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.
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 […]
Vaccination 
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First-in-human vaccine trial for deadly Marburg virus
Drug Discovery World
JULY 12, 2024
Scientists at the University of Oxford in the UK have launched a new clinical trial to test a vaccine to protect against “devastating” Marburg virus. This is the first-in-human trial of the ChAdOx1 Marburg vaccine, which has been developed and manufactured by researchers at the University of Oxford.
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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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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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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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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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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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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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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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Successful clinical trial for re-engineered Covid vaccine
Drug Discovery World
NOVEMBER 24, 2023
The University of Queensland’s re-engineered clamp platform has produced a vaccine that is equally safe and virus-neutralising as an approved Covid vaccine considered among the best in its class. The Clamp2 trial group showed a 2.5-fold fold boost in neutralising ‘titres’ and it was 2.1 in the Novavax group.
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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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NHS England launches country-wide cancer vaccine trials
Drug Discovery World
JUNE 3, 2024
Thousands of cancer patients in England are set to gain fast-tracked access to trials of mRNA personalised cancer vaccines following the launch of an NHS trial ‘matchmaking’ service to help find new life-saving treatments.
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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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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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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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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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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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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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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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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 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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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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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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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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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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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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Circular RNA: Vaccines, therapeutics and biomarkers could be revolutionised
Pharmaceutical Technology
MAY 15, 2024
CircRNA is still in early days of development, but could be in trials as vaccines, therapeutics and biomarkers in the next few years.
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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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Merck to Start Trials of New HPV Vaccine and Single-Dose Gardasil Shot
BioSpace
MARCH 13, 2024
Merck is looking to expand its offerings in the human papillomavirus space with a new vaccine and to study a single-shot variant of Gardasil 9, both of which will start trials toward the end of 2024.
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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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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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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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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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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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Nouscom extends Series C round to $82m for cancer vaccine trials
Pharmaceutical Technology
MARCH 21, 2024
Nouscom is part of a cancer vaccine landscape that has recently jump-started following years of dormancy.
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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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Gates, Wellcome-backed TB vaccine starts phase 3 trial
pharmaphorum
MARCH 20, 2024
A highly anticipated phase 3 trial of a new tuberculosis vaccine developed by GSK has started in Africa, funded by the Gates MRI and Wellcome.
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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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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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NHS platform announced to accelerate personalised cancer vaccine clinical trials
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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Africa-led HIV vaccine trial ends in failure
pharmaphorum
DECEMBER 8, 2023
Africa-led HIV vaccine trial ends in failure Phil.Taylor Fri, 08/12/2023 - 10:24 Bookmark this
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“Game-changing” personalised cancer vaccine enters UK clinical trials
Drug Discovery World
APRIL 26, 2024
A clinical trial of a personalised mRNA cancer vaccine for melanoma patients has been launched in the UK. The vaccines are personalised to each patient after a tumour sample is removed during surgery and then analysed using DNA sequencing. in the combination arm and 62.2%
Brain cancer vaccine succeeds at prolonging survival in Phase 3 trial
BioPharma Reporter
NOVEMBER 21, 2022
A Phase 3 trial for Northwest Biotherapeuticsâs DCVax-L vaccine extended survival in patients with gliobastoma for many months, or in some cases, years: according to new data.
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