European Pharmaceutical Review

APRIL 5, 2024

A 70 percent reduction in the risk of metabolic decompensation events was reported by eight participants in the 12-month pretreatment period, according to the trial results published in Nature. A novel mRNA therapy mRNA-3927 is a novel lipid nanoparticle (LNP)-encapsulated dual investigational mRNA therapy. By encoding for the PCC enzyme.

Vaccines 88

Vaccines 88

pharmaphorum

JANUARY 18, 2023

However, the Resilience Project’s scientists had used genomic data originally collected for other studies and, due to limitations in the original studies’ informed consent policies and a lack of infrastructure to recontact participants, none of the 13 individuals could be contacted with follow-up questions or requests.

Communication 96

Communication Medical Schools Insurance Pharmaceutical Companies 96

STAT

NOVEMBER 15, 2022

However, a STAT   review of documents detailing   the steps taken toward government approval found that regulators endorsed the vaccine, called Covaxin, despite discrepancies in the number of clinical trial participants. Read the rest…

Documentation 145

Documentation Vaccines 145

IDStewardship

AUGUST 1, 2023

In this article, a pharmacist from Turkey with advanced training in the area of infectious diseases provides insights on antimicrobial stewardship in Turkey. Interview with: Emre Kara, MSc., Interviewer: Timothy P. Gauthier, Pharm.D., Here, we seek to learn from others and share stories of our progress on stewardship globally.

Hospitals 212

Hospitals Community Pharmacies Dosage Communication 212

STAT

AUGUST 24, 2023

In very public ways, many colleges, law schools, and medical schools have declined to participate in the U.S. News process, while some hospitals have expressed their desire to abandon the rankings as well. News & World Report   recently issued its 2023-24 Best Hospitals ratings. Read the rest…

Hospitals 97

Hospitals Medical Schools 97

European Pharmaceutical Review

DECEMBER 5, 2023

Now, this final step in the process has been implemented by the EU-UK Specialised Committee on Participation in Union Programmes (SCPUP), the European Commission (EC) has announced. As part of its participation in Horizon Europe, the UK will contribute around €2.43 billion for 2021-27. billion for 2021-27.

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STAT

SEPTEMBER 8, 2023

Hospitals have increasingly acquired physician groups over the past 15 years, and in the process have entrenched monopoly positions for certain types of care by preventing patients from “leaking” to competitors. Oncology, in particular, is a lucrative specialty for hospitals to own.

Hospitals 130

Hospitals Chemotherapy Insurance 130

IDStewardship

MARCH 23, 2023

Perez, PharmD, BCPS-AQ ID, Director, Antimicrobial Stewardship, bioMérieux The bioMérieux experts and #ASPchat participants examined the role of rapid diagnostics in enabling proper therapeutic decisions for drug resistance infections. ASPchat -Katherine K.

Hospitals 157

Hospitals Communication Patient Care 157

STAT

DECEMBER 12, 2023

The news comes as researchers are still processing the Food and Drug Administration’s landmark approval of two cutting-edge sickle cell therapies, one made by Vertex Pharmaceuticals and CRISPR Therapeutics and the other by Bluebird Bio. These drugs have price tags of $2.2 million and $3.1 million, respectively. million and $3.1

Chemotherapy 122

Chemotherapy Immunization 122

STAT

SEPTEMBER 28, 2022

If a participant in a clinical trial becomes pregnant, that information is recorded and the researchers are required to follow up with the participant to understand if the drug affected the pregnancy. It’s a simple process, but one that will be immensely complicated by the court’s Dobbs decision.

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European Pharmaceutical Review

SEPTEMBER 7, 2023

Method and results of the Alzheimer’s study While the study was small, enrolling five participants aged 65 and older with symptoms of early-stage Alzheimer’s, data suggested that the combination therapy cleared amyloid from the brain and lowered inflammation in the blood. Quercetin was not detected in the CSF of any participants. “We

FDA 96

FDA 96

European Pharmaceutical Review

JULY 24, 2023

PACMI has several advantages, including: Making it possible to expand the samples and destructive tests and dedicate more resources, facilities, and equipment Allows for more in-depth knowledge of the product and the processes used Allows for proposed improvements that increase the overall quality for improved patient health.

