Bio Pharma Dive

SEPTEMBER 22, 2021

Positive results from Clover's Phase 3 study could mean another coronavirus vaccine option for the many countries still grappling with short supplies.

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Vaccination Vaccine Trials 329

Bio Pharma Dive

JANUARY 25, 2021

The drugmaker, one of the largest vaccine developers globally, won't move forward with either of two candidates it's been testing after disappointing data in early trials.

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Vaccination Vaccine Development Trials 351

Bio Pharma Dive

JANUARY 26, 2022

New data, meanwhile, help affirm the benefit of a third dose of Moderna's current vaccine. The study will test a version of the biotech's COVID-19 shot that's tailored to the infectious variant.

Vaccination 309

Vaccination Vaccine Trials 309

Bio Pharma Dive

FEBRUARY 10, 2023

The pharma and partner BioNTech have kicked off the first human trial of a messenger RNA shot for shingles, believing there’s room to clear the high bar set by GSK’s rival vaccine.

Vaccination 358

Vaccination Vaccine RNA Trials 358

Bio Pharma Dive

OCTOBER 16, 2024

The hold, which was made in response to a serious adverse event report, could impact the company’s plans to start a Phase 3 trial of a combination shot for COVID-19 and influenza.

Trials 284

Trials Vaccination Vaccine 284

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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Vaccination Vaccine Trials Immune Response 246

Bio Pharma Dive

SEPTEMBER 15, 2020

The Serum Institute of India, a go-to partner for coronavirus vaccine makers, will help Novavax boost capacity to levels matching its larger rivals.

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Vaccination Vaccine Manufacturing Trials 303

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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Vaccination Vaccine Development Clinical Trials 307

Pharmaceutical Technology

MAY 11, 2023

Results published in Nature for a personalised pancreatic cancer vaccine that uses neoantigens from patients’ tumours have lent further support to early positive signals. The vaccine, developed by BioNTech, led to half of the patients with pancreatic cancer in the Phase I trial remaining cancer-free 18 months later.

RNA 346

RNA Vaccination Vaccine Trials 346

Bio Pharma Dive

SEPTEMBER 8, 2020

A participant in a clinical trial of the experimental shot suffered from an unexplained illness, triggering an investigation and a pause in vaccinations.

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Vaccination Vaccine Clinical Trials Clinical Trials 337

Bio Pharma Dive

NOVEMBER 12, 2020

has sped up Moderna's timeline for its late-stage vaccine study, which now has sufficient COVID-19 cases for a first look at results. Coronavirus' fast accelerating spread in the U.S.

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Vaccination Vaccine Trials 297

Bio Pharma Dive

MARCH 8, 2021

Results from previous trials have raised questions about the vaccine and how well it works. Data from a large U.S. study could help clear up the confusion.

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Vaccination Vaccine Trials 336

Bio Pharma Dive

NOVEMBER 17, 2020

Positive results from Pfizer and Moderna offer the strongest validation yet of researchers' approach to coronavirus vaccines, but critical questions remain.

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Vaccination Vaccine Research Trials 287

Bio Pharma Dive

OCTOBER 20, 2020

The co-leader of an NIH network of coronavirus prevention studies spoke with BioPharma Dive about the FDA's big vaccine meeting this week and what will come next.

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Vaccination Vaccine Trials 310

Bio Pharma Dive

AUGUST 11, 2020

has already invested heavily in Moderna's vaccine, having previously committed $1 billion to fund clinical trials and manufacturing scale-up.

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Vaccination Vaccine Clinical Trials Clinical Trials 309

Bio Pharma Dive

DECEMBER 5, 2023

The announcement ends a lengthy setback that began when the company and partner Valneva accused a clinical trial site operator of study misconduct.

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Trials Clinical Trials Clinical Trials Vaccination 287

Pharmaceutical Technology

MARCH 28, 2023

Following on from its Covid-19 vaccine programmes, BioNTech has set its sights on a range of infectious diseases for vaccine development. The company saw major successes with its Covid-19 vaccine, developed in collaboration with Pfizer. In response to the lower vaccine sales forecasts, BioNTech shares opened at 3.9%

Vaccination 277

Vaccination Vaccine Development Clinical Trials 277

Pharmaceutical Technology

FEBRUARY 3, 2023

Only a few weeks into the new year, the prospect of getting a successful advanced HIV vaccine shrank after the discontinuation of yet another late-stage trial. On January 18, Janssen, a Johnson & Johnson (J&J) subsidiary, stated that its vaccine was not effective in preventing HIV infections.

