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.

FDA

Pharmaceutical Technology

AUGUST 7, 2025

The FDA’s decision to grant accelerated approval was based on an integrated efficacy analysis of 50 patients with recurrent H3 K27M-mutant diffuse midline glioma, chosen across five open-label studies. The safety of Modeyso was evaluated in 376 patients across four open-label clinical studies.

FDA

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.

Packaging

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.

Packaging

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. of equity shares from JB employees at the same price per share as offered to KKR.

Packaging

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.

Packaging

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.

Packaging

Pharmaceutical Technology

JUNE 6, 2025

Originally approved for children in 2021, the FDA updated the drug’s label in January this year to include adults. The mechanism of action of Qelbree, though unclear, is thought to be through inhibiting the reuptake of norepinephrine. ADHD treatments were in the political crosshairs in the US recently.

Communication

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.

FDA

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.

Labelling

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.

Health and Personal Care Stores

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?

Packaging

Pharmaceutical Technology

JULY 22, 2025

EU’s Pharma Package falls short of Europe’s goal of global competitiveness Why can’t the US figure out weight loss drug prices? Sarepta confirmed it will work with the FDA to respond to requests for information while advancing the Elevidys safety labelling supplement process.

FDA

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.

Packaging

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.

Packaging

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.

Packaging

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.

Pharmaceutical Companies

Pharmaceutical Technology

JULY 7, 2025

How will RFK Jr’s American dream for vaccines play out? Robert Barrie July 7, 2025 Share Copy Link Share on X Share on Linkedin Share on Facebook The application comes hot on the heels of positive data for Akeega unveiled at this year’s American Society of Clinical Oncology (ASCO) conference.

Labelling

Pharmaceutical Technology

JULY 4, 2025

Its European label covers a range of cancers, including lung, biliary tract, and liver, amongst others. AstraZeneca is also eying up label expansions for Imfinzi in non-muscle invasive bladder cancer (NMIBC), a larger market given that 70% of new bladder cancer diagnoses come from this segment.

Chemotherapy

Pharmaceutical Technology

JUNE 13, 2025

The US Food and Drug Administration (FDA) has approved the label expansion of AbbVie’s Mavyret (glecaprevir/pibrentasvir) for treating adults and paediatric patients three years and older with acute or chronic hepatitis C virus (HCV) infection. Credit: © AbbVie Inc. All rights reserved.

Labelling

Pharmaceutical Technology

JUNE 16, 2025

By GlobalData Learn more about Strategic Intelligence Corwin added that Elevidys’s label will likely be updated to reflect the risk of ALF. Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis. Give your business an edge with our leading industry insights.

Communication

Pharmaceutical Technology

JUNE 13, 2025

Vaccines under political pressure Whilst the label expansion reflects an easing in regulatory tension surrounding mRNA vaccines under the Trump administration, FDA approval does not automatically mean shots enter national immunisation schedules. It also gained FDA approval a year before mRESVIA, giving it first to market advantage.

Vaccines

Pharmaceutical Technology

AUGUST 8, 2025

Both Vimkunya and Ixchiq are also approved in adolescents in Europe, the latter’s licence coming via a label expansion in April 2025. For a while, Ixchiq was the only licensed vaccine for chikungunya virus prevention until Bavarian Nordic’s Vimkunya entered the market in February 2025. Sign up for our daily news round-up!

FDA

Pharmaceutical Technology

AUGUST 1, 2025

Eli Lilly is attempting to join fellow pharma companies with glucagon-like peptide-1 receptor agonists (GLP-1 RAs) – drugs originally approved for treating diabetes – gaining expanded label expansions in cardiovascular indications. Give your business an edge with our leading industry insights.

Packaging

Pharmaceutical Technology

JULY 17, 2025

July 17, 2025 Share Copy Link Share on X Share on Linkedin Share on Facebook The announcement included updates on Elevidys’ label changes for Duchenne muscular dystrophy treatment. It also announced an update regarding its Elevidys label changes for Duchenne muscular dystrophy (DMD) treatment. Credit: luchschenF/Shutterstock.com.

Labelling

Pharmaceutical Technology

JULY 21, 2025

EU’s Pharma Package falls short of Europe’s goal of global competitiveness Why can’t the US figure out weight loss drug prices? This comes just days after Sarepta said it has agreed to change the black box on the Elevidys label to include ALF and acute liver injury (ALI) warnings.

FDA

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.

Packaging

Pharmaceutical Technology

JULY 10, 2025

By GlobalData Learn more about Strategic Intelligence While success in these indications is putting value on label expansions in earlier lines of therapies, Kolesnikova noted that there are various disadvantages to CAR T therapies. How will RFK Jr’s American dream for vaccines play out? Don’t let policy changes catch you off guard.

Packaging

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.

Labelling

Pharmaceutical Technology

JUNE 30, 2025

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

Packaging

Pharmaceutical Technology

JANUARY 15, 2023

While Catalent Inc and PCI Pharma Services are in charge of the solid dose and packaging of Lupkynis, Lonza is manufacturing the small molecule API. In the same month, the EMA expanded the label of Gilead Sciences’ Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) to include its use for virologically suppressed HIV-positive children.

Labelling

Pharmaceutical Technology

NOVEMBER 7, 2022

As a vertically integrated company, SHL Medical prides itself on being an end-to-end partner, offering in-house capabilities at every stage – from design, development and production to final assembly, labelling and packaging. Download the white paper ‘Charleston, USA: A life sciences hub’ here.

Packaging

ISPE

MARCH 29, 2023

Ultimately, the summary was not adopted during the QbD pilot, but was reintroduced in 2014 when a Pharmaceutical Research and Manufacturers of America (PhRMA) team prepared a white paper describing the content and format of an improved Module 2. Table 1: Linkage among patient consideration, product design, target attributes and CQAs.

Documentation

ISPE

MARCH 29, 2023

Ultimately, the summary was not adopted during the QbD pilot, but was reintroduced in 2014 when a Pharmaceutical Research and Manufacturers of America (PhRMA) team prepared a white paper describing the content and format of an improved Module 2. Table 1: Linkage among patient consideration, product design, target attributes and CQAs.

Documentation

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.

Packaging

Pharmaceutical Technology

MARCH 21, 2023

Based on the individual contract, these CMOs manufacture small molecules or biological active pharmaceutical ingredients (APIs), as well as packaging material, and are charged with other related functions. Sharp Packaging Services is producing the solid dose of the drug and packaging it.

Packaging

Pharmaceutical Technology

FEBRUARY 27, 2023

Contract manufacturing organizations (CMOs) not only produce the active pharmaceutical ingredient (API) at the heart of a therapy, but are also responsible for the sterile manufacturing and packaging of liquid and inhalational drug constituents and packaging, depending on the needs of the particular therapy.

Packaging