World of DTC Marketing

DECEMBER 29, 2020

OBSERVATION: Biologics can take a long time to develop but COVID vaccines have been in development for almost 50 years and novel approaches were used to develop these vaccines. Vaccines typically take 10 to 15 years to develop, test and release to the public. The coronavirus vaccines, however, took less than a year.

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Vaccine Vaccination Development Clinical Trials 307

STAT News

JANUARY 18, 2023

Yet another experimental HIV vaccine has failed. The National Institute of Allergy and Infectious Diseases reported Wednesday that a Phase 3 clinical trial of a vaccine was stopped because the vaccine was ineffective at preventing HIV infection. Read the rest…

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Clinical Trials Clinical Trials Vaccine Vaccination 145

BioPharma Reporter

MARCH 14, 2022

The first participant has been dosed in a Phase 1 clinical trial of HIV trimer mRNA vaccine candidate mRNA-1574.

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Clinical Trials Clinical Trials Vaccine Vaccination 145

Pharmaceutical Technology

JUNE 16, 2023

France-based biotech company Osivax has thrown its hat into the influenza ring by dosing the first subject with its vaccine candidate OVX836. The Phase IIa trial (NCT05734040) in Australia will see a potential 500 volunteers given OVX836 in combination with quadrivalent influenza vaccines (QIVs).

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Pharmaceutical Technology

MARCH 14, 2023

The National Health Surveillance Agency (ANVISA) in Brazil has granted approval for Takeda ’s dengue virus vaccine candidate, Qdenga (Dengue Tetravalent Vaccine [Live, Attenuated]) (TAK-003). The vaccine has received approval for preventing dengue disease in people aged four years to 60 years.

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AuroBlog - Aurous Healthcare Clinical Trials blog

MAY 14, 2024

A Subject Expert Committee (SEC), which advices the national drug regulator on approvals and clinical trials related to Covid-19 vaccines, has recommended grant of permission to Serum Institute of India (SII) for Omicron XBB 1.5 The vaccine variant […]

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Bio Pharma Dive

OCTOBER 13, 2022

With data expected for several other vaccines for the respiratory disease, GSK reported positive clinical trial results showing efficacy above 80%.

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BioSpace

AUGUST 16, 2021

Moderna is expected to launch a human clinical trial as early as this week for an mRNA-based vaccine against HIV and indicated that it is looking for 56 people ages 18 to 50 who are HIV-negative.

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Clinical Trials Clinical Trials Vaccine Vaccination 145

AuroBlog - Aurous Healthcare Clinical Trials blog

MAY 13, 2024

The Subject Expert Committee (SEC), which advises the Central drug regulator regarding clinical trials and approvals of drugs, has recommended approval for additional indication of Zydus Lifesciences’ inactivated trivalent influenza vaccine in children above six months with clinical trial waiver subject to condition.

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Pharmaceutical Technology

SEPTEMBER 7, 2022

Indian company Bharat Biotech International has secured approval from Central Drugs Standard Control Organisation (CDSCO) under Restricted Use in Emergency Situation for its intranasal Covid-19 vaccine, iNCOVACC (BBV154), for usage in people aged 18 years and older. It is formulated to permit intranasal delivery via nasal drops.

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Pharmaceutical Technology

JUNE 24, 2022

Novavax has obtained emergency use authorization (EUA) for its Covid-19 vaccine, Nuvaxovid (NVX-CoV2373), from the Taiwan Food and Drug Administration for use in people of the age 18 years and above. The protein-based vaccine is engineered from the genetic sequence of the SARS-CoV-2 virus’ initial strain.

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Bio Pharma Dive

NOVEMBER 22, 2021

Four months after vaccination, no 12- to 15-year-olds in the companies' clinical trial developed COVID-19, compared to 30 who received a placebo.

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Pharma Mirror

SEPTEMBER 22, 2021

Nantes, France, Naobios, a CDMO (Contract Development and Manufacturing Organization) providing bioprocess development and GMP production of clinical batches of viral vaccines BSL2/BSL3, oncolytic viruses and viral vectors, today announces the next phase in its partnership with FluGen, Inc., The company’s.

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Pharmaceutical Technology

SEPTEMBER 5, 2022

The National Medical Products Administration of China (NMPA) has approved CanSino Biologics ’ (CanSinoBIO) recombinant Covid-19 vaccine (Adenovirus Type 5 Vector) for inhalation, Convidecia Air, as a booster. This vaccine leverages the same adenovirus vector technological platform as Convidecia, the intramuscular version.

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BioPharma Reporter

FEBRUARY 9, 2021

Health officials in Azerbaijan have granted approval for a clinical trial to take place in that country combining Russiaâs Sputnik V vaccine with the Oxford-AstraZeneca COVID-19 shot in adults 18 years and older.

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Clinical Trials Clinical Trials Vaccine Vaccination 145

Bio Pharma Dive

FEBRUARY 24, 2021

Moderna has delivered a modified version of its vaccine to NIH scientists, while Pfizer has begun testing of an additional booster shot in a clinical trial, both precautionary steps against emerging strains.

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Pharmaceutical Technology

SEPTEMBER 14, 2023

ICON will conduct Phase IIb clinical trials for the US BARDA-selected Covid-19 vaccine candidates as part of ‘Project NextGen’.

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Clinical Trials Clinical Trials Vaccine Vaccination 130

Pharmaceutical Technology

JANUARY 13, 2023

The Biomedical Advanced Research and Development Authority (BARDA) has awarded a multi-year contract to the Sabin Vaccine Institute for developing and producing single-dose vaccine candidates for Ebola Sudan and Marburg virus diseases. Currently, there are no licensed vaccines against these viruses.

