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Treatment Trials Vaccine 
Drugs.com
DECEMBER 15, 2023
15, 2023 -- A new melanoma vaccine has shown its mettle in battling the deadly skin cancer in a new trial. People with advanced melanomas who received the vaccine plus Merck's cancer drug Keytruda were 49% less likely to die or have. FRIDAY, Dec.
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PPD
JUNE 24, 2024
In the realm of vaccine development, mega trials — studies enrolling 5,000 subjects or more — have been instrumental in the fight against many pathogens, including influenza, rotavirus, malaria, RSV and most recently in the rapid development of vaccines against COVID-19.
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Fierce BioTech
JUNE 12, 2024
By Ayako Wakatsuki Pedersen, SVP of Translational Research at IO Biotech | Historically, most cancer vaccine trials have fallen short. What is the potential of new vaccines that can dismantle cancer cells' defenses?
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Drug Target Review
JANUARY 23, 2024
What innovative approaches and technologies are anticipated to reshape immuno-oncology treatments in 2024? Immuno-oncology, notably through checkpoint inhibitors, has significantly reshaped cancer treatment over the past decade.
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SCIENMAG: Medicine & Health
JUNE 8, 2023
Researchers from Edith Cowan University (ECU) are leading ground-breaking global trials which could save lives by changing how we treat cancer in the near future.
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Advarra
JANUARY 11, 2024
The applications of mRNA-based therapies in cancer research represent one of the next groundbreaking steps toward improved cancer treatments. While mRNA usage has played several roles in clinical research , oncology researchers in particular are eager to explore the possibilities of mRNA-based cancer vaccines.
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Drug Target Review
JANUARY 15, 2024
Could you provide insights into the driving factors behind exploring novel treatments for cancer types? Based on this rationale we selected skin cancer, triple-negative breast cancer, and head and neck cancers as our initial indications for our Phase 1 trials. What aspects prompted this research direction?
105 
Drug Target Review
FEBRUARY 21, 2024
This is a time when several promising treatments – including mRNA vaccines, BiTE therapies and CAR-T cell therapy, are essentially in competition with each other – they all have a common goal of treating the same disease, but they are approaching the objective from different angles.
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Alta Sciences
SEPTEMBER 27, 2024
Featuring two scenarios that explore the complexities of bioanalysis for immunomodulators, The Altascientist offers practical considerations for ensuring accurate bioanalysis, as well as pharmacokinetic, pharmacodynamic , and safety data in clinical trials. Each class of immunomodulator has a defined complexity and mechanism of action.
The Pharma Data
SEPTEMBER 7, 2021
The first patients have been enrolled in a phase 1 randomized placebo-controlled clinical trial to study a therapeutic vaccine for opioid use disorder developed by researchers at the University of Minnesota Medical School. The vaccine currently being tested stimulates the body’s immune system to produce antibodies to oxycodone.
BioPharma Drive: Drug Pricing
OCTOBER 7, 2024
The development of cancer vaccines has provided some hope in the battle against cancer worldwide; however, there are still many challenges to overcome when developing these life-saving treatments.
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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.
Codon
NOVEMBER 3, 2024
In the 1924 novel, The Magic Mountain , Thomas Mann describes a sanatorium patient named Anton Ferge as he undergoes a painful tuberculosis (TB) treatment. Even after microbiologists discovered the bacterium that causes the illness in 1882, it wasn’t until the 1920s that researchers were able to develop a vaccine for TB.
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The Pharma Data
SEPTEMBER 1, 2020
Sanofi is halting clinical trials treating serious COVID-19 patients with its Kevzara drug after the data proved inconclusive. The Phase 3 trial did not meet the primary or secondary endpoints compared with placebo and established hospital care. Conor Kavanagh. Source link.
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The Pharma Data
SEPTEMBER 9, 2020
Global trials for AstraZeneca’s much-hyped COVID-19 vaccine, currently in development in partnership with the University of Oxford, have been halted after an unexplained illness was identified in one of the participants. In large trials illnesses will happen by chance but must be independently reviewed to check this carefully.
