Drug Topics

JUNE 25, 2025

The properties of thimerosal were documented to contribute to the safe use of multidose vials and packaging of vaccines, such as seasonal and pandemic influenza vaccines. 2 Currently, there are 3 FDA-approved seasonal influenza vaccines that contain a concentration of mercury, as evident from January 15, 2025, on the CDC website.

Vaccines

PharmTech

JULY 17, 2025

Stage 1: design the compounding blueprint Establish a complete plan including ingredients, packaging, calculations, labeling, and patient-specific factors. Finalize documentation with full traceability and ensure preparations are quarantined until verified. Check out the full article here !

Compounding

Pharmaceutical Technology

JULY 11, 2025

July 11, 2025 Share Copy Link Share on X Share on Linkedin Share on Facebook Existing clinical trial models are not considered sustainable. Areas underserved by clinical trials According to the ClinicalTrials.gov, almost 26,000 clinical trials were recorded to be seeking participants across all 50 states in the US in May 2025.

Hospitals

Pharmaceutical Technology

JULY 2, 2025

July 2, 2025 Share Copy Link Share on X Share on Linkedin Share on Facebook Logistics is crucial for successful cell and gene therapy treatments. In addition, documentation of the material is required, along with clearly defined next steps for modification and expansion. How will RFK Jr’s American dream for vaccines play out?

Packaging

Pharmaceutical Technology

JULY 16, 2025

Robert Barrie July 16, 2025 Share Copy Link Share on X Share on Linkedin Share on Facebook Shares in London-listed GSK closed 1.19% down following the document release. Experts also identified poor tolerability of regimens and resulting uncertainty regarding proposed dose, as per a briefing document published on 15 July.

Documentation

Pharmaceutical Technology

JULY 15, 2025

Robert Barrie July 15, 2025 Share Copy Link Share on X Share on Linkedin Share on Facebook Hong Kong-listed Sino already owns a 4.91% stake courtesy of an investment in November 2024. How will RFK Jr’s American dream for vaccines play out? Credit: Na_Studio via Shutterstock. Give your business an edge with our leading industry insights.

Packaging

PharmaVoice

JUNE 11, 2025

Published June 11, 2025 Amy Baxter Staff Reporter post share post print email license Win McNamee via Getty Images Listen to the article 5 min This audio is auto-generated. The 1,000-plus page document is full of tax and spending cuts, including some significant changes that will impact pharma and the larger healthcare industry.

Packaging

Pharmaceutical Technology

JULY 18, 2025

Manasi Vaidya July 18, 2025 Share Copy Link Share on X Share on Linkedin Share on Facebook Credit: [H_Ko]/Shutterstock.com In 2024, 50% of the novel drugs approved by the FDA had an orphan drug designation. How will RFK Jr’s American dream for vaccines play out? Give your business an edge with our leading industry insights.

FDA

The Checkup by Singlecare

MARCH 10, 2025

Certain insurance plans (such as ones from Blue Cross Blue Shield and United Healthcare ) may cover Ozempic but require prior authorization for coverage, meaning the prescriber needs to provide information such as blood tests or documentation to prove a treatment is medically necessary. How much is semaglutide without insurance?

Compounding

Pharmaceutical Technology

JULY 18, 2025

Abigail Beaney July 18, 2025 Share Copy Link Share on X Share on Linkedin Share on Facebook The FDA’s Oncologic Drugs Advisory Committee (ODAC) has voted against the benefit/risk profile of GSK’s Blenrep. The concern of ocular toxicity was first highlighted in a document published ahead of the ODAC meeting that took place on 17 July.

FDA

Pharmaceutical Technology

JUNE 17, 2025

Manasi Vaidya June 17, 2025 Share Copy Link Share on X Share on Linkedin Share on Facebook A panel at the 2025 BIO International Convention discuss the state of the European biotech funding ecosystem. But much larger, later-stage funds are emerging in Europe, which can fund companies further. Sign up for our daily news round-up!

Communication

European Pharmaceutical Review

APRIL 8, 2025

Given that multiple work packages may often start or end together, or else take longer than others ( Figure 1 ), the introduction of new PAT requires assessment and planning by multiple departments. Any documentation, such as validation reports then helps with compliance and later regulatory submissions and requests.

Documentation

Pharmaceutical Technology

JULY 3, 2025

July 3, 2025 Share Copy Link Share on X Share on Linkedin Share on Facebook AI’s impact on the life sciences industry could be transformational. Real-world roadblocks (and how to remove them) When you start implementing these requirements, you’ll face practical challenges that don’t appear in regulatory guidance documents.

Packaging

European Pharmaceutical Review

APRIL 14, 2025

In the UK, the Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2024 1 have passed through the UK legislative procedure and will apply from 23 July 2025. In the EU, the EU pharmaceutical package of reform 5 includes a proposed new Directive, 6 which will replace the current Medicines Directive (2001/83/EC).

Hospitals

The FDA Law Blog

JULY 15, 2025

The manufacturer’s documentation of the methodology used to determine fair market value would have to be submitted, along with other reasonable assumptions, to CMS each quarter. The proposed rule will be published in the Federal Register of July 16, and comments may be submitted here until September 12, 2025.

Documentation

The FDA Law Blog

OCTOBER 5, 2022

The proposed rule is intended to align with current nutrition science, the Dietary Guidelines for Americans 2020-2025 and the 2016 nutrition labeling regulation (which also was intended to align with the Dietary Guidelines for Americans). As a result, there generally will be no incentive to fortify foods with certain beneficial nutrients.

FDA

ISPE

SEPTEMBER 11, 2023

4 , 5 Additionally, reducing shipping limitations—such as packaging, storage, and transportation durations—helps speed up patient access in certain instances while ensuring there is no negative impact to the product’s critical quality attributes (CQAs). These new operating models can help enable and accelerate the efforts of Pharma 4.0™

Health and Personal Care Stores

PharmaShots

JUNE 1, 2023

These new results reinforce our differentiating data package for PDC*lung01. After the completion of the current clinical study with PDC*lung01 (PDC-LUNG-101), we plan to conduct a randomized, open-label phase 2 clinical trial with PDC*lung in the B2 cohort setting (2025 to 2028).

Immunization

The FDA Law Blog

JANUARY 20, 2025

Nearly two years after FDA issued draft guidance on Labeling of Plant-Based Milk Alternatives and Voluntary Nutrient Statements , on January 6, 2025, FDA released draft guidance document on plant-based labeling, Labeling Plant-Based Alternatives to Animal-Derived Foods. The description or name of the food (i.e.,

Labelling