June, 2023

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Unveiling the Journal Citation Reports 2023: Supporting research integrity with trusted tools and data

Clarivate

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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Eisai, Biogen's Alzheimer's disease drug Leqembi passes muster at FDA adcomm

Fierce Pharma

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.

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WHO grants emergency use listing to SK bioscience’s SKYCovione

Pharmaceutical Technology

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.

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Ezra Earns FDA Clearance for AI Tool that Makes MRIs Faster & Cheaper

MedCity News

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.

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Increase Revenue With Better, Faster Sales Onboarding

Quotas need to be hit. Revenue goals need to be met. This reality makes shortening sales onboarding time a top priority. Organizations with a standard onboarding process boost employee retention by 58% and increase productivity by 50%. Unfortunately, many companies struggle with inefficient processes that lead to high turnover and missed revenue opportunities.

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First adult anti-inflammatory cardiovascular drug approved

European Pharmaceutical Review

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

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Wearable Ultrasound for Deep Tissue Monitoring

Medgadget

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.

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BioNTech to defend itself against COVID-19 vaccine injury claim in Germany

Fierce Pharma

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.

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Alkeus raises funds to launch Stargardt disease therapy gildeuretinol

Pharmaceutical Technology

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.

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AstraZeneca Teams Up With Startup Quell in Type 1 Diabetes, IBD Cell Therapy Pact

MedCity News

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.

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In Depth Focus QA/QC Microbiology/RMM 2023

European Pharmaceutical Review

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
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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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Pencil-on-Paper Wearable Sensor

Medgadget

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 ).

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The Managing Metadata Series: Research Idea Development and Proposal Preparation

Copyright Clearance Center

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.

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BioMarin's hemophilia gene therapy Roctavian lands FDA nod with 'glimmers' of enthusiasm among doctors

Fierce Pharma

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.

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Cybersecurity in pharma: Securing the future

Pharmaceutical Technology

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
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How Machine Learning Drives Clinical Trial Efficiency

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.

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Better Data Quality Means a Better Future for Public Health

MedCity News

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.

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Microbiome therapies: a maturing movement

European Pharmaceutical Review

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”.

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iLet Bionic Pancreas Cleared by FDA

Medgadget

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
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Generative AI’s potential to speed delivery of improved patient outcomes

Clarivate

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

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How to Stay Competitive in the Evolving State of Martech

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

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ASCO: AstraZeneca, Daiichi's Enhertu delivers 'very compelling' pan-tumor activity, experts say

Fierce Pharma

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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China grants EUA to Covid-19 vaccine against XBB descendent lineages

Pharmaceutical Technology

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
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Dying in the Waiting Room: Emergency Departments Have Become the Nexus of the Newest Healthcare Crisis

MedCity News

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.

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Alzheimer’s vaccine granted Fast Track designation

European Pharmaceutical Review

AC Immune SA has received Fast Track designation from the US Food and Drug Administration (FDA) for its anti-amyloid beta (Abeta) active immunotherapy vaccine candidate for Alzheimer’s disease. This follows FDA clearance of the Investigational New Drug (IND) application, enabling expansion to the US of the ongoing Phase Ib/II ABATE study of ACI-24.060 in Alzheimer’s patients and individuals with Down’s syndrome.

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What the FDA's New Dosage Guidance Means for the Future of Clinical Research

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.

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The Role of Artificial Intelligence and Related Technologies in Academic Publishing and How it Might Transform the Way Publishers Work

Copyright Clearance Center

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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Improving Access to Medicine: The Role of Pharma Companies in Emerging Markets

PM360

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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Bayer needs 'midsize acquisition' to reach $10B oncology sales goal, exec says

Fierce Pharma

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.

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Health Canada approves Endo’s anti-seizure pills

Pharmaceutical Technology

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

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Using Generative AI in Sales: Pros, Cons, and Considerations According to Sellers

Are your sellers unsure about using AI in their day-to-day workflows? Or are they eager to try but uncertain where to start? They might be asking: Which tasks are best suited for AI? How will using AI affect my relationship with my customers? With so many tools available, which ones are the most useful to me? To help answer these and other common questions about using AI during the sales cycle, we surveyed B2B sellers who were early adopters to get their insight and advice about how to use gen A

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To Get Better Staffing Levels, Hospitals Must Prioritize Nurses’ Hiring Demands

MedCity News

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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World’s largest lutetium-177 production site opens

European Pharmaceutical Review

A new therapeutic radionuclide facility, the world’s largest production site of lutetium-177, has opened in Germany. ITM Isotope Technologies Munich SE ( ITM )’s manufacturing plant in Neufahrn near Munich will produce the innovative medical isotope for targeted cancer therapies. “Radiopharmaceuticals are an essential new class of anti-cancer drugs that have the potential to improve therapy outcomes and quality of life for many patients.

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Embracing the 60-Plus Economy

Pharmaceutical Commerce

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.

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Improving Rare Disease Clinical Trial Design

PM360

According to the National Organization for Rare Disorders (NORD) , there are over 7,000 known rare diseases, with 90% having no effective treatment method or cure. 1 When an individual is diagnosed with a rare disease, they often experience fear, uncertainty, and anxiety. Obtaining a diagnosis is only the first step, leaving many without the direction or resources to find the additional medical care they need.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time