XTalks

JANUARY 22, 2025

seroresponse rate indicating the proportion of participants achieving antibody levels above a predefined protective threshold sustained one year after vaccination. One year post-vaccination, antibody levels remained strong, with geometric mean titers well above the required protective threshold. The findings reveal a remarkable 98.3%

Immune Response 59

Immune Response Vaccination Vaccine Trials 59

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.

Vaccination 130

Vaccination Vaccine Development Immune Response 130

pharmaphorum

SEPTEMBER 4, 2020

They are also scaling up manufacturing of the antigen and adjuvant, aiming to produce up to a billion doses in 2021. Sanofi is leading the clinical development and registration of the COVID-19 vaccine. In Japan, AZ is working with Daiichi Sankyo and partners including JCR Pharma to manufacture and distribute the vaccine.

Clinical Trials 106

Clinical Trials Clinical Trials Vaccination Vaccine 106

BioTech 365

SEPTEMBER 28, 2020

Panel of 15 potent antibodies selected that are optimally suited to clinical development and manufacturing Monoclonal antibodies have the potential to both treat infected patients and provide protection to the “at risk” population during the pandemic Viral neutralization data independently … Continue reading →

Antibody 40

Antibody Clinical Development Manufacturing Development 40

The Pharma Data

NOVEMBER 30, 2020

We continue to make meaningful progress as we work to test, manufacture and ultimately deliver NVX-CoV2373 with unprecedented speed, as well as put partnerships in place that would ensure widespread and equitable access worldwide.”. and Mexico pivotal Phase 3 trial and manufacturing scale-up. . Mexico pivotal Phase 3 trial update.

Clinical Development 52

Clinical Development Vaccination Vaccine Development 52

XTalks

JANUARY 6, 2025

However, some patients develop inhibitors antibodies that neutralize the efficacy of replacement therapies. Alhemo is a bispecific monoclonal antibody that mimics the function of factor VIII without requiring direct replacement of the missing factor. Hympavzi is administered once weekly.

FDA Approval 105

FDA Approval Antibody Drugs Clinical Trials 105

The Pharma Data

DECEMBER 14, 2020

Harbour BioMed (HBM) announced with Utrecht University on Monday that they have licensed their fully human SARS-CoV-2 neutralizing antibody, 47D11, and its program to AbbVie. AbbVie has initiated a Phase I clinical trial of the antibody, and it will conduct the initial clinical program in the U.S.

Antibody 52

Antibody Licensing Licensing In-Vitro 52

The Pharma Data

APRIL 15, 2022

The top protein neutralized the virus with similar or greater potency than antibody treatments with Emergency Use Authorization status from the U.S. Notably, the top protein also neutralized all tested SARS-CoV-2 variants, something that many clinical antibodies have failed to do. Food and Drug Administration (FDA).

Antibody 52

Antibody Protein Engineer Research 52

Pharmaceutical Technology

FEBRUARY 24, 2023

Amivantamab is under clinical development by Johnson & Johnson and currently in Phase I for Colorectal Cancer. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval. It is formulated as solution and concentrate for solution for intravenous infusion.

Recombinant DNA Technology 100

Recombinant DNA Technology Production Antibody FDA Approval 100

Pharmaceutical Technology

MARCH 2, 2023

Rituximab biosimilar is under clinical development by Dr. Reddy’s Laboratories and currently in Phase III for Rheumatoid Arthritis. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.

Production 100

Production DNA Drugs Clinical Trials 100

Pharmaceutical Technology

MARCH 1, 2023

Nedisertib is under clinical development by Merck and currently in Phase I for Neuroendocrine Tumors. It was also under development for small cell lung cancer, rectal cancer and chronic lymphocytic leukemia (CLL). Merck overview Merck, a subsidiary of E. Merck KG, is a science and technology company.

Gene Editing 100

Gene Editing DNA Cosmetics Life Science 100

Pharmaceutical Technology

MARCH 1, 2023

Nedisertib is under clinical development by Merck and currently in Phase I for Head And Neck Cancer Squamous Cell Carcinoma. It was also under development for small cell lung cancer, rectal cancer and chronic lymphocytic leukemia (CLL). Merck overview Merck, a subsidiary of E. Merck KG, is a science and technology company.

Gene Editing 100

Gene Editing DNA Cosmetics Life Science 100

Worldwide Clinical Trials

JULY 8, 2024

With radiopharmaceuticals emerging as a diagnostic and therapeutic (theranostics) procedure, many are in the clinical development pipeline and are expected to play a crucial role in the future of healthcare. The goal is to deliver a precise radiation dose to the diseased tissues while minimizing damage to surrounding healthy tissue.

