European Pharmaceutical Review

MAY 2, 2023

3 With greater scientific understanding of cancer, the industry has made significant progress in developing innovative medicines to help patients. However, access to these medicines is not close to meeting patient demand, creating inequalities in the health prospects of those diagnosed with cancer. 1,2 In the EU, an estimated 2.7

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Compounding Pharmaceutical Companies Pharmaceutical Companies Communication 99

ISPE

OCTOBER 27, 2022

Digital health is transforming the health care landscape through new technologies and platforms in patient care management, conducting of clinical trials, patient data collection, and the diagnosis and treatment of disease. What Is Digital Health?

Health and Personal Care Stores 52

Health and Personal Care Stores FDA Communication Clinic Management 52

pharmaphorum

JUNE 8, 2021

Dr Jay Mei, founder and CEO of Antengene, notes that the region has rich innovation resources but also urgent medical needs, leading to both opportunities and uncertainties for the industry. “At Home to over 60% of the world’s population, Asia Pacific (APAC) is not a region the biopharma industry can afford to ignore.

Chemotherapy 105

Chemotherapy Pharmaceutical Companies Pharmaceutical Companies Immunization 105

ISPE

OCTOBER 27, 2022

Digital health is transforming the health care landscape through new technologies and platforms in patient care management, conducting of clinical trials, patient data collection, and the diagnosis and treatment of disease. What Is Digital Health?

Health and Personal Care Stores 52

Health and Personal Care Stores FDA HIPAA Communication 52

pharmaphorum

OCTOBER 7, 2021

Promoted by the Smith Kline Foundation, the project is the combined result of a working group consisting of approximately 40 experts from the clinical, academic, regulatory, medico-legal, industrial, and health economy fields, as well as Patient Association representatives and digital health innovation organization Healthware Group.

Insurance Coverage 52

Insurance Coverage Insurance Communication 52

pharmaphorum

OCTOBER 26, 2022

And just as a family business thrives on its connection to the community, Chiesi is committed to connecting to the global patient community. We try to have a very long-term orientation because we believe that aligns our objectives very well with the objectives of society and the patients we serve, and it makes us a stable business.”. “We

Patient Care 86

Patient Care FDA 86

Omnicell

SEPTEMBER 5, 2022

We have also experienced partisan investigations that seemed to be driven more by drug industry lobbyists than a real concern with the program or patients. Now, the program faces its greatest existential threat in over two decades. To make matters worse, the U.S. 340B providers cannot sue the companies that are flouting the 340B law.

Hospitals 52

Hospitals 52

PharmaShots

MARCH 9, 2023

Designation: Chief Medical Officer (CMO) and Head of Worldwide Medical and Safety at Pfizer Previous company: Stanford University (12 yrs. Designation: Chief Medical Officer (CMO) and Head of Worldwide Medical and Safety at Pfizer Previous company: Stanford University (12 yrs.

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FDA Pharmaceutical Companies Pharmaceutical Companies Immunization 40

Hospital Pharmacy Europe

FEBRUARY 22, 2024

Many patients will not experience a therapeutic effect at standard dosages, whereas others might be more susceptible to adverse effects or toxicity. 3,4 Furthermore, several studies have shown that tailoring prescribing using a pharmacogenetic-guided approach can lead to improved patient outcomes and reduced harm.

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Hospitals Patient Care Medical Records Dosage 111

European Pharmaceutical Review

JULY 20, 2023

Background on BCT legislation in the EU Every year EU patients are treated with 25 million blood transfusions, a million cycles of medically assisted reproduction, over 35,000 transplants of stem cells and hundreds of thousands of replacement tissues.

Labelling 63

Labelling Documentation Hospitals 63

European Pharmaceutical Review

SEPTEMBER 21, 2023

In this Q&A, Karen Pinachyan, Head of Medical Affairs Europe at CSL Behring summarises key considerations for gene therapy drug development and the ideal approach for alleviating economic strain when advancing these modern treatments. How has the gene therapy landscape evolved over the last several years?

