Clinical Development, Immune Response, Licensing and Vaccine

Evaxion and ExpreS²ion partner to develop new CMV vaccine

Pharmaceutical Technology

DECEMBER 6, 2022

Evaxion Biotech and ExpreS 2 ion Biotechnologies have entered a vaccine discovery collaboration agreement to co-develop a new cytomegalovirus (CMV) vaccine candidate. Until 2025, the companies will equally share the research and intellectual property licensing expenses under the partnership.

Vaccination

Vaccination Vaccine Development Immune Response

Merck and Moderna to jointly develop personalised cancer vaccine

Drug Discovery World

NOVEMBER 8, 2022

Merck has exercised its option to jointly develop and commercialise personalised cancer vaccine (PCV) mRNA-4157/V940 pursuant to the terms of its existing collaboration and license agreement with Moderna. .

Vaccination

Vaccination Vaccine Development Immune Response

Pfizer and BioNTech Initiate Rolling Submission of Biologics License Application for U.S. FDA Approval of Their COVID 19 Vaccine

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.

Licensing

Licensing Licensing Vaccination Vaccine

Sanofi and Translate Bio initiate Phase 1/2 clinical trial of mRNA COVID-19 vaccine candidate

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.

Clinical Trials

Clinical Trials Clinical Trials Vaccination Vaccine

AstraZeneca takes COVID-19 vaccine to China with BioKangtai deal for 200M-dose capacity by 2021

The Pharma Data

AUGUST 6, 2020

We pointed out last week that China was a notable missing element in AstraZeneca’s COVID-19 vaccine strategy, despite being the drugmaker’s second-largest market. The pair will also explore the possibility of producing the vaccine for other markets. The vaccine was moved into phase 2/3 in May. That has changed.

Vaccination

Vaccination Vaccine Antibody Licensing

Pfizer and Valneva Issue Update on Phase 3 Clinical Trial Evaluating Lyme Disease Vaccine Candidate VLA15

Pfizer

FEBRUARY 16, 2023

who had been enrolled in the Vaccine Against Lyme for Outdoor Recreationists (VALOR) (NCT05477524) Phase 3 clinical study. The study is investigating the efficacy, safety and immunogenicity of an investigational Lyme disease vaccine candidate, VLA15.

Clinical Trials

Clinical Trials Clinical Trials Vaccination Vaccine

Merck Announces Positive Topline Results from Two Additional Phase 3 Adult Studies Evaluating V114, Merck’s Investigational 15-valent Pneumococcal Conjugate Vaccine

The Pharma Data

OCTOBER 19, 2020

.–( BUSINESS WIRE )– Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced findings from two additional Phase 3 studies evaluating the safety, tolerability and immunogenicity of V114, the company’s investigational 15-valent pneumococcal conjugate vaccine. among adults 65 years of age or older.

Vaccination

Vaccination Vaccine Immune Response Containment

Minervax raises €47.4m in Series B funding round for GBS shot

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. MinervaX is one company that wants to change this situation, which aims to prevent the spread of GBS infections using a vaccine instead of using an antibacterial agent.

Bacteria

Bacteria Vaccination Vaccine Immune Response

Pfizer and BioNTech Celebrate Historic First Authorization in the U.S. of Vaccine to Prevent COVID-19

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.

Vaccination

Vaccination Vaccine Clinical Trials Clinical Trials

Pfizer and BioNTech to Provide COVID-19 Vaccine Doses for Olympic Athletes at the 2020 Tokyo Games

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.”.

Vaccination

Vaccination Vaccine Clinical Trials Clinical Trials

PFIZER AND BIONTECH ANNOUNCE COLLABORATION WITH BIOVAC TO MANUFACTURE AND DISTRIBUTE COVID-19 VACCINE DOSES WITHIN AFRICA

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.

Manufacturing

Manufacturing Vaccination Vaccine Clinical Trials

Pfizer and BioNTech Share Positive Early Data on Lead mRNA Vaccine Candidate BNT162b2 Against COVID-19

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.,

Vaccination

Vaccination Vaccine Clinical Trials Clinical Trials

Pfizer and BioNTech Advance COVID-19 Vaccine Strategy With Study Start of Next-Generation Vaccine Candidate Based on Enhanced Spike Protein Design

Pfizer

JULY 26, 2022

Pfizer and BioNTech Advance COVID-19 Vaccine Strategy With Study Start of Next-Generation Vaccine Candidate Based on Enhanced Spike Protein Design. Pfizer and BioNTech Advance COVID-19 Vaccine Strategy With Study Start of Next-Generation Vaccine Candidate Based on Enhanced Spike Protein Design. deliesschef.

Vaccination

Vaccination Vaccine Protein Immune Response

Pfizer and BioNTech to Potentially Supply the EU with 200 Million Doses of mRNA-based Vaccine Candidate Against SARS-CoV-2

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.

