Novavax seeks FDA approval for updated Covid-19 vaccine
Pharmaceutical Technology
JUNE 17, 2024
1 version of its Covid-19 vaccine, NVX-CoV2705, for individuals aged 12 years and above. Novavax has sought US FDA approval for an updated JN.1
Vaccination Related Topics 
Novavax seeks EMA approval for updated JN.1 Covid-19 vaccine
Pharmaceutical Technology
JUNE 25, 2024
1 Covid-19 vaccine, NVX-CoV2705, for people aged 12 years and above. Novavax has sought EMA approval for its updated JN.1
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AstraZeneca to withdraw Covid-19 vaccine globally
Pharmaceutical Technology
MAY 8, 2024
AstraZeneca has begun the global withdrawal of its Covid-19 vaccine Vaxzevria, citing a surplus of updated vaccines.
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FDA approves Moderna’s RSV vaccine mRESVIA
Pharmaceutical Technology
JUNE 3, 2024
Moderna has secured approval from the US Food and Drug Administration (FDA) for mRESVIA (respiratory syncytial virus vaccine).
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Advertiser: Aggregage
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AstraZeneca admits Covid-19 vaccine may cause blood clots in “very rare” cases
Pharmaceutical Technology
MAY 1, 2024
AstraZeneca has maintained that while the vaccine may, in “very rare” cases, cause TTS, the casual mechanism for this effect remains unknown.
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WestGene wins FDA approval for mRNA vaccine to treat certain cancers
Pharmaceutical Technology
MAY 10, 2024
The FDA approved WestGene’s mRNA therapeutic cancer vaccine as mRNA cancer vaccine development rises in popularity.
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GSK raises forecasts on strong vaccine, HIV drug sales
Bio Pharma Dive
MAY 1, 2024
Sales of the shingles vaccine Shingrix and the RSV shot Arexvy helped fuel quarterly revenue totals that surpassed analyst expectations, though the company warned momentum could slow in the months ahead.
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MHRA agrees licence change for Pfizer-BioNTech’s Comirnaty vaccine
Pharmaceutical Technology
FEBRUARY 12, 2024
vaccine targeting Omicron variant. The UK MHRA has granted approval for a variation in licence of Pfizer-BioNTech’s Comirnaty XBB.1.5
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Moderna leads the development of mRNA vaccines in infectious diseases
Pharmaceutical Technology
JANUARY 29, 2024
The rapid sequencing of the SARS-CoV-2 and the subsequent development of mRNA vaccines led to the authorisation of the first of these vaccines in late 2020.
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CDC panel mulls changes to RSV vaccine recommendation
Bio Pharma Dive
MARCH 1, 2024
The expert committee is discussing whether, for certain older adults, to make a universal recommendation for vaccination, rather than the current policy of “shared decisionmaking.”
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CHMP recommends authorisation for Pfizer-BioNTech’s Covid-19 vaccine
Pharmaceutical Technology
JUNE 28, 2024
1-adapted Covid-19 vaccine. The EMA's CHMP has recommended granting marketing authorisation for Pfizer and BioNTech’s Omicron JN.1-adapted
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FDA rejects label expansion for Dynavax’s hepatitis B vaccine
Pharmaceutical Technology
MAY 15, 2024
The US agency rejected the expanded use of Dynavax’s vaccine for adults on haemodialysis, citing insufficient efficacy and safety data.
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RSV vaccine makers’ shares fall as CDC adjusts shot guidance
Bio Pharma Dive
JUNE 27, 2024
The new guidance more strongly urges vaccination in adults who are older or at higher risk, but removes a prior recommendation for adults aged 60 to 74 years without certain risk factors.
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Anixa expands cancer vaccine collaboration with Cleveland Clinic
Pharmaceutical Technology
MAY 9, 2024
Anixa Biosciences has expanded its partnership with Cleveland Clinic to develop additional vaccines for cancers.
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Breaking barriers: Advances and challenges in therapeutic cancer vaccines
Bio Pharma Dive
APRIL 1, 2024
The development of cancer vaccines has provided some hope in the battle against cancer worldwide; however, there are still many challenges to overcome when developing these life-saving treatments.
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The FDA awarded a record number of review designations to mRNA vaccines in 2023
Pharmaceutical Technology
JUNE 24, 2024
The success of the Covid-19 messenger ribonucleic acid (mRNA) vaccines highlighted the major advantages of utilising mRNA technology in vaccine development.
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SK bioscience’s typhoid vaccine receives WHO prequalification
Pharmaceutical Technology
FEBRUARY 26, 2024
SK bioscience has achieved a significant milestone with its typhoid conjugate vaccine, SKYTyphoid, receiving WHO prequalification.
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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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US CDC recommends routine RSV vaccination for older adults
Pharmaceutical Technology
JUNE 27, 2024
The CDC ACIP has recommended the routine use of respiratory syncytial virus (RSV) vaccines for all adults aged 75 years and above.
