics against immune targets in the body. protein-based biologics) and vaccine treatments. protein-based biologics) : are those which bind to specific components (i.e.

Protein 98

Protein Engineer Immune Response In-Vivo 98

The Pharma Data

JUNE 26, 2021

Sanofi and Translate Bio initiate Phase 1 clinical trial of mRNA influenza vaccine. The trial will evaluate the safety and immunogenicity of a monovalent flu vaccine candidate coding for the hemagglutinin protein of the A/H3N2 strain of the influenza virus. JUNE 22 , 2021.

Clinical Trials 52

Clinical Trials Clinical Trials Vaccine Vaccination 52

XTalks

SEPTEMBER 8, 2020

AZD1222 is now in Phase III clinical trials which will enroll approximately 30,000 adult volunteers in 80 states in the US, to determine whether the vaccine can help prevent symptomatic coronavirus disease from spreading. “Our AstraZeneca, a UK-based global pharmaceutical company, is leading the COVID-19 trial as a regulatory sponsor.

Manufacturing 83

Manufacturing Vaccination Vaccine Allergies 83

XTalks

NOVEMBER 19, 2024

According to recent figures, more than one-third of consumers worldwide are trying to reduce their consumption of products containing eggs from industrial farming and 13 percent do not eat them at all. Plus, on a nutritional basis, they can enhance the overall protein content. Tests have focused on faba bean protein concentrate.

Protein 52

Protein Production Containment Manufacturing 52

XTalks

SEPTEMBER 14, 2020

Vitamin K2 is a fat-soluble vitamin that activates proteins that are already present in the body that help it properly utilize calcium. When Vitamin K2 activates the protein osteocalcin, this protein binds calcium to the bone mineral matrix, helping to create strong bones.

Protein 105

Protein Research Containment Development 105

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.

Vaccine 103

Vaccine Vaccination Insulin Trials 103

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). Clinical Trials of Lenacapavir. HIV can conceal itself from the immune system and remain latent. to continue.

Drugs 98

Drugs Clinical Trials Clinical Trials Trials 98

pharmaphorum

DECEMBER 2, 2021

In September, it reported a fourth patient death in a clinical trial of its AT132 (resamirigene bilparvovec) gene therapy for the rare disease X-linked myotubular myopathy (XLMTM), possibly linked to liver side effects. Those safety issues have hit Astellas’ aspirations in gene therapy directly.

Gene Therapy 97

Gene Therapy Gene Manufacturing Clinical Trials 97

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

APRIL 26, 2021

After years of disappointing malaria vaccine trials, a malaria shot developed by researchers at the Jenner Institute at the University of Oxford has demonstrated an unprecedentedly high efficacy of 77 percent, and may be the magic bullet the world has been waiting for against the deadly disease. Malaria Vaccine Phase II Trial.

Vaccination 105

Vaccination Vaccine Immune Response Trials 105

pharmaphorum

FEBRUARY 24, 2022

Viral or bacterial infections, or airway irritants can damage lung cells, causing them to release damage associated molecular pattern (DAMP) molecules that attach to and activate the receptor for advanced glycation endproducts (RAGE) protein found on a cell’s membrane. said Cantex CEO Stephen Marcus.

Licensing 64

Licensing Licensing Development Drugs 64

The Pharma Data

JANUARY 7, 2021

HER2/ neu (human epidermal growth factor receptor 2) protein is a cell surface receptor protein that is expressed in a variety of common cancers, including in 75% of breast cancers at low (1+), intermediate (2+), and high (3+ or over-expressor) levels. GP2 is a 9 amino acid transmembrane peptide of the HER2/ neu protein.

Containment 52

Containment Clinical Trials Clinical Trials Protein 52

pharmaphorum

SEPTEMBER 14, 2020

While there may be just under 20,000 confirmed protein coding genes, it turns out that much of the genome outside of these genes is also important in regulating how the genome is controlled. Genomics also means we will be able to stratify patients, based upon their genomic makeup, to make clinical trials much more efficient and targeted.

Genomics 119

Genomics Genome Medicine Gene 119

pharmaphorum

JANUARY 3, 2023

SPK-9001 is a novel, investigation vector containing a bio-engineered adeno-associated virus (AAV) capsid (protein shell) and a high-activity human coagulation FIX gene. The clinical trial participants will be evaluated as part of a long-term study over 15 years.

Gene Therapy 98

Gene Therapy Gene Medicine Trials 98