European Pharmaceutical Review

JANUARY 10, 2023

In 2024, Pharmapack Europe, the two-day exhibition and conference for pharma’s drug delivery and packaging industry will introduce two brand new zones to the flagship event. Bio packaging zone . Pharmapack’s bio packaging zone builds on its long history of being at the forefront of innovations in biological drug delivery.

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Packaging 96

Pharmafile

JANUARY 14, 2025

Pharmapack Europe: Basel the best location for drug device innovation in Europe thanks to combination of world class manufacturing and existing biomedical research infrastructure 18 December 2024 Paris, France New research released ahead of Pharmapack Europe the continents largest partnering event for medical device and packaging innovation has (..)

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Packaging 64

European Pharmaceutical Review

AUGUST 15, 2023

CPHI, the global pharmaceutical event that spans the entire supply chain from ingredients and finished dosages to machinery, bio, and packaging will return to Fiera Milano (Rho) in 2024. The post CPHI to return to Milan in 2024 appeared first on European Pharmaceutical Review.

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Fierce Healthcare

OCTOBER 2, 2023

Independence Blue Cross unveiled Medicare Advantage (MA) packages that the company said will greatly enhance benefits for its MA members, including a bigger allowance for vision, dental, hearing an | The MA enhancements touted by Independence Blue Cross include reducing premiums for its Personal Choice 65 PPO while including a Part B giveback and a (..)

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Packaging 108

European Pharmaceutical Review

JUNE 4, 2024

Meeting the Divisions at ACHEMA 2024 IMA Active The ideal partner for each solid dose processing phase: granulation, tableting, capsule filling and banding, weight checking, coating, handling and washing. End-of-line solutions, from robotics, handling, overwrapping to case-packing and palletising are provided by the IMA EOL hub.

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The FDA Law Blog

FEBRUARY 2, 2025

By Sara M Keup In reviewing some new 2025 pharmacy rules/laws a couple interesting changes caught this bloggers attention: As of December 30, 2024, Missouri has rolled out new rules related to prescription drug delivery requirements. The California Board of Pharmacy updated many of the application forms and guidelines in late 2024.

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Pharmaceutical Commerce

MAY 29, 2024

Alison Crawley and Bourji Mourad, Sonoco ThermoSafe, react to lessons learned from the 2024 LogiPharma Masterclass and consider the future of sustainable thermal packaging as it relates to air cargo logistics.

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Packaging 52

European Pharmaceutical Review

OCTOBER 3, 2024

Preparing for the impact of EU GMP Annex 1 on primary packaging Niamh Bissett and Dr Ana Kuschel West Pharmaceutical Services, Inc. The post <em>European Pharmaceutical Review </em> Issue 4 2024 appeared first on European Pharmaceutical Review. Login or create an account to download your copy of our Issue now!

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Packaging Vaccines FDA 59

BioPharm

JANUARY 25, 2024

The 2024 Pharmapack Europe Award winners include companies involved in ground-breaking innovations in novel drug delivery solutions, reusable connected devices, and recyclable packaging.

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Packaging 52

Outsourcing Pharma

OCTOBER 2, 2024

The company will introduce its innovative siliconized moulded glass vials, positioning itself as the only global supplier offering this technology to pharmaceutical standards.

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Packaging 52

Digital Pharmacist

DECEMBER 22, 2023

Recognizing and addressing these changing dynamics is crucial as we step into 2024. Digital Transformations As in the past years, one of the top pharmacy trends of 2024 remains to be “digital.” The post 2024 Pharmacy Trends to Look For appeared first on Digital Pharmacist.

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Community Pharmacies Prescription Filling Medication Delivery Packaging 52

STAT

JULY 11, 2024

This calls for celebration with a cup of stimulation, and we are opening a new package of blueberry muffin for the occasion. Novo said it does not expect to be able to fulfill the requests during 2024, delaying the program for several months at least. What is upon us right now, however, is our ever-growing to-do list. Sound familiar?

