FDA Requires Abrysvo, Arexvy RSV Vaccine Labels to Include Guillain-Barré Warning
Drug Topics
JANUARY 8, 2025
Patients who receive either Pfizer or GSKs respiratory syncytial virus vaccine may be at increased risk of Guillain-Barr syndrome.
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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EMA panel probes heart inflammation with Pfizer/BioNTech COVID vaccine
pharmaphorum
MAY 10, 2021
A review of side effects reported with coronavirus vaccines by the EMA’s safety committee has uncovered cases of inflammation of the heart in people receiving the Pfizer/BioNTech Comirnaty shot. . It is also asking for similar data from Moderna, which manufacture a COVID-19 vaccine that like Comirnaty is based on mRNA.
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Cancer vaccines: providing the edge in oncology
pharmaphorum
FEBRUARY 9, 2022
In this article, Ben Hargreaves looks into the promise of cancer vaccines and how this treatment modality may offer advantages over existing immunotherapies in the oncology sector. One area that is gathering increasing levels of interest is the development of cancer vaccines. A broad front.
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On heels of FDA approval, trial results set up GSK's RSV vaccine for label expansion
Fierce Pharma
OCTOBER 25, 2023
Five months after becoming the first company to secure FDA approval for a respiratory syncytial virus (RSV) vaccine, GSK is taking steps toward expanding its label for Arexvy. The company has revealed that a study investigating Arexvy’s effectiveness in adults ages 50 to 59 has achieved its two primary objectives.
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How advanced technology can streamline the COVID-19 vaccine rollout
pharmaphorum
MARCH 2, 2021
Zebra Technologies healthcare lead Chris Sullivan discusses the COVID-19 vaccine rollout and how technology can streamline the process to combat new variants. . While the rollout of the COVID-19 vaccine has signified the first signs of light at the end of the tunnel, the reality is that this public health crisis is still far from over.
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Merck raises pressure on Pfizer in pneumococcal vaccine tussle
pharmaphorum
AUGUST 25, 2021
Just a month after getting approval for its new pneumococcal vaccine Vaxneuvance in adults, Merck & Co has reported positive trial results in children that will ramp up the pressure on Pfizer and its market-leading Prevnar franchise.
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EU probes low platelet safety issue with COVID-19 shots
pharmaphorum
MARCH 12, 2021
EU regulators are reviewing reports of low blood platelets in patients who received any of the three approved COVID-19 vaccines from Pfizer/BioNTech, AstraZeneca and Moderna. The PRAC will investigate and if a causal relationship is confirmed or considered likely, an update to the products’ labels will be the most likely outcome.
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Belgium halts dosing of J&J COVID vaccine in under 41s after death
pharmaphorum
MAY 26, 2021
Belgium’s Ministry of Health has paused dosing of people under the age of 41 with Johnson & Johnson’s one-shot COVID-19 vaccine, following the death of a woman from what appeared to be a blood clot-related condition. . Last month, the EU regulator concluded that the benefits of the vaccine still outweigh any risks.
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The Pandemic Treaty and the opportunity to end ‘vaccine apartheid’
pharmaphorum
DECEMBER 16, 2022
Ben Hargreaves discovers why some have referred to the distribution of COVID-19 vaccines and treatments as a form of apartheid. Vaccine access for a price. Tendayi Achium, labelled the response by the global community as a form of “vaccine apartheid,” a suggestion echoed by the organisation’s director general.
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Pfizer gets a leg up in RSV as FDA clears jab for all adults
pharmaphorum
OCTOBER 23, 2024
A new FDA approval has given Pfizer a broader label for its respiratory syncytial virus (RSV) vaccine Abrysvo than rival shots from GSK and Moderna, but it may not make much of a difference in the battle for market share.The US regulator has cleared Abrysvo for use in adults aged 18 to 59 at risk of RSV-related disease, extending its earlier label (..)
