European Pharmaceutical Review

JANUARY 9, 2025

The associations explained this is enabled through multi-country packs which are simplified by the language exemption and harmonised labelling requirements.

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Pharmaceutical Technology

JUNE 25, 2025

The updated label for GE HealthCare’s positron emission tomography (PET) imaging agent Vizamyl (flutemetamol F 18 injection) now includes quantification of amyloid in the brain, meaning patients taking an anti-amyloid therapy can be monitored for the drug’s effectiveness. Don’t let policy changes catch you off guard.

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Express Pharma

DECEMBER 24, 2024

The impact of packaging is felt only when it does not do its job and therefore pharmaceutical companies have traditionally invested quite a bit on product packs, also using them as part of their branding strategy. sq mm of material – there is more than 20 per cent reduction of packaging material. per cent CAGR. Shivshankar S.R,

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Drug Patent Watch

FEBRUARY 17, 2025

Step 4: Labeling and Packaging Once the generic drug is approved, the manufacturer must ensure that its labeling and packaging comply with FDA regulations. This involves a thorough evaluation of the proposed generic drug's chemistry, manufacturing, and controls (CMC) as well as its clinical and non-clinical data.

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Pharma Marketing Network

JUNE 14, 2025

FDA Frontlines” A reliable resource for regulatory professionals, FDA Frontlines keeps tabs on advisory committee decisions, label expansions, and safety communications. From cold chain logistics to sustainability in packaging, it offers crucial insights for manufacturing and operations leaders.

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ID Stewardship

JANUARY 13, 2025

The package insert for sulopenem recommends taking it with food to maximize bioavailability. In case you are wondering, the FDA label does not list any hepatic dose adjustments. Orlynvah [package insert]. Its oral bioavailability is 40% when taken without food and increases to 64% when consumed with a high-fat meal.

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Pharmaceutical Technology

JUNE 26, 2025

It also identifies off-label usage patterns and relevant comorbidities that may influence therapeutic decisions. Through advanced AI-driven data curation, the platform extracts real-world insights from clinician notes, including reasons for GLP-1 therapy discontinuation such as adverse events and perceived lack of efficacy.

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LifeProNow

JANUARY 18, 2025

It is placed into the bladder by a healthcare professional using a co-packaged urinary placement catheter in an outpatient setting in under five minutes and without the need for anesthesia. TAR-200 is an investigational intravesical drug releasing system designed to provide sustained local delivery of gemcitabine into the bladder.

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Express Pharma

APRIL 12, 2025

Therefore, workplaces must discourage gender biases and reward employees based on individual merit [3] Women bring instinctive creativity, empathy and emotional intelligence to their work and office place [4] Women shouldn’t let labels define them.

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GMPSOP

JUNE 15, 2025

– Be alert to damaged packages. All biological waste should be placed in “Biological Hazard” labeled bags and steam-sterilized. – Strict labelling and storage requirements indicating material status, identification, and storage conditions. – Store starting materials off the ground and under cover.

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Drug Patent Watch

MARCH 12, 2025

It's not just a matter of copying a formula and slapping a new label on it. Container Closure System : How will the drug interact with its packaging? Behind the scenes, generic drug manufacturers are working tirelessly to ensure that their products are safe, effective, and identical to their branded counterparts.

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The Nontraditional Pharmacist

JULY 1, 2025

And ultimately, it’s to ensure we get the data because the data are ultimately what turns into your FDA approved label and demonstrates what you need. Sometimes we exclude medications from our protocol, various CYP enzymes and kind of going through a package insert to see, should we exclude this drug or not?

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Pharmaceutical Technology

JUNE 27, 2025

June 27, 2025 Share Copy Link Share on X Share on Linkedin Share on Facebook Label updates have been approved for BMS’ CAR T cell therapies, Breyanzi and Abecma, to treat multiple myeloma. The regulatory agency has also given approval to the removal of the REMS requirement from the product labels. Credit: Saiful52 / Shutterstock.

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Pharmacy Times

JULY 15, 2025

What we've done is blend PillPack's innovative packaging with Amazon Pharmacy's user-friendly approach and affordability, so these patients can now get their medications in convenient, personalized packets and order everything online through our digital pharmacy.

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Express Pharma

MARCH 12, 2025

It noted that US law requires complete manufacturing addresses to be printed on generic drug packaging and listed in the FDAs Orange Book database. Private label distributors, such as Walmart, are an exception to this rule, but their products still indicate India as the country of origin.

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Pharmacy Times

JUNE 23, 2025

Along with the successful pivotal trials, Launch-HTN and Advance-HTN, and the ongoing open-label extension trial, these results comprise the core package for our planned NDA submission.” “Explore-CKD established that lorundrostat 25 mg once daily has a favorable clinical profile for this patient population.

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Pharmacy Times

JULY 3, 2025

It's cognitive behavioral therapy packaged as a digital experience. I've even seen VR experiences, so it can be packaged in any type of digital experience. Typically, it's a white-labeled experience, so it has the look and feel of that digital therapeutic throughout the entire experience.

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Pharmaceutical Technology

JULY 7, 2025

The positive results from the KONFIDENT trial were further supported by findings from the real-world KONFIDENT-S open-label extension study. How will RFK Jr’s American dream for vaccines play out? Ekterly has the potential to become the foundational treatment for HAE and our focus now is on delivering it to the people who need it.”

