The Pharma Data

DECEMBER 16, 2020

Currently in Phase 3 clinical testing in the United Kingdom for the prevention of COVID-19, NVX-CoV2373 is a recombinant protein vaccine adjuvanted with Novavax’ proprietary Matrix-M to enhance the immune response. NVX-CoV2373 is being evaluated in an ongoing Phase 3 trial in the U.K. and Australia. About Matrix-M.

Vaccine 52

Vaccine Government Immune Response Clinical Trials 52

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. and CHENGDU, China , Feb.

Vaccine 52

Vaccine Trials Virus RNA 52

The Pharma Data

NOVEMBER 14, 2020

In addition to the single-dose regimen ENSEMBLE study, Janssen has now initiated the two-dose regimen ENSEMBLE 2 trial. The ENSEMBLE and ENSEMBLE 2 trials will run in parallel. The interim analysis showed that a single dose of the COVID-19 vaccine candidate induced a robust immune response and was generally well-tolerated.

Clinical Trials 40

Clinical Trials Vaccine Trials Pharmaceutical Companies 40

The Pharma Data

FEBRUARY 22, 2021

New Phase 2 study assesses potential for refined antigen formulation to achieve optimal immune response, including in older adults. The trial will include equal numbers of adults 18 to 59 years and those 60 years and above. Results of the Phase 2 trial will inform the Phase 3 protocol. About the Phase 2 study.

Vaccine 52

Vaccine Immune Response Trials Clinical Trials 52

The Pharma Data

MARCH 9, 2021

The trial was conducted among 237 adults with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose disease progressed while on or after previous platinum-based chemotherapy and PD-(L)1 inhibitor immunotherapy 4. Two Phase III CANOPY trials continue, evaluating canakinumab in first-line and adjuvant settings 2,3.

Treatment 52

Treatment Immune Response Trials Clinical Trials 52

The Pharma Data

DECEMBER 29, 2020

As in earlier outpatient trial, immune status when patients entered the trial was a strong predictor of viral load and clinical outcomes. The analysis was prospectively designed to focus on patients who had not yet mounted their own immune response to SARS-CoV-2 (i.e., Regeneron Pharmaceuticals, Inc.

Hospitals 52

Hospitals Trials Clinical Trials Production 52

PLOS: DNA Science

OCTOBER 19, 2023

Last week DNA Science covered a setback in a clinical trial of a gene therapy for Duchenne muscular dystrophy (DMD). The two conditions and the therapeutic approaches differ, but their clinical trials illustrate the importance of selecting patients whose characteristics suggest that they are the most likely to respond.

Therapies 111

Therapies FDA Clinical Trials Disease 111

The Pharma Data

JANUARY 11, 2021

In clinical trials, it could detect COVID-19 with 90%+ accuracy in about two minutes. . By the end of January, Johnson & Johnson is expected to deliver preliminary trial results for its one-dose COVID-19 vaccine candidate. . DalCor Pharmaceuticals initiated the Phase II dal-COVID trial of dalcetrapib for COVID-19.

Vaccine 52

Vaccine Clinical Trials Immune Response Trials 52

The Pharma Data

NOVEMBER 9, 2020

Novavax expects to begin its pivotal Phase 3 clinical trial in the United States and Mexico by the end of November. Data from the event-driven trial could support global authorization and approval, including in the U.S. and globally.”. About NVX-CoV2373. and Australia.

Vaccine 52

Vaccine FDA Clinical Trials Immune Response 52

The Pharma Data

JUNE 2, 2022

” In the adult phase I/II clinical trials, AFX3772 was well tolerated in participants and demonstrated good immune responses compared to the current standard of care. Phase I/II clinical trials to assess the use of the vaccine in paediatrics are planned to begin later this year. About MAPSTM technology platform.

Vaccine 52

Vaccine Immune Response Clinical Trials Disease 52

The Pharma Data

MAY 31, 2022

In the adult phase I/II clinical trials, AFX3772 was well tolerated in participants and demonstrated good immune responses compared to the current standard of care. Phase I/II clinical trials to assess the use of the vaccine in paediatrics are planned to begin later this year. MAPS TM technology platform.

Vaccine 52

Vaccine Immune Response Clinical Trials Disease 52

The Pharma Data

NOVEMBER 30, 2020

Two of the three planned late-stage efficacy trials for NVX-CoV2373 sponsored by Novavax are fully enrolled, and more than 20,000 participants have been dosed to-date. In alignment with Novavax’ commitment to transparency, Phase 3 clinical trial protocols are posted to the company’s website at Novavax.com/resources upon finalization.

Clinical Development 52

Clinical Development Vaccine Clinical Trials Immune Response 52

The Pharma Data

MARCH 8, 2021

The trial was conducted among 237 adults with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose disease progressed while on or after previous platinum-based chemotherapy and PD-(L)1 inhibitor immunotherapy 4. Two Phase III CANOPY trials continue, evaluating canakinumab in first-line and adjuvant settings 2,3.