Compounding 67

Compounding Documentation 67

PharmaShots

APRIL 26, 2023

It means adhering to ethical and regulatory requirements established by governing bodies that guarantee the well-being of study participants and the legitimacy of study results. Researchers must observe these regulations to guarantee the well-being and safety of study participants and the validity of study results.

FDA 53

FDA 53

pharmaphorum

DECEMBER 1, 2022

Lack of access, strict regulations, and demanding schedules have made it extremely difficult for patients to participate in clinical trials. A 2018 NIH survey found that patients felt clinical trial participation to be inconvenient and burdensome, and nearly half (49.0%) said it disrupted their daily routine.

Communication 109

Communication Hospitals Vaccines 109

European Pharmaceutical Review

MARCH 9, 2023

This enabled them to learn of clinical trials in which they could participate. This enabled them to learn of clinical trials in which they could participate. Through this new approach to improve clinical trial eligibility, patients in the MUSC Health System are enrolled in the research participant pool.

Communication 91

Communication 91

European Pharmaceutical Review

MAY 2, 2023

Examples of these activities include obtaining laboratory tests at a local facility rather than a research medical centre or conducting a clinical follow-up visit in the trial participant’s home using telemedicine. In DCTs, some or all the clinical trial-related activities occur at locations other than traditional clinical trial sites.

FDA 79

FDA Packaging 79

pharmaphorum

SEPTEMBER 9, 2022

The pandemic forced clinical trial sponsors to change their processes, with a more technology-driven approach and, according to a new study by Medidata, the sector is now “stronger than ever” as a result. Increased use of simulation technologies and AI (40%), and improved access to clinical trials (38%), also featured highly.

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STAT

OCTOBER 6, 2022

Telehealth company Ro has reached an agreement with the National Institute on Aging to create a registry of patients that could participate in Alzheimer’s disease research, a new approach to tackle the stubborn issue of recruitment for clinical trials. Continue to STAT+ to read the full story…

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European Pharmaceutical Review

JUNE 6, 2023

“Pfizer was delighted to participate in the pilot [scheme] for this new certification programme to help ensure appropriate control of antimicrobial manufacturing waste, and looks forward to its adoption across the pharmaceutical industry,” stated Dermot Dolan, Internal Audit & Supplier Operations EHS Lead at Pfizer. .

Pharmaceutical Companies 93

Pharmaceutical Companies Pharmaceutical Companies 93

The FDA Law Blog

OCTOBER 4, 2023

The motion was based on the Plaintiffs’ Fifth Amendment due process argument: that absent preliminary relief, Plaintiffs and their members will suffer imminent, irreparable constitutional harm. As such, that statute was unjust, confiscatory and violated their constitutional due process rights. Order at 21. See Motion at 11.

Immunization 59

Immunization 59

European Pharmaceutical Review

APRIL 20, 2023

Participants with episodic migraines who have had no success with other preventive drugs had an average of four fewer days with migraine per month when given oral atogepant. CGRP is a protein that plays a key role in starting the migraine process. Half of the participants took 60mg of atogepant once a day as a pill during the study.

Hospitals 85

Hospitals 85

Board Vitals - Pharmacist

MARCH 10, 2024

Participate in the SOAP Program If you didn’t match anywhere and are eligible to participate in the Supplemental Offer and Acceptance Program (SOAP) , you must act fast to take advantage of this option. This special week is a significant milestone in every medical students’ career in medicine. You can still be a doctor.

Medical Schools 98

Medical Schools 98

pharmaphorum

NOVEMBER 8, 2022

The process meant that decentralised trials and tools became essential for the continued progression of treatments. In addition, there was also a close to complete (98%) conclusion by respondents that improvements were made to the clinical trial process through the lessons learnt during the height of the crisis. Areas of progress.

Vaccines 118

Vaccines 118

ISPE

SEPTEMBER 14, 2023

Wager 14 September 2023 With a recent increase in interest and participation, the ISPE GAMP® Special Interest Group (SIG) focusing on Manufacturing Execution Systems (MES) has mapped out an ambitious number of subject areas to use as the basis for future publications, presentations, and best practice guidance documents.

