Drug Discovery World

FEBRUARY 19, 2024

At all assessed doses, RBI-4000 was well-tolerated and achieved a strong immune response, with protective virus-neutralising antibody titers above the World Health Organization (WHO)-defined immune surrogate level of protection against the rabies virus.

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pharmaphorum

JULY 26, 2021

The test – originally developed by US manufacturer Chembio Diagnostics – has been introduced into the UK and Irish markets by Guilford-based Luas Diagnostics and tests for the presence of SARS-CoV-2-targeting antibodies in the blood.

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Pharmaceutical Technology

DECEMBER 6, 2022

In the partnership’s discovery phase, RAVEN, an artificial intelligence (AI) platform of Evaxion will be leveraged for designing a next-generation vaccine candidate that induces cellular as well as humoral/antibody responses. Using ExpreS 2 ion’s ExpreS2 platform, the company will manufacture the antigen constructs obtained from RAVEN.

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XTalks

AUGUST 14, 2023

The Janssen Pharmaceutical Companies of Johnson & Johnson announced that its bispecific antibody Talvey (talquetamab-tgvs) received US Food and Drug Administration (FDA) approval as a fifth-line treatment for adult patients with heavily pretreated multiple myeloma. Results were similar at the higher 0.8 mg/kg dose with an ORR of 73.6

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Pharmaceutical Technology

MAY 2, 2023

IO agents include the classes of immune checkpoint modulators, cell therapies, bispecific antibodies, oncolytic viruses, therapeutic vaccines, and cytokines. Marketed bispecific antibodies are largely bispecific T-cell engagers (BiTEs), which work by directing T-cells to antigen-expressing tumour cells.

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The Pharma Data

SEPTEMBER 17, 2020

The new Elecsys Anti-SARS-CoV-2 S test can quantitatively measure the level of antibodies against SARS-CoV-2 in patients who have been exposed to the virus. The test targets antibodies against the spike protein. The majority of current candidate vaccines aim to induce an antibody response against the spike protein. “As

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Antibody Vaccination Vaccine In-Vitro 52

Pharmaceutical Technology

FEBRUARY 3, 2023

Additionally, advances in the study of broadly neutralising antibodies (bNAbs) have led to new candidates being studied in early trials. The study was done in collaboration with the United States Army Medical Research and Development Command (USAMRDC), the Thai Ministry of Health, and others.

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The Pharma Data

JANUARY 11, 2021

a San Diego-based biotechnology company with an array of technology platforms for antibody discovery and optimization, and novel NK and T cell engager generation, today announced licensing of a panel of its anti-SARS-CoV-2 antibody clones to IGM Biosciences for COVID-19 therapy development.

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The Pharma Data

APRIL 15, 2022

We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Food and Drug Administration in the coming days with additional submissions to other regulatory agencies worldwide to follow.

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Advarra

JANUARY 11, 2024

Adoptive T Cell therapies, therapeutic antibodies, and immunomodulatory proteins represent just some of the potentially beneficial treatment strategies for successful mRNA cancer trials. Monoclonal Antibodies Monoclonal antibodies are lab-engineered immune system proteins.

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Drug Discovery World

SEPTEMBER 15, 2023

Replicate’s srRNA technology offers the potential for more robust and durable immune responses, and improved tolerability at lower doses than existing mRNA approaches,” said Zelanna Goldberg, CMO of Replicate. “In The Phase I trial will evaluate the safety, tolerability, and immunogenicity of RBI-4000 in 84 participants in the US.

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pharmaphorum

JUNE 30, 2021

Just a few months after starting clinical trials of its nasal spray vaccine for COVID-19, US biotech Altimmune is abandoning the project, saying that it generated weaker than expected immune responses in a phase 1 trial. . We believe that prior immunity in humans may be important for a robust immune response to intranasal dosing.”

