Clarivate

JUNE 28, 2023

In the 2023 release of our Journal Citation Reports, we have taken significant additional steps to foster research integrity in the Web of Science. This is part of our ongoing efforts to proactively contribute to the maintenance of public trust in scientific and scholarly research. Learn about what’s new and some future changes. Today marks the 2023 release of the annual Journal Citation Reports (JCR ).

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Management Government Marketing 128

Fierce Pharma

JUNE 9, 2023

After a daylong discussion among experts on an FDA advisory committee, Eisai and Biogen's Leqembi is heading into the final stretch of its regulatory review on strong footing. | After a daylong discussion among experts on an FDA advisory committee, Eisai and Biogen's Leqembi is heading into the final stretch of its regulatory review on strong footing.

FDA 347

FDA 347

Pharmaceutical Technology

JUNE 20, 2023

The World Health Organisation (WHO) has granted an emergency use listing (EUL) to SK bioscience’s Covid-19 vaccine, SKYCovione. SKYCovione is a self-assembled nanoparticle vaccine and the 12th Covid-19 vaccine to receive a EUL from the regulator. Developed using pharmaceutical company GSK’s pandemic adjuvant, the vaccine targets the receptor-binding domain of the SARS-CoV-2 spike protein.

Safety 145

Safety Medicine Healthcare Healthcare 145

MedCity News

JUNE 4, 2023

New York-based startup Ezra recently received FDA clearance for an AI tool it plans to use to launch “the world’s first 30-minute full body MRI scan.” The tool, named Ezra Flash, enhances the quality of MR images so that radiologists can detect cancer earlier.

FDA 137

FDA 137

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Medgadget

JUNE 6, 2023

Researchers at the University of California San Diego have created a wearable ultrasound system that can monitor deep tissues, as far as 16.5 cm (6.5 inches) below the surface of the body. Moreover, the team employed a machine learning algorithm to reduce the noise associated with movement, helping to obtain reliable readings while the wearer goes about their day.

Training 126

Training Patients 126

European Pharmaceutical Review

JUNE 21, 2023

The US Food and Drug Administration (FDA) has approved LODOCO ® , the “first drug to target cardiovascular inflammation,” reported Dr Paul Ridker, MPH, Professor of medicine at Harvard Medical School and Director of the Center for Cardiovascular Disease Prevention, Brigham and Women’s Hospital. It is the first anti-inflammatory cardiovascular treatment demonstrated to reduce the risk of myocardial infarction (MI), stroke, coronary revascularization, and cardiovascular death in adults with establ

Food and Drug Administration 121

Food and Drug Administration Medicine FDA Food 121

Fierce Pharma

JUNE 12, 2023

Two years after the initial COVID-19 vaccine push swept across the globe, Pfizer’s COVID-19 vaccine partner BioNTech is heading to court in its home country of Germany to defend itself against alle | The drugmaker will defend itself against claims from a German healthcare worker who sued the company for at least 150,000 euros ($161,500). The plaintiff alleges she suffered bodily harm resulting from Pfizer and BioNTech's Comirnaty vaccine.

Healthcare 345

Healthcare Healthcare 345

Pharmaceutical Technology

JUNE 6, 2023

Alkeus Pharmaceuticals has raised $150m in Series B financing to support the registration and launch of gildeuretinol (ALK-001) to treat Stargardt disease, a genetic cause of blindness in children and young adults. Led by Bain Capital Life Sciences, the financing round has also seen participation from Sofinnova Investments, TCGX and Wellington Management.

Food and Drug Administration 111

Food and Drug Administration Food Pharmaceutical Medicine 111

MedCity News

JUNE 9, 2023

AstraZeneca is paying $85 million to kick off an alliance with Quell Therapeutics focused on developing new cell therapies for autoimmune diseases. Type 1 diabetes and inflammatory bowel disease are the focus of research collaboration.

Biopharma 125

Biopharma Pharma 125

Medgadget

JUNE 9, 2023

Researchers at George Washington University have created a swallowable capsule containing a video camera that can assist in identifying lesions in the stomach. However, unlike similar devices that have been developed previously, this capsule can drive around the stomach under the control of a clinician. This allows it to thoroughly navigate and screen the entire area to identify any health issues in the stomach mucosa, such as ulcers or bleeding.

Specialization 110

Specialization Patients Prospecting 110

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Clinical trial data management is increasingly challenging as studies grow in complexity. Quickly accessing and analyzing study data is vital for assessing trial progress and patient safety. In this paper, we explore real-time data access and analysis for proactive study management. We investigate using adverse event (AE) data to monitor safety and discuss a clinical analytics platform that supports collaboration and data review workflows.

