The Pharma Data

JULY 18, 2021

Clinical Data Supporting Approval Demonstrated Non-Inferior Immune Responses for the Serotypes Shared with PCV13 (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F). VAXNEUVANCE Elicited Superior Immune Responses for Serotypes 3, 22F and 33F Compared to PCV13, Which Are Major Causes of Disease.

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Drug Discovery World

MAY 6, 2024

A more established Amsterdam-based enterprise is gene therapy company uniQure, developer of etranacogene dezaparvovec, the first gene therapy for haemophilia B, which was approved for use in the US in November 2022 and in the EU in February 2023. The CDD will sponsor and manage KWF-supported trials.

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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.

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The Pharma Data

DECEMBER 11, 2020

FDA authorizes COVID-19 mRNA vaccine for emergency use; companies are prepared to deliver first doses in the U.S. In collaboration with Operation Warp Speed, Pfizer and BioNTech, as well as other vaccine companies are expected to deliver hundreds of millions of vaccine doses to Americans by the end of 2021.

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The Pharma Data

MAY 6, 2021

Under the MoU, the companies and the IOC will coordinate with National Olympic Committees (NOCs) around the world to understand and work to help address the local need for vaccine doses for national delegations’ participation in the Games. We are proud to play a role in providing vaccines to athletes and national Olympic delegations.”.

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The Pharma Data

MAY 7, 2021

The Pfizer-BioNTech COVID-19 Vaccine is currently available in the U.S. Since then, the companies have delivered more than 170 million doses of the vaccine across the U.S. We are proud of the tremendous progress we’ve made since December in delivering vaccines to millions of Americans, in collaboration with the U.S.

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The Pharma Data

AUGUST 20, 2020

times the GMT of a panel of 38 sera of SARS-CoV-2 convalescent patients, and in older adults (65-85 years of age) the vaccine candidate elicited a neutralizing GMT 1.6 study of the BNT162 mRNA-based vaccine program against SARS-CoV-2, which has advanced into Phase 2/3 evaluation. and Germany. Jansen, Ph.D.,

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The Pharma Data

SEPTEMBER 9, 2020

The vaccine supply for the EU would be produced by BioNTech’s manufacturing sites in Germany and Pfizer’s manufacturing site in Belgium. Deliveries would be starting by the end of 2020, subject to clinical success and regulatory authorization. billion doses by the end of 2021. CEO and Co-founder of BioNTech.

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The Pharma Data

DECEMBER 10, 2020

. Data from 43,448 participants, half of whom received BNT162b2 and half of whom received placebo, showed that the vaccine candidate was well tolerated and demonstrated 95% efficacy in preventing COVID-19 in those without prior infection 7 days or more after the second dose. Jansen, Ph.D.,

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The Pharma Data

NOVEMBER 29, 2020

Early interim data show Cytomegalovirus (CMV)-negative kidney transplant recipients vaccinated with three doses of HB-101 had reduced incidence of CMV viremia, reduced antiviral use and no CMV disease. Observed CMV-neutralizing antibody responses and tolerability profile are consistent with previous interim results.

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The Pharma Data

OCTOBER 14, 2020

APX005M is a novel, humanized monoclonal antibody that stimulates the anti-tumor immune response. APX005M targets CD40, a co-stimulatory receptor that is essential for activating both innate and adaptive immune systems. Additional information on clinical trials for APX005M can be found at www.clinicaltrials.gov.

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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 Calquence binds covalently to BTK, thereby inhibiting its activity.4,5

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The Pharma Data

DECEMBER 20, 2020

In the first study, a phase 1/2 ‘basket’ trial of GPS in combination with the checkpoint inhibitor pembrolizumab (Keytruda), which is conducted under a Clinical Trial Collaboration and Supply Agreement with Merck & Co., Kenilworth, N.J., with a median follow-up of 9.4 Kenilworth, N.J., with a median follow-up of 9.4

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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

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

JANUARY 3, 2021

Thus, our therapeutic approach to provide rapid relief to patients already suffering with the diseases is particularly important, because vaccination is primarily to prevent COVID-19 infection, but it may not be useful for treatment of COVID-19 patients.”. A further announcement will be made in due course.

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LifeSciVC

MAY 9, 2024

These connections provide all-too-important ‘reasons to believe’ for further investment and movement into earlier lines of therapy. However, despite this long winter, new approaches, ranging from CD3 bi-specifics, to cell therapies, to cancer vaccines, and more recent novel intracellular mechanisms have started to turn the tide.

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The Pharma Data

JUNE 25, 2021

In the unprecedented context of at least 13 variants circulating within the study population subset assessed at this interim analysis, CVnCoV demonstrated an interim vaccine efficacy of 47% against COVID-19 disease of any severity and did not meet prespecified statistical success criteria. About CVnCoV.