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GSK's Arexvy maintains its RSV market dominance, looks to key label expansion as Moderna's mRNA threat looms
Fierce Pharma
MAY 1, 2024
Even with the threat of a potential new competitor in the respiratory syncytial virus (RSV) vaccine race on the horizon, GSK and its leading Arexvy shot aren’t sweating. | The company's respiratory syncytial virus vaccine Arexvy takes some two-thirds of the RSV market share, GSK reported. adults to its reach.
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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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GSK exec lauds 'great start' to RSV vaccine uptake as Arexvy nabs label expansion in adults 50-59
Fierce Pharma
JUNE 7, 2024
Thanks to respiratory syncytial virus (RSV) shot Arexvy’s new label expansion into a slightly younger pool of adults, GSK is more confident than ever that its vaccine will be able to conquer the co | The FDA approved Arexvy for RSV prevention in adults ages 50 to 59 who are at increased risk of developing RSV disease.
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FDA adds warning of rare neurological side effect to J&J COVID jab
pharmaphorum
JULY 13, 2021
The FDA has added a new warning on the Johnson & Johnson COVID-19 vaccine, saying the shot has been linked to a serious but rare side effect – Guillain-Barré syndrome – that can cause muscle weakness. The cases have mostly been recorded two weeks after vaccination and seem to be more common in men aged 50 and older.
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Moderna’s mRNA vaccine along with Keytruda obtains PRIME designation
Pharmaceutical Technology
APRIL 6, 2023
Moderna has announced that its cancer vaccine mRNA-4157/V940 along with Keytruda secured the European Medicines Agency (EMA) Priority Medicines (PRIME) scheme designation for the adjuvant treatment of high-risk stage III/IV melanoma patients after complete resection.
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EMA finds possible link between mRNA COVID jabs and myocarditis
pharmaphorum
JULY 9, 2021
The EU medicines regulator has said that there is some evidence to suggest a possible link between mRNA-based vaccines for COVID-19 and rare cases of heart inflammation. . Myocarditis is generally the result of a viral infection, so could be unrelated to the mRNA vaccines, particularly as neither of them contain any live virus.
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RxSource optimizes clinical labeling process with PRISYM 360 cloud-based solution
pharmaphorum
JANUARY 28, 2021
The Covid-19 pandemic has put further pressure on clinical trial suppliers to be fleet of foot in getting products dispatched when a new patient is recruited, as studies for vaccines have been set up and run at unprecedented speed. . To find out more about the webinar and to register, visit [link] .
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EU regulators ‘worried’ member states undermined AZ vaccine
pharmaphorum
MARCH 17, 2021
European regulators are “worried” that national regulators may have undermined trust in the Oxford University/AstraZeneca vaccine by temporarily suspending its use, despite central guidance to keep using it until a safety review has concluded later this week. . Politically motivated?
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How and why pharmacists should get involved in clinical research
Hospital Pharmacy Europe
MARCH 11, 2025
Professor Nazar adds that when it comes to research into chronic disease management, pharmacist-led studies have been shown to improve medication adherence and reduce hospital readmissions, while public health research involving pharmacists has demonstrated increased vaccination rates and contribution to antimicrobial stewardship.
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EC extends marketing authorisation for Bavarian Nordic’s smallpox vaccine
Pharmaceutical Technology
JULY 25, 2022
The European Commission (EC) has extended Bavarian Nordic ’s smallpox vaccine Imvanex (MVA-BN or Modified Vaccinia Ankara-Bavarian Nordic) marketing authorisation to offer protection from monkeypox. A non-replicating smallpox vaccine, Imvanex was developed in partnership with the US Government.
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Valneva eyes teenage label for chikungunya vaccine in Europe and Canada
Pharmaceutical Technology
SEPTEMBER 18, 2024
A single dose of Ixchiq induced a high and sustained immune response in 99.1% of adolescents, according to Valneva.
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How is virtual care changing pharmacy?