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The Pharma Data

DECEMBER 11, 2020

The test has been designed to quantitatively measure of immunoglobulin G (IgG) antibodies to aid clinicians in identifying patients with an immune Covid-19 response pre- and post-vaccination. As we follow individuals over the course of a year, we are repeatedly testing them for both virus and antibodies.”.

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Cloudbyz

MARCH 6, 2024

This shift signifies not just a change in the way drugs are manufactured and administered, but also a fundamental transformation in the approach to treating diseases at their root cause. In this blog post, we delve into the rise of biologics and explore how they are reshaping the pharmaceutical industry and improving patient outcomes.

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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. First antibody therapy to demonstrate anti-viral effect in patients hospitalized with COVID-19. Regeneron Pharmaceuticals, Inc. futility analysis). The results passed the futility analysis (p<0.3

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Antibody Trials Production Clinical Trials 52

pharmaphorum

SEPTEMBER 15, 2020

Humanigen is hoping for emergency use authorisation in the US for an antibody to treat severe COVID-19 before the end of 2020, and has teamed up with Swiss contract manufacturer Lonza to make sure it can meet demand. Lilly also has studies on the go for LY3127804, an investigational antibody targeting angiopoietin 2 (Ang2).

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pharmaphorum

MAY 27, 2021

GlaxoSmithKline’s COVID-19 drive has advanced on two fronts, with the start of phase 3 trials of its Sanofi-partnered vaccine candidate as well as an FDA emergency approval for antibody sotrovimab, developed with Vir Biotech. “Recent scientific evidence shows that antibodies created against the B.1.351

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Camargo

DECEMBER 13, 2021

A 351(k) application is a BLA process submitted by a manufacturer to get a product reviewed as a biosimilar or interchangeable, which is considered to be “highly similar” to an FDA-licensed reference product. One common characteristic for most if not all biologics is the triggering of an immune response or anti-drug antibodies.

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Development Production Immune Response Licensing 161

The Pharma Data

DECEMBER 17, 2020

NASDAQ: REGN ) today announced that the New England Journal of Medicine (NEJM) has published initial clinical data from an ongoing seamless Phase 1/2/3 trial of the antibody cocktail casirivimab and imdevimab in non-hospitalized patients with COVID-19. TARRYTOWN, N.Y. , 17, 2020 /PRNewswire/ — Regeneron Pharmaceuticals, Inc.

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pharmaphorum

JULY 13, 2022

Bicycle’s bicyclic peptide drug discovery platform is designed to produce drug candidates that have targeting properties like antibodies but are much smaller molecules, making manufacturing and dosing easier. The post Roche rings Bicycle bell again, grabbing another cancer target appeared first on.

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Immune Response Drugs Antibody Manufacturing 105

The Pharma Data

OCTOBER 28, 2020

NASDAQ: REGN) today announced positive, prospective results from an ongoing Phase 2/3 seamless trial in the COVID-19 outpatient setting showing its investigational antibody cocktail, REGN-COV2, met the primary and key secondary endpoints. Regeneron Pharmaceuticals, Inc. Yancopoulos , M.D., President and Chief Scientific Officer of Regeneron.

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pharmaphorum

MAY 11, 2021

The technology is designed to replace antibodies, which have become standard therapy in many diseases but are complicated and expensive to manufacture. ” Laronde plans to hire more than 200 people over the next two years and build what it calls a ‘Gigabase Factory’ for clinical and commercial manufacturing.

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The Pharma Data

MAY 17, 2021

Sanofi and GlaxoSmithKline (GSK) have reemerged as COVID-19 vaccine contenders after their reformulated candidate delivered a strong immune response across all age groups in a phase 2 study. 14, 2020 ). 2 infection. The interim phase 2 results will be published in a peer-reviewed journal, the companies said.

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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. and Australia.

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Protein Vaccination Vaccine Immune Response 52

The Pharma Data

JULY 21, 2021

(NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced the signing of a letter of intent with The Biovac Institute (Pty) Ltd, known as “Biovac,” a Cape Town-based, South African biopharmaceutical company, to manufacture the Pfizer-BioNTech COVID-19 Vaccine for distribution within the African Union. This press release features multimedia.

