pharmaphorum

OCTOBER 18, 2021

2 And, as of September 2021, there are 22 COVID-19 vaccines in use globally 3 , and over 2.3 In contrast to the evaluation of medicines, the supervisory framework for medical devices and IVDs is fragmented and there is no single ‘go-to’ authority, which can be problematic for some products. Real-time sharing of data.

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Vaccines Pharmaceutical Companies Pharmaceutical Companies Documentation 137

The FDA Law Blog

MARCH 19, 2023

s Mark Tobolowsky co-authored the peer-reviewed article “ Microdystrophin Expression as a Surrogate Endpoint for Duchenne Muscular Dystrophy Clinical Trials ” in the recently published edition of Human Gene Therapy. Hyman, Phelps & McNamara, P.C.’s

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ISPE

AUGUST 17, 2023

The winner of the 2022 award will be announced shortly, and authors of the winning 2022 article will be recognized at the upcoming 2023 ISPE Annual Meeting & Expo in Las Vegas, Nevada, USA. ABOUT THE AWARD ISPE’s Roger F. Sherwood Article of the Year award was established in 1993.

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European Pharmaceutical Review

MARCH 15, 2023

Using this third generation software, scientists can analyse large volumes of data from mass spectrometry, processing thousands of samples within minutes to hours. The latest version of software tool MZmine, which aids analysis of mass spectrometry data, has been released.

Compounding 137

Compounding 137

Hospital Pharmacy Europe

FEBRUARY 22, 2024

As evidence accumulates to support its use in clinical practice, pharmacists must have the requisite knowledge and skills to support and lead in implementing pharmacogenetics as part of routine healthcare. Pharmacogenetics is increasingly seen as an essential tool in drug therapy and medicines optimisation.

Hospitals 111

Hospitals Patient Care Medical Records Dosage 111

European Pharmaceutical Review

MARCH 25, 2024

Notably it aims to “cut water use by approximately half, reduce operational energy intensity by more than one-third, and produce zero waste to landfill (compared with LEED® baseline).” The news was also welcomed by the Industrial Development Authority (IDA), which is responsible for attracting inward foreign direct investment into Ireland.

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IDStewardship

MARCH 12, 2023

Authored by: Timothy P. Quality readings are a key element to giving them the tools to succeed and help support productive topic discussions or patient case reviews. Indeed this is not a single article you may have been expecting, but this is a critical stopping point for any recommended readings list. Gauthier, Pharm.D.,

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Medication Guidelines Documentation Labelling Hospitals 296

European Pharmaceutical Review

JULY 20, 2023

2 Having been in place for almost 20 years, the current legislation on blood and on tissues and cells is now outdated and does not reflect the health and societal evolutions These rules govern the sourcing and use of starting materials for innovative therapies, such as blood, tissues and cells.

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Labelling Documentation Hospitals 65

The FDA Law Blog

JANUARY 18, 2024

FDA found that marijuana continued to have a high potential for abuse, lacked accepted safety for use under medical supervision and had no currently accepted medical use in treatment in the United States. Schedule I drugs have a high potential for abuse and no currently accepted medical use in treatment in the U.S. 21 U.S.C. §

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FDA Controlled Substances Chemotherapy Compounding 69

Hospital Pharmacy Europe

MARCH 21, 2024

Supporting the successful compounding of drugs with 3D printing processes has the potential to not only fulfil unmet patient needs but also drive efficiencies in hospital pharmacies. Since then, several different methods of 3D printing have been developed, and many of these are now used for pharmaceutical purposes.

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Hospitals Compounding Dosage FDA 111

ISPE

JULY 10, 2023

ChatGPT 1 has taken the use of artificial intelligence (AI) to the next level, reaching a global user base beyond the established AI circles, and other large language models (LLMs) like LaMDA as in Bard 2 followed. ChatGPT is commonly used to refer to the chatbot web interface, and the underlying model.

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Labelling Documentation Pharmaceutical Companies Pharmaceutical Companies 52

Pharmaceutical Technology

DECEMBER 11, 2022

The US Food and Drug Administration (FDA) has granted Fast Track designation for Pfizer and BioNTech’s messenger ribonucleic acid (mRNA)-based combination vaccine candidate against Covid-19 and influenza. The vaccine is intended to prevent two respiratory ailments through a single injection. Free Whitepaper.

