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Disease Trials Vaccine 
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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SCIENMAG: Medicine & Health
SEPTEMBER 15, 2023
Enrollment in a Phase 1 trial of a new investigational universal influenza vaccine candidate has begun at the National Institutes of Health’s Clinical Center in Bethesda, Maryland.
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DrugBank
JULY 18, 2024
Vaccines have consistently demonstrated their efficacy in protecting people from infectious diseases. This led to the eradication of smallpox and polio – two debilitating diseases that historically caused global epidemics. Sugars, such as sucrose are common stabilizers in many vaccines.
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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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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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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.
SCIENMAG: Medicine & Health
NOVEMBER 27, 2023
Osaka, Japan – The global impact of the coronavirus pandemic has ignited a renewed focus on emerging and re-emerging infectious diseases. Researchers at Osaka Metropolitan University are making great strides in combating pneumococcal pneumonia, one of the leading causes of respiratory deaths worldwide.
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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 25, 2020
A trial of a new vaccine that appears to train the immune system to fight coronavirus has begun in the UK. The trial on 10,000 people will now see if the vaccine can prevent people getting ill. Some of the vaccines being developed for Covid-19 use either completely new or barely proven technologies. .
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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.
The Pharma Data
APRIL 26, 2022
Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, and Pfizer Inc. Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, and Pfizer Inc. NYSE: PFE) today reported positive Phase 2 pediatric data for their Lyme disease vaccine candidate, VLA15.
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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. Overall, the vaccine protected against symptomatic disease in 70% of cases, according to a team led by researchers from Oxford University in England. TUESDAY, Dec. 8 in The Lancet.
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FDA Law Blog: Drug Discovery
JUNE 12, 2024
Sasinowski — Hyman, Phelps & McNamara (HPM) would like to congratulate the 7 rare disease programs selected for the inaugural class of the FDA’s “Support for clinical Trials Advancing Rare disease Treatment” (START) pilot program.
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PPD
MAY 11, 2023
The global COVID-19 pandemic increased awareness of the importance of vaccine development — both for drug developers and the public. The speed at which COVID-19 vaccines were developed was remarkable, but like most newly developed vaccines, there was variation among who could receive the shots and when.
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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.
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
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
JUNE 25, 2021
(Nasdaq: NVAX), today announced that NVX-CoV2373, its recombinant nanoparticle protein-based COVID-19 vaccine, demonstrated 100% protection against moderate and severe disease, 90.4% efficacy overall, and met the primary endpoint in its PREVENT-19 pivotal Phase 3 trial. 100) against moderate or severe disease.
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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
OCTOBER 22, 2020
Moderna has completed enrollment of 30,000 participants for its phase 3 study evaluating COVID-19 vaccine candidate mRNA-1273. The randomized, placebo-controlled trial is being conducted in partnership with the NIH’s National Institute of Allergy and Infectious Diseases and HHS’ Biomedical Advanced Research and Development Authority.
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The Pharma Data
MARCH 8, 2021
Valneva SE (“Valneva”), a specialty vaccine company focused on prevention of diseases with major unmet needs, and Pfizer Inc. It will compare the three-dose vaccination schedule (Month 0-2-6) with a two-dose schedule (Month 0-6). “We We are excited to be part of the Lyme disease vaccine development program with Valneva.
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SCIENMAG: Medicine & Health
OCTOBER 18, 2023
This study is conducted by the Jiangsu Provincial Center for Disease Control and Prevention, National Institute of Diagnostics and Vaccine Development in Infectious Diseases, State Key Laboratory of Vaccines for Infectious Diseases of Xiamen University, China National Institutes for Food and Drug Control, and Xiamen Innovax Biotech Company.
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Codon
NOVEMBER 3, 2024
Physicians working in the early 20th century had little choice but to treat the world’s most rampant infectious disease with methods such as these. 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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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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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
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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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. Additionally, how do you ensure that the vaccine distribution is equitable?
