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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GSK claims Moderna infringed mRNA vaccine patents
Bio Pharma Dive
OCTOBER 16, 2024
The pharma’s lawsuit focuses on scientific work that helped clear the path for creating mRNA vaccines to fight the COVID-19 pandemic.
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A slow start for self-amplifying mRNA vaccines
Pharmaceutical Technology
OCTOBER 23, 2024
A year after the first samRNA vaccine approval, experts say others are likely to face scientific and regulatory hurdles.
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Moderna’s mRESVIA vaccine gains Health Canada approval
Pharmaceutical Technology
NOVEMBER 11, 2024
Moderna has received Health Canada's approval for its respiratory syncytial virus messenger ribonucleic acid (mRNA) vaccine mRESVIA, designed to prevent lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in individuals aged 60 and over.
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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
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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 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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Japan approves updated Covid-19 vaccine to tackle JN.1 variant
Pharmaceutical Technology
SEPTEMBER 13, 2024
Distribution of the self-amplifying mRNA vaccine Kostaive is set to align with a planned October 2024 Covid-19 vaccination campaign.
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FDA approves AstraZeneca FluMist ‘flu vaccine for self-administration
Pharmaceutical Technology
SEPTEMBER 23, 2024
The US FDA has granted approval for AstraZeneca's FluMist, a needle-free nasal spray influenza vaccine for self-administration.
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UNICEF secures one million mpox vaccines for Africa
Pharmaceutical Technology
SEPTEMBER 27, 2024
Bavarian Nordic has already said it would prioritise mpox vaccine production to fulfil orders this year.
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Emergent joins mpox fight with 50,000 vaccine dose donation to Africa
Pharmaceutical Technology
AUGUST 20, 2024
Supplies of Emergent’s smallpox vaccine ACAM2000 will accompany Bavarian Nordic’s vaccine to African countries.
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KM Biologics’ mpox vaccine approved for emergency use by WHO
Pharmaceutical Technology
NOVEMBER 20, 2024
The first mpox vaccine authorised for children will be shipped to DRC in a 3.05 million-dose donation by the Japanese Government.
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Novavax wins FDA emergency approval for updated Covid-19 vaccine
Pharmaceutical Technology
SEPTEMBER 2, 2024
The US regulatory agency has also approved updated versions of Covid-19 vaccines from Moderna and Pfizer / BioNTech’s in the past two weeks.
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GSK cuts vaccine forecasts, while predicting faster overall growth
Bio Pharma Dive
JULY 31, 2024
sales of Shingrix, the shingles vaccine that's become one of the British pharma's top sellers. Several factors are slowing U.S.
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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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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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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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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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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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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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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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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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LakeShore commences BLA submission to DRAP for rabies vaccine
Pharmaceutical Technology
NOVEMBER 8, 2024
LakeShore Biopharma has commenced the submission of its biologics license application (BLA) to the Drug Regulatory Authority of Pakistan (DRAP) seeking conditional approval for its PIKA Rabies Vaccine for post-exposure prophylaxis (PEP).
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Valneva and LimmaTech partner for shigellosis vaccine development
Pharmaceutical Technology
AUGUST 1, 2024
Valneva and LimmaTech have signed a deal to potentially develop the first marketed shigellosis vaccine.
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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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GSK and Flagship Pioneering link for new medicines and vaccines
Pharmaceutical Technology
JULY 30, 2024
GSK has announced a strategic collaboration with Flagship Pioneering for the discovery and development of medicines and vaccines.
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Pfizer’s RSV vaccine cleared by FDA for use in some younger adults
Bio Pharma Dive
OCTOBER 23, 2024
Approval of Pfizer's Abrysvo in certain adults aged 18 to 59 years old will expand the number of people eligible for vaccination with the shot.
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US FDA makes EUA changes to Pfizer-BioNTech and Moderna Covid-19 vaccines
Pharmaceutical Technology
APRIL 19, 2023
The US Food and Drug Administration (FDA) has made changes to the emergency use authorisations (EUAs) of the Pfizer -BioNTech and Moderna bivalent mRNA Covid-19 vaccines. The latest amendment aims to simplify the vaccination schedule for most people. The changes mean that the current bivalent vaccines for the original and Omicron BA.4/BA.5
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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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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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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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Pfizer and BioNTech’s Covid-19/flu combination vaccine falters in Phase III readout
Pharmaceutical Technology
AUGUST 16, 2024
While the vaccine demonstrated high responses for neutralizing influenza A titers, it failed to show sufficient efficacy against influenza B.
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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, Pfizer lifted as CDC backs broader use of pneumococcal vaccines
Bio Pharma Dive
OCTOBER 24, 2024
An agency panel recommended lowering the age for routine vaccination from 65 to 50, boosting the revenue outlook for multiple shots on the market and in development.
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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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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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Pfizer sales of RSV vaccine ebb, but company gains market share
Bio Pharma Dive
OCTOBER 29, 2024
New guidelines and the timing of COVID vaccinations impacted uptake of Abrysvo this year, according to a company executive.
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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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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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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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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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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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Novavax coughs up $123.8M to settle COVID vaccine supply dispute with UK
Fierce Pharma
NOVEMBER 6, 2024
Novavax has inked another settlement for a past COVID-19 vaccine supply deal. Novavax has inked another settlement for a past COVID-19 vaccine supply deal. million to end a COVID vaccine supply pact with the U.K. The Maryland biotech has agreed to pay $123.8
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