XTalks

AUGUST 13, 2020

and BioNTech’s lead vaccine candidate in a Phase III trial being conducted at sites in California and Oregon. The company announced that it commenced the Phase III clinical trial to evaluate the investigational COVID-19 vaccine this week. Related: Pfizer and BioNTech’s COVID-19 Vaccine Shows Positive Early Trial Results.

Vaccination 89

Vaccination Vaccine Trials Clinical Trials 89

pharmaphorum

SEPTEMBER 1, 2020

AstraZeneca has expanded development of COVID-19 vaccine AZD1222 into the US, beginning a phase 3 clinical trial across all adult age groups. The UK pharma said that the trial will recruit up to 30,000 adults aged 18 years or over to assess the safety, efficacy and immune response.

Vaccination 69

Vaccination Vaccine Trials Immune Response 69

Pharmaceutical Technology

JUNE 8, 2023

The company’s samRNA vector is based on a synthetic RNA molecule derived from a wild-type Venezuelan Equine Encephalitis Virus (VEEV) replicon with the goal of extending the duration and magnitude of immunogen expression to drive potent and durable immune responses. GlobalData is the parent company of Clinical Trials Arena.

Vaccination 130

Vaccination Vaccine Immune Response Allergies 130

Scienmag

DECEMBER 9, 2020

Phase 2 trials in 1,200 adults, young children, and infants suggest new poliovirus vaccine may have the potential to overcome outbreaks caused by a mutated polio strain linked to the oral vaccine that typically circulates in areas of low immunisation coverage, and poses one of biggest barriers to eradication.

Immune Response 75

Immune Response Vaccination Vaccine Scientist 75

Delveinsight

AUGUST 6, 2020

Zydus starts phase 2 COVID-19 vaccine trial after clearing safety test. Zydus Cadila has finished a phase 1 clinical trial of its COVID-19 vaccine ZyCoV-D, setting it up to move straight into a 1,000-subject phase 2 study. By ordering human cells to make the protein, ZyCoV-D could cause an immune response against the coronavirus.

Allergies 53

Allergies Vaccination Vaccine Gene Therapy 53

Scienmag

NOVEMBER 17, 2020

Phase 1/2 randomised controlled trial of an inactivated SARS-CoV-2 vaccine candidate (CoronaVac) involved more than 700 healthy volunteers aged 18-59 years recruited in China between 16 April and 5 May 2020 Phase 1/2 randomised controlled trial of an inactivated SARS-CoV-2 vaccine candidate (CoronaVac) involved more than 700 healthy volunteers aged (..)

Immune Response 70

Immune Response Vaccination Vaccine Trials 70

The Pharma Data

SEPTEMBER 1, 2020

AstraZeneca has started a Phase 3 trial of its experimental coronavirus vaccines in the US, making it the third company to start late-stage trials of a vaccine. . The trial will see participants receive either two doses of the vaccine or a placebo. Photo by Daniel Paquet from Regina, Canada. Conor Kavanagh. Source link.

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Vaccination Vaccine Trials Immune Response 52

Scienmag

OCTOBER 15, 2020

Phase 1/2 randomised controlled trial of an inactivated SARS-CoV-2 vaccine candidate was carried out in China between 29 April and 30 July 2020 and involved more than 600 healthy volunteers.

Immune Response 52

Immune Response Vaccination Vaccine Clinical Trials 52

XTalks

SEPTEMBER 21, 2023

announced that the first participant has been dosed in a new Phase I trial for an innovative HIV vaccine candidate, VIR-1388. The trial’s primary objective is to assess the safety of VIR-1388 and its capacity to stimulate a specific immune response against HIV in study participants. Vir Biotechnology, Inc.,

Vaccination 59

Vaccination Vaccine Trials Clinical Trials 59

Scienmag

FEBRUARY 19, 2021

Preclinical tests at UAB last year showed potent systemic and mucosal immune responses in mice after a single intranasal dose. The vaccine candidate was developed by Maryland-based Altimmune Inc. Credit: UAB BIRMINGHAM, Ala. – The Altimmune Inc.

Clinical Trials 52

Clinical Trials Clinical Trials Vaccination Vaccine 52

XTalks

JANUARY 20, 2021

Researchers at KU Leuven in Belgium have found a potential mechanism underlying irritable bowel syndrome (IBS) that involves activation of immune cells primed by past gastrointestinal infections. However, IBS patients do not have allergies to any given foods, nor any gastrointestinal conditions, such as celiac disease.