Safety

European Pharmaceutical Review

JUNE 30, 2023

A collaborative approach to advancing adoption of RMMs EPR ’s Caroline Peachey explores collaborative efforts to accelerate validation and adoption of rapid microbial methods across the pharmaceutical industry. The power of rapid methods for fungal ID By leveraging rapid identification techniques, pharmaceutical facilities can enhance their ability to detect and mitigate fungal contamination, safeguarding product quality and patient safety.

Safety 105

Safety Pharmaceutical Patients 105

Clarivate

JUNE 29, 2023

OpenAI’s launch of ChatGPT on March 14 heralds a new era of artificial intelligence that will have profound implications for society, including the life science and healthcare industries. As when any new technology appears on the horizon, a tremendous amount of overheated hyperbole has dominated coverage of the topic in the months since. There are, however, some truly alluring potential use cases for generative AI applications such as ChatGPT for the life sciences and healthcare industries – as

Patients 98

Patients Safety Healthcare Healthcare 98

Fierce Pharma

JUNE 29, 2023

After an initial rejection in 2020 and a review delay earlier this year, BioMarin’s Roctavian has finally got the FDA go-ahead to introduce a gene therapy for a not-so-rare disorder. | After an initial rejection in 2020 and a review delay earlier this year, BioMarin’s Roctavian has finally got the FDA go-ahead to introduce a gene therapy for a not-so-rare disorder.

Doctors 333

Doctors FDA 333

Pharmaceutical Technology

JUNE 5, 2023

Earlier this year, Sun Pharmaceutical Industries , one of India’s largest generic drug producers, reported a major cybersecurity breach , impacting its business operations. A ransomware group later claimed responsibility for the incident, which was one of several high-profile cybersecurity breaches in India over the past three years. Pharma companies around the world have also faced similar threats , some of which have impacted national security and public health.

Pharma 110

Pharma Food and Drug Administration Insurance Pharmaceutical 110

Advertiser: ZoomInfo

Marketing technology is essential for B2B marketers to stay competitive in a rapidly changing digital landscape — and with 53% of marketers experiencing legacy technology issues and limitations, they’re researching innovations to expand and refine their technology stacks. To help practitioners keep up with the rapidly evolving martech landscape, this special report will discuss: How practitioners are integrating technologies and systems to encourage information-sharing between departments and pr

Competition

MedCity News

JUNE 26, 2023

Public health is heavily dependent on collecting and sharing accurate patient data. Standards for data collection and interoperability can move the needle toward better health data, but it is up to healthcare organizations to take ownership of their data quality by following best practices and adopting technologies that can detect and eliminate bad patient data before it is disseminated.

Healthcare 122

Healthcare Healthcare Patients 122

Medgadget

JUNE 1, 2023

Researchers at Penn State have developed a low-cost, wearable sensor using pencil-on-paper technology. This approach involves depositing graphite (pencil ‘lead’) on paper that has been treated with sodium chloride, to create a conductive, low-cost sensor. Previously, these researchers had developed such sensors to detect moisture and even used them to develop a smart diaper ( yes, really ).

Manufacturing 103

Manufacturing Engineering Leads Patients 103

European Pharmaceutical Review

JUNE 27, 2023

Riding on the momentum of the first faecal microbiota product approved for C. difficile in December 2022, the microbiome therapies space in 2023 has continued to see revolutionary developments and continued research advancement. Recent developments in microbiome therapeutics In May this year, first-in-human study interim results revealed that a CRISPR-based microbial gene therapy can “eliminate antibiotic-resistant E. coli strains in the gut”.

Food and Drug Administration 100

Food and Drug Administration Manufacturing Medicine Pharma 100

Healthcare Success

JUNE 8, 2023

What do you consider the most important pages on your healthcare website? After the homepage, many might say it’s their products or services pages. However, the About Us page is among the most important and highly trafficked web pages. In many cases, it's also a critical part of the consumer's buying journey. Fifty-two percent of study respondents said the first thing they want to see when they land on a website is a company’s About Us page, according to a B2B Web Usability Report. 1 Most people

Healthcare 99

Healthcare Healthcare Engineering Doctors 99

Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist

What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.

FDA

Fierce Pharma

JUNE 12, 2023

Bayer recently laid out its ambition | Bayer recently laid out its ambition to achieve $10 billion in sales from its oncology business by 2030 and become a top 10 cancer drug player. To get there, the company is looking outside for a “midsize acquisition,” Bayer’s oncology chief Christine Roth said.

