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. “This trial will help us understand if we can use prototype and variant vaccines alone or together to shift immune responses to cover existing and emerging COVID-19 variants.”

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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.

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Clinical Trials Clinical Trials Vaccine Vaccination 52

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.”.

Immune Response 52

Immune Response Medicine Vaccine Vaccination 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 Vaccine Vaccination Clinical Trials 52

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. of these are in the pre-clinical stage.

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Vaccine Vaccination Immune Response Allergies 130

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. FDA turns back peanut allergy patch of DBV Technologies. The agency raised no safety concerns.

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Allergies Vaccine Vaccination Gene Therapy 53

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

Scienmag

NOVEMBER 18, 2020

Older adults are at a disproportionate risk of severe COVID-19 disease, so it is essential that any vaccine adopted for use against SARS-CoV-2 is effective in this group Peer-reviewed / Randomised Controlled Trial / People **There will be a UK Science Media Centre briefing at 10.15am UK time on Thursday 19th November about this study. […].

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Immune Response Vaccine Vaccination Trials 74

XTalks

AUGUST 13, 2020

As the rush for a COVID-19 vaccine continues, healthcare services company Kaiser Permanente has joined in on the clinical testing of Pfizer Inc. and BioNTech’s lead vaccine candidate in a Phase III trial being conducted at sites in California and Oregon. Kaiser began Phase III trials of the vaccine at the end of July.

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Vaccine Vaccination Trials Clinical Trials 67

XTalks

SEPTEMBER 21, 2023

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. This groundbreaking endeavor has received support from the National Institute of Allergy and Infectious Diseases (NIAID).

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Vaccine Vaccination Trials Clinical Trials 59

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.

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FDA Approval Gene Therapy Clinical Trials Gene 110

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.

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Vaccine Vaccination Trials Immune Response 69

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 (..)

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Immune Response Vaccine Vaccination Trials 70

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 […].

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Vaccine Vaccination Immune Response Trials 72

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 need for a preventive Nipah virus vaccine is significant,” he added. .

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Vaccine Vaccination Trials Immune Response 52

The Pharma Data

DECEMBER 23, 2020

Additionally, Phase 1 clinical data found INO-4800 to have a favorable safety and tolerability profile with no serious adverse events reported; only six Grade 1 adverse events (AEs) were observed, primarily minor injection site reactions. ” Findings from the Phase 1 Clinical Trial. mg and 2.0

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DNA Vaccination Vaccine Immune Response 40

Delveinsight

JANUARY 21, 2021

Vera Therapeutics bags USD 80 Million for trials. Vera Therapeutics has raised USD 80 million to take a drug licensed from Merck KGaA into a phase 2b kidney disease clinical trial. The drug, atacicept, has flunked multiple autoimmune clinical trials, but Vera contemplates that it is a prospect in IgA nephropathy.

Research 52

Research Protein Clinical Trials Clinical Trials 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.

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Vaccine Vaccination Immune Response Antibody 52

Scienmag

MAY 13, 2021

The new […].

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Immune Response Antibody Protein Vaccine 53

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.

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Vaccine Vaccination Immune Response Antibody 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.

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Antibody Vaccine Vaccination Manufacturing 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.

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Vaccine Vaccination Research Trials 53

The Pharma Data

SEPTEMBER 8, 2021

The BTK enzyme plays a key role in a number of immune processes including B cell expansion, production of immunoglobulins, and activation of innate cells such as mast cells, eosinophils, and basophils. BTK is an intracellular signaling molecule involved in innate and adaptive immune responses involved in certain immune-mediated diseases.

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Trials Immune Response Allergies Clinical Trials 52

Bioengineer

JULY 15, 2021

. “We’re excited–with such low doses of radiation, we didn’t expect the response to be so positive,” said lead author Ravi Patel, M.D., “In clinical trials, we tend to go with the maximum tolerable dose, the idea being that radiation kills the cancer and the more we give, the better.

Medicine 52

Medicine Clinical Trials Clinical Trials Scientist 52

The Pharma Data

JUNE 25, 2021

government, including the Department of Defense, the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Novavax is conducting late-stage clinical trials for NVX-CoV2373, its vaccine candidate against SARS-CoV-2, the virus that causes COVID-19.

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Vaccine Vaccination Trials Immune Response 40

Pfizer

NOVEMBER 2, 2022

The influenza virus is subject to constant mutations to evade the host immune response, causing a seasonal variation in circulating strains. Tell your vaccination provider about all of your medical conditions, including if you: have any allergies. are immunocompromised or are on a medicine that affects the immune system.

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Vaccine Vaccination Clinical Trials Clinical Trials 85

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.

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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.

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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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Vaccine Vaccination Trials Development 40

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.

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Clinical Trials Clinical Trials Vaccine Vaccination 52

The Pharma Data

APRIL 28, 2021

Additional analyses evaluated response rates across a broad population, and the impact of Dupixent on disease extent and severity, quality of life (QoL), and itch. The use of dupilumab in these settings is currently under clinical investigation and its safety and efficacy have not been fully evaluated by any regulatory authority.

Dermatology 40

Dermatology Trials Clinical Trials Clinical Trials 40

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. are immunocompromised or are on a medicine that affects the immune system. have a fever.

FDA Approval 102

FDA Approval Vaccine Vaccination Clinical Trials 102

Pfizer

JULY 8, 2022

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. Following a third dose in this age group , the vaccine was found to elicit a strong immune response, with a favorable safety profile similar to placebo. has a fever.

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Vaccine Vaccination Clinical Trials Clinical Trials 81

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.

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Vaccine Vaccination Medicine Clinical Trials 100

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.

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Vaccine Vaccination Research Immune Response 52

pharmaphorum

JULY 26, 2022

Earlier this year , the US National Institute of Allergy and Infectious Disease (NIAID), announced that it had begun a phase 1 clinical trial evaluating three mRNA vaccines against HIV that were developed alongside Moderna.

Gene Therapy 140

Gene Therapy Protein Vaccination Vaccine 140

The Pharma Data

APRIL 27, 2021

reflecting increased competition partially offset by demand growth partly related to clinical trial supply and price upside in Europe. to €24 million, primarily due to the COVID-19 pandemic, which has led to a decrease in infused immune reconstitution therapies such as Lemtrada ®. Aubagio ® sales decreased 1.1% Change at CER.

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Sales Vaccination Vaccine Medicine 52