Pharmaceutical Companies 74

Pharmaceutical Companies Pharmaceutical Companies FDA 74

pharmaphorum

FEBRUARY 4, 2022

This presents several challenges for manufacturers of rare and orphan disease therapies specifically, given they often cannot fulfil conventional assessment criteria due to unique factors generally associated with these drugs, such as small target populations, limited safety and efficacy data, and lack of clinical trial comparators.

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Hospital Pharmacy Europe

OCTOBER 23, 2023

The conditional marketing authorisations recommend epcoritamab as a monotherapy for adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) after two or more systemic therapies. It therefore has the potential for greater geographical accessibility and more timely administration.

Adverse Reactions 52

Adverse Reactions Immunization Hospitals 52

ISPE

MARCH 8, 2023

Reports of contaminated products from multiple sources worldwide were gathered to review overall trends and identify challenges. However, few studies have analyzed contamination trends to enable a more effective risk-based approach to control contamination in the manufacture of medicinal products.

Compounding 52

Compounding Compounding Pharmacies Packaging FDA 52

pharmaphorum

JULY 30, 2021

What started with Andrew Wakefield’s now-retracted, fraudulent 1998 paper showing a supposed link between the MMR vaccine and autism has turned into a worldwide phenomenon of mistrust against the medical and scientific communities. Impetus Digital’s N atalie Yeadon explores why. Impact of COVID-19 on health literacy.

Vaccines 119

Vaccines Pharmaceutical Companies Pharmaceutical Companies Communication 119

pharmaphorum

AUGUST 19, 2020

Mirroring the acceleration of digital transformation in pharma , many face-to-face services have quickly been provided online or via telephone to keep patients away from overstretched and potentially infectious hospitals and GP surgeries. Nevertheless, plans for post-COVID healthcare are underway and digital health looms large within them.

Patient Care 104

Patient Care Hospitals 104

The Thyroid Pharmacist

FEBRUARY 1, 2023

Did you know that, for some people, coffee may interfere with the absorption of their thyroid medication? [1] Despite being under the care of the best doctors around and taking thyroid medications, she was still experiencing several thyroid symptoms (including dry skin, weight gain, hormonal imbalances, hair loss, and cold intolerance).

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Compounding Adverse Reactions Immunization 97

The FDA Law Blog

JANUARY 8, 2023

The enactment of the Medical Marijuana and Cannabidiol Research Expansion Act (“the Act”) into law (Public Law 117-215) last month is a step in that direction. By Larry K. See President Biden Gives the Green Light for Significant Marijuana Reform, October 10, 2022. President Biden signed the law on December 2nd. Federal Research.

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Controlled Substances Inventory Control Compounding FDA 64

ISPE

SEPTEMBER 11, 2023

4 , 5 Additionally, reducing shipping limitations—such as packaging, storage, and transportation durations—helps speed up patient access in certain instances while ensuring there is no negative impact to the product’s critical quality attributes (CQAs).

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Health and Personal Care Stores Vaccines Packaging Documentation 52

ISPE

MAY 9, 2023

There is a concerted effort from multinational pharmaceutical companies in developing countries to embrace regulatory convergence with international standards, primarily ICH, and to implement these standards to meet the increasing needs for and to expedite patient access to specialized and targeted medicines.

Documentation 52

Documentation Packaging Pharmaceutical Companies Pharmaceutical Companies 52

Hospital Pharmacy Europe

JANUARY 18, 2023

Here we report on a retrospective study undertaken in a UK hospital to investigate adherence to National Institute for Health and Care Excellence (NICE) criteria and guidance in treatment of atopic dermatitis with a biologic therapy. 1 It affects 2%–10% of adults worldwide and can be associated with other systemic disorders such as asthma.

Hospitals 52

Hospitals Medical Records Documentation Pharmaceutical Companies 52

The Thyroid Pharmacist

JULY 20, 2023

I commonly see iron deficiency – with its symptoms of fatigue, restless legs, insomnia, cold intolerance, moodiness, and the upsetting “thyroid” hair loss results – in many of my clients, even after they start thyroid medications like levothyroxine, Synthroid, and even Tirosint. Get more iron in your diet and/or take an iron supplement!