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Vaccines FDA Communication 115

European Pharmaceutical Review

JANUARY 25, 2023

The European Medicines Agency (EMA) has validated the Marketing Authorization Application (MAA) for exagamglogene autotemcel (exa-cel), the first regulatory submission for a CRISPR-based medicine. The MAA from Vertex Pharmaceuticals and CRISPR Therapeutics is supported by two global Phase III studies.

Labelling 104

Labelling FDA 104

pharmaphorum

OCTOBER 4, 2022

Part 2 of this series is devoted to clinical decision support (CDS) software. peer-reviewed clinical studies and clinical practice guidelines) (Criterion 2); (3) intended for the purpose of supporting or providing recommendations to an HPC about prevention, diagnosis, or treatment of a disease or condition (Criterion 3); and. (4)

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FDA Documentation Labelling Communication 103

Omnicell

JANUARY 10, 2023

Today, we announced our Summer 2021 Release, which delivers enhancements across our entire portfolio designed to improve efficiency, expand automation, and enhance intelligence, supported through a superior customer experience, driving maximum value sooner for your technology investment. Improved Efficiency The U.S.

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Controlled Substances Omnicell Compounding Sterile Compounds 52

European Pharmaceutical Review

FEBRUARY 23, 2023

These are solely my personal opinions derived from recent and 25 years of experience in the pharmaceutical industry, supporting firms, microbiologists, industry organisations, compendia and standard-setting bodies. I would add that these do not necessarily represent the opinions of those organisations I support or work for.

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Dosage Vaccines 96

European Pharmaceutical Review

JANUARY 16, 2023

“Connectivity between the laboratory and manufacturing facility is growing, and the use of digital tools will continue to build that integration,” commented Miriam Guest. This also occupies a large resource, given the US Food and Drug Administration (FDA) requirement for double plate checking using a second ‘independent’ person.

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Vaccines FDA Research Laboratories Documentation 127

pharmaphorum

SEPTEMBER 30, 2022

Regulatory reviewers must then manually ‘mine’ the documents for information, rather than assessing the underlying data used to create the documents. A better submission strategy uses structured data files and identifiable document components incorporated into regulatory filings, which provide data and information directly to the reviewers.

Documentation 52

Documentation Pharmaceutical Companies Pharmaceutical Companies 52

European Pharmaceutical Review

OCTOBER 4, 2022

Absolute quantitation of multiple proteins (β- lactoglobulin B, α-lactalbumin and carbonic anhydrase) in a mixture was achieved in a single run. Protein quantitation, such as the preparation of synthetic isotope-labelled peptides is used as an internal standard to measure a sample’s total protein concentration.

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Labelling 82

European Pharmaceutical Review

SEPTEMBER 8, 2022

As the industry works to establish continuous bioproduction/bioprocessing in hopes of realising the benefits of reduced process costs and increased flexibility to cope with demand, the development of PAT tools that can provide real-time measurements and support real-time process control is required. Ramakrishna et al. Ramakrishna et al.

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The FDA Law Blog

OCTOBER 2, 2023

Sasinowski — This time last year, we wrote about a long-overlooked FDA statutory authority and wondered if this provision, known colloquially as the “single study plus confirmatory evidence” pathway, was having a moment (previous post here ). However, the Act does not define what may constitute such confirmatory evidence.

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FDA Documentation Labelling Medical Records 64

Pharmaceutical Technology

MAY 10, 2023

CytoMed Therapeutics has signed a research collaboration deal with the University of Texas MD Anderson Cancer Center (MD Anderson) in the US to use gamma-delta T cells (gdTc) to treat acute myeloid leukaemia (AML) and breast cancer. The study aims to use AML cells and breast cancer cell lines from patients for evaluation.

Labelling 59

Labelling 59

European Pharmaceutical Review

OCTOBER 12, 2023

Importantly, each site features advanced technologies to support development and manufacture of these therapeutics. Features such as new equipment, increased production and storage capacity and greater operational efficiency will support growing demand. Similarly, our new coating equipment boosts output approximately six-fold.”

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Vaccines Dosage Pharmaceutical Companies Pharmaceutical Companies 86

pharmaphorum

NOVEMBER 3, 2022

The Digital Medicine Society’s Library of Digital Endpoints surpassed 350 unique digital endpoints used for evaluating new medical products. Over 100 sponsors are using digital endpoints across dozens of therapeutic areas, measuring concepts from cognition to physical activity and gait to glucose levels. Moving towards implementation.

Communication 81

Communication FDA 81

The FDA Law Blog

JANUARY 15, 2024

This story goes back to the 2009 Family Smoking Prevention and Tobacco Control Act, which prohibits manufacturers from selling any “new tobacco product” without authorization from FDA. FDA said randomized clinical trials could be used, but so could observational studies with respect to cessation data.

