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The results from a trial, published in The New England Journal of Medicine , found the vaccine was associated with a strong immuneresponse and good safety profile. The response was more powerful than that generated by MenACWY-D – a licensed quadrivalent meningococcal vaccine marketed by GSK.
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.
It is the world’s first and only licensed malaria vaccine and also the first licensed for use against a human parasitic disease of any kind. Moreover, a very strong immuneresponse is needed to fend off the disease. Malaria Vaccine Phase II Trial. Two different doses of the adjuvant (MM) were assessed (25 mcg and 50 mcg).
ChAdOx1 – which is in large-scale phase 2/3 trials – was licensed by AZ in April and renamed AZD1222, and should be ready for first deliveries before the end of the year. It will be provided on a no-profit basis while the pandemic is ongoing.
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.
Now, new research from the Wyss Institute at Harvard University has revealed that this constant pattern of stretching and relaxing does even more – it generates immuneresponses against invading viruses. a Wyss Technology Development Fellow at the Institute. ” The results are published today in Nature Communications.
anaphylaxis) to any component of TICOVAC Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of TICOVAC Some individuals with altered immunocompetence may have reduced immuneresponses to TICOVAC TICOVAC contains albumin, a derivative of human blood.
We believe that mRNA technology could have several advantages for a seasonal flu application including the potential ability to demonstrate robust immuneresponses based on preclinical data to date, enable antigen specificity within a short timeframe from seasonal virus strain selection, and deploy agile manufacturing capacity.
The authorisation is based on a review by the Committee for Medicinal Products for Human Use (CHMP) of the substantial body of evidence demonstrating an increased immuneresponse after a third dose booster with Vaxzevria following a primary vaccine schedule of either Vaxzevria or an mRNA COVID-19 vaccine.(1-5). About AstraZeneca.
The companies intend to work with regulatory authorities, and as previously announced, 1,2 aim for Pfizer to potentially submit a Biologics License Application (BLA) to the U.S. VLA15 has demonstrated a strong immuneresponse and satisfactory safety profile in pre-clinical and clinical studies so far.
The vaccine candidate is based on BioNTech’s proprietary mRNA platform technology and contains mRNA strands encoding the wild-type spike protein of SARS-CoV-2 and the spike protein of the Omicron BA.4/BA.5 The information contained in this release is as of November 3, 2022. COMIRNATY® (COVID-19 Vaccine, mRNA). INDICATION.
Delivery of viral antigens in potent vaccine vectors to elicit a strong immuneresponse 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. Gritstone Forward-Looking Statements.
All 38 subjects who were evaluable for immunogenicity had balanced cellular and humoral immuneresponses following the second dose of INO-4800.
The antigen is processed naturally in the cell and triggers the desired T cell and antibody-mediated immuneresponses.
About INOVIO.
producing CD8+ T cell responses, which is thought to promote an anti-viral effect. In a preclinical murine model, a single IM immunization of BNT162b2 (0.2, CD4+ and CD8+ T-cells from splenocytes isolated from BNT162b2-immunized mice were strongly positive for IFN? Pfizer Disclosure Notice. BioNTech Forward-looking statements.
This oncolytic virus has induced long-lasting antitumor immuneresponses and abscopal effects in several tumor models, and its activity is further enhanced through combination with an anti-PD-1 antibody treatment. The Company’s validated, proprietary F.I.R.S.T
T cell immuneresponses 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 immuneresponse data from the German trial in the near future.”. “It View the full release here: [link].
Based on the acceptable safety profile and the favorable immuneresponse data, including the 4th dose response data, Pfizer received Breakthrough Therapy Designation. Disclosure Notice: The information contained in this release is as of September 15, 2020.
We believe our allogenic CAR-T platform is significantly stronger with chPD1 target licensed from Longwood University. Chimeric PD-1 T-cells also release cytokines to further initiate immuneresponses to eradicate the tumor cells. Amorette Barber of Longwood University will be heading up our chPD1 program.
Pfizer and BioNTech announced additional data on neutralizing antibody and T-cell responses from their Phase I/II trial of their COVID-19 vaccine conducted in Germany. The therapy is remestemcel-L, which contains culture-expanded mesenchymal stromal cells derived from the bone marrow of an unrelated donor.
The analysis was prospectively designed to focus on patients who had not yet mounted their own immuneresponse to SARS-CoV-2 (i.e., The EUA is temporary and does not take the place of a formal biologics license application (BLA) submission review and approval process and the use of the antibody cocktail remains investigational.
The clinical evidence from Regeneron’s outpatient trial suggests that monoclonal antibodies such as casirivimab and imdevimab have the greatest benefit when given early after diagnosis and in patients who have not yet mounted their own immuneresponse or who have high viral load.
(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 immuneresponse of an enhanced COVID-19 mRNA-based vaccine candidate at a 30 µg dose level. Emergency Use Authorization .
“We continue to see the strongest effects in patients who are most at risk for poor outcomes due to high viral load, ineffective antibody immuneresponse at baseline, or pre-existing risk factors. Yancopoulos , M.D., President and Chief Scientific Officer of Regeneron. Regeneron has shared these results with the U.S.