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Packaging FDA 105

IDStewardship

OCTOBER 14, 2024

BCPS, BCIDP Article Posted October 2024, First Released in the October 2024 IDstewardship Newsletter 1. The process is detailed in the package insert here. In this article an infectious diseases pharmacist discusses 5 examples where challenging antibiotic workflows can be an issue. Authored By: Timothy P. Gauthier, Pharm.D.,

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European Pharmaceutical Review

APRIL 26, 2024

Recent biosimilar developments In February 2024, the EMA’s Committee for Medicinal Products for Human Use (CHMP) granted a positive opinion for Pyzchiva as a biosimilar to treat the autoimmune condition plaque psoriasis. Samsung Bioepis is responsible for development, registration, intellectual property (IP), manufacturing and supply.

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Packaging Pharmaceutical Companies Pharmaceutical Companies FDA 98

European Pharmaceutical Review

DECEMBER 19, 2023

Preparations to support the implementation of the EU AI Act will start in 2024. AI-supported spectroscopy delivers superior pharmaceutical packaging QC The post European regulators prepare for AI in pharma appeared first on European Pharmaceutical Review.

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Packaging Documentation 105

Pharmaceutical Technology

DECEMBER 19, 2023

In this issue: Fixing drug nomenclature to avoid confusing names, gene therapies for sickle cell disease, childproof packaging for drugs, and UK pharma manufacturing gears up for a shake up in 2024

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Packaging 52

Hospital Pharmacy Europe

OCTOBER 30, 2023

Immediate and short-term actions include the creation of a Union list of critical medicines, which will be available by the end of 2023, guidance on procurement and further regulatory flexibilities to follow in 2024.

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Packaging Labelling Hospitals 98

European Pharmaceutical Review

AUGUST 23, 2023

Comments are welcome from 1 November 2023 to 31 January 2024. Chapter <86> Bacterial Endotoxins Test Using Recombinant Reagents, proposed by the USP Microbiology Expert Committee, is now published as a General Announcement. This is in advance of the official open comment period, according to USP.

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Packaging 98

The Checkup by Singlecare

JANUARY 11, 2024

10 potential upcoming FDA approvals for 2024 Pharmacists are on the frontline when it comes to getting patients the right medications for their treatment plan. Therefore, you’ll want to prepare and adapt to potential 2024 FDA approvals, which may include the following drugs currently in the pipeline.

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European Pharmaceutical Review

JANUARY 25, 2024

Therefore, extractables and leachables assessment should consider the packaging components of the CCS, including the labelling. However, according to the FDA, this is “less of a concern” for products, such as biological products, that are packaged in glass containers.

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European Pharmaceutical Review

NOVEMBER 23, 2023

CPI confirmed that the centre will establish operations during 2024 and be finished in late 2025. This is a first-of-its-kind collaboration for the pharma industry. Partners include AstraZeneca, GSK, and the University of Strathclyde. The project will be jointly funded by the UK and Scottish Governments.

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Packaging 104

The FDA Law Blog

AUGUST 27, 2023

FDA intends the Guidance to provide “clarity and flexibility” to trading partners to “help ensure continued patient access to prescription drugs as the supply chain transitions to the interoperable, electronic product tracing at the package level under the DSCSA” while supporting “continued availability of products to patients.”

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FDA Packaging 52

European Pharmaceutical Review

AUGUST 26, 2024

The concentration of the formulation means the treatment can be administered ocularly via eye drops packaged in single-dose containers, according to SIFI. SIFI confirmed that the first commercial launch of the eye drops is planned in Germany in Q4 of 2024.

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Packaging Hospitals FDA 69

European Pharmaceutical Review

FEBRUARY 7, 2023

Some of the current and anticipated proposals will not be adopted in 2023, or even before the end of tenure of the current European Commission in late 2024. In addition, the life sciences industry may be impacted by the introduction of class action mechanisms in the EU and initiatives to regulate the use of artificial intelligence (AI).

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Packaging 117

The FDA Law Blog

SEPTEMBER 24, 2024

Livornese — FDA issued a Federal Register notice on September 13, 2024, seeking feedback on the Integrated Review format that the Center for Drug Evaluation and Research (CDER) began using as part of its New Drugs Regulatory Program (NDRP) modernization effort several years ago. Comments are due by December 12, 2024. By Deborah L.

