European Pharmaceutical Review

JANUARY 2, 2024

A paper published in the European Journal of Pharmaceutics and Biopharmaceutics has reviewed the current application status of Quality by Design (QbD) within the framework of the ICH guidelines (ICH Q8(R2) – Q14 and ICH Q2(R2)). It also lowers the regulatory burden too, the paper reported. [In

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Documentation 100

European Pharmaceutical Review

JULY 21, 2023

European Medicines Agency (EMA) has published a draft reflection paper on using artificial intelligence (AI) to support the safe and effective development, regulation and use of medicines. Highlighted in the paper is that a human-centric approach should guide all development and deployment of AI and ML.

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Documentation FDA 87

The FDA Law Blog

APRIL 8, 2024

Department of Health and Human Services (HHS) recently published a White Paper on Policy Considerations to Prevent Drug Shortages and Mitigate Supply Chain Vulnerabilities in the United States —with input from several HHS stakeholders, including FDA, CMS, and the Administration for Strategic Preparedness and Response. By Kalie E.

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FDA Hospitals Dosage Controlled Substances 59

STAT

JULY 19, 2023

This week, in a major milestone aided by those technologies and preceded by years of work by thousands of researchers, a detailed atlas of the human kidney was unveiled to the public via a paper published in Nature.

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European Pharmaceutical Review

APRIL 9, 2024

Incorporating EBIS on 3D printed devices offers fast design and affordability, the paper stated. Managing microbial data Since many databases are only accessible to the public on rare occasions, current trends in data sharing are limited, the authors stated. Hz range, the authors stated. Childs et al.

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Dosage 87

STAT

JUNE 8, 2023

Hayes, a professor of nutrition at the Harvard School of Public Health, took on the mystery of why some cats experienced rapid deterioration of their vision. The problem, Hayes figured out, was that some brands of cat food lacked an amino acid called taurine, something cats don’t produce themselves.

Immunization 98

Immunization 98

pharmaphorum

FEBRUARY 4, 2021

A white paper has outlined a pathway that could allow Italy to realise the potential of digital therapeutics (DTx). The official journal of the Smith Kline Foundation, Tendenze Nuove, has published the paper entitled “Digital Therapeutics, an Opportunity for Italy” earlier this month.

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Documentation Communication 139

pharmaphorum

SEPTEMBER 18, 2020

The Transformational Value: Preparing for a Decade of Radical Change white paper from the Adelphi Group sets out the key tenets of the concept and the opportunity for pharma to take a big picture view of ‘transformational value’ and how to respond to it. The post Preparing for a decade of radical change in pharma appeared first on.

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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.

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Packaging Documentation 96

European Pharmaceutical Review

JUNE 27, 2022

DRUG DEVELOPMENT based on targeted protein degradation (TPD) has progressed rapidly since the publication in 2015 of three landmark papers 1-3 that highlighted important early-stage breakthroughs with drug-like molecules in this area of research.

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Pharmaceutical Companies Pharmaceutical Companies 102

Outsourcing Pharma

NOVEMBER 12, 2020

The clear evidence of increased risk of COVID-19 infection amongst ethnic minority groups, people from Black and Asian backgrounds, is of urgent public health importance, according to the authors of a paper published today by The Lancet.

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pharmaphorum

JULY 6, 2022

“The balance between shortening approval times, allowing oncology patients to receive therapies earlier, and ensuring treatments are safe and efficacious is delicate,” said the paper. She has worked on projects for pharma, charities, and agencies, and has written extensively for patients, HCPs and the public. About the author.

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Hospital Pharmacy Europe

JANUARY 17, 2024

In papers published by the NICE committee, it notes that the use of SGLT2 inhibitors is not yet well established in clinical practice and there is ‘scope to expand the use of this drug class in this indication to slow CKD disease progression’. A version of this article was originally published by our sister publication Pulse.

