XTalks

JUNE 15, 2022

The Novavax candidate NVX-CoV2373 is a protein-based vaccine developed using recombinant nanoparticle technology. 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. Clinical Trial Results.

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XTalks

MAY 24, 2024

Due to its aggressive nature, it has a poor prognosis and quickly develops resistance to chemotherapy. A Targeted Bispecific Therapy and a First-In-Class Immunotherapy Imdelltra was created with the help of Amgen’s BiTE (Bispecific T-cell Engager) technology which is designed to harness the body’s immune system to fight cancer.

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XTalks

MAY 1, 2023

Tofersen was discovered by Ionis Pharmaceuticals, and Biogen licensed tofersen from Ionis under a collaborative development and license agreement. While the exact causes of ALS are not fully understood, research suggests that the mutation of SOD1 may be linked to the development of the condition. What is SOD1 -ALS?

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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

APRIL 26, 2021

After years of disappointing malaria vaccine trials, a malaria shot developed by researchers at the Jenner Institute at the University of Oxford has demonstrated an unprecedentedly high efficacy of 77 percent, and may be the magic bullet the world has been waiting for against the deadly disease. Malaria Vaccine Phase II Trial.

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Find Me Cure

OCTOBER 13, 2019

If you follow our blog you know that we at FindMeCure take updating our readership on treatments in development very seriously. There are antibody drugs targetting those cells that are already FDA approved and there are antibody drugs still in trials.

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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. 4, 2020 08:00 UTC. CHENGDU, China.–(

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WCG Clinical

MAY 28, 2024

Today there are six CAR-T products with FDA approval for the treatment of multiple myeloma and B cell malignancies, with many related and next-generation products under development. This proliferative capacity allows a rapid response to an incoming threat, such as a viral infection.

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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

OCTOBER 26, 2020

FDA Actions. FDA Approval: Last week the FDA approved Veklury (remdesivir) for the treatment of COVID-19 requiring hospitalization in adults and pediatric patients (12 years of age and older). Aridis Chief Executive Officer Vu Truong believes his company has a better solution – an inhaled antibody.

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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. Senior Vice President and Head of Global Clinical Development at Regeneron. Yancopoulos , M.D.,

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The Pharma Data

MAY 7, 2021

The Pfizer-BioNTech COVID-19 Vaccine, which is based on BioNTech proprietary mRNA technology, was developed by both BioNTech and Pfizer. Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to the Pfizer-BioNTech COVID-19 Vaccine.

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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. Several other types of treatments are currently under development for psoriatic arthritis.

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XTalks

MAY 2, 2024

In 2023, the US Food and Drug Administration (FDA) approved a record-breaking 61 drugs, the most in history. Since January, the FDA has already signed off on more than a dozen novel drugs. The agency is reviewing applications for several highly anticipated drugs for approval in 2024.

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The Pharma Data

NOVEMBER 9, 2020

(Nasdaq: NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for NVX-CoV2373, the Company’s COVID-19 vaccine candidate. President of Research and Development, Novavax.

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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

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. These findings give confidence that Clover’s COVID-19 vaccine candidates are suitable for further clinical development.”

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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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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. hAd5-COVID-19 Oral Formulation.

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XTalks

NOVEMBER 15, 2023

XTALKS WEBINAR: Vaccine Clinical Development: Key Ingredients to Improve Efficiency Live and On-Demand: Monday, November 20, 2023, at 10am EST (4pm CET/EU-Central) Register for this free webinar to learn ways to improve the efficiency of vaccine development. Chikungunya was first found in Tanzania in 1952 and has no known treatment.

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XTalks

OCTOBER 25, 2022

The FDA clearance is the first for tremelimumab, which faced an uphill battle after having suffered several failures in trials for other cancer types over the past two decades of its development, including non-small cell lung cancer, head and neck cancer and bladder cancer.

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The Pharma Data

NOVEMBER 12, 2020

The CALAVI trials were launched based on preclinical and early clinical evidence that Calquence could decrease the hyperinflammatory immune response and improve clinical outcomes in patients hospitalised with respiratory symptoms of COVID-19.1 Related Articles: Calquence (acalabrutinib) FDA Approval History. AstraZeneca.

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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

AUGUST 17, 2020

Immunotherapy continues to be a burgeoning field, with immune-based therapies being among the leading treatments being developed in oncology and autoimmunity. Monoclonal antibodies : these are antibodies that are designed to bind to specific targets on cells. Immune system modulators (i.e.

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XTalks

JUNE 5, 2023

Today’s approval is a monumental step forward in delivering on Pfizer’s commitment to help alleviate the significant burden of RSV in higher-risk populations, which includes older adults,” said Annaliesa Anderson, PhD, senior VP and chief scientific officer, Vaccine Research and Development at Pfizer, in the company’s news release.

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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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XTalks

DECEMBER 17, 2021

Given the rapid development of the vaccines and the relative unfamiliarity of new technologies like mRNA technology among the public, vaccine hesitancy has been an ongoing issue that has hindered vaccine uptake in some cases. Young children are most affected by the deadly disease in the continent of Africa.

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Drug Discovery World

MAY 29, 2024

Marc Hummersone, Senior Director of Research and Development (R&D) at Astrea Bioseparations, shares insight on the challenges and opportunities in cell and gene therapy (CGT) with DDW’s Megan Thomas. But the unpacked capsid can give rise to an immune response, which is not good for the patient.

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The Pharma Data

NOVEMBER 20, 2020

NASDAQ: REGN) today announced that the antibody cocktail casirivimab and imdevimab administered together (formerly known as REGN-COV2 or REGEN-COV2), a therapy currently being investigated for use in COVID-19 , has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA). TARRYTOWN, N.Y.,

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The Pharma Data

NOVEMBER 21, 2020

NASDAQ: REGN) today announced that the antibody cocktail casirivimab and imdevimab administered together (also known as REGN-COV2 or REGEN-COV2), a therapy currently being investigated for use in COVID-19, has received Emergency Use Authorization (EUA) from the U.S. government allocation program. Regeneron Pharmaceuticals, Inc.

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The Pharma Data

DECEMBER 11, 2020

company, today’s news brings great pride and tremendous joy that Pfizer has risen to the challenge to develop a vaccine that has the potential to help bring an end to this devastating pandemic. We have worked tirelessly to make the impossible possible, steadfast in our belief that science will win.”. “We

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The Pharma Data

DECEMBER 27, 2020

NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, today provided a year-end review and an outline of its plans for 2021. Therapeutic product development is a long process, but we’re making great progress. 28, 2020 13:00 UTC. CARLSBAD, Calif.–(

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Drug Discovery World

JULY 8, 2024

This RNA system is based upon the one-dimensional, linear structure of RNA and utilises a singular sequence of information, prompting the creation of viral protein and triggering an immune response to them. The most developed RNAi is small interfering ribonucleic acid (siRNA)-based therapies.

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The Pharma Data

DECEMBER 10, 2020

Senior Vice President and Head of Vaccine Research & Development, Pfizer. “As 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. Jansen, Ph.D.,

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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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XTalks

SEPTEMBER 17, 2020

While the table lists acceptable surrogate endpoints for trials of more common conditions, such as asthma, type 2 diabetes and various cancer types, the document also provides key information to developers of certain rare disease therapies. Nizoral is prescribed off-label, while the others are FDA approved.

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Drug Discovery World

MAY 11, 2023

However, the increased complexity and diversity involved in the development and manufacturing of gene therapies and vaccines can cause challenges when it comes to determining the quality of the final product, particularly around the detection of impurities. In the case of therapeutics, the aim is usually to avoid patients’ immune responses.

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