Health and Personal Care Stores 61

Health and Personal Care Stores HIV Treatment and Prevention Agents Insurance Immunization 61

ISPE

SEPTEMBER 8, 2023

It is incumbent for industry to modernize manufacturing processes to improve efficiency and increase confidence in quality assurance for the benefit of patients while introducing novel technology and modalities as the science advances. The survey launched in April 2023 and is still open !

FDA 52

FDA Dosage Documentation Communication 52

ISPE

AUGUST 29, 2022

Postapproval change management of pharmaceuticals is an essential part of life-cycle management but is associated with regulatory challenges. Tabetha Bonacci, PhD. Michael Abernathy. 1 September 2022. The timing and data requirements vary depending on the reporting category, submission, and legal obligations in each individual jurisdiction.

Documentation 52

Documentation FDA Communication Packaging 52

ISPE

MARCH 29, 2023

The authors propose using Module 2.3 The authors propose using Module 2.3 Watson, PhD 1 May 2023 When working with the common technical dossier (CTD), the structure of Module 2 “follows the scope and outline of the Body of Data in Module 3,” 1 which can reduce review efficiency. Published 15 November 2021. Published June 2008.

Documentation 52

Documentation Dosage Packaging Communication 52

ISPE

MARCH 29, 2023

The authors propose using Module 2.3 The authors propose using Module 2.3 Watson, PhD 29 March 2023 When working with the common technical dossier (CTD), the structure of Module 2 “follows the scope and outline of the Body of Data in Module 3,” 1 which can reduce review efficiency. Published 15 November 2021. Published June 2008.

Documentation 52

Documentation Dosage Packaging Communication 52

ISPE

MARCH 6, 2023

The global healthcare industry is responsible for 4–5% of global emissions; in industrial nations, this rises to 10% of national emissions, with the pharmaceutical industry making up around 20% of healthcare industry emissions. 1 Intergovernmental Panel on Climate Change (IPCC). Finalized 9 August 2021. C global warming scenario.

Packaging 52

Packaging Pharmaceutical Companies Pharmaceutical Companies Compounding 52

ISPE

MARCH 7, 2023

1 United Nations. link] 2 United Nations. These expectations are defined in various national codes. 1 , 2 The effect to the pharmaceutical industry spans its end-to-end activities, including the residual impact of used and unused medicines on the environment. Department of Economic and Social Affairs: Sustainable Development.

Health and Personal Care Stores 52

Health and Personal Care Stores Pharmaceutical Companies Pharmaceutical Companies Communication 52

ISPE

AUGUST 30, 2022

A reliable supply of raw materials is critical to maintain a robust supply chain to serve patients globally. The pharmaceutical manufacturing supply chain starts with the raw materials, which are needed to ensure drug availability for patients. Tabetha Bonacci, PhD. Ailsa Surman. Lennard, PhD. William Garden. Burke, PhD.

Documentation 52

Documentation FDA Packaging Communication 52

The Thyroid Pharmacist

AUGUST 26, 2022

I have my clients and readers, family members, my own body, wonderful colleagues, and access to the latest medical research to help! Research has found that carnitine supplementation supports a reduction in fatigue in hypothyroid patients, as well as improves muscle weakness for both hypo- and hyperthyroid patients. (10-13).

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Immunization Chemotherapy Insurance Dosage 86

The Thyroid Pharmacist

FEBRUARY 10, 2023

Among the many symptoms of thyroid disease, there is one in particular that significantly impacts people’s relationships and overall happiness, yet it’s a symptom people seldom seek help for: low libido (low sex drive). In general, libido concerns are something we keep to ourselves. so many people remain silent.

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Dosage Documentation FDA Labelling 83

ISPE

SEPTEMBER 10, 2023

Connor Dennis, PhD Roger Nosal 1 September 2023 As the demand for accelerated access to medicines expands globally, the pharmaceutical industry is increasingly submitting regulatory applications in multiple countries simultaneously. Watson, PhD Melinda Imperati S.

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