Documentation 98

Documentation 98

pharmaphorum

OCTOBER 18, 2022

The analysis showed that DCT studies enable time and cost efficiencies at virtually every point in the trial process. Understanding the next part of the process for effectively planning and deploying DCT concepts to meet individual trial needs, goals, and budgets, while enhancing the patient experience, may be a greyer area.

Communication 98

Communication Vaccines 98

Blog: Ask a Student Pharmacist

DECEMBER 19, 2023

Describe how DRC professionals engage in the Interactive Process to determine reasonable accommodations in educational/clinical environments. Following successful completion of the post-seminar evaluation, CE will be confirmed via email to the participant, and participant data will be submitted to The Monitor within 10 days.

Patient Care 52

Patient Care 52

pharmaphorum

DECEMBER 22, 2021

NICE methods and process review aims to create fertile ground for innovation. The NICE methods and process review, he said, represents an opportunity to create a modern, world-class appraisals system that “fosters innovation and shows the global life sciences sector that UK plc is open for business”.

Documentation 104

Documentation 104

European Pharmaceutical Review

NOVEMBER 17, 2022

Data showed the participants were more adherent to antiretrovirals (ARVs), enabling them to experience lower viral loads. Participants were recruited from HIV clinics in the US, randomised 1:1 to either an (information system) IS or usual care (UC) group. Clinical trial data for the ingestible sensor.

Dosage 86

Dosage FDA 86

PQA

DECEMBER 18, 2023

clinical, analytic, measurement science, quality improvement), as well as considerable experience participating in PQA groups. Visit our Measure Development page to learn more about PQA’s process for developing measures that matter. clinical, analytic, measurement, and quality improvement).

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Roots Analysis

MARCH 14, 2023

Initiating a clinical trial is a complex and time-consuming process, involving suitable planning and execution. In addition, there are several other challenges, including inefficiencies related to data handling, and difficulties associated with patient enrollment and retainment, which further complicates the process.

Medical Records 52

Medical Records 52

pharmaphorum

AUGUST 26, 2021

The pandemic has transformed many aspects of our industry and one area that change has come to is patient engagement within clinical trials, where it would now seem unusual were we to not consider the patient voice when it comes to recruiting trial participants. Not an ideal scenario for most patients to be faced with. Inclusivity and trust.

Communication 104

Communication Patient Care FDA 104

ISPE

JANUARY 10, 2023

It has been a long journey from the development of primarily manual aseptic processes to fully automated systems that do not require manual intervention. It has been a long journey from the development of primarily manual aseptic processes to fully automated systems that do not require manual intervention. Trudy Patterson.

Packaging 96

Packaging Documentation 96

European Pharmaceutical Review

MARCH 28, 2024

Additionally, negative or ambiguous results from clinical trials may leave regulators and clinical trial participants wondering whether the failure was due to the drug’s lack of efficacy or to methodological flaws. The DVA assesses the progression and severity of Duchenne muscular dystrophy using video assessments as a primary endpoint.

FDA 52

FDA Packaging Insurance Communication 52

ISPE

SEPTEMBER 15, 2023

These technologies are not just trends; they are pivotal tools that enhance manufacturing processes, proactively address quality concerns, and expedite the development of life-saving drugs. QMM is a concept that underscores the pharmaceutical industry's commitment to continuous improvement in quality processes.

FDA 98

FDA Pharmaceutical Companies Pharmaceutical Companies Patient Care 98

Pharma Mirror

JUNE 15, 2023

These trials involve a series of rigorous steps, from recruiting eligible participants to collecting and analyzing data. Traditionally, clinical trials relied on manual processes The post Unveiling the Future: Key Trends in Clinical Trial Technology appeared first on Pharma Mirror Magazine.

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pharmaphorum

SEPTEMBER 2, 2020

Mobile proximity allows people to work virtually and participate in meetings from anywhere in the world. While the effects of COVID-19 have been devastating for many industries, its positive impact on accelerating the uptake of digital health technologies and virtual collaboration solutions is undeniable.

Communication 126

Communication Vaccines 126

pharmaphorum

FEBRUARY 9, 2022

The event will open with a high-level discussion of Marketing Trends for 2022 with particular focus on Pharma and Life Science markets, with the participation of Valeria De Flaviis – Head of Customer Experience at Novartis and Martina Fiore – Head of Marketing at Trueblue. The Event – Helping marketers to face Business Challenges.

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