Drug Discovery World

FEBRUARY 27, 2024

New studies have demonstrated that Vaxxinity’s vaccine VXX-401 reproducibly lowers low-density lipoprotein cholesterol (LDL-C) in non-human primates. The results support the continued clinical development of VXX-401 as a candidate for the treatment of hypercholesterolemia and prevention of atherosclerotic cardiovascular disease.

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Vaccination Vaccine Antibody Clinical Trials 104

pharmaphorum

DECEMBER 17, 2020

Trials of a fifth COVID-19 vaccine have begun in the UK, as IT issues threaten to delay the roll-out of the shot from Pfizer/BioNTech. France’s Valneva begun the phase 1/2 clinical study of the inactivated vaccine candidate VLA2001 in sites across the UK, supported by the National Institute for Health Research (NIHR).

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Vaccination Vaccine Trials Immune Response 105

Pharma Times

SEPTEMBER 1, 2020

Clinical development of AZD1222 is progressing globally with late-stage clinical trials ongoing in the UK, Brazil and South Africa

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Trials Clinical Trials Clinical Trials Vaccination 125

pharmaphorum

SEPTEMBER 14, 2020

AstraZeneca has resumed UK trials for its coronavirus vaccine, after the country’s medicines regulator gave the all-clear following a safety scare. A UK safety committee has concluded its investigations and recommended to the country’s Medicines and Healthcare products Regulatory Agency (MHRA) that trials are safe to resume.

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Vaccination Vaccine Trials Protein 103

Drug Discovery World

MARCH 30, 2023

Likang Life Sciences has been granted implied approval by China’s National Medical Products Administration (NMPA) for the clinical trial of its innovative personalised neoantigen-targeted vaccine LK101 Injection for advanced solid tumours. Hence, there is a need to increase clinical investigations in this promising area.”

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Regulation Vaccination Vaccine Trials 52

Pharmaceutical Technology

JUNE 10, 2023

Influenza vaccine 2 is under clinical development by Shanghai Institute of Biological Products and currently in Phase I for Pandemic Influenza. GlobalData uses proprietary data and analytics to create drugs-specific PTSR and LoA in the Influenza vaccine 2 LoA Report. Buy the report here.

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Production Vaccination Vaccine Immune Response 100

Pharmaceutical Technology

JUNE 10, 2023

Influenza vaccine 2 is under clinical development by Shanghai Institute of Biological Products and currently in Phase I for Pandemic Influenza. GlobalData uses proprietary data and analytics to create drugs-specific PTSR and LoA in the Influenza vaccine 2 LoA Report. Buy the report here.

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Production Vaccination Vaccine Immune Response 100

Pharmaceutical Technology

JUNE 23, 2022

The US Food and Drug Administration (FDA) has granted approval for Merck's (MSD outside the US and Canada) pneumococcal 15-valent conjugate vaccine, Vaxneuvance, for use in children aged six weeks to 17 years. The post US FDA grants approval for Merck’s pneumococcal vaccine for children appeared first on Pharmaceutical Technology.

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Vaccination Vaccine Immune Response Clinical Trials 147

BioPharma Reporter

MARCH 3, 2021

Convergence towards common global standards for clinical trial application (CTA) rules, along with unilateral and mutual recognition of CTA approvals are some suggestions made by industry insiders in a new paper to enable robust and timely development of vaccines.

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Clinical Development Vaccination Vaccine Development 52

XTalks

MARCH 1, 2021

(NYSE: PFE ) and BioNTech SE (Nasdaq: BNTX ) have announced that they are beginning a trial to evaluate the safety and efficacy of a third booster dose for their COVID-19 vaccine (BNT162b2), as well as new vaccine variants. The study will be a part of current Phase I, II and III trials.

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Vaccination Vaccine Development In-Vitro 111

pharmaphorum

APRIL 19, 2021

The UK’s unique offering as a life sciences research hub helped convince US biotech Novavax to develop its COVID-19 jab there, according to the head of the country’s Vaccines Taskforce. . If you look at the development, we signed 15,000 people in six weeks in a trial set up by the NHS.

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Vaccination Vaccine Manufacturing Clinical Development 141

XTalks

DECEMBER 13, 2023

This episode features an interview with vaccine scientists and executives from Vaccines Global Clinical Development at Merck, Dr. Heather Platt, MD, Distinguished Scientist and Pneumococcal Vaccine Lead; and Dr. Ulrike Buchwald, MD, Scientific Associate Vice President, Global Clinical Research and Pneumococcal Vaccine Section Head.

