XTalks

JANUARY 20, 2025

Pfizer announced promising results from its Phase III trial investigating the efficacy of sasanlimab, an anti-PD-1 monoclonal antibody, in combination with standard of care Bacillus Calmette-Guerin (BCG) immunotherapy for patients with high-risk non-muscle invasive bladder cancer (NMIBC) who are BCG-nave.

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Camargo

DECEMBER 13, 2021

Both the FDA’s Center for Drug Evaluation and Research (CDER) and its Center for Biologics Evaluation and Research (CBER) have regulatory responsibility for therapeutic biological products, which are subject to both the Federal Food, Drug and Cosmetic (FD & C) Act and the Public Health Service (PHS) Act.

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Pfizer

JULY 8, 2022

FDA Approval of their COVID-19 Vaccine COMIRNATY® For Adolescents 12 through 15 Years of Age. FDA Approval of their COVID-19 Vaccine COMIRNATY® For Adolescents 12 through 15 Years of Age. Today’s approval is based on data from a Phase 3 clinical trial of 2,260 participants 12 through 15 years of age.

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XTalks

NOVEMBER 22, 2022

Provention Bio’s Tzield (teplizumab) has won US Food and Drug Administration (FDA) approval to delay the onset of stage 3 type 1 diabetes in adults and pediatric patients eight years of age and older who have stage 2 type 1 diabetes. Related: GLP-1 Agonists for Diabetes: Mounjaro Versus Ozempic.

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pharmaphorum

NOVEMBER 2, 2021

Dr Laura Moriarty, senior marketing manager at Bio-Rad, looks at the impressive immuno-therapeutic potential of bispecific antibodies (bsAbs). Though their bispecific nature complicates large-scale production and purification workflows, with challenges such as antibody chain mispairing, bsAbs have come a long way since first developed.

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pharmaphorum

OCTOBER 31, 2022

s Inmazeb (consisting of the monoclonal antibodies atoltivimab, maftivimab, and odesivimab-ebgn). It is the first FDA-approved treatment for Zaire ebolavirus. The “normal and robust” immune response exhibited has become what is considered to be the “gold standard” for developing human antibody therapeutics.

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Pharmaceutical Technology

APRIL 24, 2023

Covid-19 vaccines from Moderna and Pfizer /BioNTech, which use lipid nanoparticles, became the only two FDA-approved vaccines for almost all ages. However, after a period of slow movement in the field, the FDA approved the first nanodrug, Doxil, for Kaposi sarcoma in 1995.

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XTalks

NOVEMBER 3, 2021

In this episode, Ayesha discusses the FDA’s authorization of Pfizer/BioNTech’s COVID-19 vaccine for children between five and 11 years of age. The team also learned about the FDA approval of Genentech’s new ocular implant drug delivery system, called Susvimo, for the treatment of neovascular, or wet, age-related macular degeneration (nAMD).

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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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XTalks

JUNE 15, 2022

protein that triggers the immune system to generate antibodies against the virus. Adjuvants can help boost the effectiveness of a vaccine and elicit a stronger immune response. If approved, NVX-CoV2373 would become the first available protein-based vaccine against COVID-19 in the US. Novavax Vaccine Research.

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XTalks

SEPTEMBER 23, 2021

The results showed that the vaccine was safe, well-tolerated and produced robust neutralizing antibody responses in children five to 11 years old. Results showed that the SARS-CoV-2–neutralizing antibody geometric mean titer (GMT) was 1,197.6 Pfizer Inc. Results for children under the age of five are expected later this year.

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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

APRIL 20, 2022

Adding vidutolimod gives Regeneron an opportunity for combination therapies with its own immuno-oncology drugs, headed by its Sanofi-partnered PD-1 inhibitor Libtayo (cemiplimab) which is FDA-approved for skin cancers cutaneous squamous cell carcinoma and basal cell carcinoma and non-small cell lung cancer.

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The Pharma Data

MAY 7, 2021

Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to the Pfizer-BioNTech COVID-19 Vaccine. The Pfizer-BioNTech COVID-19 Vaccine may not protect all vaccine recipients.

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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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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. and Australia. Source: Novavax, Inc. .

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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. INTERCHANGEABILITY.

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The Pharma Data

AUGUST 16, 2021

The data we’ve seen to date suggest a third dose of our vaccine elicits antibody levels that significantly exceed those seen after the two-dose primary schedule. We are pleased to submit these data to the FDA as we continue working together to address the evolving challenges of this pandemic.”. In the U.S.,

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XTalks

AUGUST 5, 2022

The Janssen Pharmaceutical Companies of Johnson & Johnson this week announced the US Food and Drug Administration (FDA) approval of Stelara (ustekinumab) to treat active psoriatic arthritis in pediatric patients six years and older. The featured speakers will discuss how to facilitate trial participation in rare disease.

