Pharmaceutical Technology

OCTOBER 25, 2022

Based on positive data from the open-label, international, randomised, multicentre Phase III HIMALAYA clinical trial, the regulatory agency granted the approval. A human monoclonal antibody, Imfinzi attaches to the PD-L1 protein and hinders the PD-L1 interaction with the PD-1 and CD80 proteins.

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Protein Immune Response Antibody FDA Approval 173

XTalks

APRIL 22, 2022

Flow cytometric receptor occupancy assays are being increasingly used in preclinical and clinical studies. Both the areas of drug development and clinical trials are increasingly using in vitro assays to help determine the efficacy of an investigational therapeutic. What is Flow Cytometry?

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Clinical Trials Clinical Trials Trials Antibody 98

pharmaphorum

DECEMBER 16, 2020

AbbVie is to begin clinical development of an antibody designed to neutralise the SARS-CoV-2 coronavirus after licensing the therapy in from Harbour BioMed and Utrecht University. AbbVie has begun a phase 1 clinical trial of the antibody, with clinical development beginning in the US and expanding into Europe.

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Antibody Trials Licensing Licensing 98

pharmaphorum

SEPTEMBER 16, 2020

Regeneron’s COVID-19 antibody cocktail has been added to the UK’s RECOVERY trial, one of the largest of its kind in the world that is testing several potential coronavirus therapies at the same time. REGN-COV2 is a combination of two monoclonal antibodies, designed to block infections of SARS-CoV-2, the virus that causes COVID-19.

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Antibody Trials Manufacturing Protein 98

XTalks

DECEMBER 10, 2024

Rilzabrutinib works by targeting BTK, a protein involved in immune cell communication. By inhibiting this protein, the drug disrupts pathways that contribute to platelet destruction and insufficient production. Recent advancements in ITP treatments include CM313, an anti-CD38 monoclonal antibody that achieved a 95.5

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Trials Protein Clinical Development Drugs 104

Scienmag

APRIL 13, 2022

A new protein-based antiviral nasal spray developed by researchers at Northwestern University, University of Washington and Washington University at St. Louis is being advanced toward Phase I human clinical trials to treat COVID-19.

Antibody 88

Antibody Protein Clinical Trials Clinical Trials 88

Pharmaceutical Technology

DECEMBER 7, 2022

Last week, the quest for an effective Alzheimer’s disease therapy received a notable fillip at the Clinical Trials on Alzheimer’s Disease (CTAD) Conference 2022, with new data on Eisai’s disease-modifying therapy lecanemab. Lecanemab is an amyloid antibody that targets oligomers and protofibrils of amyloid.

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Development Drugs Clinical Trials Clinical Trials 264

Pharmaceutical Technology

DECEMBER 7, 2022

Last week, the quest for an effective Alzheimer’s disease therapy received a notable fillip at the Clinical Trials on Alzheimer’s Disease (CTAD) Conference 2022, with new data on Eisai’s disease-modifying therapy lecanemab. Lecanemab is an amyloid antibody that targets oligomers and protofibrils of amyloid.

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Development Drugs Clinical Trials Clinical Trials 246

Worldwide Clinical Trials

SEPTEMBER 29, 2022

For studies of humanized therapeutics (monoclonal antibodies [mAb], fusion protein, antibody-drug conjugates [ADC], bispecific antibodies, etc.), In contrast, clinical trials focus on both safety and efficacy — the relationship between drug concentrations and pharmacological effects. anti-human IgG).

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Reagent Clinical Trials Clinical Trials Antibody 130

Pharmaceutical Technology

APRIL 26, 2023

Biotechnology company Adcentrx Therapeutics has raised $38m in Series A+ financing to advance its pipeline of new antibody-drug conjugate (ADC) therapeutics into clinical development. Adcentrx Therapeutics is focused on developing protein conjugate therapeutics to treat cancer and other life-threatening diseases.

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Clinical Development Development Clinical Trials Clinical Trials 147

Pharmaceutical Technology

JUNE 15, 2023

ALE.C04 is an investigational antibody designed to target exposed CLDN1 in cancer cells. This approval has been granted for ALE.C04 both as a monotherapy and in combination with pembrolizumab in a first-in-human clinical study in recurrent or metastatic head and neck squamous cell carcinoma (HNSCC).

FDA Approval 130

FDA Approval Antibody Clinical Trials Clinical Trials 130

Pharmaceutical Technology

NOVEMBER 29, 2022

For this approach, the team leveraged an oncolytic herpes simplex virus for releasing chemokines, which are signalling proteins that aid in attracting immune cells to tumours. This chemokine is connected to the epidermal growth factor receptor (EGFR) antibody causing attachment to tumour cells.