Immune Response 52

Immune Response Research Allergies Protein 52

The Pharma Data

APRIL 3, 2021

Johnson & Johnson (the Company) has begun vaccinating adolescent participants in the ongoing Phase 2a clinical trial for its COVID-19 vaccine candidate, developed by the Janssen Pharmaceutical Companies of Johnson & Johnson. Vice Chairman of the Executive Committee and Chief Scientific Officer at Johnson & Johnson.

Clinical Trials 52

Clinical Trials Clinical Trials Vaccination Vaccine 52

Delveinsight

AUGUST 27, 2020

Moderna’s COVID-19 vaccine triggers an immune response in older adults. The phase 1 study that is being run by the National Institute of Allergy and Infectious Diseases tests three dose levels of the vaccine, mRNA-1273, given in two injections a month apart in 120 adults.

Vaccination 53

Vaccination Vaccine Research Trials 53

Pfizer

JULY 26, 2022

(NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced that the companies have initiated a randomized, active-controlled, observer-blind, Phase 2 study to evaluate the safety, tolerability, and immune response of an enhanced COVID-19 mRNA-based vaccine candidate at a 30 µg dose level. IMPORTANT SAFETY INFORMATION . has a fever.

Vaccination 111

Vaccination Vaccine Protein Immune Response 111

The Pharma Data

JUNE 25, 2021

efficacy overall, and met the primary endpoint in its PREVENT-19 pivotal Phase 3 trial. Our vaccine will be a critical part of the solution to COVID-19 and we are grateful to the study participants and trial staff who made this study possible, as well as our supporters, including the U.S. Government.” About PREVENT-19.

Vaccination 40

Vaccination Vaccine Trials Immune Response 40

The Pharma Data

NOVEMBER 9, 2020

Trial Also Met the Primary Endpoint in Patients With Low Levels of Eosinophils. In the subgroup of patients with baseline eosinophil counts less than 300 cells per microliter, the trial met the primary endpoint with tezepelumab demonstrating a statistically significant and clinically meaningful reduction in AAER.

Trials 52

Trials Production Sales Manufacturing 52

The Pharma Data

SEPTEMBER 8, 2021

The Phase 3 PEGASUS trial evaluating rilzabrutinib to treat pemphigus, a rare autoimmune skin condition, did not meet its primary or key secondary endpoints. The Phase 3 study, which is the first placebo-controlled trial of a BTK inhibitor in pemphigus, enrolled adult patients with moderate-to-severe pemphigus vulgaris or pemphigus foliaceus.

Trials 52

Trials Immune Response Allergies Clinical Trials 52

The Pharma Data

DECEMBER 21, 2020

21, 2020 /PRNewswire/ — Amgen (NASDAQ:AMGN) and AstraZeneca today announced the SOURCE trial did not meet the primary endpoint of a statistically significant reduction in the daily oral corticosteroid (OCS) dose, without loss of asthma control, with tezepelumab compared to placebo. THOUSAND OAKS, Calif. ,

Trials 40

Trials Production Sales Manufacturing 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 Vaccination Vaccine Immune Response 40

Pfizer

JULY 19, 2022

The companies’ previously announced safety, tolerability and immunogenicity data from a Phase 2/3 trial that found a 30 µg booster dose of the Omicron-adapted bivalent vaccine candidate elicited a superior immune response against Omicron BA.1 is immunocompromised or are on a medicine that affects the immune system.

Vaccination 100

Vaccination Vaccine Medicine Clinical Trials 100

Pfizer

JULY 8, 2022

The submission included data from a Phase 2/3 randomized, controlled trial that included 4,526 children 6 months to less than 5 years of age. In the trial, children received the third 3-µg dose at least two months after the second dose at a time when Omicron was the predominant variant. About the Phase 1/2/3 Trial in Children.

Vaccination 81

Vaccination Vaccine Clinical Trials Clinical Trials 81

Pfizer

JULY 8, 2022

Favorable safety profile observed across more than 2,200 adolescents who participated in the clinical trial. Today’s approval is based on data from a Phase 3 clinical trial of 2,260 participants 12 through 15 years of age. Tell your vaccination provider about all of your medical conditions, including if you: have any allergies.

FDA Approval 102

FDA Approval Vaccination Vaccine Clinical Trials 102

The Pharma Data

NOVEMBER 17, 2020

The Company is thereby partnering with leading academic institutions to explore and select the best SARS-CoV antigens incorporated into virosome particles, while optimizing the route of administration and thermostability of the vaccine, before moving into human clinical trials. For further information, please visit www.mymetics.com.

