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 104

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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Immunity Immunization Labelling Vaccines 103

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 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

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 104

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

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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Vaccines Labelling Immunity Immunization 52

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.

Labelling 52

Labelling Immunity Immunization Vaccines 52

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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Vaccines Adverse Reactions Documentation Labelling 117

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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Immunity Immunization Vaccines Communication 82

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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Vaccines Labelling Immunity Immunization 98

pharmaphorum

AUGUST 31, 2021

Shares in AC Immune leaped today after the company said its tau-targeting Alzheimer’s disease candidate semorinemab hit one of its objectives in a phase 2 trial, although it missed another. AC Immune has a lot riding on the tau hypothesis.

Immunity 52

Immunity Immunization Labelling Vaccines 52

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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Vaccines Labelling Immunity Immunization 98

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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Vaccines Immunity Immunization Medical Schools 95

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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Packaging Dosage Labelling Immunity 88

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.

Immunity 40

Immunity Immunization Vaccines Health and Personal Care Stores 40

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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Immunity Immunization Dosage Packaging 103

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 59

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.

Vaccines 57

Vaccines Immunity Immunization Medical Schools 57

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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Vaccines Immunity Immunization Labelling 98

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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Vaccines Immunity Immunization Labelling 78

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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Dosage Labelling Immunity Immunization 56

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

Clinical Pharmacology 40

Clinical Pharmacology Immunity Immunization Pharmaceutical Companies 40

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

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

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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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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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.

HIV Treatment and Prevention Agents 75

HIV Treatment and Prevention Agents Community Pharmacies Labelling Chemotherapy 75

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

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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Vaccines Immunity Immunization Medical Schools 59

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 Diabetes 59