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Development Research Antibody Engineer 130

Pharmaceutical Technology

JANUARY 19, 2023

Nuvaxovid is a protein-based vaccine created from the genetic sequence of the initial SARS-CoV-2 virus strain. The expanded manufacturing and marketing approval was based on the data obtained from the Phase II trial, conducted in Australia and the US; a separate Phase II trial held in South Africa; and the UK-sponsored COV-BOOST trial.

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Vaccine Vaccination Immune Response Protein 147

Pharmaceutical Technology

OCTOBER 20, 2022

The regulatory agency based its decision on findings from the Phase III Prevent-19 clinical trial, as well as from the COV-BOOST trial, sponsored by the UK. In the Phase III trial, the vaccine booster was given to healthy adult subjects nearly eight or 11 months following the primary regimen.

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Vaccine Vaccination Antibody Trials 130

Pharmaceutical Technology

APRIL 4, 2023

Ultomiris is intended to treat NMOSD adult patients who are anti-aquaporin-4 (AQP4) antibody positive (Ab+). Ultomiris works by inhibiting the C5 protein in the terminal complement cascade, which is part of the body’s immune system. “We

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Marketing Clinical Trials Clinical Trials Trials 130

XTalks

APRIL 9, 2025

Primary IgAN is a rare autoimmune disease in which deposits of IgA provoke glomerular inflammation and excessive protein leakage into the urine. Vanrafia is expected to be available through specialty pharmacies and nephrology clinics across the US later this quarter. Topline data from that analysis are anticipated in mid2026.

FDA Approval 59

FDA Approval Clinical Trials Clinical Trials Trials 59

XTalks

OCTOBER 23, 2024

Otsuka Pharmaceutical has announced positive interim results from its Phase III clinical trial for sibeprenlimab. Sibeprenlimab, which has a Breakthrough Therapy designation, is a monoclonal antibody that blocks APRIL ( A PR oliferation- I nducing L igand), a critical step in the immune cascade contributing to IgAN.

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Trials Clinical Trials Clinical Trials Antibody 101

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.

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Clinical Trials Clinical Trials Vaccine Vaccination 76

Pharmaceutical Technology

JULY 5, 2022

Researchers at the UNC School of Medicine have discovered that hepatitis A virus (HAV) replication needs particular interactions between the human protein ZCCHC14 and TENT4 poly(A) polymerases, a group of enzymes. In addition, the scientists later found that the HAV needs TENT4A/B for its replication.

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Protein RNA Genomics Genome 130

Pharmaceutical Technology

SEPTEMBER 2, 2022

The committee’s opinion is based on findings from two Phase II clinical trials in Australia and South Africa, as well as the COV-BOOST trial sponsored by the UK. According to the findings, the third dose elicited higher responses in line with or above levels linked to protection in Phase III trials.

Vaccine 147

Vaccine Vaccination Trials Clinical Trials 147

Pharmaceutical Technology

MAY 11, 2023

Approved as the first and only long-acting C5 complement inhibitor, Ultomiris is indicated to treat adults with anti-aquaporin-4 (AQP4) antibody-positive (Ab+) NMOSD in the European Union (EU). It inhibits the C5 protein in the terminal complement cascade, part of the body’s immune system.

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Trials Clinical Trials Clinical Trials Medicine 130

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.

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Vaccine Vaccination Protein Immune Response 111

XTalks

JULY 25, 2022

Epidermal growth factor receptor 2 (HER2)-positive breast cancer is one such type in which there is an overexpression of the HER2 protein. Later lines of treatment can include monoclonal antibodies, tyrosine kinase inhibitors and antibody-drug conjugates (ADCs). Clinical Trial Results for [Vic-]Trastuzumab Duocarmazine .

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Antibody Drugs Clinical Trials Clinical Trials 59

Pharmaceutical Technology

SEPTEMBER 13, 2022

Extending beyond standard monoclonal antibodies, it now includes a variety of new development candidates, such as therapeutic proteins and antibody-drug conjugates. Together, these strategies are anticipated to boost development processes from pre-clinical to first-in-human clinical trials with quicker transition times.

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Antibody Development Clinical Trials Clinical Trials 130

Pharmaceutical Technology

FEBRUARY 19, 2023

Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval. It is a monoclonal antibody conjugate that acts by targeting f olate receptor alpha (FolR alpha). Sutro Biopharma owns a manufacturing facility in San Carlos, California.

