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Additionally, this project will be part of the development pipeline of Evaxion under EVX-V1. According to the agreement, ExpreS 2 ion will hold the exclusive right for licensing the CMV vaccine candidate under a possible development and commercialisation agreement.
Swiss pharma giant Roche has moved to strengthen its position in the KRAS-mutated cancer space through a $25 million licensing and collaboration agreement with Austrian arenaviral technology firm Hookipa Pharma. Roche also has the option to license a second, undisclosed, novel arenaviral immunotherapy.
Xtalks spoke with Maria Reyes Boceta-Muñoz, Clinical Operations Head of Development R&D at GlaxoSmithKline in Spain, Portugal & Israel, to understand the current vaccine development climate and where the sector is headed. However, guidelines do not provide matters specific to each vaccine type.
Biond Biologics announced today that it has entered into a potentially $1 billion global licensing agreement with Sanofi to take a joint stab at defeating advanced forms of cancer with a more comprehensive and expedited approach to immuno-oncology. . Keitma/Shutterstock.
The hypothesis is that it will induce immune tolerance by stimulating anti-inflammatory regulatory T- (Treg) cells and cytokines that dampen down the immuneresponse. Gilead is collaborating with EVOQ on preclinical-stage projects, and has taken an option to exclusively license rights if they live up to their early promise.
The initial assessment of AT845 is based on four patients who received two doses of the gene therapy, with no evidence of serious adverse events, according to Astellas’ head of clinicaldevelopment for gene therapies Weston Miller. Shares in the drugmaker rose just over 1% after the FORTIS data was announced.
AstraZeneca reached a licensing deal with Chinese firm BioKangtai to help provide its adenovirus vector-based COVID-19 vaccine candidate, created by the University of Oxford, to China, AstraZeneca said (Chinese) in a social media post on Thursday. China has several home-grown COVID-19 vaccines in clinicaldevelopment.
Clinical trial to assess safety, immuneresponse and reactogenicity, after preclinical data showed high neutralizing antibody levels. The joint development team is working on improving the temperature stability of the mRNA vaccine candidate and targeting a -20°C storage temperature for late-stage clinical trials and at launch.
(Nasdaq: RIGL) today announced a global exclusive license agreement and strategic collaboration to co-develop and commercialize Rigel’s R552, a receptor-interacting serine/threonine-protein kinase 1 (RIPK1) inhibitor, for all indications including autoimmune and inflammatory diseases. vice president of immunology at Lilly.
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.
Discovered by Vanderbilt University Medical Center and licensed to AstraZeneca in June 2020, the human monoclonal antibodies bind to distinct sites on the SARS-CoV-2 spike protein16 and were optimised by AstraZeneca with half-life extension and reduction of Fc effector function. 1-3 Evusheld was generally well-tolerated in the trial.
BT-001 is being co-developed through a 50/50 collaboration between BioInvent and Transgene. “This clinical trial approval sets the stage to further broaden BioInvent’s promising clinical pipeline. BT-001 is our fourth program in clinicaldevelopment. The Company’s validated, proprietary F.I.R.S.T
The vaccine candidate combines Pfizer’s quadrivalent modRNA-based influenza vaccine candidate, qIRV (22/23), which is currently in Phase 3 clinicaldevelopment , and Pfizer and BioNTech’s authorized Omicron-adapted bivalent COVID-19 BNT162b2 (Original/Omicron BA.4/BA.5) a 2-dose primary series to individuals 5 years of age and older.
The clinical trial remains ongoing with other sites not operated by the third party, and Pfizer continues to enroll new participants at those sites. 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.
Anokion is responsible for preclinical activities and Phase I clinicaldevelopment of partnered programs, and Bristol Myers Squibb will fund subsequent trials and commercial activities at clinical proof-of-concept.
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?
We believe our allogenic CAR-T platform is significantly stronger with chPD1 target licensed from Longwood University. Barber’s work will give Kiromic a significant acceleration in the clinicaldevelopment of its therapy platform and an even more significant advantage over its competitors. “We believe Prof.
(NASDAQ: REGN) today announced encouraging initial data from an ongoing Phase 1/2/3 clinical trial of the Regeneron antibody cocktail, casirivimab and imdevimab, in hospitalized COVID-19 patients requiring low-flow oxygen. Evaluation of its safety and efficacy is ongoing in multiple clinical trials. futility analysis). .
(Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced that the first participant was enrolled in the observational PRECISION study (TNX-C002), to examine the immuneresponses to COVID-19 in healthy volunteers who have recovered from COVID-19 or were asymptomatic. 1 Noyce RS, et al.
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].
Valneva SE, who developed the worlds first FDA-approved chikungunya vaccine , has now unveiled promising Phase III data for its single-shot chikungunya vaccine, IXCHIQ, in adolescents aged 12 to 17. IXCHIQ is the only licensed chikungunya vaccine in the US for adults aged 18 and older at increased risk of exposure to the virus.
In addition to the COVID-19 vaccine program, Pfizer aims to deliver five innovative vaccines by 2025, subject to clinical success and regulatory approval. Based on the acceptable safety profile and the favorable immuneresponse data, including the 4th dose response data, Pfizer received Breakthrough Therapy Designation.
During preclinical and clinical studies, BNT162b1 and BNT162b2 emerged as strong candidates based on assessments of safety and immuneresponse. Food and Drug Administration (FDA), based on preliminary data from Phase 1/2 studies that are currently ongoing in the U.S. and Germany as well as animal immunogenicity studies.
“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. Senior Vice President and Head of Global ClinicalDevelopment at Regeneron. Yancopoulos , M.D., combined dose groups; 6.5%
Senior Vice President and Head of Global ClinicalDevelopment at Regeneron and lead author of the publication. patients under an Emergency Use Authorization, and we also continue a robust clinicaldevelopment program.” “The investigational cocktail is now available to indicated high-risk U.S.
HOOKIPA’s viral vectors target antigen presenting cells in vivo to activate the immune system. Both technologies enable repeat administration to augment and refresh immuneresponses. To expand its infectious disease portfolio, HOOKIPA entered into a collaboration and licensing agreement with Gilead Sciences, Inc.
(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 .
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 Pfizer-BioNTech COVID-19 Vaccine may not protect all vaccine recipients.
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 1 as compared to the companies’ current COVID-19 vaccine. Emergency Use Authorization.
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. NEW YORK and MAINZ, GERMANY, July 8, 2022 — Pfizer Inc. have completed a primary series.
Following a third dose in this age group , the vaccine was found to elicit a strong immuneresponse, with a favorable safety profile similar to placebo. Some people with weakened immune systems may have reduced immuneresponses to Pfizer-BioNTech COVID-19 Vaccine or COMIRNATY® (COVID-19 Vaccine, mRNA).
Pfizer and BioNTech expect to file a Biologics License Application for possible full regulatory approval in 2021.
A breakdown of the diversity of clinical trial participants can be found here from more than 150 clinical trial sites in the U.S., NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) announced today that the U.S.
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.
Proceeds will advance the clinicaldevelopment of MinervaX’s novel GBS vaccine through phase 2 clinical trials, as well as manufacturing and regulatory preparation for phase 3. GBS is responsible for nearly half of all life-threatening infections in newborns. The post Minervax raises €47.4m
STRIDE regimen of a single priming dose of tremelimumab added to Imfinzi is the first dual immune checkpoint blockade regimen to improve overall survival in a Phase III trial in this setting. Tremelimumab blocks the activity of CTLA-4, contributing to T-cell activation, priming the immuneresponse to cancer and fostering cancer cell death.
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 Pfizer-BioNTech COVID-19 Vaccine may not protect all vaccine recipients.
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. Procedures should be in place to avoid injury from fainting.
A breakdown of the diversity of clinical trial participants can be found here from approximately 150 clinical trials sites in the U.S., 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.
“We are encouraged by the data shown in these two studies of GPS in combination with checkpoint inhibitors and look forward to additional data from these studies,” stated Dragan Cicic, MD, Senior Vice President, ClinicalDevelopment of SELLAS. “We Kenilworth, N.J.,
Together, these nine companies have collectively developed more than 70 novel vaccines that have helped to eradicate some of the world’s most complex and deadly public health threats, underscoring their experience in clinicaldevelopment and regulatory rigor, as well as their longstanding commitments to patient safety and public health.
Together, these nine companies have collectively developed more than 70 novel vaccines that have helped to eradicate some of the world’s most complex and deadly public health threats, underscoring their experience in clinicaldevelopment and regulatory rigor, as well as their longstanding commitments to patient safety and public health.
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