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.
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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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China grants EUA to Covid-19 vaccine against XBB descendent lineages
Pharmaceutical Technology
JUNE 9, 2023
5+delta) protein vaccine (Sf9 cell). This marks the world’s first Covid-19 vaccine approved for emergency use against XBB descendent lineages of SARS-CoV-2. The vaccine has been developed by WestVac Biopharma along with the West China Medical Center and Sichuan University. recombinant Covid-19 trivalent (XBB.1.5+BA.5+delta)
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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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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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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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How did pharma develop a vaccine so quickly?
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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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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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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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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BARDA awards contract for Sabin’s Ebola Sudan and Marburg virus vaccines
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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Breakthrough Vaccine Shows High Protection Against Drug-Resistant Superbug in Mice
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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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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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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Novavax’s Covid-19 vaccine gets Taiwan FDA EUA for use in adults
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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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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EC approves Novavax’s Covid-19 vaccine CMA expansion for adolescents
Pharmaceutical Technology
JULY 6, 2022
The European Commission (EC) has granted approval for the expanded conditional marketing authorization (CMA) of Novavax’s Covid-19 vaccine, Nuvaxovid (NVX-CoV2373), in the European Union (EU) for adolescents of the age 12 to 17 years. A protein-based vaccine, NVX-CoV2373 is made from the genetic sequence of the SARS-CoV-2 virus’ first strain.
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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 says coronavirus vaccine study still on track for October readout
Bio Pharma Dive
SEPTEMBER 15, 2020
Importantly, the study committee hasn't had reason to pause vaccinations in the trial, something AstraZeneca and the University of Oxford recently reported in tests of their vaccine.
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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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Merck stops coronavirus vaccine development in surprise setback
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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China NMPA grants approval for CanSinoBIO’s Covid-19 vaccine as booster
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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