The Pharma Data

DECEMBER 3, 2020

Strong Th1 cell-mediated immune responses were also observed for the vaccine candidates with either adjuvant. We are encouraged by the high level of neutralizing antibodies in combination with the strong Th1 response which we believe could play an important role in controlling infection.

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DECEMBER 7, 2023

Researchers from the Laboratory of Bacteriology at The Rockefeller University have now found that bacteria sense phages by a defensive response named CBASS (cyclic oligonucleotide-based antiphage signalling system) which detects viral RNA. In bacteria , cGAS-like cyclases are central parts of the CBASS immune response.

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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. The company will work with Medsafe, New Zealand’s regulatory agency, to obtain product approvals as needed.

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The Pharma Data

SEPTEMBER 3, 2020

S, prevented severe clinical disease in Syrian golden hamsters, upon challenge with SARS-CoV-2, the virus that causes COVID-19 in people. Four weeks later, the animals were exposed to a high dose of SARS-CoV-2 virus. Janssen’s lead SARS-CoV-2 investigational vaccine candidate, Ad26.COV2.S, Mortalities were absent in vaccinated animals.

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Drug Target Review

DECEMBER 5, 2024

However, the production process of fully assembled rAAV particles generates by-products and requires thorough characterisation to ensure efficacy while minimising the potential for immunogenicity and off-target effects. Therefore, vectors based on these serotypes may enable targeted gene delivery and optimal transduction efficiency.

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The Pharma Data

AUGUST 16, 2021

Still, with the continuing threat of the Delta variant and possible emergence of other variants in the future, we must remain vigilant against this highly contagious virus,” said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. We continuously strive to stay at least one step ahead of the virus.

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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.

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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. Trimer-Tag© is an innovative drug development platform which allows the production of novel, covalently-trimerized fusion proteins. About Dynavax.

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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. In the overall patient group with detectable virus at baseline, the average daily reduction in viral load through day 7 was a 0.36

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The Pharma Data

DECEMBER 10, 2020

In the study, immunization with the hAd5-COVID-19 vaccine inhibited SARS-CoV-2 virus replication in 100% (10 of 10) of Rhesus macaques, with a drop in viral replication starting on the first day of vaccine administration, and undetectable viral levels as early as three to five days post-challenge in most of the animals.

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The Pharma Data

JANUARY 31, 2021

Clover expects to produce hundreds of millions of vaccine doses in 2021 and up to 1 billion vaccine doses in peak annual production as required by global demand. Similar to other enveloped RNA viruses such as HIV, RSV and Influenza, SARS-CoV-2 is also an RNA virus that has a trimeric spike (S) protein on its viral envelope.

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The Pharma Data

NOVEMBER 9, 2020

NVX-CoV2373 is a vaccine candidate engineered from the genetic sequence of SARS-CoV-2, the virus that causes COVID-19 disease. In preclinical trials, NVX-CoV2373 demonstrated induction of antibodies that block binding of spike protein to receptors targeted by the virus, a critical aspect for effective vaccine protection.

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The Pharma Data

JUNE 26, 2021

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. Th e first clinical trial of a seasonal mRNA flu vaccine candidate is an exciting milestone in our quest for the next generation of inf lu enza vaccines.

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The Pharma Data

AUGUST 28, 2020

There are also plans to strengthen the Medicines and Healthcare products Regulatory Agency (MHRA)’s powers to roll out an unlicensed vaccine rapidly if one becomes available before the new year. Oxford coronavirus vaccine triggers immune response. UK signs deals for 90 million virus vaccine doses.

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The Pharma Data

NOVEMBER 30, 2020

Therefore, the Company has been working closely with the FDA to complete trial-initiation gating activities related to its commercial-scale production at FUJIFILM Diosynth Biotechnologies in Research Triangle Park, North Carolina. Novavax will use vaccine material produced at commercial scale for this trial. Novavax was awarded $1.6

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The Pharma Data

MARCH 11, 2021

Clinical trial to assess safety, immune response and reactogenicity, after preclinical data showed high neutralizing antibody levels. Efforts are also underway to enable the product to be stable at routine refrigerator temperature (2-8°C). Expected to enroll 415 participants; interim results expected in Q3 2021.

