European Pharmaceutical Review

FEBRUARY 13, 2023

This is like antigens which can trigger an immune response and act as a vaccine. Firstly, using liquid chromatography and mass spectrometry, they carry out a systematic comparison of different fragments of a mRNA molecule to be tested with a similarly fragmented reference mRNA labelled with a stable carbon isotope.

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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. This is a compelling example of the power of inducing trained innate immune memory to potentially provide long-term, durable effects against serious, life-threatening diseases.”.

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Labelling Immunity Immunization Vaccines 105

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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European Pharmaceutical Review

SEPTEMBER 22, 2023

Active anti-Abeta immunotherapies In the 2000s, the concept of active immunotherapy targeting Abeta in Alzheimer’s patients was assessed with the ELAN vaccine (AN1792), consisting of full-length aggregated Abeta 1-42 peptide mixed with the QS21 adjuvant. 8 However, as this trial was not placebo-controlled, conclusions are difficult to draw.

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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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Vaccines Immunity Immunization Medical Schools 57

Pharma Packaging Solutions

JUNE 30, 2023

Whole blood, organ and tissue transplants, breast milk, antibodies for passive immunity, fecal microbiota, human reproductive cells, and stem-cell therapy are all examples of this type of biologic. We offer a variety of packaging services, including vial and ampule labeling, pharmaceutical kit assembly, and more.

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Packaging Immunity Immunization Vaccines 52

FADIC

MARCH 22, 2024

Fevers may also transpire after the administration of common childhood immunizations. Because antipyretics can also be found in many allergy, cold, cough, and flu products, patients should be advised to always read all medication labels prior to administration to avoid therapeutic duplications or possible medication overdose.

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FDA Law Blog: Biosimilars

JUNE 2, 2023

“All In” Manufacturer Definition CMS believes that the National Rebate Agreement (NRA) requires a “manufacturer” to report to Medicaid all of its covered outpatient drugs, under all of its labeler codes. This includes newly acquired labeler codes and newly formed subsidiaries.

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Labelling Vaccines Drug Pricing Immunity 59

PharmaShots

JUNE 1, 2023

PDC*line is much more potent than conventional dendritic cell-based vaccines in priming and boosting antitumor antigen-specific cytotoxic T-cells, including the T-cells specific for neoantigens, and is synergistic with checkpoint inhibitors. We reported at ESMO-IO the analysis of immune response of the first 3 cohorts of patients.

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Immunity Immunization Vaccines Health and Personal Care Stores 40

pharmaphorum

NOVEMBER 23, 2022

The EC approved Libtayo – a fully human monoclonal antibody targeting the immune checkpoint receptor PD-1 on T-cells – based on data from the global open-label, multi-centre phase 3 EMPOWER-Cervical 1 trial of 608 patients across 14 countries, conducted with the GOG Foundation, Inc.

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Chemotherapy Labelling Immunity Immunization 59

pharmaphorum

FEBRUARY 7, 2022

At the moment CAD is managed using off-label therapies, including rituximab and corticosteroid drugs, and sutimlimab’s potential to improve treatment earned it a breakthrough designation from the FDA. It is also being developed for other indications including immune thrombocytopenic purpura.

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Labelling Immunity Immunization Vaccines 52

Express Pharma

MAY 10, 2023

CCI is the ability of a container closure system to maintain the sterility of final pharma, biological and vaccine products throughout their shelf life. There can still be the threat of microbe introductions, which can be highly dangerous depending on the microbe and the condition of the already compromised immune system of the patient.

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RX Note

FEBRUARY 6, 2025

Medications that have to be refrigerated are mainly injections , which comprises of insulins, vaccines, immunoglobulins and biologics. For example, Fludarabine injection - store under refrigeration or at room temperature, as specified according to manufacturer's labelling. The storage condition of a medicine can vary across brands.

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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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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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Vaccines Labelling Immunity Immunization 105

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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European Pharmaceutical Review

JUNE 28, 2022

Cellular immunity and vaccination. The development of vaccines with a strong Type 1 T helper (TH1)-type cellular immune component, such as CD8+ cytotoxic T lymphocytes (CTL), has been limited to the historical observation that only live?attenuated

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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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Vaccines Labelling Immunity Immunization 105

pharmaphorum

JANUARY 13, 2022

The algorithm looks at the structure of the SARS-CoV-2 spike protein used to gain entry to host cells, looking for changes that could enable the virus to evade immunity, as well as other features that could affect the ‘fitness’ of the virus – its ability to reproduce and transmit between people.

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Vaccines Immunity Immunization Labelling 97

Pharmaceutical Technology

JULY 22, 2022

While the virus had some elements of seasonality ever since it emerged two years ago in 2020, epidemiologists state that factors, such as variant evolution, population immunity, and behavioural changes, have made seasonality less apparent. All these factors combined makes Covid-19 surges much less predictable, the article noted.

