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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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.
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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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
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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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.
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.
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
Bio Pharma Dive
JULY 22, 2022
The positive decision comes as governments aim to expand supply and quicken distribution of the vaccine to combat a widening global outbreak. Separately, the EMA backed approvals of 11 other medicines.
Bio Pharma Dive
OCTOBER 21, 2022
The company is considering charging as much as between $110 and $130 per dose — roughly four times the vaccine’s current price — once sales transition to the private market.
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.
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
Bio Pharma Dive
FEBRUARY 1, 2023
The agency is currently assessing applications filed by the two companies for what they hope will become the first vaccines against the virus in older adults.
Bio Pharma Dive
MAY 24, 2022
began releasing supplies of an approved Bavarian Nordic shot, Moderna said it's beginning development of its own vaccine against the virus. One day after the U.S.
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.
Bio Pharma Dive
JANUARY 26, 2021
The French drugmaker, having hit delays with its own coronavirus shot, agreed to manufacture over 100 million doses of Pfizer and BioNTech's vaccine for supply in Europe.
Bio Pharma Dive
DECEMBER 16, 2021
Days after the FDA strengthened safety warnings for the company's shot, a CDC panel recommended Pfizer's and Moderna's vaccines be "preferred" over J&J's.
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.
Bio Pharma Dive
AUGUST 31, 2021
Marion Gruber and Phil Krause, two veteran vaccine reviewers, are unexpectedly leaving the agency at a critical time. The search for their replacements will begin "imminently," division head Peter Marks said in a letter.
Pharmaceutical Technology
MAY 10, 2024
The FDA approved WestGene’s mRNA therapeutic cancer vaccine as mRNA cancer vaccine development rises in popularity.
Bio Pharma Dive
OCTOBER 12, 2022
The drugmaker’s decision to grab rights to the shot deepens its ties with the COVID-19 vaccine developer and comes weeks before a key data release.
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.
Bio Pharma Dive
JANUARY 5, 2022
The pharma company, already partnered with BioNTech on vaccines for COVID-19 and influenza, will pay $225 million upfront to further expand its work with the German biotech.
Pharmaceutical Technology
OCTOBER 23, 2024
A year after the first samRNA vaccine approval, experts say others are likely to face scientific and regulatory hurdles.
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.”
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.
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.
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.
Bio Pharma Dive
MAY 31, 2023
The shot’s clearance comes several weeks after the regulator made GSK’s Arexvy the first vaccine for RSV in the U.S.
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.
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%
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.
Pharmaceutical Technology
NOVEMBER 29, 2023
Japan’s MHLW has approved CSL and Arcturus Therapeutics’ self-amplifying mRNA (sa-mRNA) Covid-19 vaccine, ARCT-154.
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.
Bio Pharma Dive
APRIL 14, 2021
Advisers to the agency agreed to wait for more data before recommending new guidance, but aim to reconvene quickly to decide on whether vaccinations with J&J's should be resumed, and for whom.
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.
Pharmaceutical Technology
AUGUST 20, 2024
Supplies of Emergent’s smallpox vaccine ACAM2000 will accompany Bavarian Nordic’s vaccine to African countries.
Bio Pharma Dive
OCTOBER 15, 2021
Agency advisers unanimously supported offering a second dose of J&J's coronavirus vaccine to adults who previously received it, though guidance could change as regulators evaluate mixing boosters.
Pharmaceutical Technology
SEPTEMBER 27, 2024
Bavarian Nordic has already said it would prioritise mpox vaccine production to fulfil orders this year.
Pharmaceutical Technology
AUGUST 17, 2022
On August 8, Pfizer and Valneva announced the initiation of a Phase III study with their Lyme disease vaccine , bringing the prospect of an injection to prevent the condition disease one step closer to reality. This means that the vaccine works against multiple serotypes of the disease, she explains. A one-size-fits-all approach.
Pharmaceutical Technology
DECEMBER 12, 2024
Sanofi has announced that its two combination vaccine candidates have received fast track status from the US FDA.
Pharmaceutical Technology
DECEMBER 18, 2024
Abera and Orexo have entered a partnership to develop and test the powder formulations of the formers vaccine candidates.
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.
Pharmaceutical Technology
AUGUST 1, 2022
Moderna has entered a new supply contract with the US Government to deliver 66 million doses of its Covid-19 vaccine booster candidate, mRNA-1273.222. The contract comprises a $1.74bn award to produce and supply these vaccine doses and options to further procure up to 234 million additional doses of the company’s booster candidates.
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