The Pharma Data

SEPTEMBER 2, 2020

Sanofi and GSK have begun a Phase I/II clinical trial testing their adjuvanted COVID-19 vaccine in healthy adults. The vaccine candidate, developed in partnership by the firms, is based on the recombinant protein-based technology used in Sanofi’s seasonal influenza vaccines and GSK’s pandemic adjuvant technology.

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pharmaphorum

DECEMBER 15, 2020

million (around $56 million) in a Series B funding round to take its novel group B streptococcus (GBS) vaccine into mid-stage clinical trials. 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.

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The Pharma Data

DECEMBER 3, 2020

Strong Th1 cell-mediated immune responses were also observed for the vaccine candidates with either adjuvant. Based on the positive Phase 1 results reported and the unprecedented need for COVID-19 vaccines, Clover and its partners are confident to enter late-stage clinical development for both adjuvanted vaccines.

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The Pharma Data

OCTOBER 25, 2020

We are advancing the clinical development of mRNA-1273 with our Phase 3 COVE study, which is now fully enrolled with a representative demography of participants across ages, ethnicities and high-risk populations. For more information about the COVE study, click here. mRNA-1273 currently is not approved for use by any regulatory body.

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pharmaphorum

JANUARY 25, 2021

The company – known as MSD outside North America – said that although the vaccines were well tolerated, the immune responses seen were weaker than natural immunity and those reported for other SARS-CoV-2 vaccines. government to advance the manufacturing and initial distribution of MK-7110.

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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. Vaccine doses for Europe would be produced in BioNTech’s German manufacturing sites, as well as in Pfizer’s manufacturing site in Belgium. billion doses by the end of 2021.

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The Pharma Data

JANUARY 17, 2021

REX-001, Ixaka’s lead MCT product, is an autologous cell-based product in clinical development for the treatment of CLTI. REX-001 is currently being evaluated in the pivotal Phase III SALAMANDER clinical trial at multiple sites across Europe. A total of $15.4 References 1. About Ixaka.

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The Pharma Data

DECEMBER 10, 2020

The vaccine targeted both the inner nucleocapsid (N) and the outer spike (S) proteins of the virus to maximize the immune response. The study showed this broad immune response led to the complete clearance of the virus in a matter of days after infection of previously-vaccinated primates. and its affiliate NantKwest, Inc.

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The Pharma Data

DECEMBER 11, 2020

Pfizer and BioNTech appreciate the continued participation of the approximately 44,000 trial volunteers and remain committed to the companies’ pledge to always make their safety and well-being the companies’ top priority. Manufacturing and Delivery Capabilities. About the Phase 2/3 Study. Pfizer is leveraging three of its U.S.

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The Pharma Data

MAY 7, 2021

Pfizer and BioNTech initiated the BLA by submitting the nonclinical and clinical data needed to support licensure of the COVID-19 vaccine for use in individuals 16 years of age and older. The companies will submit the required manufacturing and facility data for licensure in the coming weeks to complete the BLA.

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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.

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The Pharma Data

AUGUST 20, 2020

The companies are continuing to analyze data from the Phase 1 trials in the U.S. 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. This press release features multimedia. View the full release here: [link].

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The Pharma Data

DECEMBER 10, 2020

The ongoing Phase 3 clinical trial of BNT162b2, which is based on BioNTech’s proprietary mRNA technology, has enrolled more than 44,000 participants, the vast majority of whom have received their second dose. About the Phase 2/3 Study. Germany, Turkey, South Africa, Brazil and Argentina.

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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., The trial is currently evaluating patients with ovarian cancer (second or third line).

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XTalks

MARCH 13, 2023

The US Food and Drug Administration’s (FDA) Office of Tissues and Advanced Therapies (OTAT) held a recent town hall where three experts from the regulator provided guidance on how to design and conduct gene therapy clinical trials for rare diseases. All except for Adstiladrin were cleared for rare disease indications.