Immune Response 52

Immune Response Clinical Trials Trials Treatment 52

Drug Target Review

OCTOBER 26, 2023

9 In addition, host immune responses further add to the complexity of developing cell-specific AAV capsids for clinical applications. It has been well established that exposure to wild-type AAV results in priming of the immune system against the virus. Nature reviews Drug discovery 18 , 358-378 (2019). Nyberg WA, et al.

Engineering 105

Engineering Virus Therapies Immune Response 105

The Pharma Data

NOVEMBER 10, 2020

The trial is a dose-ranging, open-label study that will enroll 60 patients in the U.S. Oral administration of anti-CD3 monoclonal antibody is a novel approach to induce an anti-inflammatory immune response to suppress inflammation by inducing T regulatory (Tregs) cells in animal studies 3 ,4. NEW YORK and LONDON, Nov.

Clinical Trials 40

Clinical Trials Science Disease Trials 40

The Pharma Data

JANUARY 6, 2021

Quantitative imaging of CD8 T cells enables quicker identification of drug efficacy, therefore potentially reducing the length of clinical trials, reducing costs and helping new therapies to advance to market faster, which ultimately will improve treatment and care of cancer patients.

Licensing 52

Licensing Licensing Clinical Trials Pharmaceutical Companies 52

The Pharma Data

OCTOBER 28, 2020

Today’s data, involving an additional 524 patients from the ongoing Phase 2/3 trial, provides definitive final virology results and meets the clinical endpoint of reducing medical visits. TARRYTOWN, N.Y. , 28, 2020 /PRNewswire/ — . Regeneron has shared these results with the U.S. Regeneron Pharmaceuticals, Inc.

Virus 40

Virus Trials Clinical Trials Production 40

The Pharma Data

DECEMBER 23, 2020

Joseph Kim , President and CEO of INOVIO, said, “We are very pleased to share peer-reviewed Phase 1 clinical data for INO-4800 published in The Lancet’s EClinicalMedicine , and are grateful for the support of all participants and investigator staff involved in the clinical trial.” mg and 2.0 mg and 2.0 The 1.0

DNA 40

DNA Vaccine Clinical Trials Immune Response 40

The Pharma Data

JULY 6, 2021

In addition, the data showed that the durability of the immune response lasted through at least eight months, the length of time evaluated to date. In addition, we observe a persistent and particularly robust, durable cellular immune response,” said Mathai Mammen, M.D., 2) variants during the study period.

Vaccine 52

Vaccine Immune Response Clinical Trials Disease 52

Drug Target Review

APRIL 26, 2023

Injected nanoparticles tend to accumulate in the liver, which is why clinical trials are currently evaluating mRNA treatments for liver diseases. In 2019, they successfully created nanoparticles made of polymers that could deliver mRNA encoding a bioluminescent protein to lung cells.

RNA 98

RNA Medical Schools Engineering DNA 98

The Pharma Data

SEPTEMBER 3, 2020

The data, published today in Nature Medicine , demonstrated that the Company’s investigational adenovirus serotype 26 (Ad26) vector-based vaccine elicited an immune response as demonstrated by “neutralizing antibodies” and prevented severe clinical disease – including weight loss, pneumonia and mortality – in Syrian golden hamsters upon challenge.

Vaccine 52

Vaccine Disease Immune Response Pharmaceutical Companies 52

The Pharma Data

OCTOBER 26, 2020

Novavax will present data from an ongoing Phase I/II clinical trial, including new Phase II reactogenicity data from its COVID-19 vaccine candidate. CoV2373 on Friday during the CDC’s Advisory Committee on Immunization Practices’ (ACIP) meeting. They expect to launch a Phase III trial of the drug in the first quarter of 2021. .

Vaccine 52

Vaccine FDA Approval FDA Clinical Trials 52

The Pharma Data

NOVEMBER 1, 2020

Trial facilitated with coll a boration of Harvard Medical School and one of the world’s top Neurologist, Dr. Howard Weiner. This clinical trial will be coordinated by the team at the INTRIALS, a leading, full-service Latin America Clinical Research Organization (CRO), based in Sao Paulo City, Brazil. About Foralumab.

Clinical Trials 52

Clinical Trials Trials Medical Schools Hospitals 52

The Pharma Data

OCTOBER 9, 2021

Safety profile of deucravacitinib consistent with other trials and no new safety signals reported. Deucravacitinib has been shown to be a highly effective, first-in-class, oral, selective TYK2 inhibitor in psoriasis and we have ongoing Phase 3 trials exploring the potential of deucravacitinib in psoriatic arthritis,” said Samit Hirawat, M.D.

Disease 52

Disease Trials Science Immune Response 52

The Pharma Data

JANUARY 29, 2021

January 29, 2021 – Johnson & Johnson (NYSE: JNJ) (the Company) today announced topline efficacy and safety data from the Phase 3 ENSEMBLE clinical trial, demonstrating that the investigational single-dose COVID-19 vaccine in development at its Janssen Pharmaceutical Companies met all primary and key secondary endpoints.