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H1 Blog
SEPTEMBER 26, 2023
Breaking Down Barriers to International Clinical Trials Global Disruptions, Health Equity & Data Sharing As the U.S. When it comes to developing new treatments and vaccines, the development timeline is often long and arduous, especially outside of the U.S. First let’s look at some challenges and then opportunities.
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The Pharma Data
JULY 21, 2021
Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need, and Pfizer Inc. If successful, this trial could enable the inclusion of a pediatric population in the Phase 3 trial.
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The Pharma Data
NOVEMBER 16, 2020
November 16, 2020 — An independent data and safety monitoring board (DSMB) overseeing the Phase 3 trial of the investigational COVID-19 vaccine known as mRNA-1273 reviewed trial data and shared its interim analysis with the trial oversight group on Nov.
Reprocell
JANUARY 18, 2023
Today, clinical trials are conducted to aid our understanding of, and to assess new treatments for, medical conditions or disorders that affect the human population.
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. “Our About the Phase 1/2 clinical trial.
The Pharma Data
SEPTEMBER 12, 2020
Food and Drug Administration to expand the enrollment of their Phase 3 pivotal COVID-19 vaccine trial to up to approximately 44,000 participants which also allows for the enrollment of new populations. The pivotal trial is event-based and there are many variables that will ultimately impact read-out timing.
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The Pharma Data
DECEMBER 21, 2020
The trial will be conducted at 10 sites across Germany and led by principal investigator Prof. The FOCUS trial is Ultimovacs’ fourth Phase II clinical trial with UV1 and comes in addition to the collaboration Phase II trial announced in May 2020. “We Mascha Binder, M.D.,
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PPD
SEPTEMBER 7, 2023
For more than 40 years, drug developers have been dedicated to advancing HIV clinical research in the quest for treatments and, ultimately, a cure. Though there has been considerable progress in treatment options, 39 million people across the globe are infected with HIV, with an estimated 1.3 million new infections in 2022.
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. . The company has already tested the treatment on 10 adults between the ages of 56-70, and 10 over 71. The company is set to charge between $32 and $37 per dose.
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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.
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DrugBaron
JANUARY 2, 2021
Over the past week a furious debate has broken out over the merits of delaying the second dose of the approved COVID vaccines, to increase the number of people who can be given a single dose. The case against doing so is clear: the labels of the approved vaccines are unambiguous that two doses should be given within a certain time window.
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The Pharma Data
APRIL 26, 2022
This action makes Veklury the first approved COVID-19 treatment for children less than 12 years of age. As COVID-19 can cause severe illness in children, some of whom do not currently have a vaccination option, there continues to be a need for safe and effective COVID-19 treatment options for this population,” said Patrizia Cavazzoni, M.D.,
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Codon
JANUARY 21, 2024
Today, refined versions of these human challenge studies have become standard practice in testing vaccines for vector-borne diseases (e.g., yellow fever, malaria, and dengue), evaluating new drugs or treatments, and studying pathogenesis, the process by which a disease develops. Why are challenge trials becoming more popular?
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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. Overall, the vaccine candidate elicited strong neutralizing antibody levels that were comparable to those generated by natural infection, with higher levels observed in younger adults (18 to 59 years old).
Advarra
JUNE 13, 2024
Recombinant DNA technologies and genetically modified biological agents are being adapted for a wide scope of therapeutic applications, and their use is becoming increasingly common in clinical trials. The SOP should list these symptoms and any available prophylaxis for post-exposure treatment. That should be in the SOP as well.
The Pharma Data
JUNE 25, 2021
In the unprecedented context of at least 13 variants circulating within the study population subset assessed at this interim analysis, CVnCoV demonstrated an interim vaccine efficacy of 47% against COVID-19 disease of any severity and did not meet prespecified statistical success criteria. About CVnCoV.
