Drug Target Review

JUNE 9, 2023

This exclusive interview with Dr Sharon Benzeno, Chief Commercial Officer, Immune Medicine at Adaptive Biotechnologies, unveils some ground-breaking research on T- cell therapy for cancer , which has seen the first TCR-based therapeutic candidate progress to clinical development, offering promising advancements in innovative cancer treatments.

Treatment

Drug Target Review

NOVEMBER 17, 2023

NK cells are among the front line of protection from infected and abnormal cells as part of the ‘innate immune response’. They recognise ‘cell stress molecules’ on the surface of infected, old, injured and cancerous cells without the need for complex pre-stimulation signals of the adaptive immune system (eg, T cells).

Therapies

The Pharma Data

SEPTEMBER 25, 2020

The data demonstrate that a single dose of JNJ-78436735 induced a strong neutralizing antibody response in nearly all participants aged 18 years and older and was generally well-tolerated. Immune responses were similar across the age groups studied, including older adults. Immune Response Data.

Clinical Trials

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 contains purified protein antigen and can neither replicate, nor can it cause COVID-19. About Novavax.

Vaccine

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. GSK’s response to COVID-19 has been one of the broadest in the industry, with two potential treatments in addition to our vaccine candidates in development. GSK commitment to tackling COVID-19.

Vaccine

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

The Pharma Data

JUNE 24, 2021

Secondary objectives are to describe immune responses produced by each of the vaccines. Food and Drug Administration (FDA), but has been authorized for emergency use by FDA under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) for use in individuals 12 years of age and older. The Pfizer?BioNTech

Vaccine

The Pharma Data

AUGUST 16, 2021

Food and Drug Administration (FDA), but has been authorized for emergency use by FDA under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) for use in individuals 12 years of age and older.

Vaccine

The Pharma Data

NOVEMBER 9, 2020

NVX-CoV2373 was created using Novavax’ recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and contains Novavax’ patented saponin-based Matrix-M adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies.

Vaccine

The Pharma Data

OCTOBER 19, 2020

Immune responses following vaccination with PNEUMOVAX 23 (month 13) were comparable in both vaccination groups for the 15 serotypes in V114. Results from both studies are based on opsonophagocytic activity (OPA) responses – a measure of vaccine-induced functional antibodies.

Vaccine

The Pharma Data

JANUARY 6, 2021

The alliance, announced on October 14, 2019 , has assisted in advancing the 89Zr CD8 Immuno-PET technology. CD8 T cells are the main effector cells involved in the immune response against tumor cells induced by immunotherapies and they also play a key role in multiple autoimmune diseases.

Licensing

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. . in January 2019 and is similar to EYSUVIS except at a higher 1% concentration of LE for post-surgery, versus.25% INVELTYS launched in the U.S. 25% for dry eye disease treatment.

Treatment

The Pharma Data

AUGUST 6, 2020

Early clinical results showed AstraZeneca’s candidate, AZD1222, triggered both antibody and T-cell immune responses. Clover Biopharmaceuticals has an S-Trimer subunit vaccine candidate, SCB-2019 , which is being evaluated with two adjuvant systems by GlaxoSmithKline and Dynavax in phase 1 study, with results expected this month.

Vaccine

PLOS: DNA Science

OCTOBER 19, 2023

The disease may develop in response to an environmental factor, such as repeated head injuries. One widely-quoted study that investigated nearly 20,000 professional football players who had participated in at least one game between 1960 and 2019 revealed a four-fold elevated risk of developing ALS compared to the general population.

Therapies

Drug Target Review

FEBRUARY 28, 2024

Crain’s New York Business recognised Kate as one of the top women in tech in 2019. gammadelta T cells link innate and adaptive immune responses. She helped lead Curadigm’s spin-out from Nanobiotix and developed collaborations and partnerships around a novel platform to increase therapeutic bioavailability. Kalyan S, Kabelitz D.

Therapies

The Pharma Data

NOVEMBER 30, 2020

NVX-CoV2373 was created using Novavax’ recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein adjuvanted with Novavax’ patented saponin-based Matrix-M to enhance the immune response and stimulate high levels of neutralizing antibodies.

Clinical Development

The Pharma Data

JULY 23, 2021

Food and Drug Administration (FDA), but has been authorized for emergency use by FDA under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) for use in individuals 12 years of age and older. AUTHORIZED USE IN THE U.S.:

Vaccine

The Pharma Data

DECEMBER 23, 2020

All 38 subjects who were evaluable for immunogenicity had balanced cellular and humoral immune responses following the second dose of INO-4800. The antigen is processed naturally in the cell and triggers the desired T cell and antibody-mediated immune responses. About INOVIO.

DNA

The Pharma Data

OCTOBER 9, 2021

Due to the innovative design of deucravacitinib, Bristol Myers Squibb earned recognition with the 2019 Thomas Alva Edison Patent Award for the science underpinning the clinical development of deucravacitinib. At therapeutic doses, deucravacitinib does not inhibit JAK1, JAK2 or JAK3. Deucravacitinib is not approved for use in any country.

