2028 and Documentation - Pharmacist Digest

NICE says yes to Novartis’ multiple sclerosis therapy Kesimpta

pharmaphorum

APRIL 20, 2021

NICE’s final appraisal document for Kesimpta will be followed by technology appraisal guidance (TAG) that will pave the way for NHS prescribing in England and Wales. billion by 2028. billion in sales in 2028. The Scottish Medicines Consortium is expected to publish its final advice on the drug later this year.

Hospitals

Hospitals Documentation

USP General Chapter —Glass revised

European Pharmaceutical Review

NOVEMBER 14, 2023

In the document, it was reasoned that global shortage of these vials threatened the delivery of COVID-19 vaccines and availability of existing parenteral products. Europe’s pharmaceutical packaging market to value over $35bn by 2028 The post USP General Chapter <660>—Glass revised appeared first on European Pharmaceutical Review.

Packaging

Packaging Vaccines Documentation

European regulators prepare for AI in pharma

European Pharmaceutical Review

DECEMBER 19, 2023

The workplan, which runs until 2028, will help the European medicines regulatory network (EMRN) embrace the opportunities of AI for personal productivity, automating processes and systems, increasing insights into data and supporting more robust decision-making to benefit public and animal health.

Packaging

Packaging Documentation

The EU AI Act: will regulation drive life science innovation away from Europe?

European Pharmaceutical Review

NOVEMBER 28, 2024

The added requirements will not only prolong approval timelines but also increase operational costs, as companies must invest in specialised compliance teams and detailed documentation for each certification layer.

Documentation

Documentation Compounding

Top biopharmaceutical Covid-19 vaccine companies boosted with over 80% revenue growth

Pharmaceutical Technology

SEPTEMBER 15, 2022

According to GlobalData’s report, Paxlovid, the company’s small-molecule Covid-19 oral therapy, was shown to reduce Covid-19 infections by 32% in adults and is forecast to be the top-selling drug by total sales, generating $81bn between 2021 and 2028. Bristol Myers Squibb (BMS) documented a 9.1% AbbVie reported a 22.7%

Vaccines

Vaccines Drug Pricing Biosimilars Documentation

MSD secures full approval for Keytruda’s use in MSI-high solid tumours

Pharmaceutical Technology

MARCH 30, 2023

billion in 2028. There, the FDA suggested that the drugs undergo randomised controlled trials, which the document describes as the preferred approach, rather than single-arm trials. In 2022, the company reported Keytuda sales of $20.9 billion in its FY 2022 results. GlobalData is the parent company of Pharmaceutical Technology.

Chemotherapy

Chemotherapy Packaging Documentation

Understanding Large Molecule Drug Development: From Biologics to Market

Syner-G

SEPTEMBER 15, 2023

billion by 2028. Process reliability and product consistency are critical during scaling up to commercial production, necessitating comprehensive documentation of process parameters, analytic results, and manufacturing data. New methodologies provide insights into protein thermal stability across the proteome and in biological systems.

Drug Development

Drug Development Documentation Process Improvement Compounding

A history of blood cancer treatment

pharmaphorum

SEPTEMBER 13, 2022

The first well-documented case of multiple myeloma was reported in 1844 by renowned British surgeon Samuel Solly. As of 2022, more than 800 new cell therapies are being developed for five blood cancers, with the market for oncology cell therapies expected to exceed $37 billion in value globally by 2028.

Chemotherapy

Chemotherapy Immunization Immunity Documentation

Eric Halioua, President & CEO at PDCline Pharma Shares Insights on the Results from P-I/II Trial with PDClung01

PharmaShots

JUNE 1, 2023

PDC*line Pharma has developed a novel approach using an allogeneic plasmacytoid dendritic cell (PDC) line as an antigen-presentation platform showing great potency to prime and expand tumor-specific CD8+ T cells in vitro and in vivo in a humanized mouse model (data illustrated in Part III of this document).

Immunization

Immunization Immunity Vaccines Health and Personal Care Stores

March 2024 Newsletter

Safe Biologics

MAY 10, 2024

From the post: The HHS Budget in Brief document describes the policy objective simply enough: “ Permit Biosimilar Substitution without Prior FDA Determination of Interchangeability” and clarifies that this means “deem all approved biosimilars to be interchangeable with their respective reference products”. 1 and go into effect in 2026.

Can your LNP manufacturing platform cope with the pace of the mRNA revolution?

Pharmaceutical Technology

APRIL 27, 2023

billion by 2028. Regulatory documentation including a materials traceability report is provided and an extractables report is available upon request. Genomic medicine development was ranked as the top industry trend for 2023 in a survey of 198 GlobalData Pharma clients and prospects conducted between October and November 2022.

Vaccines

Vaccines Drug Development Documentation Communication

EY-Parthenon and Microsoft launch AI framework to guide life sciences sector transformation

Express Pharma

FEBRUARY 25, 2025

billion by 2028, the challenge lies in achieving widespread implementation across the industry. AI is also reshaping the regulatory landscape by automating document analysis, streamlining submissions for regulatory approval, and monitoring compliance. With the AI market in pharmaceuticals projected to reach US$16.49

Documentation

FDA’s Final Rule on the Implied Nutrient Content Claim “Healthy” Maintains Focus on Foods Rather than on Nutrients

FDA Law Blog: Biosimilars

JANUARY 2, 2025

Recognizing that the final rule redefining the term healthy is a significant change from FDAs previous approach (in effect for thirty years), FDA plans to issue guidance documents intended to help industry understand the rule and how to work with FGEs. The compliance date is February 25, 2028.

Labelling

Labelling Documentation

NHC Submits Comments to CMS on Advance Notice of Methodological Changes for CY 2026 for Medicare Advantage Capitation Rates and Part C and Part D Payment Policies

Putting Patients First Blog

FEBRUARY 11, 2025

CMS should also work directly with providers to minimize administrative burdens caused by risk adjustment changes, as increased documentation requirements could further strain providers, particularly those treating high-cost populations. Equally critical is clear and accessible communication with beneficiaries. 3 American Medical Association.

Insurance Coverage and Processing

Insurance Coverage and Processing Communication Documentation Hospitals

Pharmacist Digest