Vaccination 40

Vaccination Vaccine Containment Development 40

Pharmaceutical Technology

FEBRUARY 3, 2023

Only a few weeks into the new year, the prospect of getting a successful advanced HIV vaccine shrank after the discontinuation of yet another late-stage trial. This marks the second time one of Janssen’s HIV vaccines failed after another showed disappointing results in the Phase IIb Imbokodo trial in August 2021.

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Vaccination Vaccine Antibody Trials 293

Scienmag

NOVEMBER 12, 2020

Inhaled delivery of a formulation of a key protein involved in the immune response – interferon beta-1a – to hospitalised COVID-19 patients in the UK reduced the odds that they would develop severe disease or die from SARS CoV-2 infection.

Immune Response 75

Immune Response Protein Clinical Trials Clinical Trials 75

Scienmag

JUNE 27, 2021

The first human trial has shown no obvious side effects and a good immune response. Hiroshi Kiyono, CC BY 4.0 A new vaccine to protect against deadly cholera has been made by grinding up genetically modified grains of rice. Researchers based […].

Vaccination 72

Vaccination Vaccine Immune Response Trials 72

XTalks

NOVEMBER 30, 2023

The safety and efficacy of Cabenuva were established through two randomized, open-label, controlled clinical trials involving 1,182 HIV-infected adults who were virologically suppressed (HIV-1 RNA less than 50 copies/mL) before initiating Cabenuva treatment. The Phase I trial for HB-500 is scheduled to start in the first half of 2024.

FDA Approval 111

FDA Approval Gene Therapy Gene Clinical Trials 111

pharmaphorum

JULY 12, 2022

Researchers in the US have started a clinical trial of a vaccine against Nipah virus, a serious infection caught from animals that has a fatality rate of between 40% and 70%, developed by mRNA specialist Moderna. The post NIH starts trial of Moderna’s mRNA Nipah virus vaccine appeared first on.

Vaccination 52

Vaccination Vaccine Trials Immune Response 52

XTalks

MAY 17, 2024

Led by the National Institutes of Health’s National Institute of Allergy and Infectious Diseases (NIAID), World AIDS Vaccine Day emphasizes the importance of awareness and education in the fight against HIV/AIDS. HIV Vaccine Clinical Trials on the Watch: Past and Present Several promising clinical trials with HIV vaccines have been underway.

Vaccination 52

Vaccination Vaccine Research Immune Response 52

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.

Vaccination 52

Vaccination Vaccine Immune Response Antibody 52

The Pharma Data

JULY 8, 2021

8) There were no clinically meaningful differences in safety results between the tezepelumab and placebo groups in the NAVIGATOR trial.(8) 8) There were no clinically meaningful differences in safety results between the tezepelumab and placebo groups in the NAVIGATOR trial.(8)

Allergies 52

Allergies Trials In-Vivo Medicine 52

XTalks

NOVEMBER 5, 2024

Its lead candidate, PL-14, targets nasal allergies and is scheduled for US Food and Drug Administration (FDA) submission via the 510(k) pathway, with preclinical trials expected to start in the second quarter of 2025 and pivotal trials by the end of 2025. Polyrizon’s partnerships further strengthen its R&D capabilities.

Drug Delivery 111

Drug Delivery Drugs Immune Response Allergies 111

The Pharma Data

JULY 8, 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.

Vaccination 52

Vaccination Vaccine Immune Response Antibody 52

pharmaphorum

SEPTEMBER 29, 2022

The disorder – driven by type 2 inflammation characterised by an antibody-based immune response – causes hard lumps or nodules to form on the skin that are so itchy they can lead patients to scratch themselves to the point of bleeding or pain. The suffering he notes from the #itch is 100… [link]. — Brian S.

Drugs 69

Drugs Immune Response Allergies Sales 69

Pfizer

NOVEMBER 2, 2022

(NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced the advancement of an mRNA-based combination vaccine candidate for influenza and COVID-19 to a Phase 1 trial with the aim to address two severe respiratory diseases with one vaccine. are immunocompromised or are on a medicine that affects the immune system. have a fever.

Vaccination 85

Vaccination Vaccine Clinical Trials Clinical Trials 85

The Pharma Data

JANUARY 17, 2021

The NDA was built on data from the Phase III VICTORIA trial. The NDA was supported by results from two pivotal trials, Phase III AURORA and Phase II AURA-LV. By inhibiting calcineurin, the drug blocks IL-2 expression and T-cell mediated immune responses. HFrEF was formerly known as systolic heart failure.

Manufacturing 52

Manufacturing Immune Response Allergies Drugs 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.

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Vaccination Vaccine Trials Development 40