pharmaphorum

JANUARY 4, 2023

The hypothesis is that it will induce immune tolerance by stimulating anti-inflammatory regulatory T- (Treg) cells and cytokines that dampen down the immune response. 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.

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Drug Discovery World

MARCH 24, 2023

dendritic cells, monocytes) triggers a broad immune response that includes significant increases in cytotoxic CD8 plus T cells armed with chemo-induced tumour antigens to target cancer. This synergy was demonstrated by the AIPAC Phase IIb trial’s encouraging efficacy and safety, including a over 2.9-month

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pharmaphorum

FEBRUARY 8, 2022

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 clinical development for gene therapies Weston Miller. Shares in the drugmaker rose just over 1% after the FORTIS data was announced.

Gene Therapy 52

Gene Therapy Gene Immune Response Licensing 52

The Pharma Data

MARCH 11, 2021

Clinical trial to assess safety, immune response 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.

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pharmaphorum

DECEMBER 15, 2020

Proceeds will advance the clinical development 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

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The Pharma Data

AUGUST 6, 2020

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 clinical development.

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The Pharma Data

OCTOBER 19, 2020

Immune responses 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.

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The Pharma Data

MARCH 29, 2022

Evusheld significantly reduced the risk of developing symptomatic COVID-19 in PROVENT Phase III trial, with protection lasting at least six months Evusheld retains neutralising activity against the Omicron BA.2 2 subvariant, now the dominant strain in Europe. 1-3 Evusheld was generally well-tolerated in the trial. W911QY-21-9-0001.

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Pfizer

FEBRUARY 16, 2023

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.

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The Pharma Data

DECEMBER 20, 2020

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, Clinical Development of SELLAS. “We NEW YORK, Dec. 21, 2020 (GLOBE NEWSWIRE) — SELLAS Life Sciences Group, Inc.

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The Pharma Data

DECEMBER 11, 2020

Pfizer and BioNTech expect to file a Biologics License Application for possible full regulatory approval in 2021. 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.

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The Pharma Data

MAY 6, 2021

The Pfizer-BioNTech COVID-19 Vaccine, which is based on BioNTech proprietary mRNA technology, was developed by both BioNTech and Pfizer. The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S. The Pfizer-BioNTech COVID-19 Vaccine may not protect all vaccine recipients.

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XTalks

SEPTEMBER 5, 2023

Vaccines have been an integral piece of the global public health toolbox for over 200 years, but the COVID-19 pandemic brought about a new era in vaccine development with renewed interest in mRNA technology and unprecedented accelerated regulatory approvals. What are the major challenges you’re facing right now in vaccine development?

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The Pharma Data

JULY 21, 2021

To facilitate Biovac’s involvement in the process, technical transfer, on-site development and equipment installation activities will begin immediately. We believe that our mRNA technology can be used to develop vaccine candidates addressing other diseases as well. CEO and Co-founder of BioNTech. “We

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Manufacturing Vaccination Vaccine Clinical Trials 52

The Pharma Data

JANUARY 4, 2021

. Kiromic’s deep understanding of the tumor micro environment (TME) and the tumors’ escape and masking mechanisms led to development of a promising platform for chimeric antigen receptor therapy (CAR-T). We believe our allogenic CAR-T platform is significantly stronger with chPD1 target licensed from Longwood University.

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The Pharma Data

SEPTEMBER 9, 2020

We would like to thank the European Commission for its commitment and confidence in our development efforts,” said Albert Bourla, Chairman and CEO, Pfizer. “We Our aim is to develop a safe and effective vaccine to contribute to bringing this pandemic to an end in Europe and across the world. CEO and Co-founder of BioNTech.

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The Pharma Data

DECEMBER 29, 2020

(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).

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The Pharma Data

AUGUST 20, 2020

T cell immune responses elicited by BNT162b2 are being evaluated in the German study and the companies expect to submit the data for peer review and potential publication. Senior Vice President and Head of Vaccine Research & Development, Pfizer. “We This press release features multimedia. View the full release here: [link].

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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. Emergency Use Authorization .

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The Pharma Data

OCTOBER 28, 2020

“We continue to see the strongest effects in patients who are most at risk for poor outcomes due to high viral load, ineffective antibody immune response at baseline, or pre-existing risk factors. Senior Vice President and Head of Global Clinical Development at Regeneron. Yancopoulos , M.D., combined dose groups; 6.5%

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The Pharma Data

FEBRUARY 22, 2021

(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.