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Documentation FDA Packaging 59

pharmaphorum

FEBRUARY 12, 2021

UK’s withdrawal from the EU has also created opportunities for Ireland, according to Mullen, with pharma packaging and distribution services such as Central Pharma opening Irish operations. Following Brexit, the U K will also be a major target for Ireland as British companies look to establish an EU base.

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Packaging Pharmaceutical Companies Pharmaceutical Companies 124

STAT

SEPTEMBER 12, 2024

This calls for celebration with a cup of stimulation, and we are opening a new package of pecan pie for the occasion. billion, between 2024 and 2027 in a concession to investors who have viewed the company’s outlays following its pandemic-era windfall as profligate, STAT writes. Sound familiar? Have a great day, everyone.

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Packaging Vaccines 58

Pharmaceutical Technology

MAY 25, 2023

The regulatory approval was based on a comprehensive data package of preclinical, analytical and clinical trials. It is also seeking an interchangeability designation for Yuflyma from the FDA, with approval expected in the fourth quarter of 2024. The company intends to launch the biosimilar in the US in July 2023.

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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 parties anticipate beginning the technology transfer process in January next year, with the first trial batches planned to be manufactured in 2024.

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Pharmaceutical Technology

JULY 29, 2022

Injectables and their packaging requirements have never been more important to marketed treatments, given the volume of vaccines being packaged that are required to tackle the Covid-19 pandemic, as well as the rising presence of biologics in pipelines and their marketed approvals. The expansion will be operational in 2024.

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Vaccines Packaging Immunization FDA 52

DiversifyRx

JULY 11, 2024

Small Dispensers and the 6/12/2024 FDA Announcement Concerning DSCSA This week’s article on the recent DSCSA postponement comes from PRS Pharmacy Services. Not All Pharmacies Can Exempt from The 11/27/2024 DSCSA Requirements. The original article can be found HERE. The DSCSA Adventure continues. The DSCSA Adventure continues.

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Independent Pharmacies FDA Documentation CPhT 52

The FDA Law Blog

MARCH 3, 2024

3558 ) on January 25, 2024. Conclusion Although the BIOSECURE Act has not been passed by Congress (or signed by the President), its sponsors are expected to push for its inclusion in the FY25 NDAA or as part of other omnibus legislative packages that arise this year. House of Representatives ( H.B. 7085 ) and Senate ( S.B.

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Packaging FDA 102

Pharmaceutical Technology

APRIL 5, 2023

The European Medicines Agency (EMA) has announced plans to expedite scientific advice and support the preparation of regulatory packages under its PRIority Medicines (PRIME) scheme. PRIME is an EMA scheme to support the development of medicines for rare diseases and conditions with high unmet need.

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Packaging 52

The Checkup by Singlecare

JANUARY 7, 2025

The FDA followed this up in 2024 by proposing that products like DayQuil Cold and Flu stop using phenylephrine. Amoxicillin retails for about $20 for 21, 500 mg capsules, while the DayQuil and Nyquil Cold and Flu package costs about that much for 48 tablets. Without insurance, their prices are fairly comparable.

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pharmaphorum

MARCH 10, 2022

Once the hub becomes operational in 2024, it will specialise in developing and producing active ingredients, monoclonal antibodies, enzymes, and other proteins, bringing a new generation of expertise in-house. Reducing reliance on external resources gives drugmakers greater control over production processes, from cells to a final product.

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The FDA Law Blog

FEBRUARY 21, 2024

Mullen — More than five years after FDA first announced its plan to harmonize 21 CFR Part 820 with ISO 13485, on February 2, 2024, FDA finally issued the Quality Management System Regulation (QMSR) Final Rule. Under § 820.45, FDA also requires manufacturers to inspect labeling and packaging for accuracy.

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DiversifyRx

NOVEMBER 24, 2023

While DSCSA (the Drug Supply Chain Security Act) enforcement is postponed until November 2024, it is critical to move forward in becoming compliant sooner rather than later. This tracking involves the use of unique product identifiers, such as serial numbers and barcodes, on drug packaging to track their movement.

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Independent Pharmacies Packaging Documentation FDA 40