Drug Pricing, Labelling and Packaging

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. 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.”

Packaging

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Swissmedic approves Novartis’ malaria medicine for babies

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

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

Pharmaceutical Technology

JUNE 30, 2025

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. 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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Vertex and NHS England agree reimbursement for Alyftrek

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

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

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

Insurance Coverage and Processing

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

Pharmaceutical Technology

JULY 14, 2025

Sectors Sections Clinical Trials Drug Manufacturers Therapy Area Pricing and Market Access Latest EC approves BeOne’s Tevimbra for nasopharyngeal carcinoma Formulate Faster. The label expansion sought by GSK is a bid to compete with Pfizer and Moderna in the younger age groups of the RSV vaccine market.

Labelling

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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. How will RFK Jr’s American dream for vaccines play out? You will receive an email shortly. Unfortunately, there could be more in store.

Health and Personal Care Stores

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Vetter breaks ground on $285m US clinical manufacturing site

Pharmaceutical Technology

JUNE 30, 2025

The facility will support Vetter’s commitment to provide quality services and drug products during initial phases of clinical development. 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

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

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.

Immunization

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Sarepta halts Elevidys shipments following FDA pressure

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.

Insurance Coverage and Processing

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

Packaging

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

Pharmaceutical Technology

JULY 15, 2025

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Packaging

Packaging Communication Hospitals Drug Development

Why global 3PL providers are essential to easing supply chain challenges

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

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J&J eyes prostate cancer label expansion for Akeega

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

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

Pharmaceutical Technology

JULY 4, 2025

The European approval follows a similar decision made by the US Food and Drug Administration (FDA) in March 2025. Its European label covers a range of cancers, including lung, biliary tract, and liver, amongst others. How will RFK Jr’s American dream for vaccines play out? Give your business an edge with our leading industry insights.

Chemotherapy

Chemotherapy Packaging Labelling Communication

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

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

Packaging Communication Hospitals Vaccines

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.

Insurance Coverage and Processing

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Sarepta refuses to pull gene therapy despite FDA order

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.

Labelling

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

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

Packaging Hospitals Compounding Communication

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

Pharmaceutical Technology

JULY 10, 2025

Sectors Sections Clinical Trials Drug Manufacturers Therapy Area Pricing and Market Access Latest E. 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.

Packaging

Packaging Hospitals Compounding Communication

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

September 2023 Newsletter

Safe Biologics

NOVEMBER 12, 2023

6 would prevent the HHS Secretary from requiring a switching study as part of the data package to receive the interchangeable designation. Pitts: The IRA makes the risks of developing new drugs too high On September 14th, an op-ed by former FDA Associate Commissioner Peter J. However, S.6 ASBM surveys of U.S.

November 2023 Newsletter

Safe Biologics

DECEMBER 3, 2023

The most recen t of the webinars, hosted July 29th, examined the negative impact of the Inflation Reducation Act’s Medicare drug price setting provisions. The guidance removed the interchangeability statement from the product label/package insert of interchangeable biosimilars.

October 2023 Newsletter

Safe Biologics

DECEMBER 6, 2023

REMINDER: FDA Draft Guidance Would Remove Interchangeability Statement from Interchangeable Biosimilars Comments Due November 17th On September 15th, the Food and Drug Administration (FDA) released draft guidance removing the interchangeability statement from the product label/package insert. ASBM surveys of U.S. However, S.6

Private equity firms back PCI Pharma in bet on drug production

BioPharma Dive

JULY 14, 2025

PCI helps biopharmaceutical companies manufacture and package drug products used in clinical trials as well as commercially. You can unsubscribe at anytime. That funding was supported by a “significant reinvestment” from current backer Mubadala Investment Co. Informa PLCs registered office is 5 Howick Place, London SW1P 1WG.

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