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Pfizer wins FDA approval of new meningococcal vaccine
Bio Pharma Dive
OCTOBER 23, 2023
The clearance of the pentavalent shot Penbraya adds to Pfizer’s infectious disease portfolio as it adjusts to slumping COVID-19 vaccine sales.
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Merck wins FDA OK for vaccine rival to Pfizer’s pneumococcal shot
Bio Pharma Dive
JUNE 18, 2024
The new vaccine, which Merck will sell as Capvaxive, will compete with Pfizer’s blockbuster Prevnar franchise.
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Cervical cancer elimination in the UK is within sight with HPV vaccine
Pharmaceutical Technology
MAY 20, 2024
A recent study in England has shown that the HPV vaccine in teenagers reduced the rate of cervical cancer by up to 85%.
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Novavax gets a lifeline with Sanofi vaccine pact
Bio Pharma Dive
MAY 10, 2024
Sanofi will ally with the under-pressure biotech, paying $500 million upfront for rights to co-commercialize Novavax’s COVID shot and develop combination influenza vaccines.
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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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SK Bioscience gains UK authorisation for SKYCovion Covid-19 vaccine
Pharmaceutical Technology
MAY 30, 2023
SK Bioscience has received marketing authorisation from the UK’s medicines and healthcare products regulatory agency (MHRA) for its Covid-19 vaccine, SKYCovion. The authorisation allows the distribution of the vaccine in Scotland, Wales and England.
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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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Cancer Research UK and CRIS fund lung cancer vaccine research
Pharmaceutical Technology
MARCH 25, 2024
Cancer Research UK and the CRIS Cancer Foundation have awarded a £1.7m ($2.1m) grant for developing the lung cancer vaccine LungVax.
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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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AI Enables Individualized Cancer Vaccines
BioSpace
JUNE 16, 2024
The use of artificial intelligence in the development of cancer vaccines allows for individualized therapy, but the prospect of an ever-changing product poses new challenges for drug developers and regulators.
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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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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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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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Japan grants approval for CSL and Arcturus’ Covid-19 vaccine
Pharmaceutical Technology
NOVEMBER 29, 2023
Japan’s MHLW has approved CSL and Arcturus Therapeutics’ self-amplifying mRNA (sa-mRNA) Covid-19 vaccine, ARCT-154.
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Latest WHO Covid-19 vaccine guidance may decrease future demand
Pharmaceutical Technology
APRIL 3, 2023
The World Health Organisation (WHO) has revised its recommendations regarding the use of Covid-19 vaccines following a meeting of the agency’s Strategic Advisory Group of Experts on Immunisation (SAGE). The panel emphasised that the extra booster dose recommendation only pertains to one shot and is not for continued annual booster vaccines.
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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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COVID-19 vaccinations now ‘alarmingly low’ in Europe
pharmaphorum
MAY 30, 2024
COVID-19 vaccination rates have fallen precipitously in Europe and should be ramped up this autumn so they are at least in line with influenza vaccine uptake.
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FDA weighs shift in COVID vaccination strategy
Bio Pharma Dive
JANUARY 23, 2023
Agency scientists are proposing to update COVID shots once a year to match circulating coronavirus strains, as well as simplifying current vaccination regimens.
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Sanofi and Biovac partner to produce polio vaccines in Africa
Pharmaceutical Technology
JUNE 21, 2024
Sanofi and Biovac have announced a partnership to establish the first African-based manufacturing capabilities for polio vaccines.
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Micron Biomedical receives funds to produce needle-free vaccines
Pharmaceutical Technology
NOVEMBER 17, 2023
in funding from the Bill & Melinda Gates Foundation for the bulk manufacturing of needle-free vaccines. Micron Biomedical has received $23.6m
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BioNTech and CEPI expand deal to boost Africa’s vaccine capabilities
Pharmaceutical Technology
MAY 30, 2024
BioNTech and CEPI have announced an expansion of their strategic partnership, aiming to strengthen the mRNA vaccine ecosystem in Africa.
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Takeda’s dengue vaccine obtains WHO prequalification
Pharmaceutical Technology
MAY 16, 2024
Takeda's new dengue vaccine, TAK-003, has received prequalification from the World Health Organization (WHO).
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FDA fast tracks MimiVax’s glioblastoma vaccine SurVaxM
Pharmaceutical Technology
OCTOBER 13, 2023
The Phase IIb SurVaxM vaccine study will enrol 265 patients and has an estimated completion date in Q2 2024.
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‘Project NextGen’ picks new mRNA, intranasal COVID vaccines for funding
Bio Pharma Dive
OCTOBER 13, 2023
The awards, to biotechs Gritstone, Codagenix and CastleVax, are part of the program’s plan to develop vaccines with broader or longer-lasting benefits.
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