Hormones 130

Hormones Regulation Clinical Trials Clinical Trials 130

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.

Antibody 52

Antibody Medicine Production Trials 52

The Pharma Data

NOVEMBER 29, 2020

Prior to joining Gannex, Dr. Palmer was Head of Liver Disease Clinical Development at Takeda Pharmaceuticals. She has also held senior leadership positions at Shire Pharmaceuticals and Kadmon Corporation, where she was in charge of the global development of NASH and other liver disease programs. . ” About Ascletis.

Clinical Development 40

Clinical Development Development Clinical Trials Clinical Trials 40

Pharmaceutical Technology

FEBRUARY 18, 2023

Gevokizumab is a monoclonal antibody commercialized by Novartis, with a leading Phase I program in Metastatic Renal Cell Carcinoma. According to Globaldata, it is involved in 34 clinical trials, of which 20 were completed, 1 is ongoing, and 13 were terminated. It was under development for renal cell carcinoma as first line therapy.

Generic Pharmaceutical 100

Generic Pharmaceutical Dermatology Antibody Development 100

pharmaphorum

MARCH 7, 2022

The World Health Organization (WHO) announced the opening of a global biomanufacturing hub located in South Korea to provide training to low- and middle-income countries seeking to produce vaccines and other biologics, such as insulin and monoclonal antibodies. . Long-term progress.

Vaccination 98

Vaccination Vaccine Manufacturing Production 98

The Pharma Data

MAY 27, 2022

Roche today announced that new pivotal data on its investigational CD20xCD3 T-cell engaging bispecific antibody, glofitamab, will be presented for the first time at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting from 3-7 June and the European Hematology Association (EHA) 2022 Congress from 9-12 June.

Antibody 52

Antibody In-Vitro Medicine Engineer 52

Roots Analysis

FEBRUARY 27, 2024

The firm also has the right to obtain exclusive licenses to the Affimer proteins for clinical development and commercialization. What are Affimers : Affimers are small proteins that target and bind molecules on cellular surfaces in a manner analogous to monoclonal antibodies.

Antibody 52

Antibody Licensing Licensing Contract Manufacturing 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.

Vaccination 52

Vaccination Vaccine Manufacturing Clinical Trials 52

pharmaphorum

NOVEMBER 12, 2020

In 2018, it bought Element Genomics – a spin-out of Duke University in the US – to add genome-editing technologies, and has also been growing its internal exercise at its Boston R&D hub, although so far it hasn’t advanced and gene therapies into clinical development.

Gene Therapy 52

Gene Therapy Gene Manufacturing Contract Manufacturing 52

The Pharma Data

AUGUST 10, 2020

Novavax is partnering up with the Serum Institute of India Private Limited (SIIPL) in a licensing deal to development and marketing of up to one billion doses of its potential recombinant COVID-19 vaccine candidate, NVX?CoV2373. Negotiations are currently ongoing to have SIIPL manufacture the candidate within India. M adjuvant.

Vaccination 52

Vaccination Vaccine Licensing Licensing 52

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.

Antibody 40

Antibody Trials Production Clinical Trials 40

The Pharma Data

OCTOBER 25, 2020

Company Confirms COVID-19 Antibody Home Test and Two Severity Triage Tests can be Submitted to U.S. SQI is accelerating the clinical development of its direct-to-consumer COVID-19 HOME Antibody Test, its COVID-19 RALI-dx Severity Triage Test and its COVID-19 RALI- fast Severity Triage Point-of-Care (POC) Test.

Development 52

Development Antibody Clinical Development FDA Approval 52

The Pharma Data

DECEMBER 23, 2020

During this global health crisis response, we must establish partners with the strongest capabilities, like Aurobindo, to expand the manufacturing and delivery of our vaccine. Aurobindo Pharma and COVAXX are partnering on clinical development, manufacturing and marketing of COVAXX’s vaccine candidate, UB-612.

Vaccination 52

Vaccination Vaccine Manufacturing Antibody 52

The Pharma Data

DECEMBER 23, 2020

24, 2020 /PRNewswire/ — COVAXX’s UB-612 is the first multitope, synthetic peptide-based COVID-19 vaccine candidate in clinical trials and it utilizes normal refrigeration (no freezing required) for distribution. COVAXX is currently conducting a Phase 1 clinical trial for the vaccine candidate. .