The clinical evidence from Regeneron’s outpatient trial suggests that monoclonal antibodies such as REGEN-COV2 have the greatest benefit when given early after diagnosis and in patients who have not yet mounted their own immuneresponse or who have high viral load.
Senior Vice President and Head of Global Clinical Development at Regeneron and lead author of the publication. “The investigational cocktail is now available to indicated high-risk U.S. patients under an Emergency Use Authorization, and we also continue a robust clinical development program.”
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 immuneresponse against Omicron BA.1 The information contained in this release is as of July 19, 2022.
Food and Drug Administration (FDA) approved the companies’ supplemental Biologics License Application (sBLA) for their COVID-19 vaccine, known as COMIRNATY® (COVID-19 Vaccine, mRNA), to include individuals 12 through 15 years of age. The information contained in this release is as of July 8, 2022. have completed a primary series.
population in just a few months, the BLA submission is an important cornerstone of achieving long-term herd immunity and containing COVID-19 in the future,” said Ugur Sahin, M.D., The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S. The information contained in this release is as of May 7, 2021.
The company announced donanemab received Breakthrough Therapy designation for treatment of Alzheimer’s disease and its intention to submit a biologics license application (BLA) for donanemab under the accelerated approval pathway later this year based on data from TRAILBLAZER-ALZ. Loxo Oncology at Lilly and Kumquat Biosciences Inc.
MRT5500 (SP0254), an mRNA vaccine candidate against SARS-CoV-2, entered Phase 1/2 to assess safety, immuneresponse and reactogenicity. On January 12, 2021 Sanofi entered into a global licensing agreement with Biond Biologics for BND-22, a novel immune checkpoint inhibitor targeting the ILT2 receptor. Collaborations.
Tofersen was discovered by Ionis Pharmaceuticals, and Biogen licensed tofersen from Ionis under a collaborative development and license agreement. Qalsody contains tofersen, an antisense oligonucleotide that specifically targets the mRNA made from mutated SODI genes to prevent the formation of toxic SOD1 proteins.
“With more than 26 million adults over the age of 19 who have been previously vaccinated with PREVNAR 13®, today’s ACIP vote recognizes the importance of helping to protect them against the seven additional serotypes contained in PREVNAR 20®,” said Angela Hwang, President, Global Biopharma Business, Pfizer.
The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S. Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immuneresponse to the Pfizer-BioNTech COVID-19 Vaccine. The information contained in this release is as of May 6, 2021.
The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S. Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immuneresponse to the Pfizer-BioNTech COVID-19 Vaccine. The information contained in this release is as of July 21, 2021.
Immuneresponses following vaccination with PNEUMOVAX 23 (month 13) were comparable in both vaccination groups for the 15 serotypes in V114. Results from both studies are based on opsonophagocytic activity (OPA) responses – a measure of vaccine-induced functional antibodies. among adults 65 years of age or older.
The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S. Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immuneresponse to the Pfizer-BioNTech COVID-19 Vaccine. The information contained in this release is as of March 11, 2021.
The vaccine also contains capsular polysaccharide conjugates for seven additional serotypes (8, 10A, 11A, 12F, 15B, 22F and 33F) that cause invasive pneumococcal disease (IPD), 8,9,10,11,12 and have been associated with high case-fatality rates, 13,14,15,16 antibiotic resistance, 4,17,18 and/or meningitis. IMPORTANT SAFETY INFORMATION.
Secondary objectives are to describe immuneresponses produced by each of the vaccines. The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S. Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immuneresponse to the Pfizer?BioNTech
Both vaccine candidates incorporate Novavax’ proprietary saponin-based Matrix-M adjuvant in order to enhance the immuneresponse and stimulate high levels of neutralizing antibodies. Moderna”) contains “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Sanofi, Empowering Life.
Both vaccine candidates incorporate Novavax’ proprietary saponin-based Matrix-M adjuvant in order to enhance the immuneresponse and stimulate high levels of neutralizing antibodies. This press release contains “forward-looking statements” of. With more than 100,000 people in 100 countries, Sanofi. Empowering Life. Moderna, Inc.
The Phase 3 trial is designed as a 1:1 vaccine candidate to placebo, randomized, observer-blinded study to obtain safety, immuneresponse, and efficacy data needed for regulatory review. The information contained in this release is as of December 10, 2020. Germany, Turkey, South Africa, Brazil and Argentina.
Specifically, tezepelumab targets and blocks TSLP, a key epithelial cytokine that sits at the top of multiple inflammatory cascades and initiates an overreactive immuneresponse to allergic, eosinophilic and other types of airway inflammation associated with severe asthma.
” EB05 is an experimental monoclonal antibody that Edesa believes could regulate the overactive immuneresponse associated with Acute Respiratory Distress Syndrome (ARDS) – the leading cause of death in COVID-19 patients. The company is based in Markham, Ontario, Canada, with a U.S. Sign up for news alerts.
Specifically, tezepelumab targets and blocks TSLP, a key epithelial cytokine that sits at the top of multiple inflammatory cascades and initiates an overreactive immuneresponse to allergic, eosinophilic and other types of airway inflammation associated with severe asthma.
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