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Life Science Vaccination Vaccine Scientist 52

Drug Discovery World

AUGUST 12, 2022

Pfizer has launched a Phase III clinical trial of a vaccine to protect people against Lyme disease, in collaboration with pharmaceutical company Valneva. . The trial will enrol up to 6,000 participants aged five years and older and will be conducted across 50 sites where Lyme disease is highly endemic. April 2022.

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Vaccination Vaccine Trials Bacteria 52

pharmaphorum

MARCH 22, 2021

million grant from the European Commission to accelerate clinical development of mRNA therapies for hard-to-treat cancers. mRNA therapies have been in the spotlight since BioNTech and Pfizer used the technology to create a vaccine against COVID-19 last year. Belgian immunotherapy firm eTheRNA has received a €6.9

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Vaccination Vaccine Development Trials 75

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. . KEYNOTE-942 is an ongoing randomised, open-label Phase II trial that enrolled 157 patients with high-risk melanoma.

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Vaccination Vaccine Development Immune Response 52

Pharmaceutical Technology

JULY 1, 2022

The latest filing is based on non-clinical and clinical data for Paxlovid and also comprised data from the Phase II/III EPIC-HR clinical trial. Furthermore, findings from the final trial report showed a relative risk decline of 86%.

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HR Clinical Development Trials Vaccination 264

XTalks

NOVEMBER 6, 2020

Canadian clinical-stage biotech company Symvivo Corporation has developed an oral COVID-19 vaccine that entered clinical trials this week. The first healthy volunteer was dosed with the vaccine in Australia as part of the bacTRL-Spike COVID-19 Phase I clinical trial.

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Clinical Trials Clinical Trials Vaccination Vaccine 75

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.

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Clinical Trials Clinical Trials Vaccination Vaccine 76

pharmaphorum

DECEMBER 4, 2020

Valneva has said it plans to accelerate research into its Lyme disease vaccine candidate VLA15, bringing forward a trial including children into the first quarter of 2021. Pfizer will pay up to $45 million in development related milestone payments and up to $143 million if the vaccine hits early sales targets.

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Vaccination Vaccine Bacterium Protein 118

pharmaphorum

FEBRUARY 10, 2022

AstraZeneca confirmed today that it has discontinued clinical development of a follow-up to its COVID-19 vaccine Vaxzevria targeted at the Beta variant of the virus, which started development before the emergence of the Delta and Omicron strains.

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Vaccination Vaccine Development Immune Response 52

pharmaphorum

MARCH 2, 2022

Pfizer’s vaccine for Clostridium difficile (C. diff) looks like it may join a growing list of candidates that have been shelved or delayed, after the shot failed to meet its primary objective in a phase 3 trial. With no approved vaccines to date, C. First, the bad news. The only other company with a C.

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Vaccination Vaccine Trials Bacterium 52

XTalks

NOVEMBER 4, 2022

Pfizer announced positive top-line data from a Phase III trial evaluating its respiratory syncytial virus (RSV) prefusion vaccine candidate, RSVpreF (or PF-06928316) for pregnant individuals to help protect their infants from RSV disease after birth. Related: Pfizer to Acquire RSV Antiviral Developer ReViral in $525 Million Deal.

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Vaccination Vaccine Clinical Trials Clinical Trials 97

BioPharma Reporter

AUGUST 2, 2021

Arcturus Therapeutics and its Vietnam partner Vinbiocare will take ARCT-154, a next-generation Arcturus vaccine targeting SARS-CoV-2 variants of concern, into a Phase 1/2/3 trial. The companies will also establish a vaccine manufacturing centre in Vietnam.

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Vaccination Vaccine Trials Manufacturing 105

pharmaphorum

DECEMBER 4, 2020

Pfizer slashed its production targets for its COVID-19 vaccine because of a lack of raw materials for its supply chain, according to press reports. The big pharma has said in recent weeks that it expects to produce 50 million doses of the vaccine it developed with the German BioNTech, down from an earlier target of 100 million doses.

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Vaccination Vaccine Production Regulation 125

pharmaphorum

JULY 21, 2022

GSK’s former head of vaccines R&D – Dr Emmanuel Hanon – is heading up a new biotech called Vicebio that will go up against his former employer with a vaccine against respiratory syncytial virus (RSV) infections. ” The post Ex-GSK vaccine chief to lead new UK biotech Vicebio appeared first on. Dr Emmanuel Hanon.

