European Pharmaceutical Review

SEPTEMBER 15, 2023

Catalent: Case Management Services for Cell/Gene Therapies Cipla: Digital Innovation at Cipla Global Supply Chain Thermo Fisher Scientific: mySupply Platform Packaging Bilcare Limited: Elite PVC-free Compact Barrier Coldform Blister GASPOROX AB: AutoMAP Pharma IMA S.p.A.:

Packaging 119

Packaging Drug Development 119

pharmaphorum

AUGUST 6, 2020

Blenrep, which is predicted by analysts to produce revenues of around $1.5bn in 2026, is an antibody-drug conjugate that works by targeting B-cell maturation antigen (BCMA), a protein commonly found on the surface of the malignant B-cells that cause the disease.

Adverse Reactions 87

Adverse Reactions Packaging 87

Pharmaceutical Business Review

OCTOBER 1, 2024

The latest FDA approval for Otulfi is based on a detailed assessment of the comprehensive data package which comprised pre-clinical, analytical, clinical and manufacturing findings. A human monoclonal antibody, Ustekinumab acts on the interleukin-12 and interleukin-23 cytokines which hold a key role in inflammatory and immune responses.

Biosimilars 52

Biosimilars Packaging Immunity Immunization 52

European Pharmaceutical Review

SEPTEMBER 26, 2023

The regulatory package submitted to the EC included evidence derived extensive analytical characterisation. The site is planned to be completed by 2026. Sandoz has the rights to commercialise and distribute it in all markets under the deal.

Biosimilars 59

Biosimilars Dosage Packaging 59

Pharmaceutical Technology

NOVEMBER 24, 2022

The financing will aid Biovac in advancing its expertise from vaccine vial filling and packaging to end-to-end vaccine product development and production of the drug substance. The initial segment of the project is supported by $6.9m (R120m) funds from Wellcome Trust and the Bill & Melinda Gates Foundation.

Vaccines 59

Vaccines Packaging 59

European Pharmaceutical Review

FEBRUARY 12, 2024

Indeed, optimisation of the process and investment in new technologies has enabled the site to further enhance manufacturing capabilities to triple output annually, meaning more patients can avail of potentially life-changing medicines – and the facility is now targeting to serve 650,000 patients annually by 2026,” says Dunne.

Process Improvement 98

Process Improvement Packaging 98

FDA Law Blog: Biosimilars

FEBRUARY 21, 2024

This amendment marks the first significant revision of Part 820 since 1996, which established the Quality System (QS) regulation and “included requirements related to the methods used in, and the facilities and controls used for, designing, manufacturing, packaging, labeling, storing, installing, and servicing of devices intended for human use.”

Labelling 59

Labelling Packaging Documentation 59

Pharmaceutical Technology

JUNE 10, 2025

As per its IPO prospectus in January, the monotherapy trial was set to commence in Q1 2025, with the combo trial slated for the same quarter in 2026. Two pre-clinical programmes also stood to benefit from cash generated from the IPO. Give your business an edge with our leading industry insights.

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National Association of Boards of Pharmacy

OCTOBER 23, 2024

Exchanging transaction information, verifying product identifiers, responding to regulator requests for transaction information, and gathering transaction information at the package level. What are the current DSCSA compliance requirements for all trading partners?

Packaging 49

Packaging Documentation Pharmacy Technician 49

pharmaphorum

OCTOBER 1, 2020

While no guarantee can be placed on approval, we view this as a vote of confidence in pacritinib’s data package and the FDA’s dedication to addressing unmet medical needs in as timely a fashion as possible,” he said in a research note. Jakafi had sales of more than $1.1

Packaging 52

Packaging Labelling 52

European Pharmaceutical Review

FEBRUARY 7, 2023

Launch of the EU pharmaceutical package The European Commission plans to commence initiatives relating to the European Pharmaceutical Strategy (strategy) with the publication of the revised EU pharmaceutical package scheduled during the first quarter of 2023. of the MDR and Article 110.4

Packaging 117

Packaging Drug Development 117

National Association of Boards of Pharmacy

JULY 19, 2024

On June 12, 2024, Food and Drug Administration (FDA) issued exemptions for certain dispensers and in limited scenarios, their trading partners, from certain requirements of section 582 under the Food Drug and Cosmetic Act (FD&C Act) until November 27, 2026. Gathering transaction information for recalls at the package level.