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The Pharma Data

FEBRUARY 23, 2022

* Final analysis of the global VAT02 booster trial confirms universal ability to boost neutralizing antibodies 18- to 30-fold across vaccine platforms (mRNA, adenovirus). * When used as a two-dose primary series, the Sanofi-GSK vaccine delivered robust levels of neutralizing antibodies, with GMTs reaching 3711 units.

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XTalks

MAY 24, 2024

.” XTALKS WEBINAR: AI-based Antibody Therapeutics Developability Assessment and Its Engineering Live and On-Demand: Friday, June 21, 2024, at 10am EDT (4pm CEST/EU-Central) Register for this webinar today to learn how AI can be used to improve developability screening of antibody therapeutics and optimization of antibody candidates.

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XTalks

JUNE 9, 2022

Evkeeza — generically known as evinacumab — is a monoclonal antibody. It is the first US Food and Drug Administration (FDA)-approved and European Commission-approved therapy that targets angiopoietin-like 3 (ANGPTL3) for patients aged 12 and older with HoFH. Ongoing and Future Studies.

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The Pharma Data

DECEMBER 10, 2020

The vaccine targeted both the inner nucleocapsid (N) and the outer spike (S) proteins of the virus to maximize the immune response. The goal of targeting both S and N was to both activate virus-specific T cells and generate anti-SARS-CoV-2-neutralizing antibodies. This press release features multimedia. Graphic: Business Wire).

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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. FDA approval for prevention of infection caused by all known subtypes of hepatitis B virus in adults age 18 years and older.

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XTalks

MARCH 8, 2024

Denosumab is a RANKL (receptor activator of nuclear factor kappa beta ligand) monoclonal antibody that blocks the ability of RANKL to bind to its receptor RANK. Jubbonti is the first interchangeable biosimilar approved to treat osteoporosis and increase bone mass.

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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. and Australia. Source: Novavax, Inc. .

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Delveinsight

SEPTEMBER 8, 2021

Hydroxychloroquine and BENLYSTA are the FDA-approved therapies for SLE treatment. With the approval of these therapies, the outlook for SLE patients improved from a 4-year survival rate of ~50% in 1950 to a 15-year survival rate of ~85% by 2013. Currently, the SLE therapeutics market is revolving around only one drug i.e

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XTalks

MAY 30, 2024

CIDP is a rare autoimmune disorder where the body’s immune system mistakenly attacks its own tissues. The exact cause of this immune response is unknown, and there appears to be no identifiable genetic predisposition to CIDP. In early 2021, the FDA approved Pfizer’s Panzyga for the treatment of CIDP.

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Find Me Cure

OCTOBER 13, 2019

There are antibody drugs targetting those cells that are already FDA approved and there are antibody drugs still in trials. However, a combination of HER2-targeted antibody drugs and a chemotherapy drug can prove to be more potent.

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The Pharma Data

JULY 6, 2021

GlaxoSmithKline plc (LSE/NYSE: GSK) and Alector (Nasdaq: ALEC), today announced a strategic global collaboration for the development and commercialisation of two clinical-stage, potential first-in-class monoclonal antibodies (AL001 and AL101) designed to elevate progranulin (PGRN) levels. There are multiple heritable forms of FTD.

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The Pharma Data

DECEMBER 15, 2020

On top of this, another 8 million carry auto-antibodies, blood molecules that indicate a person’s chance of developing an autoimmune disease. Monoclonal Antibodies. The human monoclonal antibody targets specific immune plasma cells. The cells secrete auto-antibodies, but do not respond to standard immunosuppression.

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Clinical Trials Clinical Trials Antibody Trials 52

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.

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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 FDA Approval of their COVID-19 Vaccine COMIRNATY® For Adolescents 12 through 15 Years of Age.

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Pfizer

JULY 8, 2022

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. Some people with weakened immune systems may have reduced immune responses to Pfizer-BioNTech COVID-19 Vaccine or COMIRNATY® (COVID-19 Vaccine, mRNA). 07.08.2022.

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XTalks

SEPTEMBER 17, 2020

Nizoral is prescribed off-label, while the others are FDA approved. However, due to serious risks – including the drug’s potential to stimulate the production of anti-metreleptin antibodies and an increased risk of lymphoma – it is only available through a Risk Evaluation and Mitigation Strategy mandated by the FDA.

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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

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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. BNT162b2 (SARS-CoV-2 vaccine) FDA Approval History. Germany, Turkey, South Africa, Brazil and Argentina. Source: Pfizer Inc. .

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