Vaccination 294

Vaccination Vaccine Antibody Trials 294

AuroBlog - Aurous Healthcare Clinical Trials blog

AUGUST 19, 2024

The Indian Council of Medical Research (ICMR) and Panacea Biotec have announced the initiation of the first-ever phase 3 clinical trial for a dengue vaccine in India. The trial will evaluate the efficacy of India’s indigenous tetravalent dengue vaccine, DengiAll, developed by Panacea Biotec.

Clinical Trials 189

Clinical Trials Clinical Trials Vaccination Vaccine 189

Bio Pharma Dive

OCTOBER 25, 2021

The trial results should allow the company to ask the FDA for approval of its vaccine in younger children, just as Pfizer nears a crucial decision for its shot in 5- to 11-year olds.

Immune Response 312

Immune Response Vaccination Vaccine Trials 312

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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Vaccination Vaccine Trials Clinical Trials 210

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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Vaccination Vaccine Clinical Trials Clinical Trials 287

Bio Pharma Dive

SEPTEMBER 28, 2020

The FDA has suspended the planned start of a late-stage trial of Inovio's experimental shot, dealing another setback to one of the most advanced DNA-based vaccine programs in development.

Vaccination 276

Vaccination Vaccine DNA Trials 276

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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Vaccination Vaccine Clinical Trials Clinical Trials 263

Bio Pharma Dive

JANUARY 10, 2023

Moderna’s Stéphane Bancel and Pfizer’s Albert Bourla hinted Monday at greater dealmaking to come for their companies, while Gilead gave investors an update on an important cancer drug trial.

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Trials Drug Trials Development Vaccination 295

Bio Pharma Dive

NOVEMBER 18, 2020

Reaching the main goal of their large trial, Pfizer and BioNTech reported 162 cases of COVID-19 among participants who received a placebo, and just 8 for those who were vaccinated.

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Vaccination Vaccine Trials 296

Pharmaceutical Technology

FEBRUARY 7, 2023

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorisation for Takeda ’s dengue virus vaccine candidate, Qdenga (Dengue Tetravalent Vaccine [Live, Attenuated]). The vaccine candidate has been approved for active immunisation against the infection in people from four years of age.

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Vaccination Vaccine Genetics Trials 265

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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Vaccination Vaccine Engineer Gene 246

Pharmaceutical Technology

SEPTEMBER 5, 2024

Moderna is currently running a Phase I/II trial of the mRNA mpox vaccine mRNA-1769 in healthy participants.

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Vaccination Vaccine Trials 246

Pharmaceutical Technology

APRIL 14, 2023

Ghana’s Food and Drug Authority (FDA) has approved R21/Matrix-M malaria vaccine in children aged 5 to 36 months, marking the first regulatory clearance for the University of Oxford-developed vaccine in any country in the world. Children between the ages of five and 36 months are at highest risk of death from malaria.

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Vaccination Vaccine Manufacturing Containment 279

Bio Pharma Dive

JUNE 11, 2021

An advisory panel could not reach consensus on how long or large trials in young children should be. Some experts argued falling infection rates might mean vaccination of kids under 12 is unnecessary.

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Vaccination Vaccine Trials 205

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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Vaccination Vaccine Clinical Trials Clinical Trials 263

Bio Pharma Dive

DECEMBER 10, 2021

Data from a small Phase 1 trial showed the biotech's vaccine spurred immune responses to four common strains, although they didn't appear significantly greater than an already available shot from Sanofi.

Vaccination 276

Vaccination Vaccine Immune Response Trials 276

Bio Pharma Dive

FEBRUARY 4, 2021

The government-funded trial will evaluate the effects of mixing vaccines and varying timing between shots.

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Vaccination Vaccine Trials 263

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.

Vaccination 246

Vaccination Vaccine Scientist Trials 246

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.

Vaccination 265

Vaccination Vaccine Protein Clinical Trials 265

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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Vaccination Vaccine Gene Therapy Antibody 265