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The Pharma Data

SEPTEMBER 4, 2020

The data, published in Nature Medicine, show that the investigational adenovirus serotype 26 (Ad26) vector-based vaccine elicited an immune response as demonstrated by neutralising antibodies and prevented severe clinical disease, including weight loss, pneumonia and mortality, the firm said.

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pharmaphorum

AUGUST 11, 2021

The decision to move not phase 3 comes after initial results from a phase 1/2 study found that it stimulated neutralising antibodies against SARS-CoV-2 in all 80 recipients, with no safety issues recorded.

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Pharmaceutical Technology

APRIL 18, 2023

Adeno-associated virus vectors, alcohol dehydrogenase compositions, and antibody serum stabilisers are some of the accelerating innovation areas, where adoption has been steadily increasing. Among maturing innovation areas are anti-influenza antibody compositions and anti-interleukin-1, which are now well established in the industry.

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pharmaphorum

NOVEMBER 25, 2022

A universal flu vaccine could help avoid the variability in effectiveness seen with current seasonal jabs, which is generally around 60%, but can fall to as low as 10% if health authorities and manufacturers incorrectly guess the strains that end up spreading in the flu season.

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XTalks

JULY 8, 2021

The drugs are monoclonal antibodies against the IL-6 receptor. Patients with severe COVID-19 often have an overactivation of the immune system, which involves the increased release of cytokines (cytokine release syndrome) such as IL-6. By blocking the cytokine from binding to its receptor, the hyperactive immune response can be tamed.

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The Pharma Data

OCTOBER 26, 2020

Diagnostics Update : To-date the FDA has authorized 284 individual EUAs, which include 221 molecular tests, 56 antibody tests and 7 antigen tests. . Only a fraction of intravenous antibody treatments will make their way to the lungs of COVID-19 patients, which is where the infection is primarily located. Please read more here. .

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XTalks

FEBRUARY 27, 2024

Of the 73 patients who received Amtagvi, the response rate was 31.5 percent) patients who achieved a complete response and 20 (27.4 percent) patients with a partial response. More than 30 ATCs are already prepared to collect and ship tumor tissue from patients for Amtagvi manufacturing, said Iovance.

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The Pharma Data

SEPTEMBER 2, 2020

The randomised, double blind and placebo-controlled trial is designed to evaluate the safety, reactogenicity (tolerability) and immunogenicity (immune response) of the experimental COVID-19 vaccine candidate. Source link.

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The Pharma Data

OCTOBER 14, 2020

Food and Drug Administration (FDA) to begin a Phase I clinical trial of hAd5-COVID-19, the company’s novel COVID-19 vaccine candidate that targets both the inner nucleocapsid (N), engineered to activate T cells, and outer spike (S) protein, engineered to activate antibodies against the coronavirus (SARS-CoV-2).

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The Pharma Data

DECEMBER 3, 2020

S-Trimer adjuvanted with GSK’s pandemic adjuvant system induced neutralizing antibody titers (seroconversion) in 100% of participants at the selected 9 µg S-Trimer dose in both adult and elderly groups, with geometric mean titers (GMT) greater than 1:1,800.

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pharmaphorum

SEPTEMBER 2, 2021

Over the last 30 years, we have seen dramatic improvements in patient outcomes due to the emergence of biologics – particularly monoclonal antibodies – as therapies for a wide variety of diseases and infections. Block B encodes the component(s) of the immune machinery to be recruited to the site of the pathology.

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pharmaphorum

JANUARY 27, 2021

Sanofi has said it is to begin manufacturing the COVID-19 shot from Pfizer and BioNTech in a week when supplies are in the spotlight. The French pharma will use its production infrastructure to boost supplies of the vaccine and perform late-stage manufacturing to supply over 125 million doses to the EU.

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