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The Pharma Data

OCTOBER 27, 2020

Adagrasib is an investigational small molecule and selective KRAS G12C inhibitor in clinical development as a monotherapy and in combinations. MRTX1133 is an investigational small molecule and selective KRAS G12D inhibitor in preclinical development. Forward-Looking Statements.

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The Pharma Data

MAY 6, 2021

Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to the Pfizer-BioNTech COVID-19 Vaccine. Severe allergic reactions have been reported following the Pfizer-BioNTech COVID-19 Vaccine during mass vaccination outside of clinical trials.

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The Pharma Data

SEPTEMBER 8, 2020

More specifically, the agency requires that scientific evidence for regulatory approval must come from large, high quality clinical trials that are randomized and observer-blinded, with an expectation of appropriately designed studies with significant numbers of participants across diverse populations.

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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. Results showed no significant difference in virologic or clinical efficacy between the REGN-COV2 high dose (8 grams) and low dose (2.4

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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. In the U.S.

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The Pharma Data

DECEMBER 27, 2020

This year has been difficult, but it has reinforced the importance of our mission: to treat and potentially even reverse the effects of serious diseases and conditions by advancing our novel cell therapy product candidates through clinical trials and into the hands of physicians.

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The Pharma Data

SEPTEMBER 8, 2020

More specifically, the agency requires that scientific evidence for regulatory approval must come from large, high quality clinical trials that are randomized and observer-blinded, with an expectation of appropriately designed studies with significant numbers of participants across diverse populations. About AstraZeneca. AstraZeneca.

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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.

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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.

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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. 1 Gilbert C and Boivin G.

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The Pharma Data

SEPTEMBER 25, 2020

Johnson & Johnson Posts Interim Results from Phase 1/2a Clinical Trial of its Janssen COVID-19 Vaccine Candidate. Johnson & Johnson Posts Interim Results from Phase 1/2a Clinical Trial of its Janssen COVID-19 Vaccine Candidate. Immune responses were similar across the age groups studied, including older adults.

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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.

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XTalks

SEPTEMBER 5, 2023

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.

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Pfizer

JULY 8, 2022

Favorable safety profile observed across more than 2,200 adolescents who participated in the clinical trial. Today’s approval is based on data from a Phase 3 clinical trial of 2,260 participants 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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Pfizer

JULY 8, 2022

In the trial, children received the third 3-µg dose at least two months after the second dose at a time when Omicron was the predominant variant. 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.

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The Pharma Data

JUNE 26, 2021

BNT111 is the lead product candidate from BioNTech’s FixVac platform that targets a fixed combination of mRNA-encoded, tumor-associated antigens with the objective of triggering a strong and precise immune response against cancer and is fully owned by BioNTech. About FixVac. About BioNTech.

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The Pharma Data

JUNE 2, 2022

A 30-plus valent pneumococcal candidate vaccine is also in pre-clinical development. We look forward to working with the many talented people at Affinivax to combine our industry-leading development, manufacturing, and commercialisation capabilities to make this exciting new technology available to those in need.”

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The Pharma Data

MAY 31, 2022

A 30-plus valent pneumococcal candidate vaccine is also in pre-clinical development. We look forward to working with the many talented people at Affinivax to combine our industry-leading development, manufacturing, and commercialisation capabilities to make this exciting new technology available to those in need.”.

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The Pharma Data

SEPTEMBER 9, 2020

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? The study is an event-driven trial.

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The Pharma Data

JANUARY 31, 2021

Delivery of viral antigens in potent vaccine vectors to elicit a strong immune response is a cornerstone of successful infectious disease vaccines,” said Karin Jooss, PhD, Executive Vice President of Research and Chief Scientific Officer of Gritstone.

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XTalks

AUGUST 18, 2021

Of important note is the aberrant immune response that occurs in patients with COVID-19, including the intensive release of cytokines (cytokine storm), which can make a patient infected with SARS-CoV2 more susceptible to contracting a bacterial respiratory infection.

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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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