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The Pharma Data

JANUARY 18, 2021

Next Generation AAVs enhance gene therapies by increasing transduction efficiency and specificity while reducing immune responses and cost. Use of AAVnerGene capsid library provided to Neurophth for ophthalmic gene therapy. WUHAN, China and NEWARK, DE. , a subsidiary of Wuhan Neurophth Biotechnology Ltd.

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The Pharma Data

JANUARY 22, 2021

This allows the vaccine to pass through hostile conditions in the stomach without loss of efficacy and provides long-term product stability at ambient temperatures. Novavax’s vaccine is a recombinant protein vaccine adjuvanted with Novavax’s nanoparticle technology, Matrix-M, which enhances immune response in recipients.

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The Pharma Data

JANUARY 13, 2021

The vaccine produced an immune response of all 805 clinical trial participants within two months of inoculation, according to results published Jan. The new vaccine is made up of a deactivated cold virus into which scientists cut-and-paste a genetic version of the “spike” protein used by the coronavirus to infect cells.

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The Pharma Data

DECEMBER 17, 2020

About casirivimab and imdevimab Casirivimab and imdevimab (formerly known as REGN-COV2 or REGEN-COV2) is a cocktail of two monoclonal antibodies (also known as REGN10933 and REGN10987, respectively) and was designed specifically to block infectivity of SARS-CoV-2, the virus that causes COVID-19.

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The Pharma Data

AUGUST 22, 2021

Many of the elderly patients who survived the virus were poor: not exactly the demographic you would expect to fare well in a health crisis. One of the most dangerous phenomena COVID-19 can trigger in your body is something called a cytokine storm, which is a potentially fatal amplification of an immune response.

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The Pharma Data

DECEMBER 28, 2020

Orphan drug status is intended to facilitate drug development for rare diseases and may provide several benefits to drug developers, including tax credits for qualified clinical trials costs, exemptions from certain FDA application fees, and seven years of market exclusivity upon regulatory product approval. . HOUSTON , Dec.

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The Pharma Data

JANUARY 31, 2021

Delivery of viral antigens in potent vaccine vectors to elicit a strong immune response is a cornerstone of successful infectious disease vaccines,” said Karin Jooss, PhD, Executive Vice President of Research and Chief Scientific Officer of Gritstone. This press release features multimedia. View the full release here: [link].

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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. About TNX-1800.

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The Pharma Data

APRIL 22, 2023

According to Kirimanjeswara, the spike protein of the SARS-CoV-2 virus is under heavy selection pressure, which can result in mutations that drive the emergence of new variants. These epitopes elicit an immune response from a broad selection of T cells, ensuring a sustained coverage of future variants.

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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. Janssen will aim to enroll participants in Belgium, Colombia, France, Germany, the Philippines, South Africa, Spain, the United Kingdom and the United States.

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The Pharma Data

JUNE 24, 2021

This follows the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) positive opinion to authorize the vaccine in this age group. Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to the Pfizer?BioNTech The Pfizer?BioNTech

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The Pharma Data

SEPTEMBER 9, 2020

(NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced preliminary preclinical data in mouse and non-human primate models from their BNT162b2 mRNA-based vaccine program against SARS-CoV-2, the virus that causes COVID-19 disease. producing CD8+ T cell responses, which is thought to promote an anti-viral effect.

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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.

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The Pharma Data

MAY 7, 2021

The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical product under Section 564 (b) (1) of the FD&C Act unless the declaration is terminated or authorization revoked sooner.

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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. BNT162b2 encodes an optimized SARS-CoV-2 full-length spike glycoprotein (S), which is the target of virus neutralizing antibodies. and Germany as well as animal immunogenicity studies.

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The Pharma Data

OCTOBER 21, 2020

Replimune is developing novel, proprietary therapeutics intended to improve the direct cancer-killing effects of selective virus replication and the potency of the immune response to the tumor antigens released. About Replimune Replimune Group, Inc.,

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The Pharma Data

JULY 21, 2021

At full operational capacity, the annual production will exceed 100 million finished doses annually. This is why we will continue to evaluate sustainable approaches that will support the development and production of mRNA vaccines on the African continent.”. “We Procedures should be in place to avoid injury from fainting.

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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.”. This press release features multimedia.

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The Pharma Data

MAY 6, 2021

The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical product under Section 564 (b) (1) of the FD&C Act unless the declaration is terminated or authorization revoked sooner.

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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. The study also will explore prevention of infection by SARS-CoV-2, the virus that causes COVID-19.

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The Pharma Data

DECEMBER 21, 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.

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