BioPharma Drive: Drug Pricing

JULY 27, 2023

The pharma said its latest shot, which covers 21 strains of bacteria, cleared two Phase 3 trials and in some cases spurred a stronger immune response than Pfizer’s Prevnar 20.

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Drug Patent Watch

DECEMBER 9, 2024

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. Robust Clinical Trial Design : Clinical trials for biosimilars should be designed to demonstrate equivalence or non-inferiority to the reference product.

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Drug Discovery Today

APRIL 15, 2021

First subjects dosed with AKS-452, COVID-19 vaccine candidate in the Netherlands trial the vaccine is shelf-stable for 4 months at 25 degrees Celsius (77° Fahrenheit). 176 volunteers will participate in the clinical trial the safety and immune response read-outs expected in Q2 2021

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SCIENMAG: Medicine & Health

JUNE 12, 2023

Peer-reviewed / Randomised Controlled Trial / People Study of healthy US adults found that a single dose of the VLA1553 vaccine candidate was generally safe, well tolerated and provokes an immune response.

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Broad Institute

FEBRUARY 26, 2025

We hope this will spur additional studies to identify ways to tackle edema [brain swelling] using different drugs and also to think about how we design clinical trials based on those results, Miller said.

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The Pharma Data

OCTOBER 22, 2020

AstraZeneca’s COVID-19 vaccine candidate, AZD1222, currently being evaluated in phase 3 global trials, delivers a strong immune response, according to a new UK study. Source link.

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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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Plenge Gen

APRIL 7, 2020

Repurposing of approved therapies is the fastest way to impact patients today, as these medicines have regulatory approval to enable investigator-initiated trials and have a manufacturing process to ensure drug supply. appeared first on Plenge Gen @rplenge.

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The Pharma Data

MAY 16, 2021

Adjuvanted recombinant COVID-19 vaccine candidate triggered strong neutralizing antibody responses in all adult age groups. High immune response after a single dose in patients with prior infection shows strong booster potential. For media and investors only. Issued: London UK. 1.351 (South African) variants.

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Codon

NOVEMBER 3, 2024

Fortunately, some novel preventatives and therapies are in the works, including a vaccine equipped with adjuvants that efficiently prime the immune system and newer antibiotics against which the bacteria have yet to evolve resistance. A phase 3 clinical trial for M72/AS01E, funded by the Gates Foundation, began this year.

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Drug Target Review

JANUARY 23, 2024

Cell-based therapies, such as tumour-infiltrating lymphocyte (TIL) therapy, have also drawn significant attention following promising results in a melanoma trial. Individualised cancer vaccines are tailored to each patient’s tumour, helping the immune system mount cancer-specific immune responses that can boost checkpoint inhibitor efficacy.

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ASPET

SEPTEMBER 12, 2023

Significance Statement This first-in-human clinical trial of KPL-404, a fully humanized IgG4 monoclonal antibody, was designed with two independent (by route of administration) placebo-controlled single-ascending-dose-level groups, one with four intravenous single-dose cohorts and another with two subcutaneous single-dose cohorts.

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The Pharma Data

NOVEMBER 10, 2020

Canadian biopharmaceutical company Medicago has announced that its investigational COVID-19 vaccine generated “significant antibody and cellular immune responses” after two doses in all subjects in an early-stage clinical trial. Based on the promising phase 1 data, the company plans to proceed with a phase 2/3 clinical trial. “We

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Conversations in Drug Development Trends

OCTOBER 14, 2024

With the support of global networks like ours at Worldwide Clinical Trials (Worldwide), autoimmune and bone health research is accelerating, providing new solutions to patients around the world. One of the biggest hurdles in developing new therapies is recruiting diverse patients for clinical trials.

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The Pharma Data

JUNE 29, 2021

A sub-analysis from the Oxford-led COV001 and COV002 trials with Vaxzevria induced strong immune responses following either a prolonged second dose interval of up to 45 weeks or following a third boosting dose. In the UK, Vaxzevria is known as COVID-19 Vaccine AstraZeneca.

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The Pharma Data

NOVEMBER 2, 2020

German biopharma company CureVac announced yesterday that its COVID-19 vaccine hopeful generated immune responses and was generally well-tolerated in phase 1 trial participants, lending support for a pivotal trial before year’s end. Source link.

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Broad Institute

OCTOBER 11, 2023

By then, a few cancer immunotherapies had entered clinical trials and only a handful had been approved by the FDA. As a first step, Manguso set his sights on treatments called PD-1 checkpoint inhibitors, which at the time had shown tremendous promise in clinical trials and would receive their first FDA approval in 2014.

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Alta Sciences

FEBRUARY 19, 2025

These interactions may disrupt protein function, trigger immune responses, or contribute to other toxicological risks. to ligands or linkers) may elicit immune responses. Immunogenicity: While oligonucleotides are typically non-immunogenic, modifications or conjugations (e.g.,

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DrugBaron

APRIL 13, 2020

This gives a clear indication of current (or very recent) infection, but it tells us nothing about the cumulative number of people exposed, nor the degree or nature of their immune response to the virus. The solution is a test for the immune response to the virus (often called a “serology test”).