The Checkup by Singlecare
APRIL 3, 2025
They are kiosks that contain prescription medications, labeling equipment, and technology that can connect the patient to a remote pharmacist in real time. They can accept new or refill prescription orders, store medications, label and prepare prescriptions, and, at the discretion of a remote pharmacist, dispense prescriptions to patients.
FDA expands Pfizer’s RSV vaccine label to include all high-risk adults
Pharmaceutical Technology
OCTOBER 23, 2024
Abrysvo is now approved to prevent lower respiratory tract disease caused by RSV in high-risk adults over 18 years of age.
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Resourceful or risky? The UK’s controversial COVID-19 vaccine strategy
pharmaphorum
JANUARY 8, 2021
As COVID-19 vaccines are hastily deployed in the UK for priority groups, a debate rages over the government’s controversial strategy to delay time between vaccine doses. When the UK announced the approval of the Pfizer-BioNTech and Oxford-AstraZeneca COVID-19 vaccines, it marked an exciting moment for the nation.
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FDA-Approved Labeling: Is Enough Enough?
The FDA Law Blog
AUGUST 21, 2023
Livornese — I saw the sign…and the answer is no—FDA-approved labeling apparently is not enough under state failure-to-warn laws, according to certain courts. A recent state law failure-to-warn case in the SDNY makes that very point.
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Resourceful or risky? The UK’s controversial COVID-19 vaccine strategy
pharmaphorum
JANUARY 8, 2021
As COVID-19 vaccines are hastily deployed in the UK for priority groups, a debate rages over the government’s controversial strategy to delay time between vaccine doses. When the UK announced the approval of the Pfizer-BioNTech and Oxford/AstraZeneca COVID-19 vaccines, it marked an exciting moment for the nation.
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Bavarian Nordic receives European approval of vaccine label Imvanex
Pharma Times
JULY 25, 2022
Imvanex to include protection from monkeypox and diseases caused by vaccinia virus
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Moderna follows Pfizer in asking FDA for second COVID booster okay
pharmaphorum
MARCH 18, 2022
Moderna has asked the FDA for emergency use authorisation for a fourth dose of its mRNA COVID-19 vaccine SpikeVax, following in the footsteps of Pfizer/BioNTech, which filed their Comirnaty shot earlier this week. There’s no guidance yet from the CDC or FDA on whether a second booster will be needed.
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Monkeypox cases are rising. Should we be worried?
pharmaphorum
MAY 24, 2022
” Vaccines and drugs are available. Meanwhile, attention is now being turned to other measures to control the outbreak, including the use of vaccines against smallpox – a related virus – in a ‘ring vaccination’ approach designed to control the spread among contacts.
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As cases rise, WHO says monkeypox risk is “moderate”
pharmaphorum
MAY 30, 2022
One concern for public health experts is that with vaccination against the similar smallpox virus ending more than 40 years ago, there is little immunity in global populations to help curb the spread of infections. It says it has the capacity to produce around 30 million doses per year.
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BioNTech, InstaDeep showcase early warning system for COVID variants
pharmaphorum
JANUARY 13, 2022
A paper detailing the new AI has been made available on the preprint server BioRxiv and submitted to a peer-reviewed journal, said BioNTech, which alongside Pfizer developed the most widely-used mRNA-based vaccine against COVID-19. ” IHU has not yet been labelled a variant of concern by the WHO.
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Molnupiravir treatment reduces recovery time in high-risk vaccinated patients
Hospital Pharmacy Europe
OCTOBER 12, 2022
Molnupiravir treatment for five days improved recovery time in high-risk vaccinated COVID-19 patients but not hospitalisation or death. But whether molnupiravir was of value among those who have been vaccinated was much less clear. had at least one dose of a COVID-19 vaccine and 93% had received three doses of a vaccine.