Vaccination

Vaccination Vaccine Clinical Trials Clinical Trials

Pfizer and BioNTech Announce Publication of Results from Landmark Phase 3 Trial of BNT162b2 COVID-19 Vaccine Candidate in The New England Journal of Medicine

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.,

Vaccination

Vaccination Vaccine Trials Medicine

HOOKIPA Announces Positive Phase 2 Interim Safety, Immunogenicity, and Efficacy Data for its Cytomegalovirus Vaccine Candidate HB-101

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.

Vaccination

Vaccination Vaccine Clinical Trials Clinical Trials

2023 cancer research highlights: Drug development at its best

Drug Discovery World

FEBRUARY 28, 2024

With the safety of MOv18 IgE having been established in cancer patients, biotechnology company Epsilogen has licensed the drug and will continue its clinical development following this successful clinical trial.

Development

Development Research Drugs Antibody

Evusheld long-acting antibody combination approved in the EU for pre-exposure prophylaxis (prevention) of COVID-19 in a broad population

The Pharma Data

MARCH 29, 2022

Evusheld has the potential to provide long-lasting protection against COVID-19 for a broad population of individuals, including those who aren’t adequately protected by a COVID-19 vaccine, as well as those at increased risk of exposure.”. 1-3 Evusheld was generally well-tolerated in the trial.

Antibody

Antibody In-Vivo Vaccination Vaccine

Pfizer and BioNTech Complete Submission to European Medicines Agency for Omicron BA.1 Adapted Bivalent Vaccine Candidate

Pfizer

JULY 19, 2022

1 Adapted Bivalent Vaccine Candidate. 1 Adapted Bivalent Vaccine Candidate. NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced they have completed a submission to the European Medicines Agency (EMA) for an Omicron-adapted bivalent COVID-19 vaccine candidate, based on the BA.1 Tue, 07/19/2022 - 11:22. Booster Series.

Vaccination

Vaccination Vaccine Medicine Clinical Trials

Pfizer and BioNTech Announce U.S. FDA Approval of their COVID-19 Vaccine COMIRNATY® For Adolescents 12 through 15 Years of Age

Pfizer

JULY 8, 2022

FDA Approval of their COVID-19 Vaccine COMIRNATY® For Adolescents 12 through 15 Years of Age. FDA Approval of their COVID-19 Vaccine COMIRNATY® For Adolescents 12 through 15 Years of Age. The vaccine was previously made available to this age group in the U.S. Fri, 07/08/2022 - 11:48. Pfizer and BioNTech Announce U.S.

FDA Approval

FDA Approval Vaccination Vaccine Clinical Trials

Pfizer and BioNTech Submit a Variation to EMA for the Vaccination of Children 6 Months to less than 5 Years with COMIRNATY®

Pfizer

JULY 8, 2022

Pfizer and BioNTech Submit a Variation to EMA for the Vaccination of Children 6 Months to less than 5 Years with COMIRNATY®. Pfizer and BioNTech Submit a Variation to EMA for the Vaccination of Children 6 Months to less than 5 Years with COMIRNATY®. Pfizer-BioNTech COVID-19 Vaccine is FDA authorized to provide: Primary Series.

Vaccination

Vaccination Vaccine Clinical Trials Clinical Trials

GSK’s Maria Reyes Boceta-Muñoz Talks Vaccine Development in a Post-Pandemic World

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.

Vaccination

Vaccination Vaccine Development Clinical Trials

Biopharma Leaders Unite To Stand With Science

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.

Vaccination

Vaccination Vaccine Containment Clinical Trials

Biopharma Leaders Unite To Stand With Science

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.

Vaccination

Vaccination Vaccine Containment Clinical Trials

SELLAS Announces Promising Initial Clinical Data for Galinpepimut-S (GPS) in Combination with Checkpoint Inhibitors in Two Solid Tumor Indications

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 Kenilworth, N.J.,

Life Science

Life Science Immune Response Trials Clinical Trials

Gilead Sciences and Gritstone Announce Collaboration Utilizing Gritstone’s Vaccine Platform Technology for HIV Cure

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.

Vaccination

Vaccination Vaccine Clinical Trials Clinical Trials

Pfizer and BioNTech Announce Data from Preclinical Studies of mRNA-based Vaccine Candidate Against COVID-19

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.,

Vaccination

Vaccination Vaccine RNA Clinical Trials

Tonix Pharmaceuticals Enrolls First Participant in the PRECISION Study, an Observational Study to Facilitate Development of Precision Medicine Techniques for COVID-19 Vaccines and Therapeutics

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.