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The Pharma Data
NOVEMBER 29, 2020
AstraZeneca’s COVID-19 vaccine candidate is facing another potential delay as the company plans to undertake a new global clinical trial to confirm the vaccine’s 90 percent efficacy based on a one-and-a-half-dose regimen. An additional trial could further delay AZ’s efforts to earn an EUA in the U.S., James Miessler.
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The Pharma Data
JANUARY 31, 2021
Clover plans to initiate a global Phase 2/3 efficacy trial of its protein-based S-Trimer COVID-19 vaccine candidate adjuvanted with Dynavax’s CpG 1018 plus alum in the first half of 2021 with an interim analysis for vaccine efficacy potentially in the middle of 2021. EMERYVILLE, Calif.
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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
JANUARY 31, 2021
Adjuvanted S-Trimer COVID-19 vaccine candidates demonstrated favorable safety and tolerability profiles and strong neutralizing immune responses in a phase 1 trial. The phase 1 clinical trial was a randomized, double-blind and placebo-controlled study in 150 adult and elderly participants.
The Pharma Data
SEPTEMBER 23, 2020
September 23, 2020 – Johnson & Johnson (NYSE: JNJ) (the Company) today announced the launch of its large-scale, pivotal, multi-country Phase 3 trial (ENSEMBLE) for its COVID-19 vaccine candidate, JNJ-78436735, being developed by its Janssen Pharmaceutical Companies. NEW BRUNSWICK, N.J.,
BioPharma Drive: Drug Pricing
JULY 26, 2023
The companies are enrolling people with melanoma in a Phase 3 trial aimed at testing whether the shot can prevent disease recurrence.
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The Premier Consulting Blog
JUNE 18, 2023
One exciting application of these technologies is the use of in silico trials in the development of novel therapies for rare diseases. However, with rare diseases there may be no available treatments that could serve as SoC or active control in a clinical trial and assigning patients to placebo may be unethical.
PPD
SEPTEMBER 7, 2023
Approved treatments and therapies have turned what was once a certain death sentence into a manageable condition for those with the disease. However, for patients who go untreated, HIV remains a fatal disease. With continued evolution and access to treatment, the HIV drug development landscape is ripe with opportunity.
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.
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. If a vaccine is available, clinical personnel working with the IP should consider vaccination status.
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.
The Pharma Data
JUNE 17, 2022
In a Phase 2/3 clinical trial, the Pfizer-BioNTech COVID-19 Vaccine elicited a strong immune response in this age group Three 3-µg doses had favorable safety profile similar to placebo in young children ages 6 months through 4 years in Phase 2/3 clinical trial Pfizer-BioNTech COVID-19 Vaccine now authorized in the U.S.
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The Pharma Data
SEPTEMBER 3, 2020
Johnson & Johnson Announces that Janssen’s COVID-19 Investigational Vaccine Candidate Prevents Severe Clinical Disease in Pre-clinical Studies. Johnson & Johnson Announces that Janssen’s COVID-19 Investigational Vaccine Candidate Prevents Severe Clinical Disease in Pre-clinical Studies.
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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 2, 2021
First subjects vaccinated in study of Pfizer’s RSV bivalent prefusion F subunit investigational vaccine candidate in adults ages 60 or older. RSV is a common and pervasive cause of severe acute respiratory illness in older adults with no vaccine currently available. NEW YORK–(BUSINESS WIRE)– Pfizer Inc. Jansen, Ph.D.,
The Pharma Data
SEPTEMBER 4, 2020
The findings have validated confidence in the experimental vaccine, the firm noted. Janssen’s lead SARS-CoV-2 investigational vaccine candidate, Ad26.COV2.S, S, prevented severe clinical disease in Syrian golden hamsters when challenged with SARS-CoV-2, the virus that causes COVID-19 in people.
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Agency IQ
MARCH 7, 2024
Vaccines advisory panel endorses move to trivalent formulation for U.S. flu vaccines Yesterday, FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) weighed in on strains for seasonal influenza vaccines for the Northern hemisphere 2024-2025 season.
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