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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Quality Matters

FEBRUARY 9, 2023

Africa’s growing vaccine capacity Manufacturing products locally for more equitable pandemic responses Every year, vaccines prevent nearly 5 million deaths around the globe. Yet, Africa produces less than 1 percent of the vaccines it needs to protect patients and communities across the continent.

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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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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

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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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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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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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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Pharmacy Times

JUNE 16, 2025

The findings emphasize nemolizumab’s swift response in treating atopic dermatitis symptoms, along with its long-term effectiveness in prurigo nodularis, as demonstrated in the OLYMPIA open-label extension trial (NCT04204616).

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Pharmacy Times

JUNE 9, 2025

months versus 2.1 months versus 2.1 The findings were presented at the 2025 American Society of Clinical Oncology Annual Meeting, which was held in Chicago, Illinois. It is the first PROTAC to be evaluated in a phase 3 clinical trial, according to the investigators.

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Pharmaceutical Technology

JUNE 16, 2025

At the 2025 Congress of the European Hematology Association (EHA 2025), held from 12 June 12 to 15 June in Milan, Italy, preliminary dose-escalation and optimisation results from the global, multicentre, open-label, single-arm Phase I/II SYRUS clinical trial (NCT06137118) were presented on the second day.

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Pharmacy Times

JUNE 11, 2025

Its efficacy was evaluated in the 2 multicenter, single-arm open-label phase 2 clinical trials TRUST-I (NCT04395677) 3 and TRUST-II (NCT04919811). Taletrectinib is an oral, potent, central nervous system (CNS)–active, selective, next generation ROS1 inhibitor approved for the treatment of adults with advanced ROS1+ NSCLC.

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Pharmacy Times

JUNE 11, 2025

1,2 Image Credit: © stockdevil - stock.adobe.com Results from 2 single-dose, open-label, randomized phase 1 crossover studies of healthy adults served as the basis for this approval. These trials were designed to establish bioequivalence between zanubrutinib capsules and zanubrutinib tablets.

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Pharmacy Times

JUNE 9, 2025

2 However, Dalton noted that some procedures can change once a treatment is FDA-approved, with complications from Risk Evaluation and Mitigation Strategy programs as well as the occasional surprise on an FDA label. But doing so requires a new kind of expertise that spans science, strategy, and systems thinking.

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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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Pharmacy Times

JUNE 12, 2025

Primary chemoablation of recurrent low-grade intermediate-risk nonmuscle-invasive bladder cancer with UGN-102: A single-arm, open-label, phase 3 trial (ENVISION). Prasad SM, Shishkov D, Mihaylov NV, et al. February 1, 2025. doi:10.1097/JU.0000000000004296 0000000000004296 4.

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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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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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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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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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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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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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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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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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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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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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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

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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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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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 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.

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Pharmacy Times

JUNE 9, 2025

3 neoCARHP was a multicenter, open-label, randomized, noninferiority phase 3 trial (NCT04858529) that compared the efficacy and safety of TCbHP with THP in the neoadjuvant setting. If caught early, the cancer can often be treated and cured, according to Cleveland Clinic.

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Pharmacy Times

JUNE 15, 2025

In the randomized, open-label, multicenter phase 3 NATALEE clinical trial (NCT05306340), ribociclib (Kisqali; Novartis) plus endocrine therapy, a nonsteroidal aromatase inhibitor (NSAI), significantly improved invasive disease-free survival among individuals with HR-positive (HR+) and HER2-negative (HER2-) early breast cancer.

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Pharmacy Times

JUNE 12, 2025

Molecular model of pembrolizumab | Image Credit: © Dr_Microbe - stock.adobe.com The FDA’s decision was based on data from the randomized, multicenter, open-label KEYNOTE-689 trial (NCT02358031). This marks the first FDA approval for a perioperative treatment approach in locally advanced HNSCC.

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Pharmacy Times

JUNE 9, 2025

These conclusions were presented as part of an abstract from the open-label, phase 3 CheckMate 816 trial (NCT02998528) at the 2025 American Society of Clinical Oncology Annual Meeting in Chicago, Illinois, and subsequently published in the Journal of Clinical Oncology.

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PharmaTech

JUNE 12, 2025

Companies marketing unapproved or misbranded products, such as dietary supplements and topical analgesics, were warned for noncompliance with labeling and authorization rules. The products, labeled “Silver Bullet elite douche” and “Silver D elite douche,” contain colloidal silver intended for use in treating vaginal infections.

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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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