Insurance, Labelling and White Paper - Pharmacy Technician Pulse

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.

Labelling

Labelling Packaging Communication FDA

GSK’s world-first gonorrhoea vaccine launched in England

Pharmaceutical Technology

AUGUST 5, 2025

As protection against gonorrhoea is not currently a licensed indication for the 4CMenB vaccine in England, the programme utilises off-label use of the vaccine. Evaluating immunogenicity data and a cost-effective modelling analysis, the panel recommended a targeted vaccination programme 4CMenB in those at the highest risk.

Vaccines

Vaccines Communication Hospitals Packaging

Ascendis Pharma’s Skytrofa gains FDA approval for growth hormone deficiency

Pharmaceutical Technology

JULY 29, 2025

The FDA’s approval for adults with GHD was based on the findings from the Phase III parallel-arm, randomised, active-controlled (open-label) and placebo-controlled (double-blind) foresiGHt trial. This therapy is administered subcutaneously once a week, ensuring a sustained release of active, unmodified somatropin.

FDA

FDA Packaging Labelling Communication

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.

Labelling

Labelling FDA Packaging Communication

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!

Communication

Communication Hospitals Packaging Labelling

FDA approves KalVista’s Ekterly for hereditary angioedema

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. 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.” Give your business an edge with our leading industry insights.

FDA

FDA Packaging Communication Hospitals

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.

FDA

FDA Communication Hospitals Packaging

FDA gives accelerated approval to Jazz Pharma’s diffuse midline glioma therapy

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

FDA Adverse Reactions Packaging Labelling

Swissmedic approves Novartis’ malaria medicine for babies

Pharmaceutical Technology

JULY 8, 2025

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Packaging

Packaging Hospitals Communication Labelling

Chugai and Gero link on antibody drugs for age-related conditions

Pharmaceutical Technology

JULY 8, 2025

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Packaging

Packaging Immunization Hospitals Communication

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. Give your business an edge with our leading industry insights.

Packaging

Packaging Communication Hospitals Labelling

Vertex and NHS England agree reimbursement for Alyftrek

Pharmaceutical Technology

JULY 15, 2025

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Packaging

Packaging Communication Hospitals Vaccines

Health Canada extends Evkeeza approval for children with HoFH

Pharmaceutical Technology

JULY 15, 2025

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Packaging

Packaging Communication Hospitals Vaccines

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

Communication Hospitals Packaging Labelling

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. Give your business an edge with our leading industry insights.

FDA

FDA Packaging Labelling Communication

GSK eyes FDA label expansion for RSV vaccine Arexvy to include younger patients

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. Give your business an edge with our leading industry insights.

Labelling

Labelling Vaccines FDA Packaging

Vetter breaks ground on $285m US clinical manufacturing site

Pharmaceutical Technology

JUNE 30, 2025

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Packaging

Packaging Compounding Hospitals Communication

Sarepta halts Elevidys shipments following FDA pressure

Pharmaceutical Technology

JULY 22, 2025

It is important for the patients we serve that Sarepta maintains a productive and positive working relationship with FDA, and it became obvious that maintaining that productive working relationship required this temporary suspension while we address any questions that FDA may have and complete the Elevidys label supplement process.”

FDA

FDA Labelling Communication Packaging

EC approves BeOne’s Tevimbra for nasopharyngeal carcinoma

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.” Give your business an edge with our leading industry insights.

Packaging

Packaging Hospitals Communication Labelling

Sino Biopharma spends $951m to acquire China-based LaNova Medicines

Pharmaceutical Technology

JULY 15, 2025

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Packaging

Packaging Communication Hospitals Vaccines

LEO Pharma secures rights to Boehringer’s Spevigo for $105m

Pharmaceutical Technology

JULY 15, 2025

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Packaging

Packaging Communication Hospitals Vaccines

J&J eyes prostate cancer label expansion for Akeega

Pharmaceutical Technology

JULY 7, 2025

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. Give your business an edge with our leading industry insights.

Labelling

Labelling Packaging Communication Hospitals

AstraZeneca’s Imfinzi approved in Europe for muscle-invasive bladder cancer

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

Chemotherapy Packaging Labelling Communication

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.

Labelling

Labelling FDA Communication Hospitals

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.

Communication

Communication Hospitals Vaccines Packaging

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.

Vaccines

Vaccines FDA Labelling Communication

From data to impact: How real-world evidence will transform healthcare

pharmaphorum

JULY 7, 2025

Skip to main content Monday 7 July 2025 BlueSky linkedin youtube rss User account menu Subscribe Channels Channels Digital Market Access Oncology Patients R&D Sales & Marketing Spotlight on Content type Content type Digital -News -Views & Analysis -Deep Dive -Webinars -Podcasts -Video -White Papers -Event Market Access -News -Views & (..)

Pharmaceutical Companies

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FDA removes Ixchiq partial pause but tightens vaccine’s use

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

FDA Vaccines Packaging Communication

Eli Lilly’s Mounjaro shows cardiovascular gains, but analysts underwhelmed

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

Packaging Communication Hospitals Labelling

Sarepta Therapeutics to cut 500 jobs amid restructuring

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

Labelling Communication Packaging Hospitals

Sarepta refuses to pull gene therapy despite FDA order

Pharmaceutical Technology

JULY 21, 2025

“This guides every decision we make, as evidenced by our conservative decision to pause shipments of Elevidys for non-ambulant patients while we work with the FDA to update the label and evaluate the use of an enhanced immunosuppression regimen to mitigate the risk of acute liver failure (ALF).”

FDA

FDA Labelling Packaging Communication

Pulmonary arterial hypertension market to reach $9.35bn across 7MM by 2034

Pharmaceutical Technology

JULY 8, 2025

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Packaging

Packaging Hospitals Compounding Communication

J&J bids to extend prostate cancer uses for Akeega

pharmaphorum

JULY 7, 2025

Skip to main content Monday 7 July 2025 BlueSky linkedin youtube rss User account menu Subscribe Channels Channels Digital Market Access Oncology Patients R&D Sales & Marketing Spotlight on Content type Content type Digital -News -Views & Analysis -Deep Dive -Webinars -Podcasts -Video -White Papers -Event Market Access -News -Views & (..)

Pharmaceutical Companies

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CTO East Coast 2025: Global oncology cell therapy market to hit $25bn by 2031

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. Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis.

Packaging

Packaging Compounding Hospitals Communication

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.

Labelling

Labelling Communication Hospitals Vaccines

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

The “Medical Bypass”: new drugs to strike obesity

Pharmaceutical Technology

NOVEMBER 30, 2022

weight reduction in obese individuals, as per its label. Furthermore, in order to make up for shortages Novo Nordisk’s Ozempic, a version of semaglutide that is approved to treat type 2 diabetes, was used off-label for obese patients. In the US, most private health insurers have been slow to cover the cost of anti-obesity therapeutics.

Labelling

Labelling Insurance Communication FDA

The “Medical Bypass”: new drugs to strike obesity

Pharmaceutical Technology

NOVEMBER 30, 2022

weight reduction in obese individuals, as per its label. Furthermore, in order to make up for shortages Novo Nordisk’s Ozempic, a version of semaglutide that is approved to treat type 2 diabetes, was used off-label for obese patients. In the US, most private health insurers have been slow to cover the cost of anti-obesity therapeutics.

Labelling

Labelling Insurance Communication FDA