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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. Package insert. These trials were designed to establish bioequivalence between zanubrutinib capsules and zanubrutinib tablets. News Release.

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PharmaTech

JUNE 25, 2025

Thakar ; Varanya Chaiyaperm June 23rd 2025 Article Bulk drug calculations for different types of active moieties and drugs require different calculations and labeling. BASF Opens GMP Manufacturing Facility in Michigan Susan Haigney June 19th 2025 Article The new facility offers cleanroom packaging and high-sensitivity analytical testing.

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Dosage Drug Development Packaging Labelling 59

Pharmaceutical Technology

JULY 8, 2025

How will RFK Jr’s American dream for vaccines play out? Give your business an edge with our leading industry insights.

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Pharmaceutical Technology

JUNE 30, 2025

How will RFK Jr’s American dream for vaccines play out? of equity shares from JB employees at the same price per share as offered to KKR. of equity shares from JB employees at the same price per share as offered to KKR. Give your business an edge with our leading industry insights.

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Packaging Communication Hospitals Drug Pricing 52

Pharmaceutical Technology

JUNE 23, 2025

Bayer has responded by eying a label extension that would allow injections of its high-dose version in intervals of up to six months. Like Eylea, Vabysmo is approved for a range of retinal diseases but has higher uptake due to the longer intervals between injections, giving it market advantage. Sign up for our daily news round-up!

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Pharmaceutical Technology

JULY 15, 2025

How will RFK Jr’s American dream for vaccines play out? Give your business an edge with our leading industry insights.

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Packaging Communication Hospitals Vaccines 52

Pharmaceutical Technology

JULY 15, 2025

How will RFK Jr’s American dream for vaccines play out? Give your business an edge with our leading industry insights.

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Packaging Communication Hospitals Vaccines 52

Pharmaceutical Technology

JUNE 18, 2025

Subjects who conclude the trial will be qualified for an open-label extension trial. By GlobalData Learn more about Strategic Intelligence The study is assessing the safety and efficacy of 15 mg or 30 mg of the therapy against a placebo, administered once daily for 12 weeks to those with genetically and phenotypically defined MELAS.

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Pharmaceutical Technology

JUNE 30, 2025

The agency said that safety information can be adequately conveyed using drug product labelling. How will RFK Jr’s American dream for vaccines play out? This includes a boxed warning for the risks of CRS and neurological toxicities. Give your business an edge with our leading industry insights.

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Pharmaceutical Technology

JULY 14, 2025

Robert Barrie July 14, 2025 Share Copy Link Share on X Share on Linkedin Share on Facebook Broader label coverages for Pfizer and Moderna’s vaccines mean they have made in-roads into GSK’s RSV dominant market share. How will RFK Jr’s American dream for vaccines play out? Give your business an edge with our leading industry insights.

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Pharmaceutical Technology

JUNE 30, 2025

Free Whitepaper Future-proofing parenteral packaging against nitrosamines The discovery of large quantities of nitrosamines in many drugs has led to a high number of product recalls in recent years. Download to learn about the causes of contamination and how to adapt your parenteral packaging – one potential source – to minimise the risk.

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Express Pharma

JULY 8, 2025

However, the use of Glutathione as a skin whitening agent is undertaken on an off-label basis by physicians. Off-label use means the usage of an approved drug for purposes other than for which it has been approved. Weight loss is yet another sphere where self-medication and excessive off-label use of drugs have gained traction.

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Pharmaceutical Technology

JUNE 30, 2025

Reports Contract Injectable Packaging Trends in the Bio/Pharma Industry Data Insights The gold standard of business intelligence. Reports Contract Injectable Packaging Trends in the Bio/Pharma Industry Data Insights The gold standard of business intelligence. How will RFK Jr’s American dream for vaccines play out?

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Pharmaceutical Technology

JULY 8, 2025

How will RFK Jr’s American dream for vaccines play out? Give your business an edge with our leading industry insights.

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Immunity Immunization Packaging Hospitals 52

FDA Law Blog: Biosimilars

MAY 4, 2025

DEA seized five packages in Eagle Pass, Texas, identifying IMC Pro as the shipper containing 26.4 IMC Pro agreed to provide the Chinese companies with access to the shipping companys accounts for common carriers to generate domestic shipping labels for goods and products the Chinese companies sold or manufactured.

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Pharmaceutical Technology

JULY 11, 2025

With a comprehensive EU label spanning lung and gastrointestinal cancers, and more than 100 regulatory approvals globally, we are delivering on our ambition to bring innovative therapies to more patients around the world.” How will RFK Jr’s American dream for vaccines play out? Give your business an edge with our leading industry insights.

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Pharmaceutical Technology

JULY 15, 2025

How will RFK Jr’s American dream for vaccines play out? Give your business an edge with our leading industry insights.

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RX Note

DECEMBER 25, 2024

Strategies for sodium reduction include Make reading food labels a habit. meats, fruits and vegetables) rather than their packaged counterparts. When available, buy low-sodium, reduced-sodium or no-sodium versions of foods (e.g. breakfast cereals, canned or frozen foods). Rinse canned foods to remove some sodium.

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Pharmaceutical Technology

JULY 16, 2025

This can be achieved by taking responsibility for warehousing, packing and labelling, order management, distribution, freight audit, and transportation trend management of pharma materials. How will RFK Jr’s American dream for vaccines play out? 3PLs can unlock cost savings that their customers might find harder to achieve.

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