Rethinking Clinical Trials

APRIL 18, 2023

There are many hypothesized causes that may co-exist in the same patient, such as persistent virus or antigens, reactivation of other viruses, uncontrolled immune responses, damage to a wide range of organs and tissues, and injury to blood vessels and abnormal blood clotting. It’s all over the place.

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Drug Patent Watch

DECEMBER 9, 2024

The Role of Analytical Characterization Analytical characterization is a critical step in the development of biosimilars. Additionally, the immunogenicity of biosimilars, which is the ability of the drug to trigger an immune response, can be highly variable and impact the safety and efficacy of the drug. References Bilea, A.

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Pharmaceutical Technology

OCTOBER 6, 2022

from the US National Institutes of Health (NIH) unit National Institute of Allergy and Infectious Diseases (NIAID) to develop a prophylactic intranasal vaccine against Neisseria gonorrhoeae (NG). Leveraging its outer membrane vesicles (OMV) platform technology, Intravacc will develop the vaccine.

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Pharmaceutical Technology

AUGUST 24, 2022

Patients provide blood samples for clinical trial sponsors to develop and deliver these emerging immunotherapies. Each sample they give is precious, as they all provide a wealth of biological data that contributes to therapy development. The data are used for decision-making during drug development (purpose).

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Pharma Mirror

NOVEMBER 30, 2020

Chippenham, UK: Vectura Group plc, an industry leading inhalation CDMO, today announces that it has signed a global out licence and development agreement with Kinaset Therapeutics Inc. for the development and commercialisation of VR588, a preclinical novel inhaled pan-JAK inhibitor for the prevention and treatment of severe asthma.

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Pharmaceutical Technology

OCTOBER 6, 2022

BioLink Life Sciences has received a contract worth $750,000 from the US Biomedical Advanced Research and Development Authority (BARDA) to develop Ramatroban for treating Covid-19 pneumonia patients in the hospital setting. Ramatroban will be analysed in a placebo-controlled, randomised Phase II/III RAMBAN-1 clinical trial.

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pharmaphorum

SEPTEMBER 7, 2020

A trial of Russia’s Sputnik V coronavirus vaccine has shown the jab produces an immune response, although the study was too small to produce conclusive findings, particularly on safety. But there are concerns that Russia has rushed development of the vaccine to claim a political victory in the race to get a vaccine approved.

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Pharmaceutical Technology

APRIL 28, 2023

Biotechnology company Therini Bio has raised $36m in a Series A financing round to develop fibrin-targeted therapies to treat neurodegenerative and retinal diseases. Therini Bio will use part of the funds to advance its potential first-in-class investigational antibody, THN391, into clinical trials.

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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.

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XTalks

APRIL 1, 2025

It did not increase the risk of clinical sequelae, including infection or sepsis, which are some of the main drivers of the high mortality associated with aGVHD. It occurs when immune cells from the donor perceive the host tissues as foreign and subsequently initiate an immune response against them.

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Immune Response Trials Licensing Licensing 94

Camargo

DECEMBER 13, 2021

The development of biological products (or biologics) represents a major advancement in modern medicine, enabling the treatment of patients with many illnesses where no other therapeutics were previously available. One common characteristic for most if not all biologics is the triggering of an immune response or anti-drug antibodies.

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Pharmaceutical Technology

JUNE 16, 2023

The Phase IIa trial (NCT05734040) in Australia will see a potential 500 volunteers given OVX836 in combination with quadrivalent influenza vaccines (QIVs). The developer has tested OVX836 in four completed clinical trials.

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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.

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Pharmaceutical Technology

JUNE 30, 2022

At present, the vaccine is being analysed in clinical trials in the US, Brazil and South Korea. This technology can stimulate an immune response with a dose up to 20 times lower than current vaccines, which enhances safety, lowers costs, and increases production speed. .

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Pharmaceutical Technology

JUNE 23, 2022

It was based on findings from seven double-blind, randomised, clinical trials that evaluated the safety, tolerability and immunogenicity of the vaccine in infants, children and adolescents. The post US FDA grants approval for Merck’s pneumococcal vaccine for children appeared first on Pharmaceutical Technology.

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XTalks

NOVEMBER 15, 2024

MDS are a group of blood disorders caused by abnormal development of blood cells in the bone marrow. This progression occurs when the abnormal cells in the bone marrow increase uncontrollably, leading to the development of a more aggressive form of blood cancer. “We

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Medical Xpress

JANUARY 30, 2023

A newly published paper in The Lancet shows that an experimental vaccine against Marburg virus (MARV) was safe and induced an immune response in a small, first-in-human clinical trial.

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Worldwide Clinical Trials

JUNE 21, 2024

The 2024 ASCO Annual Meeting from the American Society of Clinical Oncology is a fantastic platform for clinical researchers to discuss the latest advancements and challenges in oncology research. Currently, there are 12 approved ADC drugs, and several hundred more are in the development pipeline.