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Hospitals 105

The FDA Law Blog

APRIL 8, 2024

Last year, OPQ saved a more quantitative analysis of its efforts for the other yearly publication it put out, on the State of Pharmaceutical Quality. Claud — CDER’s Office of Pharmaceutical Quality (OPQ) issued its 2023 Annual Report last week, and it’s an upbeat assessment of the Office’s policy and outreach efforts.

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pharmaphorum

SEPTEMBER 1, 2021

The new Cancer Care in Europe: Recovering from COVID-19 Disruption white paper assesses the disruption to patient care and the changes physicians implemented during the acute phase of the pandemic, with a focus on the way in which treatment strategies were altered. Read Cancer Care in Europe: Recovering from COVID-19 Disruption in full.

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Patient Care 110

European Pharmaceutical Review

JULY 28, 2023

Publication of results of the Phase III SKYLARK study “is a pinnacle moment in treating postpartum depression ( PDD ),” stated Dr Kristina M Deligiannidis, Professor at the Institute of Behavioral Science at the Feinstein Institutes, the trial’s principal investigator, lead author of the paper.

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FDA 93

pharmaphorum

MAY 30, 2022

The World Health organisation’s latest assessment of the monkeypox outbreak is that it poses a moderate threat to public health, as cases of the infection continue to rise. For comparison, there were just seven cases of monkeypox in the UK between 2018 and 2021, according to a just-published paper in The Lancet Infectious Diseases.

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pharmaphorum

OCTOBER 12, 2021

That’s according to a new policy paper from the European Alliance for Value in Health. The policy paper calls for a broad assessment of health system resilience and using the findings as a basis for the building of a value-based system that will improve care across the board. Value-based healthcare reforms.

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pharmaphorum

MARCH 8, 2021

In January, for example the UK Government published their policy paper outlining a ‘Rare Diseases Framework’ which pledges to: Ensure patients get the right diagnosis faster. This is to be commended – especially amidst the ambush of research resources that dealing with the global public health crisis of coronavirus has necessitated.

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Communication 110

pharmaphorum

JULY 12, 2021

A new policy paper promises to make it easier for innovators and developers to build and deploy tech and AI solution. Never before has the public at large had such an interest in the detail of daily changes in disease rates. So, will it help make the vision of a data-driven health service a reality? Proposals: Data infrastructure.

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Documentation Vaccines 74

ISPE

APRIL 12, 2023

Paper-Based Validation in Biotech: No Longer a Choice The complexities of biological processes like cell line development, protein expression, and capsid engineering demand extreme precision and thorough documentation for regulatory bodies. The continued use of paper validation in a Pharma 4.0 1 Weeks, L. ValGenesis. 2 Jarvis, P.,

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Documentation FDA 98

pharmaphorum

OCTOBER 4, 2021

That picture of how patient needs and patient-doctor interactions are changing will shortly be fully painted by the release of a new white paper from M3 on engaging doctors in a post-COVID-19 world. The publication will also look at the pandemic’s impact on communications between the industry and doctors.

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Communication 71

Hospital Pharmacy Europe

NOVEMBER 9, 2023

Juan García Burgos, head of public and stakeholder engagement at the EMA, said: ‘Electronic product information will allow for the latest information about a medicine to reach end users like patients and healthcare professionals as quickly as possible.

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pharmaphorum

FEBRUARY 15, 2021

The deal comes shortly after the publication of a white paper that laid out a framework that could be adopted by Italy to realise the potential of DTx, including the creation of a reimbursement pathway similar to that set up in Germany. .

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Communication Hospitals 95

pharmaphorum

NOVEMBER 20, 2020

Havas Lynx Group’s 2020 white paper provides a blueprint for pharma brands to inject meaning into their media. The latter is the subject of our 2020 white paper, Media Means Business. Download the Media Means Business white paper today at [link]. What do we mean by ‘media’? With content that drives impact. About the author.