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Sputnik V data in Lancet should end “fake news” on its efficacy, says RDIF
pharmaphorum
FEBRUARY 2, 2021
The publication of data backing Russia’s COVID-19 vaccine Sputnik V in a peer review journal should bring a campaign to discredit the shot to an end, says the head of the Russian Direct Investment Fund (RDIF). The new data – made available in The Lancet today – give the vaccine a protection rate of 91.6%
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Merck’s Lagevrio ‘no better than placebo’ in COVID hospitalisations
pharmaphorum
OCTOBER 7, 2022
Although, unlike PANORAMIC, that excluded patients who had been vaccinated against SARS-CoV-2. The UK was the first country to authorise Lagevrio, giving it a green light in November 2021 a few weeks ahead of the US, which cleared the drug with a more restrictive label. The European Commission has yet to approve it for use in the EU.
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Amoxicillin interactions to avoid
The Checkup by Singlecare
OCTOBER 30, 2023
Amoxicillin food interactions According to the amoxicillin product labeling , there are no drug-food interactions of concern. Amoxicillin and oral live vaccines Antibacterial drugs such as amoxicillin can impact the effectiveness of the oral typhoid and cholera vaccines.
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Trial finds molnupiravir treatment unable to reduce adverse COVID-19 outcomes among high-risk vaccinated patients
Hospital Pharmacy Europe
JANUARY 8, 2023
Molnupiravir treatment failed to reduce both COVID-related hospitalisation and mortality among high-risk vaccinated adults in the community. But with millions of individuals now vaccinated against COVID-19, it remains uncertain whether molnupiravir treatment is still an effective option in such patients. Lancet 2022.
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FDA accepts to review ImmunityBio’s BLA for bladder cancer treatment
Pharmaceutical Technology
JULY 29, 2022
The open-label, three-cohort, multicentre trial analysed intravesical BCG, N-803 combination in BCG-unresponsive high-grade NMIBC patients. In January, ImmunityBio and Amyris have concluded a joint venture (JV) agreement announced previously to accelerate the marketing of a Covid-19 vaccine.
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FDA Mandates Updates to Prescribing Information for RSV Vaccines Abrysvo, Arexvy for Increased Guillain-Barré Syndrome Risk
PharmExec
JANUARY 9, 2025
Abrysvo and Arexvy will now be required to come with labeling that includes a warning about a potential increased risk of Guillain-Barr Syndrome.
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GSK’s RSV vaccine Arexvy effective in adults aged 50-59 years
Pharmaceutical Technology
OCTOBER 26, 2023
GSK plans to submit the data to regulatory agencies to support label expansion for Arexvy in the younger adult patient population in 2024.
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Monkeypox update – August 2022
European Pharmaceutical Review
AUGUST 10, 2022
countries with manufacturing capacity for diagnostics, vaccines and therapeutics. Monkeypox is a disease caused by a zoonotic orthopoxvirus (the monkeypox virus) with similar but less severe symptoms to smallpox – a related disease eradicated through vaccination campaigns by May 1980 – including a rash and fever. But what is monkeypox?
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Europe orders another 200m doses of Pfizer/BioNTech COVID shot
pharmaphorum
FEBRUARY 17, 2021
The European Commission has ordered another 200 million doses of the Pfizer/BioNTech COVID-19 vaccine Comirnaty, bringing the bloc’s total order to 500 million doses. The vaccine is based on BioNTech’s proprietary mRNA technology and was developed by both companies.
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Astellas takes $170m charge as it drops DMD gene therapies
pharmaphorum
APRIL 22, 2022
Astellas also revealed today that it is terminating the development of ASP2390, a DNA vaccine for house dust mite-induced allergic rhinitis, and GITR agonist antibody ASP1951 for cancer – both in early-stage clinical development – along with DMD gene therapies AT702, AT751 and AT753.
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AZ, Sanofi get first green light for RSV prophylactic antibody
pharmaphorum
NOVEMBER 6, 2022
The antibody-based drug has been cleared by the European Commission with a broad label, covering both full-term and pre-term babies and those with a range of health conditions that could make the vulnerable to RSV, said the two pharma groups in a statement. It is the first approval for Beyfortus (nirsevimab) by any regulatory authority.
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