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pharmaphorum

JULY 18, 2022

MBA, managing director at CanSino Biologics Europe, tells us about Convidecia, a single dose SARS-CoV-2 vaccine offered as an injectable and inhalant that allows ease of storage, an alternative option for individuals with needle phobias, and robust elongated CD4 and CD8 cellular response. Morgon, PharmD, LL.M, The inhalant version.

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BioPharma Reporter

FEBRUARY 13, 2023

Scancell has reported preliminary immunogenicity data from its Phase 1 COVIDITY clinical trial: with the plasmid DNA based COVID-19 vaccine candidates inducing immune responses when delivered via needle-free tech.

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BioPharma Reporter

JUNE 15, 2021

Co-administration of Novavaxâs COVID-19 vaccine candidate and an approved influenza vaccine induced robust immune responses, according to data from a clinical trial. âThe findings suggest simultaneous vaccination may be a viable immunization strategy,â says the company.

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Pharmaceutical Technology

MAY 19, 2023

OncoResponse has secured a $13m grant from the Cancer Prevention and Research Institute of Texas (CPRIT) and raised an additional $14m in funding from investors for advancing OR502 to investigational new drug (IND) and clinical trials. It is planned to enter clinical studies this year. ”

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Pharmaceutical Technology

MAY 10, 2023

XinThera’s therapy targeting MK2 is expected to enter clinical trials later in 2023. Gilead Sciences stated that the two programmes have the potential to address a number of indications and to provide development opportunities both alone and along with its wider portfolio.

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XTalks

SEPTEMBER 5, 2023

Vaccines have been an integral piece of the global public health toolbox for over 200 years, but the COVID-19 pandemic brought about a new era in vaccine development with renewed interest in mRNA technology and unprecedented accelerated regulatory approvals. What are the major challenges you’re facing right now in vaccine development?

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pharmaphorum

NOVEMBER 20, 2022

One standout success we have all benefitted from is vaccine development, with notable vaccines from Pfizer/BioNTech, AstraZeneca, and Moderna. New hurdles from COVID-19 vaccine development. Trials testing SARS-CoV-2 vaccines saw high enrollment, which reduced the time between each clinical trial phase.

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The Pharma Data

AUGUST 16, 2021

Better activation of innate and adaptive immune responses was achieved with CV2CoV, resulting in faster response onset, higher titers of antibodies, and stronger memory B and T cell activation as compared to the first-generation candidate, CVnCoV. “In Induction of innate immunity was investigated via specific cytokine markers.

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pharmaphorum

MARCH 4, 2021

UK chancellor Rishi Sunak has announced a budget loaded with initiatives designed to kick-start the UK’s economy as it recovers from the coronavirus pandemic, with vaccine development, pharma and life sciences playing a key role. The post Budget 2021: Sunak focuses on vaccine development to restart economy appeared first on.

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pharmaphorum

FEBRUARY 25, 2021

A nasal delivery method will also produce an immune response at the point where the virus enters the body. The company announced a phase 1 trial is beginning of its nasal spray vaccine just as scientists in the UK said they are considering a similar approach.

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Pharmaceutical Technology

AUGUST 5, 2022

The scientific approach of MiroBio for immune balance restoration to treat autoimmune diseases complements the inflammation research and development works of Gilead. MB272, the lead investigational antibody of MiroBio, is a selective immune inhibitory receptor B- and T-Lymphocyte Attenuator (BTLA) agonist.

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Pharmaceutical Technology

NOVEMBER 20, 2022

The latest development was based on findings from a Phase II clinical trial of the vaccine in South Africa as well as from the Phase III Prevent-19 trial in the US and Mexico. The vaccine is indicated for active immunisation to prevent the disease.

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Worldwide Clinical Trials

JUNE 15, 2022

At the end of May, we hosted a webinar titled “ Changing Times, Changing Therapies: Keeping Up with Advancements in Cell and Gene Therapies ” to provide a quick update on the latest advancements and ongoing in development of these advanced therapeutics. Clinical holds are becoming more common, especially in gene therapy programs.

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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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pharmaphorum

FEBRUARY 9, 2022

However, the industry is constantly looking to discover the next frontier in treatment development and technology to provide more effective, safer treatments to patients. One area that is gathering increasing levels of interest is the development of cancer vaccines. A broad front. Prior success.

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Cloudbyz

MARCH 5, 2024

In the intricate dance of drug discovery and development, two protagonists emerge as the cornerstones of modern medicine: biologics and small molecules. They are often used to mimic or enhance natural biological processes, such as immune responses. Their small size allows them to distribute widely throughout the body.

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Pharmaceutical Technology

JANUARY 19, 2023

It has been developed using the company’s recombinant nanoparticle technology. 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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Pharmaceutical Technology

JUNE 10, 2023

Influenza vaccine 2 is under clinical development by Shanghai Institute of Biological Products and currently in Phase I for Pandemic Influenza. GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data.

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Pharmaceutical Technology

JUNE 10, 2023

Influenza vaccine 2 is under clinical development by Shanghai Institute of Biological Products and currently in Phase I for Pandemic Influenza. GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data.

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