Vaccine 40

Vaccine Trials Pharmaceutical Companies Clinical Trials 40

The Pharma Data

AUGUST 6, 2020

Early clinical results showed AstraZeneca’s candidate, AZD1222, triggered both antibody and T-cell immune responses. The pair just kicked off a phase 1 trial in China with the goal to enroll 144 healthy volunteers. The pair just kicked off a phase 1 trial in China with the goal to enroll 144 healthy volunteers.

Vaccine 52

Vaccine Licensing Licensing Immune Response 52

The Pharma Data

OCTOBER 26, 2020

The corticosteroid then works to relieve swelling, redness and itching by targeting the immune response that drives dry eye disease flares. . The FDA approved EYSUVIS based on the positive results from one Phase II and three Phase III trials. Dean of the University of Alabama at Birmingham School of Optometry.

Disease 52

Disease Treatment FDA FDA Approval 52

The Pharma Data

NOVEMBER 19, 2020

The findings were that the death rate in several demographics exceeded the same period in 2019. The 2019 full data is not yet publicly available, but they calculated the 2019 death estimates using 2018 CDC data and 2019 population estimates from the U.S. The data was from the U.S. Source link.

Research 52

Research Nurses Disease Immune Response 52

The Pharma Data

SEPTEMBER 10, 2021

POSEIDON Phase III trial showed the addition of a short course of tremelimumab to Imfinzi plus chemotherapy improved patient outcomes without an increase in treatment discontinuation. OS data cut-off date was 12 March 2021; PFS data cut-off date was 24 July 2019. Hazard ratio (95% CI). PFS rate at 12 months (%). months (range 0–44.5).

Treatment 52

Treatment Immune Response Trials Clinical Trials 52

The Pharma Data

MARCH 25, 2021

Regulatory submissions for TAK-003 include long-term safety and efficacy data through 36 months from the ongoing pivotal Phase 3 Tetravalent Immunization against Dengue Efficacy Study (TIDES) trial. About the Phase 3 TIDES (DEN-301) Trial. 4,5 Efficacy varied by serotype. 4 The study is comprised of five parts. About Dengue.

Vaccine 52

Vaccine Virus Trials Hospitals 52

The Pharma Data

SEPTEMBER 17, 2020

The Elecsys Anti-SARS-CoV-2 serology test can be used to quantitatively measure antibodies in people who have been exposed to the Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) and can play an important part in characterising a vaccine-induced immune response. said Thomas Schinecker, CEO Roche Diagnostics.

Vaccine 52

Vaccine Virus Clinical Trials Immune Response 52

New Drug Approvals

DECEMBER 16, 2023

3 Additionally, iptacopan has the benefit of targeting factor B, which only affect the alternative complement pathway, leaving the classic and lectin pathway untouched for the body to still mount adequate immune responses against pathogens. April 2019). 1] It is a complement factor B inhibitor that was developed by Novartis. [1]

FDA 62

FDA Small Molecule FDA Approval Treatment 62

Drug Target Review

FEBRUARY 28, 2024

Preclinical research on γδ T cells has made great strides since the cells were first identified in the 1980s, with γδ T-cell therapies from several companies, including IN8bio, now in or nearing clinical trials for various cancers. Crain’s New York Business recognised Kate as one of the top women in tech in 2019. Kalyan S, Kabelitz D.

Therapies 105

Therapies Engineering Molecular Biology Science 105

The Pharma Data

SEPTEMBER 9, 2020

producing CD8+ T cell responses, which is thought to promote an anti-viral effect. In a preclinical murine model, a single IM immunization of BNT162b2 (0.2, CD4+ and CD8+ T-cells from splenocytes isolated from BNT162b2-immunized mice were strongly positive for IFN? The study is an event-driven trial. Argentina and Brazil.

Vaccine 52

Vaccine RNA Clinical Trials Trials 52

The Pharma Data

AUGUST 11, 2020

.–( BUSINESS WIRE )– Bristol Myers Squibb (NYSE: BMY) today announced the Phase 3 CheckMate -577 trial evaluating Opdivo (nivolumab) as an adjuvant therapy for patients with resected esophageal or gastroesophageal junction (GEJ) cancer met its primary endpoint of disease-free survival (DFS) at a pre-specified interim analysis.

Therapies 52

Therapies Trials Disease Treatment 52

The Pharma Data

FEBRUARY 24, 2022

The positive opinion adopted by the CHMP is based on an evaluation of interim safety and efficacy data from a clinical trial of a booster dose of the vaccine in those aged 16 and over, together with published literature and post authorisation data plus real-world evidence from the use of booster doses in young patients in Israel.

Vaccine 52

Vaccine FDA Small Molecule Immune Response 52

The Pharma Data

OCTOBER 28, 2020

We are pursuing an accelerated approval pathway for remestemcel-L in the treatment of children with SR-aGVHD, and a parallel approval pathway for COVID-19 ARDS if the randomized controlled Phase 3 trial is positive.”. The dosing regimen in the Phase 3 is the same as in the pilot trial.

Treatment 40

Treatment Trials Production Disease 40