Disease

The Pharma Data

JULY 6, 2021

Sanofi has final development and commercialization rights in North America and all other regions in the world excluding the Sobi territory and has manufacturing responsibility for Eloctate/Elocta and Alprolix. BTK is involved in innate and adaptive immune responses and is a signaling molecule in immune mediated diseases.

Therapies

The Pharma Data

JUNE 24, 2021

Food and Drug Administration (FDA), but has been authorized for emergency use by FDA under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) for use in individuals 12 years of age and older. AUTHORIZED USE IN THE U.S.: The Pfizer?BioNTech

Vaccine

The Pharma Data

JANUARY 31, 2021

Clover’s S-Trimer antigen adjuvanted with CpG 1018 plus alum demonstrated low reactogenicity while providing high levels of neutralizing antibodies and a strong Th1-biased cell-mediated immune response. Dynavax developed CpG 1018 to provide an increased vaccine immune response, which has been demonstrated in HEPLISAV-B.

Vaccine

The Pharma Data

FEBRUARY 24, 2022

The Committee considered that the available evidence was sufficient to conclude that the immune response to a booster dose in adolescents would be at least equal to that in adults. No new safety concerns were identified from the data available.

Vaccine

The Pharma Data

NOVEMBER 10, 2020

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. Crohn’s & Colitis 360, Volume 1, Issue 2, July 2019, otz009. Weiner, H. Korzenik, J. and Snapper, S.

Clinical Trials

The Pharma Data

NOVEMBER 14, 2020

The interim analysis showed that a single dose of the COVID-19 vaccine candidate induced a robust immune response and was generally well-tolerated. PHASE 3 ENSEMBLE 2 STUDY.

Clinical Trials

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?

Vaccine

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

The Pharma Data

AUGUST 20, 2020

T cell immune responses elicited by BNT162b2 are being evaluated in the German study and the companies expect to submit the data for peer review and potential publication. trial and we look forward to sharing T cell immune response data from the German trial in the near future.”. “It View the full release here: [link].

Vaccine

The Pharma Data

DECEMBER 11, 2020

The Phase 3 trial is designed as a 1:1 vaccine candidate to placebo, randomized, observer-blinded study to obtain safety, immune response, and efficacy data needed for regulatory review. A breakdown of the diversity of clinical trial participants can be found here from more than 150 clinical trial sites in the U.S.,

Vaccine

The Pharma Data

OCTOBER 14, 2020

(Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced that the first participant was enrolled in the observational PRECISION study (TNX-C002), to examine the immune responses to COVID-19 in healthy volunteers who have recovered from COVID-19 or were asymptomatic.

Vaccine

The Pharma Data

MAY 7, 2021

Food and Drug Administration (FDA), but has been authorized for emergency use by FDA under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) for use in individuals 16 years of age and older. The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S. AUTHORIZED USE IN THE U.S.:

Licensing

The Pharma Data

OCTOBER 28, 2020

“We continue to see the strongest effects in patients who are most at risk for poor outcomes due to high viral load, ineffective antibody immune response at baseline, or pre-existing risk factors. Yancopoulos , M.D., President and Chief Scientific Officer of Regeneron. Regeneron has shared these results with the U.S.

Virus

The Pharma Data

JULY 21, 2021

Food and Drug Administration (FDA), but has been authorized for emergency use by FDA under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) for use in individuals 12 years of age and older. AUTHORIZED USE IN THE U.S.:

Vaccine

The Pharma Data

MAY 6, 2021

Food and Drug Administration (FDA), but has been authorized for emergency use by FDA under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) for use in individuals 16 years of age and older. The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S. AUTHORIZED USE IN THE U.S.:

Vaccine

The Pharma Data

SEPTEMBER 9, 2020

During preclinical and clinical studies, BNT162b1 and BNT162b2 emerged as strong candidates based on assessments of safety and immune response. Food and Drug Administration (FDA), based on preliminary data from Phase 1/2 studies that are currently ongoing in the U.S. and Germany as well as animal immunogenicity studies.

Vaccine

The Pharma Data

NOVEMBER 9, 2020

Specifically, tezepelumab targets and blocks TSLP, a key epithelial cytokine that sits at the top of multiple inflammatory cascades and initiates an overreactive immune response to allergic, eosinophilic and other types of airway inflammation associated with severe asthma. 2019 May 23;380(21):2082]. Front Immunol. N Engl J Med.

Trials

The Pharma Data

DECEMBER 17, 2020

Securities and Exchange Commission, including its Form 10-K for the year ended December 31, 2019 and its Form 10-Q for the quarterly period ended September 30, 2020. Senior Vice President and Head of Global Clinical Development at Regeneron and lead author of the publication.

Hospitals