Sales goal 327

Sales goal Sales 327

Pharmaceutical Technology

JUNE 9, 2023

WestVac Biopharma has announced that the Chinese authorities have granted emergency use authorisation (EUA) for coviccine trivalent XBB.1.5-recombinant Covid-19 trivalent (XBB.1.5+BA.5+delta) protein vaccine (Sf9 cell). This marks the world’s first Covid-19 vaccine approved for emergency use against XBB descendent lineages of SARS-CoV-2. The vaccine has been developed by WestVac Biopharma along with the West China Medical Center and Sichuan University.

Biopharma 107

Biopharma Safety Medical 107

MedCity News

JUNE 5, 2023

The ED boarding crisis is not one that’s going to be solved overnight. But left to continue unchecked, it will only engender wider discontent, decrease patient satisfaction, and ultimately lead to worse outcomes.

Healthcare 120

Healthcare Healthcare Leads Patients 120

Medgadget

JUNE 8, 2023

The iLet Bionic Pancreas for use by type 1 diabetes patients has been cleared by the FDA and is now available commercially. The device is offered by Beta Bionics , a medtech company based in Massachusetts and California, but the underlying technology originally developed by researchers at Boston University. The system can be paired with a Bluetooth glucose monitor to deliver personalized insulin dosing every five minutes, and calculates doses based on past and current glucose levels and its expe

FDA 102

FDA Medicine Prospecting Patients 102

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Planning on running clinical trials in Japan? How can you reliably supply these studies? Discover Catalent’s clinical supply packaging facility in Shiga, Japan. Strategically located between Tokyo and Osaka, and one of largest in Japan, this 6,000 square meter facility offers comprehensive services including primary and secondary clinical packaging and labelling, comparator sourcing, cold chain storage, local and global distribution, local language support and white glove service to support stud

Distribution

Copyright Clearance Center

JUNE 20, 2023

The post The Role of Artificial Intelligence and Related Technologies in Academic Publishing and How it Might Transform the Way Publishers Work appeared first on Copyright Clearance Center.

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PM360

JUNE 26, 2023

Access to medicines have persisting and systemic differences across the globe and within countries. It is estimated that nearly two billion people globally do not have access to essential medicines. 1 The issue of access to medicines is addressed as part of the United Nations Sustainable Development Goals, with the objective to “provide access to medicines for all.

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Medicine Marketing Pharma Manufacturing 98

Fierce Pharma

JUNE 4, 2023

AstraZeneca and Daiichi Sankyo’s Enhertu has already made waves in breast cancer treatment. | AstraZeneca and Daiichi Sankyo’s Enhertu has already made waves in breast cancer treatment. Now, the companies are positioning the HER2 antibody-drug conjugate for expansion into other tumor types with data that researchers view as very compelling.

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Pharmaceutical Technology

JUNE 30, 2023

Health Canada has approved Endo International’s Xcopri as adjunctive therapy in the management of partial-onset seizures in adults with epilepsy.

Management 116

Management 116

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When selecting a clinical supply provider, consideration often focuses upon the manufacturing, packaging, storage and distribution capabilities available that will, at face-value, be sufficient to meet the needs of the sponsor and their trial. However, there are human-based and knowledge-driven factors that are often overlooked that go beyond these basic physical capabilities and are integral to the development and delivery of high performing clinical supply chains.

Specialization

MedCity News

JUNE 13, 2023

Many health systems aren’t employing the right tactics for hiring and retaining nurses, according to a new report. It argued that hospitals would have an easier time hiring and retaining nurses if they focused more on the things workers want most from their employers — such as flexible scheduling and professional development opportunities.

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Pharmaceutical Commerce

JUNE 14, 2023

In this latest Harvard Business School Healthcare Alumni Association Q&A, Susan Wilner Golden, DSC, lecturer at the Stanford Graduate School of Business, reveals an untapped $22 trillion global opportunity for all companies and others supporting healthy aging and longer life spans.

Healthcare 98

Healthcare Healthcare 98

Copyright Clearance Center

JUNE 29, 2023

This is the first in a series of blog posts in which CCC shares this analysis with the scholarly community to spark dialogue and drive action with respect to metadata management during each stage of the research lifecycle.

Management 98

Management 98

PM360

JUNE 26, 2023

The healthcare industry is coming to terms with the longstanding practice of clinical trials that underrepresented clinically relevant communities—a practice with potentially serious implications. In explaining the issue, the National Institutes of Health (NIH) notes that for years most trials were based on white male participants. Meanwhile the life sciences market research trade association, Intellus, noted that market insights participants are often white, female, and upper middle income, eve

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Recruitment Physicians Marketing Transportation 98

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As the development pipeline for new drugs continues to grow, biopharmaceutical companies are re-evaluating how to best manage and balance resources across an increasing number of development projects and complex clinical trials. There are two approaches that can be used to speed a drug from development to clinic faster: timeline compression and parallel processing, but only one that considers the benefits of integrating clinical supply into the overall drug development process.

Management