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The Pharma Data
JANUARY 17, 2021
The treatment could be administered in primary care centers to people who test positive for COVID-19, avoiding hospitalization due to the progression of the disease and complementing the vaccine in the early phase after vaccination. BARCELONA, Spain , Jan. BARCELONA, Spain , Jan.
The Pharma Data
OCTOBER 18, 2021
Food and Drug Administration announced it has awarded 11 new clinical trial research grants, equaling more than $25 million of funding over the next four years. “Supporting the development and evaluation of new treatments for rare diseases is a critical part of the FDA’s mission,” said Acting FDA Commissioner Janet Woodcock, M.D.
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.
BioPharma Drive: Drug Pricing
APRIL 2, 2024
While the company claimed its shot showed signs of working in a Phase 2 trial, the data weren’t strong enough to prove a treatment benefit.
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The Pharma Data
OCTOBER 30, 2020
More recently, the FDA announced regulatory approval for the first treatment for Covid-19. FDA approves first treatment for Covid-19. On October 22, the FDA approved the antiviral drug Veklury for use in adult and pediatric patients for the treatment of Covid-19 requiring hospitalization.
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Tebu Bio: Drug Discovery
APRIL 24, 2020
mRNA vaccines are developing very quickly with dozens of ongoing clinical trials against cancers or infectious diseases (e.g. Recombinant monoclonal antibody (mAB) based treatments have proven their efficacy. Pre-clinical and clinical trials […] HIV or more recently SARS-Cov-2).
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The Pharma Data
FEBRUARY 23, 2022
* Final analysis of the global VAT02 booster trial confirms universal ability to boost neutralizing antibodies 18- to 30-fold across vaccine platforms (mRNA, adenovirus). * efficacy against any symptomatic COVID-19 disease, in line with expected vaccine effectiveness in today’s environment dominated by variants of concern.
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The Pharma Data
SEPTEMBER 14, 2020
A new antibody treatment is to be trialled on Covid-19 patients in UK hospitals. It forms part of the UK Recovery Trial, which found that a cheap steroid called dexamethasone could save lives. We need to know, and the way to know is to do the trials that will tell us whether that hope turns into reality.”.
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The Pharma Data
FEBRUARY 25, 2021
Takeda Provides Updates on Phase 1/2 Clinical Trials of Novavax’ and Moderna’s COVID-19 Vaccine Candidates in Japan. – Takeda is making two COVID-19 vaccines available in Japan, by manufacturing Novavax’ recombinant vaccine candidate and distributing Moderna’s mRNA vaccine candidate, with the support of the Japanese Government.
The Pharma Data
OCTOBER 20, 2020
20, 2020 — British scientists are infecting healthy volunteers with COVID-19, in hopes of speeding up vaccine development, TheWashington Post reported Tuesday. Led by scientists at Imperial College London, people in this challenge trial will be guaranteed treatment if they become ill. TUESDAY, Oct. © 2020 HealthDay.
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The Pharma Data
APRIL 18, 2022
Takeda today announced that it has received manufacturing and marketing approval from the Japan Ministry of Health, Labour and Welfare (MHLW) for Nuvaxovid ® Intramuscular Injection (Nuvaxovid), a novel recombinant protein-based COVID-19 vaccine, for primary and booster immunization in individuals aged 18 and older. TAK-019 Clinical Trial.
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The Pharma Data
AUGUST 31, 2021
SK bioscience (SK) and GlaxoSmithKline plc (GSK) today announced the initiation of a Phase 3 clinical study of SK’s COVID-19 vaccine candidate, GBP510, in combination with GSK’s pandemic adjuvant following positive interim Phase 1/2 results. GSK commitment to tackling COVID-19.
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Olympian Clinical Research
FEBRUARY 26, 2021
Clinical trials are research studies designed to evaluate or test a medical, surgical, or behavioral intervention. Most recently, clinical trials have gained recognition through the development and testing of Covid-19 vaccines. Gain access to new treatments before the general public. .
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