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pharmaphorum

FEBRUARY 10, 2021

The recommendations for the Country’s pathway towards DTx are captured in the White Paper “Digital Therapeutics, an Opportunity for Italy” The official journal of the Smith Kline Foundation, Tendenze Nuove , published the White Paper “ Digital Therapeutics, an Opportunity for Italy ” on 13 January 2021.

Documentation 52

Documentation 52

pharmaphorum

OCTOBER 5, 2021

The white paper Transform patient experience with intelligent hyper-personalisation examines some of the key ways in which pharma companies can transform patient experience by identifying, meeting and exceeding expectations. Read: Transform patient experience with intelligent hyper-personalisation in full.

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Pharmaceutical Companies Pharmaceutical Companies 117

pharmaphorum

DECEMBER 8, 2021

The software-as-a-medical device (SaaMD) is the subject of 13 scientific papers, including a study that the company says showed that patients using HypnoVR reported a 93% reduction in anxiety when catheterised for implantable ports.

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Hospitals 98

pharmaphorum

MARCH 10, 2022

That includes supporting public and patient involvement (PPI), thinking about diversity and inclusion, and what happens to the outputs of research.”. The entire response depended on access to data in near real time, which in turn opened a fast track to publication that has advantages and disadvantages. Upcoming projects.

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pharmaphorum

MARCH 17, 2022

The paper on the results of the phase 3 ENGAGE and EMERGE trials has appeared in the Journal of Prevention of Alzheimer’s Disease (JPAD), a fairly well-established publication, but one which has less prestige than might be expected to feature the first drug claimed to be disease-modifying in Alzheimer’s.

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FDA 58

European Pharmaceutical Review

JULY 20, 2022

1 But while data on adverse reactions is rightly used to help with these decisions, there is currently no additional modelling on the positive impact regulatory action could have on public health. Monitoring and studying the side effects of licensed medicines is an essential part of drug development to ensure public safety.

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Adverse Reactions Hospitals Vaccines 84

pharmaphorum

DECEMBER 9, 2021

The need for companies to make multiple dossiers and submissions could lead to “profound implications for UK patients needing access to innovative and novel therapies”, says a new Association of the British Pharmaceutical Industry (ABPI) vison paper. ” Prerequisites for global competitiveness. Recommendations.

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Vaccines 98

Pharmaceutical Technology

DECEMBER 21, 2022

Moderna CEO Stéphane Bancel said: “Our new state-of-the-art facility will bring mRNA manufacturing to UK shores, providing the UK public with access to pandemic response capabilities through Moderna Covid-19 vaccines and future respiratory virus vaccine candidates. “We This construction is planned to create over 150 highly skilled jobs.

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Vaccines Communication 140

Hospital Pharmacy Europe

DECEMBER 7, 2023

The paper comes as the UK Government is looking at making PrEP available in settings other than specialist sexual health services, including GP practices, in order to meet the target of zero HIV transmissions by 2030. A version of this article was originally published by our sister publication Pulse.

Hospitals 59

Hospitals 59

pharmaphorum

JANUARY 25, 2021

public education. That said, while industry is already scrutinised from within, increased public pressure for transparency will require all clinical trial experts (including regulators) to communicate proactively with the public. Proactive public engagement efforts need to replace age-old recruitment and retention processes”.

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Communication Patient Care FDA 124

pharmaphorum

SEPTEMBER 9, 2022

Just as in the wake of COVID-19, the world will look to pharma to fulfil its public health needs. Abbvie, for example, believes extreme weather events could boost its immunology product portfolio, and Roche has considered expanding into developing malaria treatments as the disease spreads into new climates,” said the paper. “To

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Pharmaceutical Companies Pharmaceutical Companies Vaccines 104

pharmaphorum

JANUARY 14, 2022

The paper notes that the COVID-19 pandemic has exposed that there are relatively few multi-member state trials, with most still being carried out at a national level, as well as “disharmony” between regulatory requirements between EU countries.

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Documentation 126