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Pharmaceutical Technology

AUGUST 2, 2022

Samsung Biologics and GreenLight Biosciences have completed the initial commercial-scale engineering run for their messenger ribonucleic acid (mRNA) Covid-19 vaccine under their manufacturing collaboration. Following the demonstration at Samsung, the clinical trial of GreenLight’s Covid-19 booster vaccine is anticipated to commence this year.

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Pharma Times

SEPTEMBER 20, 2023

The universal vaccine could protect people against more strains of flu - News - PharmaTimes

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Pharmaceutical Technology

DECEMBER 7, 2022

Health Canada has granted approval for a supplement to a New Drug Submission (sNDS) of Novavax ’s Covid-19 vaccine (Recombinant protein, Adjuvanted), Nuvaxovid (NVX-CoV2373), for use in adolescents aged 12 to 17 years. The trial is designed to analyse the safety and effectiveness of the vaccine.

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Pharmaceutical Technology

OCTOBER 14, 2022

German pharmaceutical firm Merck has extended its partnership with Moderna to jointly develop and sell mRNA-4157/V940, an investigational personalised cancer vaccine (PCV). They subsequently expanded the collaboration to include the development of antigen mRNA cancer vaccines in 2018.

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Pharma Mirror

JANUARY 23, 2023

This webinar focused on the need for a coordinated clinical trials enterprise, one that can quickly characterize emerging viral threats and evaluate the effectiveness of vaccines, therapeutics, and other countermeasures across a diversity of trial participants.

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Clinical Trials Clinical Trials Trials Clinical Research 147

AuroBlog - Aurous Healthcare Clinical Trials blog

AUGUST 3, 2023

An experimental vaccine that aims to slow down or prevent the progression of Alzheimer’s disease has been trialed in mice with promising early results. Mice engineered with genes that put them at greater risk of an Alzheimer’s-like disease had fewer amyloid plaques following the vaccine.

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AuroBlog - Aurous Healthcare Clinical Trials blog

OCTOBER 8, 2023

The World Health Organization has approved a new vaccine that scientists argue will be a game-changer in the fight against malaria, which kills half a million people in Africa every year.

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Vaccine Vaccination Scientist Trials 246

Pharmaceutical Technology

JULY 15, 2022

Health Canada has granted approval for the usage of Moderna’s messenger RNA (mRNA) Covid-19 vaccine, Spikevax, in a 25µg two-dose regimen for active immunisation to prevent Covid-19 in children aged six months to five years. So far, children aged below five years were not eligible to receive the Covid-19 vaccine in Canada.

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Bio Pharma Dive

MAY 19, 2023

The biotech, best known for its vaccine research, said its clinical trial is the first to report results of a messenger RNA therapeutic designed for intracellular protein replacement.

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Pharma Times

MAY 31, 2024

The CVLP platform will speed up access to BioNTech and Genentech’s mRNA personalised cancer vaccines

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Bio Pharma Dive

FEBRUARY 17, 2023

Violations of study standards by a “third-party clinical trial site operator” prompted the partners to stop evaluating a large portion of the volunteers in their trial, the largest test of a Lyme disease vaccine in decades.

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Clinical Trials Clinical Trials Vaccine Vaccination 286

Pharmaceutical Technology

JUNE 20, 2023

The World Health Organisation (WHO) has granted an emergency use listing (EUL) to SK bioscience’s Covid-19 vaccine, SKYCovione. SKYCovione is a self-assembled nanoparticle vaccine and the 12th Covid-19 vaccine to receive a EUL from the regulator.

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Velocity Clinical Research

NOVEMBER 12, 2024

Over the past decade, Germany’s share of global clinical trial activities has dropped year on year. of trials in 2021 , down from 7.2% Aiming to revitalize the country’s pharmaceutical industry, it signaled a shift from policymakers on clinical research and drug development issues. The country accounted for just 3.9%

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Pharmaceutical Technology

DECEMBER 27, 2022

Along the way, mergers and acquisitions continued to happen, new drugs and devices got approved, and innovations in the clinical trial industry were introduced. A few months later, the monkeypox outbreak showed the difficulty in accessing vaccines and antivirals despite a plan to stockpile them. Tracking the news.

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Clinical Trials Clinical Trials Trials Vaccine 306

World of DTC Marketing

APRIL 11, 2021

QUICK THOUGHT: People believe the COVID-19 vaccine was developed in less than a year but that’s not true. Based on the virus a number of vaccines targeting the spike protein were designed, tested in animal models and found to be quite promising against SARS and other coronavirus illnesses like Middle East respiratory syndrome.

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Pharmaceutical Technology

AUGUST 15, 2022

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted conditional authorisation for Moderna ’s Covid-19 booster vaccine, mRNA-1273.214 (Spikevax Bivalent Original/Omicron), for use in adults aged 18 years and above. It comprises mRNA-1273 (Spikevax) and a vaccine candidate that acts on the SARS-CoV-2 virus’ BA.1

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Pharmaceutical Technology

DECEMBER 2, 2022

India’s Central Drugs Standard Control Organisation (CDSCO) has granted approval for Bharat Biotech’s BBV154 vaccine for treating Covid-19. BBV154 is claimed to be the first intra-nasal vaccine for Covid-19 in the world.

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AuroBlog - Aurous Healthcare Clinical Trials blog

MAY 1, 2024

Scientists have developed a vaccine against a notorious drug-resistant superbug, targeting molecules on its surface that are also found on other bacteria and fungi.

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NPR Health - Shots

AUGUST 9, 2022

There isn't currently a Lyme disease vaccine on the U.S. Researchers are hoping to change that. Image credit: Bertrand Guay/AFP via Getty Images)

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Clinical Trials Clinical Trials Vaccine Vaccination 145