Vaccination

Vaccination Vaccine Development Medicine

Pfizer and BioNTech Initiate Phase 1 Study of Single Dose mRNA-Based Combination Vaccine Candidate for Influenza and COVID-19

Pfizer

NOVEMBER 2, 2022

Pfizer and BioNTech Initiate Phase 1 Study of Single Dose mRNA-Based Combination Vaccine Candidate for Influenza and COVID-19. Pfizer and BioNTech Initiate Phase 1 Study of Single Dose mRNA-Based Combination Vaccine Candidate for Influenza and COVID-19. Wed, 11/02/2022 - 15:44. Thursday, November 03, 2022 - 06:45am. Ugur Sahin, M.D.,

Vaccination

Vaccination Vaccine Clinical Trials Clinical Trials

Pfizer Investor Day Features Significant Number of Pipeline Advances for COVID-19 Programs and Across Numerous Therapeutic Areas

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.

Gene Therapy

Gene Therapy Vaccination Vaccine Trials

BioInvent and Transgene receive CTA approval for Phase l/lla trial of oncolytic virus BT-001 in solid tumors

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

Trials

Trials Antibody Clinical Trials Clinical Trials

Clinical Research Informer

Evaxion and ExpreS²ion partner to develop new CMV vaccine

Merck and Moderna to jointly develop personalised cancer vaccine

Trending Sources

Pfizer and BioNTech Initiate Rolling Submission of Biologics License Application for U.S. FDA Approval of Their COVID 19 Vaccine

Sanofi and Translate Bio initiate Phase 1/2 clinical trial of mRNA COVID-19 vaccine candidate

AstraZeneca takes COVID-19 vaccine to China with BioKangtai deal for 200M-dose capacity by 2021

Pfizer and Valneva Issue Update on Phase 3 Clinical Trial Evaluating Lyme Disease Vaccine Candidate VLA15

Merck Announces Positive Topline Results from Two Additional Phase 3 Adult Studies Evaluating V114, Merck’s Investigational 15-valent Pneumococcal Conjugate Vaccine

Minervax raises €47.4m in Series B funding round for GBS shot

Pfizer and BioNTech Celebrate Historic First Authorization in the U.S. of Vaccine to Prevent COVID-19

Pfizer and BioNTech to Provide COVID-19 Vaccine Doses for Olympic Athletes at the 2020 Tokyo Games

PFIZER AND BIONTECH ANNOUNCE COLLABORATION WITH BIOVAC TO MANUFACTURE AND DISTRIBUTE COVID-19 VACCINE DOSES WITHIN AFRICA

Pfizer and BioNTech Share Positive Early Data on Lead mRNA Vaccine Candidate BNT162b2 Against COVID-19

Pfizer and BioNTech Advance COVID-19 Vaccine Strategy With Study Start of Next-Generation Vaccine Candidate Based on Enhanced Spike Protein Design

Pfizer and BioNTech to Potentially Supply the EU with 200 Million Doses of mRNA-based Vaccine Candidate Against SARS-CoV-2

Pfizer and BioNTech Announce Publication of Results from Landmark Phase 3 Trial of BNT162b2 COVID-19 Vaccine Candidate in The New England Journal of Medicine

HOOKIPA Announces Positive Phase 2 Interim Safety, Immunogenicity, and Efficacy Data for its Cytomegalovirus Vaccine Candidate HB-101

2023 cancer research highlights: Drug development at its best

Evusheld long-acting antibody combination approved in the EU for pre-exposure prophylaxis (prevention) of COVID-19 in a broad population

Pfizer and BioNTech Complete Submission to European Medicines Agency for Omicron BA.1 Adapted Bivalent Vaccine Candidate

Pfizer and BioNTech Announce U.S. FDA Approval of their COVID-19 Vaccine COMIRNATY® For Adolescents 12 through 15 Years of Age

Pfizer and BioNTech Submit a Variation to EMA for the Vaccination of Children 6 Months to less than 5 Years with COMIRNATY®

GSK’s Maria Reyes Boceta-Muñoz Talks Vaccine Development in a Post-Pandemic World

Biopharma Leaders Unite To Stand With Science

Biopharma Leaders Unite To Stand With Science

SELLAS Announces Promising Initial Clinical Data for Galinpepimut-S (GPS) in Combination with Checkpoint Inhibitors in Two Solid Tumor Indications

Gilead Sciences and Gritstone Announce Collaboration Utilizing Gritstone’s Vaccine Platform Technology for HIV Cure

Pfizer and BioNTech Announce Data from Preclinical Studies of mRNA-based Vaccine Candidate Against COVID-19

Tonix Pharmaceuticals Enrolls First Participant in the PRECISION Study, an Observational Study to Facilitate Development of Precision Medicine Techniques for COVID-19 Vaccines and Therapeutics

Pfizer and BioNTech Initiate Phase 1 Study of Single Dose mRNA-Based Combination Vaccine Candidate for Influenza and COVID-19

Pfizer Investor Day Features Significant Number of Pipeline Advances for COVID-19 Programs and Across Numerous Therapeutic Areas

BioInvent and Transgene receive CTA approval for Phase l/lla trial of oncolytic virus BT-001 in solid tumors

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