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.

Community Pharmacies 52

Community Pharmacies Prescription Filling Medication Delivery Packaging 52

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 (..)

Packaging 109

Packaging 109

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

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 86

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

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 92

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.

Packaging 92

Packaging 92

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 85

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.

FDA 52

FDA Packaging Patient Care 52

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.

Independent Pharmacies 52

Independent Pharmacies Packaging Documentation FDA 52

European Pharmaceutical Review

AUGUST 30, 2023

The agreement stipulates that certain conditions must be met in the labelling and packaging of these medicinal products. After this date: Under the framework, medicines can have the same packaging and labelling across the UK. UK packaging must carry a clearly legible ‘UK only’ label to be allowed onto the UK market.

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Packaging Labelling 98

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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Vaccines Packaging 59

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

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

Pharmaceutical Technology

APRIL 21, 2023

While the FDA sent Lilly a complete response letter detailing issues pertaining to the proposed manufacturing of mirikizumab, the regulator raised no concerns about the clinical data package or label for the medicine. The recent setback dents mirikizumab’s chances to be the first among the IL-23 inhibitors to launch in the US for UC.

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FDA Packaging Labelling 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

pharmaphorum

SEPTEMBER 15, 2022

Reproxalap outperformed Xiidra in a phase 2 study on symptoms including eye discomfort and itching, which will stand in its favour, but the category is heading for a shake-up with low-cost generic competitors to Restasis set to emerge in 2024.

FDA 52

FDA Packaging 52

European Pharmaceutical Review

MARCH 28, 2024

FDA is expected to provide initial feedback on the data submitted by July 2024, with further data to be collected and analysed over the next two years. How does the qualification package support more meaningful endpoints and rare disease research as a result?

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FDA Packaging Insurance Communication 52

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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FDA Immunization Patient Care Packaging 52

The FDA Law Blog

JANUARY 11, 2024

The first commercial marketing of each, according to the biosimilar patent settlement agreement, was July 1, 2023, which would render the FIE expiration date July 1, 2024. But because the statute sets FIE expiration at the earlier of the relevant conditions, the April 15, 2023 and September 28, 2023 dates were the FIE expiration dates.

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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 122

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.

Pharmaceutical Companies 94

Pharmaceutical Companies Pharmaceutical Companies Packaging Immunization 94

Pharmacy Friday Pearls

AUGUST 29, 2022

Insulin [Lexi-drugs] Dextrose injection package insert High dose insulin therapy. Intensive care medicine , 33 (11), 2019–2024. High-dose insulin., Goldfrank’s Toxicologic Emergencies, 11e. McGraw Hill [Electronic version] Ko et al., Beta Safe Than Sorry! Powerpoint slides]. Pharmacy & Acute Care University 3. Cole, Ann M.

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Packaging Documentation 52

The Checkup by Singlecare

FEBRUARY 6, 2024

Here are some common steps to take: Check the label : Always read the drug information in the product package for potential warnings, and follow the instructions on your prescription label for the appropriate dosage. You can reduce the risk of interactions when using meclizine in various ways.

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Adverse Reactions Labelling Packaging Dosage 52

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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FDA Documentation Method Validation Packaging 90

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

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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FDA Labelling Packaging Documentation 59

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 96

STAT

OCTOBER 13, 2023

… Walgreens Boots Alliance expects to cut at least $1 billion in costs in 2024 as part of its ongoing efforts, which include shutting unprofitable stores, after the pharmacy chain operator forecast financial year 2024 profit below Wall Street expectations , Reuters tells us. But be safe. See you soon.

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Packaging 81

The Checkup by Singlecare

MARCH 7, 2024

In fact, many credible online platforms selling Ozempic only do so as part of a membership package, which actually increases your overall costs. These membership packages often include an online visit with a healthcare provider who may prescribe the drug for you. Ozempic cost comparison for 0.25 appeared first on The Checkup.

Health and Personal Care Stores 52

Health and Personal Care Stores Insurance Packaging Insurance Coverage 52

The Checkup by Singlecare

MARCH 21, 2024

has said they expect the shortage to last at least until March 2024. The limits for 2024 are $22,590 for individuals and $30,660 for married couples. Sends medications that look different than usual, have foreign text on the labels, have no expiration date, or come in broken packaging.

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Insurance Coverage Insurance Dosage Mail-Order Pharmacies 98

Pharmaceutical Technology

MAY 23, 2023

While a handful of incentives are offered by the reform package, they are overshadowed by the potential drawbacks for the innovative sector. The passage of legislation is not anticipated before the next EU parliamentary elections in 2024, potentially resulting in delays until late 2024 or even 2025.

Pharmaceutical Companies 52

Pharmaceutical Companies Pharmaceutical Companies Packaging 52

PharmaShots

APRIL 25, 2023

Currently, AstraZeneca is conducting a P-I clinical trial for the evaluation of ALXN2030 in healthy individuals with data anticipated in 2024. AstraZeneca is currently evaluating the potential of ALXN2030 in multiple clinical development programs for siRNA targeting complement C3 nephrology. R&D Expenditure: $14.6B

HIV Treatment and Prevention Agents 40

HIV Treatment and Prevention Agents Packaging Immunization Vaccines 40

The Checkup by Singlecare

APRIL 5, 2024

Samples often come in a package of four 2.5 Important note: Like Mounjaro, many of these drugs are in demand—and as of early 2024, some are in short supply, so they could be difficult to get. Keep in mind that a healthcare provider will only give you free samples if they think it would benefit your specific condition.

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Insurance Compounding Pharmacies Compounding Insurance Coverage 59

IDStewardship

NOVEMBER 29, 2023

In 2021 I enrolled in a Master’s for Microbiology and cell science at the University of Florida and I am expecting to complete it in December of 2024. I think that is where I do my best work I. think it comes very natural to me understanding these organisms and these reactions and that is where I have been working all these years.

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Patient Care Hospitals Packaging Communication 222

PharmaShots

MARCH 1, 2023

osteoporosis in postmenopausal women and men with high fractures risk, treatment-induced bone loss The submission was based on the comprehensive analytical and clinical data package, incl.

FDA 40

FDA Packaging Labelling 40

PharmaShots

JUNE 1, 2023

These new results reinforce our differentiating data package for PDC*lung01. Eric Halioua: We forecast to get the final report of the current clinical trial (P-I/II PDC-LUNG-101 trial) in Q2 2024. Smriti: Please share the development timeline for the PDC*lung01, when can we expect the next phase of development?

Immunization 40

Immunization Vaccines Health and Personal Care Stores Labelling 40