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The Pharma Data

SEPTEMBER 9, 2020

BNT162b2 immunization prevented lung infection in 100% of the SARS-CoV-2 challenged rhesus macaques, with no viral RNA detected in the lower respiratory tract of immunized and challenged animals. Senior Vice President and Head of Vaccine Research & Development, Pfizer. “We Jansen, Ph.D.,

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Drug Target Review

JULY 17, 2024

How does GigaGen’s single-cell discovery and development platform differ from traditional methods of producing polyclonal antibody therapies? Current methods for producing pAb therapies rely on regular plasma donations for their development.

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Drug Discovery World

MAY 30, 2023

From antibody-drug conjugates and RNA, to CRISPR and CAR-T therapy, DDW asked the drug discovery industry what the most important development in oncology over the last five years has been. Immunopheresis is a ‘subtractive therapy,’ in contrast to alternative drugs that constitute ‘additive’ therapies.

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The Pharma Data

MAY 31, 2022

billion in potential development milestones Proposed acquisition provides access to next-generation 24-valent pneumococcal vaccine candidate in phase II development and highly innovative, MAPS TM technology Supports development of a strong portfolio of innovative vaccines and specialty medicines. GSK to pay $2.1

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The Pharma Data

JUNE 2, 2022

Affinivax is pioneering the development of a novel class of vaccines, the most advanced of which are next-generation pneumococcal vaccines. The number of serotypes in current vaccines is limited due to the degree of immunological interference observed when using existing conjugation technologies.

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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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Drug Discovery World

NOVEMBER 13, 2023

Enkelejda Miho, PhD, Professor, University of Applied Sciences and Arts Northwestern Switzerland, and Managing Director, aiNET, on: ‘The singular immune response to dengue and machine learning identification of antibodies in high-throughput sequences’. It is called, ‘An unexpected future for immune oncology therapies?’

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Drug Target Review

JANUARY 15, 2024

To be therapeutically useful, antigenic peptides must be presented in a way that allows immune responses to destroy cancer cells without causing unacceptable damage to healthy tissue. Engineering soluble T-cell receptors for therapy. Cancer Therapy With TCR‑Engineered T Cells. The FEBS Journal 288:6159–6173 (2021).

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Drug Discovery World

FEBRUARY 15, 2023

Cancer is a complex heterogenous multistep disease characterised by uncontrolled cell proliferation combined with a dysregulated immune response. Existing therapies have been focused on eliminating the cancer cells and/or on preventing its progression by using a combination of chemotherapy, radiotherapy, and surgical approaches.

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The Pharma Data

OCTOBER 14, 2020

Study May Lead to Biomarkers for Tailoring COVID-19 Vaccines and Therapeutics. Potential Development of Human Monoclonal Antibody Therapeutics to SARS-CoV-2. Results from the PRECISION Study Expected in First Half of 2021. CHATHAM, N.J., About TNX-1800. 1 Noyce RS, et al. 2018) PLoS One.

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The Pharma Data

JUNE 26, 2021

BioNTech SE (NASDAQ: BNTX, “BioNTech” or “the Company”), announced that the first patient has been treated in its BNT111 Phase 2 cancer vaccine trial (2020-002195-12; NCT04526899). “Our vision is to harness the power of the immune system against cancer and infectious diseases. About BioNTech.

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The Pharma Data

SEPTEMBER 15, 2020

Major revenue contributions through 2025 anticipated from Oncology, Vaccines, Rare Disease and Inflammation and Immunology. New stability, immunogenicity, and tolerability data for COVID-19 vaccine candidate, BNT162b2, presented. BNT162 mRNA-based Vaccine Program.

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Agency IQ

JUNE 9, 2023

For this reason, animal models are still used both during drug discovery and the more intensive nonclinical studies conducted during clinical development. However, this guideline is primarily intended to provide recommendations on evaluating the immune system’s response to small molecule drugs.

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Drug Discovery World

SEPTEMBER 29, 2022

Vice President, Clinical Development, Infectious Diseases at Moderna examines the data on cytomegalovirus (CMV), why attempts at vaccines for CMV have so far proved elusive and the emerging options to address this unmet need. . Progression of vaccines . Allison August, M.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. The Company’s validated, proprietary F.I.R.S.T

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Drug Target Review

JULY 11, 2023

Spending a couple of years practicing on the wards around London, and then moving into management consulting at McKinsey & Company which led her to work in pharmaceutical research and development (R&D). This level of insight highlights the tantalising potential of diagnostics based on immune repertoires.

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The Pharma Data

OCTOBER 26, 2020

An overall response rate of 23.5% 8 patients achieved confirmed response, including 1 complete response and 7 partial responses (according to RECIST 1.1). Responses were observed in all primary tumor types and across all lines of prior therapy. months versus 0% and a PFS of 1.4

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The Pharma Data

APRIL 4, 2023

Food and Drug Administration (FDA) has approved KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with Padcev (enfortumab vedotin-ejfv) for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (la/mUC) who are not eligible for cisplatin-containing chemotherapy. in these patients.

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