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FDA Documentation 115

The Checkup by Singlecare

MARCH 8, 2024

Improve cholesterol levels The omega-3s found in sardines and other fatty fish such as anchovies and salmon help regulate cholesterol levels , according to Vicki Shanta Retelny, RDN , a Chicago-based dietitian and author of Total Body Diet For Dummies. a functional medicine practitioner and author of Digestive Reset.

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Labelling 105

Pharmaceutical Technology

NOVEMBER 22, 2022

The live attenuated vaccine was authorized by the EMA and FDA five years later in 2019 — half the time than normal. Single- and multi-nation funding opportunities flooded in. 326 days after SARS-CoV-2 was first sequenced, the FDA approved Pfizer and BioNTech’s Comirnaty® under Emergency Use Authorization (EUA).

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Vaccines Immunization FDA 52

pharmaphorum

NOVEMBER 8, 2021

A single dose of the COVID-19 monoclonal antibody therapy developing Regeneron reduced the risk of contracting the virus by around 82% for up to eight months, according to new trial data. The new result suggests that REGEN-COV could be used much more broadly than at present.

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Vaccines Immunization Hospitals 105

Hospital Pharmacy Europe

NOVEMBER 11, 2023

Figures released by the NHS Business Services Authority (NHSBSA) reveal that in the financial year 2022/23, the cost of medicines issued in hospitals was £9.45bn, making up 49.2% of its total medicines expenditure. An additional £93.6m was spent on medicines prescribed by hospitals and dispensed in the community.

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Hospitals Community Pharmacies 52

European Pharmaceutical Review

FEBRUARY 28, 2024

Starting in 2025, health technology assessment (HTA) experts from across Europe will join forces to produce joint clinical assessment (JCA) reports, which will be used to support national health economic assessments as well as inform pricing and reimbursement discussions. A more flexible approach is needed.

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European Pharmaceutical Review

SEPTEMBER 22, 2022

Rare disease drug development poses unique challenges that can be overcome by using real-world evidence (RWE). As an alternative, regulatory agencies have allowed the use of RWE to estimate a historical control (HC) compared to patients enrolled in an uncontrolled study. Benefits of historical controls.

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FDA Pharmaceutical Companies Pharmaceutical Companies Documentation 114

pharmaphorum

JANUARY 4, 2023

The intention is to streamline the process for patients wishing to access their medical records via electronic health record systems (“EHR systems”) and to facilitate the ability for researchers, innovators, and policy makers to use the data in a trusted and secure way that preserves privacy. Secondary use of health data.

Medical Records 97

Medical Records Insurance Hospitals 97

ISPE

SEPTEMBER 11, 2023

Advanced Manufacturing In the biopharmaceutical industry, “advanced manufacturing” refers to the operating models and supporting technologies that aim to transform or modernize the production of therapeutic products. Fit for use is a critical factor that companies must evaluate when selecting a manufacturing operating model.

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Health and Personal Care Stores Vaccines Packaging Documentation 52

Pharmaceutical Technology

SEPTEMBER 1, 2022

The US Food and Drug Administration (FDA) has granted Emergency Use Authorizations (EUAs) for bivalent formulations of Moderna and Pfizer -BioNTech’s Covid-19 vaccines as boosters. Moderna’s bivalent vaccine is intended to be administered as a single booster dose in people aged 18 years and above.

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FDA Vaccines 104

pharmaphorum

OCTOBER 6, 2020

But for many life sciences organisations, these tools are either not yet fully adopted or are not being put to good use within their regulatory functions. According to Accenture research, most organisations are still struggling to understand the basic ‘truth’ of the data they use and exchange with others.

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Documentation Communication Labelling Data Entry 107

pharmaphorum

SEPTEMBER 14, 2021

The European health tech industry has made a “quantum leap” into using digital health technology due to the pandemic with the help of a growing number of trailblazing entrepreneurs, according to AlbionVC. At the same time, teleconsultations jumped from low single digit percentage points to almost 70%,” the report notes.“We’re

Medical Records 122

Medical Records Hospitals 122

European Pharmaceutical Review

JANUARY 23, 2023

Monitoring medicine shortages Since November 2022, MSSG and its working party, the Medicines Shortages Single Point of Contact (SPOC) working party, have been closely monitoring the EU antibiotic shortages. In addition, MSSG supports temporary national measures such as unit dose dispensing and compounding.

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Packaging Compounding Labelling Communication 95