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Vaccination Vaccine Manufacturing Development 104

pharmaphorum

SEPTEMBER 1, 2020

AstraZeneca has expanded development of COVID-19 vaccine AZD1222 into the US, beginning a phase 3 clinical trial across all adult age groups. The UK pharma said that the trial will recruit up to 30,000 adults aged 18 years or over to assess the safety, efficacy and immune response.

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Vaccination Vaccine Trials Immune Response 69

pharmaphorum

OCTOBER 20, 2020

The UK government has signed a contract to develop a controversial COVID-19 human challenge trial, where participants will be deliberately infected in a controlled environment with coronavirus to test whether a vaccine is effective. hVIVO will also be expanding its clinical operations in London to conduct the trial.

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Trials Vaccination Vaccine Clinical Development 98

Drug Discovery World

SEPTEMBER 14, 2023

Evaluating Immatics’ IMA203 TCR-T therapy, targeting PRAME, in combination with Moderna’s PRAME mRNA-based cancer vaccine. Evaluating Immatics’ IMA203 TCR-T therapy, targeting PRAME, in combination with Moderna’s PRAME mRNA-based cancer vaccine.

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Development Vaccination Vaccine In-Vivo 52

pharmaphorum

AUGUST 11, 2020

Russia has become the first country in the world to approve a coronavirus vaccine, amid scepticism from international experts who have been unable to review or verify clinical data from the jab called ‘Sputnik V’ According to press reports the vaccine has been tested on one of President Vladimir Putin’s daughters.

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Vaccination Vaccine Trials Clinical Development 98

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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Vaccination Vaccine Trials Immune Response 52

XTalks

MAY 19, 2023

Clinical trials play a vital role in advancing patient treatment and medical care. This article delves into ten trends and statistics in the world of clinical trials for 2023. Increasing Number of Registered Clinical Trials As of May 17, 2023, there are 452,604 registered clinical trials globally on ClinicalTrials.gov.

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Clinical Trials Clinical Trials Trials Clinical Research 97

Drug Discovery World

DECEMBER 22, 2022

Shelley McLendon , SVP of Vaccine and Infectious Diseases Program Management at ICON, attended the World Vaccine Congress Europe from 16-19 October 2022 in Barcelona, Spain. For instance, responsive clinical trials can use surveillance data to identify geographic areas and communities that are at high risk for disease.

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Vaccination Vaccine Clinical Trials Clinical Trials 52

BioTech 365

OCTOBER 27, 2020

5,500 volunteers enrolled to date in pivotal Phase 3 clinical trial in the U.K. Study expanded to 15,000 participants Full enrollment expected by end of November Event-driven interim data expected as soon as early first quarter 2021 U.S. pivotal Phase … Continue reading →

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Clinical Development Development Clinical Trials Clinical Trials 40

Pharmaceutical Technology

MAY 26, 2023

GlobalData separates immuno-oncology treatments into six broad classes, which include bispecific antibodies, cancer vaccines, and cell therapies. There are currently over 700 immuno-oncology products in Phase I-III of development in the eight major markets, said Chalk.

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Marketing Vaccination Vaccine Development 264

pharmaphorum

OCTOBER 16, 2020

Sanofi will shortly start human trials of a second coronavirus vaccine, developed with US biotech Translate Bio, after reporting that it stimulated antibodies against SARS-CoV-2 in preclinical testing. It started human testing of a protein subunit vaccine with partner GlaxoSmithKline last month.

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Trials Vaccination Vaccine Antibody 98

pharmaphorum

NOVEMBER 12, 2020

The European Union has ordered 300 million doses of BioNTech/Pfizer’s COVID-19 vaccine following this week’s landmark announcement that it was effective in more than 90% of patients. Vaccine doses for Europe will be produced in BioNTech’s German manufacturing sites, as well as in Pfizer’s manufacturing site in Belgium.

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Drug Discovery World

FEBRUARY 28, 2024

Lu Rahman selects some of the year’s interesting and noteworthy advances in cancer research drug discovery and development. As always, a year within cancer drug discovery and development brings with it significant breakthroughs, and 2023 has been no exception. Figures from the Amercian Cancer Society 1 state that “a little over 1.9

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