Labelling, Packaging and White Paper

GE HealthCare’s PET imaging agent gains Alzheimer’s label expansion

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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How AI and machine learning are transforming drug discovery

Pharmaceutical Technology

JUNE 26, 2025

Free Whitepaper How value-based care is reshaping the life sciences This free white paper examines the benefits of value-based care (VBC) and how this translates into the wider life-sciences landscape. It also identifies off-label usage patterns and relevant comorbidities that may influence therapeutic decisions.

Compounding

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Tisento’s MELAS treatment receives fast track status from FDA

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.

Communication

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Bayer’s Eylea market grip set to slip as Alvotech biosimilar closes in

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!

CMO Moves: Regulatory catalysts for therapy manufacturing -January

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.

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Meeting global demand for patient independence: SHL Medical expands production in Charleston, US

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.

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FDA approves label updates for BMS’ CAR T cell therapies

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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FDA approves label expansion of AbbVie hepatitis C therapy

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.

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FDA removes safety programme for CAR-T therapies to boost uptake

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.

Insurance Coverage and Processing

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Vetter breaks ground on $285m US clinical manufacturing site

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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Torrent Pharmaceuticals to acquire stake in JB Pharma for $3bn

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

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WHO accuses China of withholding Covid-19 genetic data

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

Packaging Communication Hospitals Vaccines

EHA 2025: AstraZeneca’s surovatamig is potential next-gen BiTE for R/R B-ALL

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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CMO Moves: Regulatory catalysts for drug manufacturing – March 2023

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.

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CMO Moves: Regulatory catalysts for drug manufacturing- February

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.

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Sarepta and Roche halt DMD gene therapy’s use after second death

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.

Insurance Coverage and Processing

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Moderna’s mRNA RSV vaccine wins expanded FDA approval for younger adults

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.

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ADHD drugs back in the spotlight after study debunks rising prevalence

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

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US trade tariffs and the potential impact on pharma supply chains

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

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Pharmacist Digest

GE HealthCare’s PET imaging agent gains Alzheimer’s label expansion

How AI and machine learning are transforming drug discovery

Trending Sources

Tisento’s MELAS treatment receives fast track status from FDA

Bayer’s Eylea market grip set to slip as Alvotech biosimilar closes in

CMO Moves: Regulatory catalysts for therapy manufacturing -January

Meeting global demand for patient independence: SHL Medical expands production in Charleston, US

FDA approves label updates for BMS’ CAR T cell therapies

FDA approves label expansion of AbbVie hepatitis C therapy

FDA removes safety programme for CAR-T therapies to boost uptake

Vetter breaks ground on $285m US clinical manufacturing site

Torrent Pharmaceuticals to acquire stake in JB Pharma for $3bn

WHO accuses China of withholding Covid-19 genetic data

EHA 2025: AstraZeneca’s surovatamig is potential next-gen BiTE for R/R B-ALL

CMO Moves: Regulatory catalysts for drug manufacturing – March 2023

CMO Moves: Regulatory catalysts for drug manufacturing- February

Sarepta and Roche halt DMD gene therapy’s use after second death

Moderna’s mRNA RSV vaccine wins expanded FDA approval for younger adults

ADHD drugs back in the spotlight after study debunks rising prevalence

US trade tariffs and the potential impact on pharma supply chains

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