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The Pharma Data

SEPTEMBER 8, 2020

Nine CEOs sign historic pledge to continue to make the safety and well-being of vaccinated individuals the top priority in development of the first COVID-19 vaccines. FDA has established clear guidance for the development of COVID-19 vaccines and clear criteria for their potential authorization or approval in the US.

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The Pharma Data

DECEMBER 17, 2020

Senior Vice President and Head of Global Clinical Development at Regeneron and lead author of the publication. patients under an Emergency Use Authorization, and we also continue a robust clinical development program.” and Roche will develop, manufacture and distribute it outside of the U.S.

Antibody 52

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The Pharma Data

DECEMBER 10, 2020

Senior Vice President and Head of Vaccine Research & Development, Pfizer. “As A breakdown of the diversity of clinical trial participants can be found here from approximately 150 clinical trials sites in the U.S., Jansen, Ph.D., Germany, Turkey, South Africa, Brazil and Argentina.

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The Pharma Data

SEPTEMBER 8, 2020

— Nine CEOs sign historic pledge to continue to make the safety and well-being of vaccinated individuals the top priority in development of the first COVID-19 vaccines. FDA has established clear guidance for the development of COVID-19 vaccines and clear criteria for their potential authorization or approval in the US.

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The Pharma Data

NOVEMBER 29, 2020

NASDAQ: HOOK, ‘HOOKIPA’), a company developing a new class of immunotherapeutics based on its proprietary arenavirus platform, today announced positive interim efficacy results, as well as additional safety and immunogenicity data, for its prophylactic Cytomegalovirus (CMV) vaccine candidate HB-101. NEW YORK and VIENNA, Austria, Nov.

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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 1 as compared to the companies’ current COVID-19 vaccine. Emergency Use Authorization.

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The Pharma Data

OCTOBER 14, 2020

Potential Development of Human Monoclonal Antibody Therapeutics to SARS-CoV-2. The research is part of an ongoing collaboration between Columbia University and Tonix that focuses on T cell and antibody responses to SARS-CoV-2 (CoV-2), the virus that causes COVID-19. CHATHAM, N.J., 1 Noyce RS, et al. 2018) PLoS One.

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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. COMIRNATY, which is based on BioNTech’s proprietary mRNA technology, was developed by both BioNTech and Pfizer. Emergency Use Authorization.

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Pfizer

JULY 8, 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. NEW YORK and MAINZ, GERMANY, July 8, 2022 — Pfizer Inc. have completed a primary series.

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The Pharma Data

JANUARY 31, 2021

Gilead and Gritstone will develop an HIV-specific therapeutic vaccine using Gritstone’s proprietary prime-boost vaccine platform, comprised of self-amplifying mRNA (SAM) and adenoviral vectors, with antigens developed by Gilead. Curing HIV remains the ultimate aspiration for Gilead’s HIV research and development efforts.

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Vaccination Vaccine Clinical Trials Clinical Trials 52

The Pharma Data

SEPTEMBER 9, 2020

“Collectively, these preclinical results, combined with our clinical data collected to date, continue to support the promise and validity of our mRNA-based vaccine program against SARS-CoV-2 and selection of the BNT162b2 candidate, which we believe has the potential to prevent many millions of COVID-19 cases,” said Kathrin U. Jansen, Ph.D.,

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The Pharma Data

DECEMBER 20, 2020

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 clinical development. LUND, Sweden and STRASBOURG, France , Dec.

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Trials Antibody Clinical Trials Clinical Trials 52

The Pharma Data

APRIL 26, 2022

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. 5 Chronic liver diseases are associated with inflammation that over time can lead to the development of HCC.5.

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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. Many drug makers are investing in new science and hope to develop new therapeutics that address autoimmune disease. The cause of many of the diseases is unknown. . Inflammatory Overreaction.

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The Pharma Data

SEPTEMBER 15, 2020

(NYSE: PFE) provided an extensive overview of pipeline advances and shared updates on the Company’s efforts to battle the COVID-19 pandemic on multiple fronts, including new data on the BNT162b2 vaccine candidate being developed in collaboration with BioNTech SE. UPDATES ON COVID-19 DEVELOPMENT PROGRAMS.

Gene Therapy 52

Gene Therapy Vaccination Vaccine Trials 52

Pfizer

NOVEMBER 2, 2022

The vaccine candidate combines Pfizer’s quadrivalent modRNA-based influenza vaccine candidate, qIRV (22/23), which is currently in Phase 3 clinical development , and Pfizer and BioNTech’s authorized Omicron-adapted bivalent COVID-19 BNT162b2 (Original/Omicron BA.4/BA.5) The companies will share the development costs.

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