Vaccination 52

Vaccination Vaccine Development Manufacturing 52

The Pharma Data

DECEMBER 5, 2020

NASDAQ: REGN) today announced updated data for REGN5458, a BCMAxCD3 bispecific antibody, from the Phase 1 portion of a Phase 1/2 trial in patients with relapsed or refractory (R/R) multiple myeloma. These allow for the creation of bispecific antibodies that closely resemble natural human antibodies with no linkers or artificial sequences.

Antibody 40

Antibody Production Trials Medicine 40

XTalks

JANUARY 6, 2025

However, some patients develop inhibitors antibodies that neutralize the efficacy of replacement therapies. Alhemo is a bispecific monoclonal antibody that mimics the function of factor VIII without requiring direct replacement of the missing factor. Hympavzi is administered once weekly.

FDA Approval 52

FDA Approval Antibody Drugs Clinical Trials 52

The Pharma Data

JUNE 25, 2021

protofibril antibody for the treatment of Alzheimer’s disease (AD). Breakthrough Therapy designation is an FDA program intended to expedite the development and review of medicines for serious or life-threatening conditions. Lecanemab selectively binds to neutralize and eliminate soluble, toxic amyloid-beta (A?)

Antibody 40

Antibody Clinical Trials Clinical Trials Development 40

The Pharma Data

SEPTEMBER 2, 2020

Preclinical data – due to be published later this year – show an acceptable reactogenicity profile following two injections of the adjuvanted recombinant vaccine, and high levels of neutralising antibodies comparable to levels in humans who recovered from COVID-19 infection. Source link.

Vaccination 52

Vaccination Vaccine Trials Immune Response 52

Pharmaceutical Technology

FEBRUARY 19, 2023

Camrelizumab is under clinical development by Jiangsu Hengrui Medicine and currently in Phase I for Solid Tumor. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval. It is formulated as solution for intravenous route.

Medicine 100

Medicine Drugs Production Development 100

The Pharma Data

AUGUST 6, 2020

It signed a manufacturing and distribution agreement with R-Pharm in Russia and tapped the Serum Institute of India to provide for low-income countries. South Korea’s SK Bioscience recently joined AZ’s COVID-19 vaccine manufacturing network, and Daiichi Sankyo stated in late June that it’s in discussions to supply the shot in Japan.

Vaccination 52

Vaccination Vaccine Antibody Licensing 52

The Pharma Data

AUGUST 7, 2020

Most importantly, we are continuing to see patients benefit from the profound therapeutic effects of both approved products and those currently in clinical development. NIH tests antibodies in Covid-19 clinical trial alongside Eli Lilly and AbCellera . Dr. Francis S.

Clinical Trials 52

Clinical Trials Clinical Trials Gene Trials 52

Delveinsight

JULY 28, 2020

AstraZeneca has inked an oncology deal with Daiichi Sankyo to jointly develop and commercialize an antibody-drug conjugate DS-1062 (trastuzumab deruxtecan), worldwide except in Japan. The company also received additional funding from the BARDA worth USD 472 Million to support the Phase III clinical development of the vaccine.

Gene Therapy 52

Gene Therapy Trials Gene Vaccination 52

The Pharma Data

OCTOBER 30, 2020

NASDAQ: REGN) received today a recommendation from the independent data monitoring committee (IDMC) for the REGN-COV2 antibody cocktail treatment trials for COVID-19 that the current hospitalized patient trial be modified. and Roche will develop, manufacture and distribute it outside the U.S. TARRYTOWN, N.Y. ,

Production 52

Production Antibody Manufacturing Trials 52

XTalks

FEBRUARY 24, 2023

Lunsumio is a CD20xCD3 T-cell engaging bispecific antibody that works by targeting the protein CD20 on the surface of B cells and CD3 on the surface of T cells. Dr. Laport: Lunsumio (mosunetuzumab-axgb) is the first CD20xCD3 T-cell engaging bispecific antibody approved by the FDA.

Drugs 52

Drugs FDA Approval Antibody Medicine 52

The Pharma Data

JANUARY 27, 2021

RIIB antibody BI-1206 in combination with rituximab (anti-CD20 monoclonal antibody) in patients with indolent relapsed or refractory B-cell non-Hodgkin’s lymphoma (NHL). ET ) to discuss the results and next steps in clinical development of BI-1206. (Nasdaq: CASI), a U.S. Wei-Wu He , Ph.D.,

Antibody 52

Antibody Containment Development Trials 52