FDA lifts pause on Novavax flu vaccine trials
Bio Pharma Dive
NOVEMBER 11, 2024
After an investigation, the agency concluded that a case of muscle weakness in one of Novavax’s trials was actually ALS and unrelated to vaccination.
FDA clears Novavax to resume trials of Covid-19 and flu combo vaccine
Pharmaceutical Technology
NOVEMBER 12, 2024
The FDA agreed for Novavax to continue trials of its vaccine combo after addressing a serious adverse event that paused trials.
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FDA puts Novavax flu vaccine trials on hold
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.
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ICMR and Panacea Biotec initiate phase 3 clinical trial for the first indigenous dengue vaccine, DengiAll
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.
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Bavarian eyes Mpox vaccine label expansion to include toddlers, kickstarts Phase II trial
Pharmaceutical Technology
OCTOBER 29, 2024
The registrational trial is expected to support the approval for Bavarian’s mpox/smallpox vaccine use in children 2-11 years of age.
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Race for universal flu vaccine ramps up as Osivax kicks off Phase IIa trial
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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HilleVax slashes workforce by 40% after norovirus vaccine trial failure
Pharmaceutical Technology
AUGUST 1, 2024
HilleVax’s norovirus vaccine HIL-214 failed to meet key endpoints in its Phase IIb trial in infants prompting the company to let go of 41 employees.
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Moderna mpox mRNA vaccine shows early promise in monkey study
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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Overcoming challenges with maternal vaccine trials
pharmaphorum
MAY 17, 2024
Navigating maternal vaccine trials: addressing safety, efficacy, and preterm birth risks. Insights on vaccines for pregnant women and maternal health.
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Moderna, in bid for transparency, discloses detailed plan of coronavirus vaccine trial
Bio Pharma Dive
SEPTEMBER 17, 2020
The biotech, among the furthest along in coronavirus vaccine development, is the first developer to share the so-called study protocol of its large Phase 3 trial.
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GSK sets high bar with trial results for RSV vaccine
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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Pfizer, after delay, completes enrollment in Lyme vaccine trial
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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Merck to start trials investigating single dosing regimen of HPV vaccine
Pharmaceutical Technology
MARCH 13, 2024
The two trials will evaluate alternative dosing regimens for Gardasil 9 vaccine compared to the currently approved three-dose regimen.
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SEC recommends permission to SII for Omicron XBB 1.5 variant Covid-19 vaccine
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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MinervaX raises $57m for Phase III trial of maternal strep vaccine
Pharmaceutical Technology
OCTOBER 11, 2023
MinervaX is currently conducting Phase II trials of the prophylactic maternal vaccine against group B streptococcus bacterial infections.
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BioNTech targets infectious diseases for vaccine development
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%
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Experimental Alzheimer’s Vaccine Shown to Delay Symptoms in Mice
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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Malaria Could Be Eliminated by 2040: New Vaccine Offers Hope
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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HIV vaccine being developed by Johnson & Johnson fails clinical trial
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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BioNTech’s RNA vaccine sparks potential in pancreatic cancer
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.
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Pfizer begins plan to challenge Shingrix with an mRNA vaccine
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.
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Moderna follows Pfizer in beginning trial of omicron vaccine
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.
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HIV vaccines suffer setbacks but new approaches could turn the tide
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.
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RNA glioblastoma vaccine shows promise in first human trial
pharmaphorum
MAY 2, 2024
A personalised vaccine for the aggressive brain cancer glioblastoma developed has shown encouraging signs of efficacy in its first human trial.
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Brazil’s ANVISA approves Takeda’s dengue vaccine candidate Qdenga
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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ICON partners with US Government for clinical trials of Covid-19 vaccines
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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Moderna’s HIV vaccine prepped for trials in Africa
pharmaphorum
MAY 19, 2022
Moderna has joined forces with non-profit organisation IAVI on a third phase 1 trial of its candidate HIV vaccine in Africa, where the burden of the virus is still being keenly felt. One candidate – mRNA-1644 – has already shown its potential in an earlier phase 1 trial (IAVI G001) run in the US.
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CanSino, Canada abandon plans for a coronavirus vaccine trial
Bio Pharma Dive
AUGUST 27, 2020
Canada was set to help CanSino produce its experimental shot as part of a deal to run what would've been the country's first coronavirus vaccine study.
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NHS England launches pioneering trials for world-first cancer vaccine
BioPharma Reporter
JUNE 3, 2024
Thousands of patients in England are set to be enrolled into groundbreaking trials for personalized cancer vaccines through an innovative NHS 'matchmaking' initiative aimed at saving lives.
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UK MHRA approves Takeda’s dengue vaccine Qdenga
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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Chinese drugmaker Clover says vaccine prevents COVID-19 in large trial
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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Novavax says vaccine 90% effective against COVID-19 in large trial
Bio Pharma Dive
JUNE 14, 2021
Highly anticipated results from a Phase 3 study testing the biotech company's shot showed it to be strongly protective and safe, a potential boon for the world's vaccination efforts.
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Osivax begins phase 2a booster trial for influenza vaccine
Pharma Times
NOVEMBER 14, 2024
First participant vaccinated in study of ovx836 booster dose
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India grants approval for Bharat Biotech’s intranasal Covid-19 vaccine
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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SEC recommends approval for Zydus Lifesciences’ trivalent influenza vaccine in children
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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As trials progress, FDA weighs COVID-19 vaccine authorizations for children
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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Ebola experimental vaccine trial may begin soon in Uganda
STAT News
SEPTEMBER 29, 2022
A clinical trial of one or perhaps two experimental vaccines designed to protect against the Ebola Sudan virus could soon begin in Uganda, as long as the country agrees to allow the research to take place, an official of the World Health Organization said Wednesday. Read the rest…
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Ghana becomes first country to approve Oxford’s malaria vaccine
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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HilleVax’s norovirus vaccine ineffective in large trial of infants
Bio Pharma Dive
JULY 8, 2024
Shares in HilleVax plummeted after the company reported its experimental shot failed to meet the primary and secondary goals of the Phase 2b study.
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CMV Vaccine Trials: Moderna’s CMV mRNA Vaccine Enters Phase III
XTalks
FEBRUARY 19, 2024
Moderna has been testing an experimental mRNA vaccine aimed at combating the human cytomegalovirus (CMV), which poses significant health risks to newborns and immunocompromised patients. The team used the data and patient samples from a gB/MF59 Phase II trial in adolescent girls as a benchmark to assess the new mRNA-based vaccine.
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Health Canada approves Novavax’s Covid-19 vaccine for adolescents
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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GSK speeds up the race to bring first RSV vaccine for older adults to market
Pharmaceutical Technology
OCTOBER 31, 2022
After decades of setbacks, the respiratory syncytial virus (RSV) vaccine field has bounced back with positive Phase III trial results in older adults. There are currently five players in the race, with vaccines in Phase III of development from GlaxoSmithKline (GSK) , Pfizer , Johnson & Johnson , Moderna and Bavarian Nordic.
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Pfizer and BioNTech post early win for combination Covid-19/flu vaccine
Pharmaceutical Technology
OCTOBER 26, 2023
A pivotal Phase III trial will be initiated in the coming months to further evaluate the lead formulations of the combination vaccine.
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Mixed results for Moderna mRNA flu vaccine trial
Medical Xpress
FEBRUARY 16, 2023
US biotech company Moderna said Thursday it had mixed results from a large-scale trial of its mRNA flu shot, based on the same technology used in its successful Covid-19 vaccine.
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