Pharmacy Technician 45

Pharmacy Technician Documentation Communication Packaging 45

European Pharmaceutical Review

NOVEMBER 24, 2022

One area in which the problem can be tackled effectively is product packaging. With predictions that the global market for anticounterfeiting packaging is set to reach almost $250 billion by 2026, growth in authentication and anti-tamper devices such as holograms appear to have a healthy future.”

Packaging 111

Packaging Labelling Documentation Dosage 111

European Pharmaceutical Review

SEPTEMBER 22, 2023

According to a report by Research Nester, the global aseptic packaging market is projected to reach a revenue of $35 billion by 2033 and is estimated to reach a compound annual growth rate (CAGR) of 10 percent between 2023 and 2033. The post Aseptic packaging market to value $35bn by 2033 appeared first on European Pharmaceutical Review.

Packaging 105

Packaging Vaccines Compounding 105

Safe Biologics

AUGUST 23, 2024

” From the FDA’s statement: FDA has generally recommended switching studies in the past as part of the data package needed to demonstrate interchangeability of a biosimilar; however, of the 13 approved interchangeable biosimilars, 9 were approved without additional clinical (switching study) data. .”

Biosimilars 130

Biosimilars Chemotherapy Packaging 130

Putting Patients First Blog

SEPTEMBER 30, 2024

billion through fiscal year 2026. With the funding deadline occurring after the November elections, the next round of negotiations will be impacted by the election results. Under the CR, the Fund distributes $3.2 The CR also provides $27.1

Department of Veterans Affairs 98

Department of Veterans Affairs Packaging Drug Development 98

Express Pharma

NOVEMBER 24, 2023

Fette Compacting Machinery India, Ace Technologies & Packaging Systems, DPB Antibiotics, Lee Pharma, Omniscient Health, hcare, Venkata Narayana Active Ingredients, Unilab Chemicals and Pharmaceuticals, and many others. A vaccine manufacturing powerhouse, India leads by supplying over 60 per cent of global vaccine demand.

Packaging 105

Packaging Vaccines Pharmaceutical Manufacturing Hospitals 105

Putting Patients First Blog

AUGUST 28, 2023

Appropriations The most pressing deadline facing Congress as they return from August recess is passing a federal spending package. When the House and Senate return to session in September, it is expected that these bills will be consolidated into an end of year health care package.

Packaging 52

Packaging Drug Pricing 52

pharmaphorum

JANUARY 4, 2023

The CGT market in Europe, for example, is projected to increase by 23% by 2026. A successful logistics strategy also requires access to advanced packaging solutions, such as dry shippers, a network of charging stations, and real-time location tracking and temperature monitoring.

Packaging 98

Packaging 98

Express Pharma

JANUARY 12, 2024

. – Considering that the government promotes companies to “Make in India”, we request that the time limit for commencing manufacturing or production be further extended to 31 March 2026. Therefore, the sunset period should be extended for borrowings in foreign currency up to 31 March 2026; this would support the vision of “Make in India”.

Insurance Coverage and Processing 52

Insurance Coverage and Processing Pharmaceutical Companies Pharmaceutical Companies Health Insurance Companies 52

Ramblings of a pharmacist

MAY 16, 2025

In December, it was included in the budget package, and I started to get hopeful that pharmacists would see change. And then Elon Musk started tweeting that the bill was too long, and that hope died. The next day, Elon tweeted “What is a Pharmacy Benefit Manager? On May 13, the Senate Judiciary Committee held a hearing about PBMs.

Specialty Pharmacies 122

Specialty Pharmacies Compounding Pharmacies Packaging Compounding 122

STAT

MAY 22, 2025

  The hearing was supposed to focus on the Trump administration’s 2026 budget request, but instead covered a wide range of other FDA issues currently in the political spotlight. billion for the upcoming year, with $3.6 billion coming from industry user fees.

Packaging 263

Packaging Vaccines Drug Development 263