The Pharma Data

NOVEMBER 9, 2020

(Nasdaq: NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for NVX-CoV2373, the Company’s COVID-19 vaccine candidate. President of Research and Development, Novavax.

Vaccine 52

Vaccine FDA Clinical Trials Immune Response 52

The Pharma Data

DECEMBER 10, 2020

–( BUSINESS WIRE )– ImmunityBio , a privately-held immunotherapy company, today announced its COVID-19 vaccine candidate protected nasal and lung airways of non-human primates against coronavirus (SARS-CoV-2) in a challenge study. 11, 2020 02:48 UTC. CULVER CITY, Calif.–(

Vaccine 52

Vaccine Immune Response Virus Clinical Trials 52

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.

Vaccine 52

Vaccine Immune Response Disease Clinical Trials 52

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.

Vaccine 52

Vaccine Licensing Licensing Immune Response 52

The Pharma Data

JANUARY 31, 2021

Adjuvanted S-Trimer COVID-19 vaccine candidates demonstrated favorable safety and tolerability profiles and strong neutralizing immune responses in a phase 1 trial. The candidate vaccines were given in two doses, three weeks apart. CHENGDU, China , Feb. CHENGDU, China , Feb.

Clinical Trials 52

Clinical Trials Vaccine Trials Virus 52

The Pharma Data

OCTOBER 25, 2020

We appreciate the confidence of the Ministry of Health of Qatar in our mRNA vaccine platform and the collaboration we have had to date,” said Stéphane Bancel, Moderna’s Chief Executive Officer. “We Moderna currently has strategic alliances for development programs with AstraZeneca PLC and Merck & Co., About Moderna.

Vaccine 52

Vaccine Clinical Development RNA Clinical Trials 52

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.

Disease 52

Disease Immune Response Vaccine FDA Approval 52

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.

Drug Development 162

Drug Development Research Clinical Trials Drugs 162

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.

Vaccine 52

Vaccine Clinical Trials Licensing Licensing 52

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.

Vaccine 52

Vaccine Clinical Trials Licensing Licensing 52

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.,

Vaccine 52

Vaccine Clinical Trials Trials Immune Response 52

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.”.

Vaccine 52

Vaccine Clinical Trials Licensing Licensing 52

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 52

Licensing Licensing Vaccine FDA Approval 52

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.

Vaccine 52

Vaccine Clinical Trials Trials Government 52

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.,

Vaccine 52

Vaccine Trials Clinical Trials Therapies 52

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.

Treatment 40

Treatment Immune Response Clinical Trials Clinical Development 40

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.

Vaccine 52

Vaccine Clinical Trials Disease Trials 52

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.

Vaccine 52

Vaccine Virus Immune Response Government 52

Drug Discovery World

MAY 6, 2024

Professor Dr Carla van Gils, Director of KWF, comments: “Many of academia’s most innovative agents can be difficult to bring into clinical development. Partnering with the Centre for Drug Development enables us to jump into the bench-to-bedside gap and fast track academic findings into clinical trials.

Drugs 147

Drugs Science Molecular Biology Clinical Trials 147

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

Trials 52

Trials Clinical Trials Immune Response FDA Approval 52

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.

Science 52

Science Vaccine Clinical Trials Pharmaceutical Companies 52

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.

Science 52

Science Vaccine Clinical Trials Pharmaceutical Companies 52

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.,

Immune Response 52

Immune Response Clinical Trials Therapies Trials 52

The Pharma Data

JANUARY 20, 2021

INOVIO intends to use the net proceeds from this offering for the development of its clinical pipeline, including clinical development expenses relating to INO-4800 and research and development expenses, and for general corporate purposes, including working capital and general and administrative expenses.

DNA 40

DNA Immune Response Disease Clinical Trials 40

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.

Clinical Trials 40

Clinical Trials Science Treatment Trials 40

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.

Vaccine 52

Vaccine Trials Immune Response Virus 52

LifeSciVC

MAY 9, 2024

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. Another promising approach to I-O is cancer vaccines. While early, these data demonstrate clear promise to advance this modality.

Immune Response 76

Immune Response Vaccine Therapies Engineering 76

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.,

Vaccine 52

Vaccine RNA Clinical Trials Immune Response 52

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

Vaccine 52

Vaccine Immune Response Clinical Trials Disease 52

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.

Vaccine 52

Vaccine Immune Response Clinical Trials Disease 52

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.

Vaccine 52

Vaccine Science Clinical Trials Licensing 52

Drug Target Review

JULY 17, 2024

While current polyclonal antibody (pAb) therapies are derived from plasma, GigaGen has developed single-cell discovery and development platforms to produce diverse and potent recombinant pAb therapies that are made in the laboratory.

Immune Response 59

Immune Response Laboratories Therapies Vaccine 59

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.

Clinical Trials 52

Clinical Trials Vaccine Trials Immune Response 52

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.

Vaccine 40

Vaccine Pharmaceuticals Small Molecule Virus 40

PerkinElmer

JANUARY 25, 2023

To help make more timely and informed clinical candidate decisions going forward, scientists need to be able to securely, intuitively, and quickly find, analyze and share critical discovery-stage data, as well as do reliable predictive analysis. These same challenges and needs also extend from research and discovery to clinical development.

Science 52

Science Laboratories Immune Response Disease 52

Drug Discovery World

MAY 30, 2023

Very recent data from Moderna’s and BioNTech’s personalised vaccines in combination with ICIs in melanoma and pancreatic cancer respectively have shown dramatic improvements when given as part of a triple combination (vaccine plus ICI and chemo/radiotherapy).

Research 130

Research Targeted Protein Degradation Drugs RNA 130

Creative Biolabs

JULY 12, 2020

They are currently working with Boehringer Ingelheim to further identify and develop these antibodies. They are expected to enter clinical development later this year. ” The researchers studied the SARS-CoV-2 antibody response of 12 people who recovered from COVID-19. .”

Immune Response 52

Immune Response Laboratories Clinical Trials Virus 52