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Drug Target Review

FEBRUARY 9, 2024

Additionally, ADSCs possess immunomodulatory properties, enabling them to modulate immune responses and promote tissue healing. What experimental models and assays are commonly used to assess the therapeutic potential of stem cells, and how well do these models predict the outcomes observed in later-stage clinical trials?

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Drug Target Review

MARCH 1, 2024

This antigen-spreading is critical to long-term protection because tumour often develop with inconsistent antigen expression – equipping the immune response to target many diverse tumour antigens may allow for more complete anti-tumour activity. Dr Haqq holds multiple patents and publications.

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The Pharma Data

AUGUST 27, 2020

Moderna has announced that its coronavirus vaccine candidate has shown promise in generating an immune response in elderly patients in an early-stage clinical trial. . Moderna started a large-scale Phase 3 trial last month that will test the vaccine’s safety and effectiveness on 30,000 people with results expected in October.

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The Pharma Data

JULY 15, 2021

Antibody and T-cell immune responses strong and stable at eight months after immunization Demonstrated neutralizing antibody activity against the Delta variant (B.1.617.2) In addition, the T-cell responses are especially strong and stable over time, which is also potentially important for activity against these variants.”.

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The Pharma Data

SEPTEMBER 14, 2020

It forms part of the UK Recovery Trial, which found that a cheap steroid called dexamethasone could save lives. Prof Martin Landray from the University of Oxford, who is co-leading the Recovery Trial, said: “This is the first type of treatment that’s targeted for this specific virus. ” How will the trial work?

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The Pharma Data

MARCH 31, 2022

A Phase 2 clinical trial evaluating various additional COVID-19 booster shots has begun enrolling adult participants in the United States. The study, known as the COVID-19 Variant Immunologic Landscape (COVAIL) trial, is sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health.

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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.

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DrugBank

JULY 18, 2024

Adjuvants are substances added to vaccines to enhance the immune response. They work by decreasing the solubility of the vaccine, which sustains the release of the drug and prolongs the immune response. Even after a vaccine is approved and distributed, the pharmaceutical industry's responsibility does not end.

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The Pharma Data

SEPTEMBER 25, 2020

Johnson & Johnson Posts Interim Results from Phase 1/2a Clinical Trial of its Janssen COVID-19 Vaccine Candidate. Johnson & Johnson Posts Interim Results from Phase 1/2a Clinical Trial of its Janssen COVID-19 Vaccine Candidate. Immune responses were similar across the age groups studied, including older adults.

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The Pharma Data

DECEMBER 8, 2020

8, 2020 — AstraZeneca’s COVID-19 vaccine is safe and effective, new data from late-stage trials shows. The interim findings are from phase 3 trials in the United Kingdom and Brazil that included more than 11,600 participants. TUESDAY, Dec. 8 in The Lancet. New data posted Tuesday on the U.S. © 2020 HealthDay.

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The Pharma Data

DECEMBER 20, 2020

UK drug developer Scancell said it has chosen a COVID-19 vaccine candidate, SN14, from more than a dozen potential products to advance to a clinical trial. . In October, Scancell signed a manufacturing deal for SN14 with Cobra Biologics, a Cognate BioServices subsidiary, ahead of a planned phase 1 trial in 2021. Source link.

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SugarCone Biotech

JUNE 10, 2024

Targeting 4-1BB remained of interest to the immuno-oncology field as cell culture experiments and tumor models in mice suggested that robust anti-tumor immune responses could be triggered by anti-4-1BB antibody therapies. This is the T cell type most closely associated with anti-tumor immune responses. One more question.

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The Pharma Data

DECEMBER 23, 2020

In the context of a substantial amount of COVID-19-related research and the launch of numerous clinical trials, the French government created this steering committee to prioritize and accelerate high potential clinical trials. This Phase IIa trial follows a preliminary study conducted by Prof.

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The Pharma Data

DECEMBER 14, 2020

The randomized trial of the two-dose vaccine is expected to enroll more than 35,000 participants aged 18 and up at sites throughout Europe and Latin America. Participants will also be monitored in a yearlong study following the trial’s conclusion that will collect additional data to help assess the vaccine’s duration of effectiveness.

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The Pharma Data

NOVEMBER 18, 2020

18, 2020 — Children should be included in clinical trials for a severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccine at the earliest stages, according to a letter from the president of the American Academy of Pediatrics (AAP), on behalf of more than 67,000 pediatricians and pediatric medical and surgical subspecialists.

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The Pharma Data

SEPTEMBER 2, 2020

. Sanofi and GSK have begun a Phase I/II clinical trial testing their adjuvanted COVID-19 vaccine in healthy adults. The randomised, double blind and placebo-controlled trial is designed to evaluate the safety, reactogenicity (tolerability) and immunogenicity (immune response) of the experimental COVID-19 vaccine candidate.

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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.

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Drug Target Review

JUNE 6, 2023

Natural killer (NK) cells are another immune cell type that, as the name suggests, also have potent cell-killing activity, and have a well-known role in the anti-tumour immune response. In the context of a tumour microenvironment, Tregs are often present in high numbers, preventing an effective immune response to the tumour.

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