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Antibody Protein Clinical Development Manufacturing 100

Pharmaceutical Technology

JUNE 15, 2023

Crovalimab is an anti-C5 recycling antibody. C5 is an important component of the complement system [a system of plasma proteins] and the drug is expected to control its activity. Given via subcutaneous administration, the therapy will reduce the treatment burden for patients and their caregivers. “A

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Clinical Trials Clinical Trials Trials Protein 130

XTalks

MAY 9, 2024

Genmab, a trailblazer in the field of antibody therapeutics, celebrates this milestone by reflecting on its impressive journey from a small-scale startup to a global leader in cancer treatment and beyond. Since then, innovative science has been at Genmab’s core, as we harness the power of human antibodies to improve the lives of patients.

Antibody 52

Antibody Clinical Trials Clinical Trials Medicine 52

Pharmaceutical Technology

AUGUST 23, 2022

It comprises messenger ribonucleic acid (mRNA) that encodes for the initial spike protein of SARS-CoV-2 along with mRNA that encodes for Omicron BA.4/BA.5 5 variant spike protein. According to pre-clinical findings, a booster dose of this vaccine elicited a robust neutralising antibody response against the variants Omicron BA.1,

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Vaccine Vaccination Gene Therapy Protein 130

Roots Analysis

MAY 21, 2024

Proteins are the chains of amino acids linked together in different combinations and perform a wide variety of functions. However, continuous regulation of the cellular proteome is essential for maintaining the right balance of different proteins necessary for normal cellular function, survival, and proliferation.

Protein 40

Protein Marketing Development Antibody 40

pharmaphorum

NOVEMBER 26, 2020

Danyelza (naxitamab) is an antibody that targets GD2, a protein found on the surface of some tumour cells, and it has been cleared by the US regulator for use alongside GM-CSF – a cytokine drug – as a second-line neuroblastoma treatment after a priority review. Both the antibodies stem from research carried out at the institution.

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Drugs Antibody Clinical Trials Clinical Trials 105

pharmaphorum

AUGUST 10, 2020

Biogen’s Alzheimer’s drug aducanumab could be on the market in the next few months after the FDA accepted a clinical trial dossier and granted a fast Priority Review. At the time the announcement was a complete shock as the trials had been deemed failures following an analysis last spring.

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Drugs Clinical Trials Clinical Trials Trials 105

Roots Analysis

AUGUST 9, 2023

Novel antibody therapies are chimeric proteins having antibodies attached lethal effector molecules. Multiple novel antibody formats have been engineered to enhance therapeutic efficacy. Around 50% of the articles focused on novel antibody therapies were published post-2020.

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Antibody Marketing Development Engineer 52

The Pharma Data

NOVEMBER 25, 2020

26, 2020 /PRNewswire/ — Cantargia AB (OMXS: CANTA) and BioInvent International AB (OMXS: BINV), today announced that BioInvent has been contracted as manufacturer of Cantargia’s antibody CAN10 in preclinical development for the treatment of systemic sclerosis and myocarditis. LUND, Sweden , Nov. About Cantargia.

Antibody 52

Antibody Manufacturing Clinical Trials Clinical Trials 52

The Pharma Data

MARCH 11, 2021

Clinical trial to assess safety, immune response and reactogenicity, after preclinical data showed high neutralizing antibody levels. The Companies expect interim results from this trial in the third quarter of 2021. About the Phase 1/2 clinical trial. About previously-published preclinical results.

Clinical Trials 52

Clinical Trials Clinical Trials Vaccine Vaccination 52

pharmaphorum

AUGUST 18, 2020

The consortium aims to rapidly develop drugs to fight SARS-CoV-2 and find virus neutralising antibodies. The trick is to look for proteins that are used across all coronavirus types and tend not to vary much from one virus species to another. But also included in the 77.7

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Protein Pharma Companies RNA Drugs 121

XTalks

AUGUST 30, 2022

The hemophilia A gene therapy Roctavian delivers a functional gene to enable the body to make an essential blood clotting protein on its own. A lack of sufficient functioning factor VIII and factor IX blood clotting proteins would result in the development of hemophilia A and hemophilia B, respectively.

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Gene Therapy Gene Clinical Trials Clinical Trials 98

The Pharma Data

APRIL 15, 2022

A new protein-based antiviral nasal spray developed by researchers at Northwestern University, University of Washington and Washington University at St. Louis is being advanced toward Phase I human clinical trials to treat COVID-19. “Our minibinders sit on top of the spike protein like a tripod and block all three.

Antibody 52

Antibody Protein Engineer Research 52