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Vaccines Immunity Immunization Labelling 52

Big Molecule Watch

FEBRUARY 17, 2025

On February 5, 2025 Valneva SE (Valneva) announced that the United Kingdoms Medicines and Healthcare products Regulatory Agency (MHRA) granted marketing authorization for Valnevas chikungunya vaccine, IXCHIQ. The post UKs MHRA Grants Marketing Authorization for Chikungunya Vaccine appeared first on Big Molecule Watch.

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pharmaphorum

JUNE 24, 2022

Before the monkeypox outbreak, really, only the US and Canada had stockpiled our drug and very few people had actually stockpiled the vaccine between Canada, the US, and a few other countries,” Siga CEO Phil Gomez told pharmaphorum. “So I was part of the team that worked on the first SARS vaccine that went into humans.

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PharmaShots

MARCH 9, 2023

Birthplace: Belén was born in Almansa (Spain) Additional Information: Merck became a significant international participant in immunology, oncology, and immune oncology under her leadership of the Healthcare business. Designation: Global Head Previous company: Merck Global Vaccines (2 yrs. and Banco Bilbao Vizcaya Argentaria S.A

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Clinical Pharmacology Immunity Immunization Pharmaceutical Companies 40

Pharmaceutical Business Review

NOVEMBER 27, 2024

The vaccine, which is approved for adults currently, may soon be available for use in adolescents aged 12 to 17 years if the extension is granted. The label extension application is supported by positive Phase III data from adolescent trials reported in May this year.

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RX Note

FEBRUARY 23, 2023

Terazosin - Off-label use in ureteral stone(s) expulsion Topical Corticosteroids - Apply thinly on the skin using fingertip unit. Statins - Not all statins need to be taken at night.

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HIV Treatment and Prevention Agents Community Pharmacies Labelling Chemotherapy 58

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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Labelling Immunity Immunization Vaccines 52

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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Digital Pharmacist

AUGUST 28, 2023

Increase pharmacy revenue and help your patients prepare for flu season each year by continuously improving your vaccination program. Whether you’re just getting started or are looking to scale, here are some tips to help you generate more immunization revenue with a vaccination program. Here’s how to get started.

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Immunity Immunization Vaccines Labelling 98

LifeProNow

APRIL 19, 2023

The safety of immunization with live viral vaccines during or after ABECMA treatment has not been studied. Vaccination with live virus vaccines is not recommended for at least 6 weeks prior to the start of lymphodepleting chemotherapy, during ABECMA treatment, and until immune recovery following treatment with ABECMA.

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pharmaphorum

SEPTEMBER 7, 2021

The EU regulator has started to review a marketing application filed by Pfizer and BioNTech for a third, booster dose of their Comirnaty COVID-19 vaccine given six months after the first course to people aged 16 and over. The two companies said they would also file the dossier with other regulators “in the coming weeks.”

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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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PharmaShots

FEBRUARY 21, 2023

Nordic is advancing the development of CD37-targeted therapies for hematological cancers and immune diseases. FAP-2286 (labeled with lutetium-177), a peptide-targeted radionuclide therapy (PTRT) and imaging agent targeting fibroblast activation protein (FAP), is the company’s lead asset amongst radiopharma products.

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Pharmaceutical Technology

APRIL 24, 2023

Since then, the field of nanomedicine has steadily progressed to reach high points such as the successful use of nanotechnology to deliver messenger RNA (mRNA)-based Covid-19 vaccines. In the case of most mRNA vaccines, a lipid nanoparticle-based approach was chosen due to its ability to protect the mRNA in the body and prevent degradation.

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European Pharmaceutical Review

SEPTEMBER 12, 2022

The first aims to explore whether intradermal delivery of the Jynneos monkeypox vaccine is efficacious, and could thereby be used to expand the limited vaccine supply ; while the second aims to establish the efficacy of SIGA’s antiviral tecovirimat (TPOXX). Intradermal vaccine delivery.

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Pharmaceutical Technology

MARCH 21, 2023

A few weeks later, the EC extended the approval label of AstraZeneca’s Forxiga (dapagliflozin) to include the treatment of symptomatic hearth failure. The vaccine ACI-24.060 elicited an anti-Abeta antibody response in the first patient cohort after six weeks, as per the results.

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Packaging Vaccines Labelling Communication 59

The Thyroid Pharmacist

NOVEMBER 8, 2024

It is a comprehensive stool-based test that addresses a wide range of microbial targets (bacteria, opportunistic organisms, viruses, parasites, fungi, and normal flora), as well as immune and digestive markers. This can allow the body’s immune system to attack the thyroid (or elsewhere) versus the infection. [17]

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