Sat.May 07, 2022 - Fri.May 13, 2022

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Lilly wins FDA approval of new kind of diabetes drug

Bio Pharma Dive

Tirzepatide, now branded as Mounjaro, helped improve blood sugar control in testing and has been shown to have powerful weight loss effects as well, making it one of the most closely watched drugs in Lilly's pipeline.

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International Nurses Day 2022

Deltaclinical

On May 12, we celebrate Nurses Day! Sometimes it seems that we have forgotten the past 2 years. Because even after a pademic, nurses are there for us day and night. And they do this with a clear goal in mind: making other people better and taking care of those in need. It is therefore more than deserved to put all nurses in the spotlight today! THANK YOU to everyone who provides warm and professional care every day!

Nurses 130
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Emmes launches Advantage eClinical as a standalone cloud native clinical technology platform

Pharma Mirror

Rockville, Emmes – a global, full-service Contract Research Organization (CRO) dedicated to supporting the advancement of public health and biopharmaceutical innovation, announces that it will introduce to market its third generation version of Advantage eClinical at Society for Clinical Trials (SCT) in San Diego, May 15th – 18th. The cloud platform of Advantage eClinical will be available as a standalone software product after undergoing more than two years of development.

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The antimicrobial pipeline is ‘dry’ and that’s a problem

pharmaphorum

Antimicrobial resistance is a growing problem and one that is already claiming over a million lives per year. The situation is urgent but finding a sustainable solution is a difficult prospect, finds Ben Hargreaves. Alexander Fleming discovered the world’s first antibiotic, penicillin, in 1928. However, the difficulty in developing a method to adequately produce sufficient levels of the product meant that the age of the antibiotic did not truly begin until the 1940s.

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The New Age of Decentralized Clinical Trials

White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations

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In first, Verve gets clearance to test base editing inside the body

Bio Pharma Dive

Regulators in New Zealand have allowed human testing to proceed, another milestone for the gene editing technology. Verve plans to soon ask for approval to begin testing in the U.S. and U.K., too.

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International Nurses Day 2022

Deltaclinical

On May 12, we celebrate Nurses Day! Sometimes it seems that we have forgotten the past 2 years. Because even after a pademic, nurses are there for us day and night. And they do this with a clear goal in mind: making other people better and taking care of those in need. It is therefore more than deserved to put all nurses in the spotlight today! THANK YOU to everyone who provides warm and professional care every day!

Nurses 130

More Trending

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Roche extends Kaiku digital monitoring partnership again

pharmaphorum

Roche has elevated a longstanding alliance with Finland’s Kaiku Health focusing on digital patient monitoring and management (DPMM) to the level of a strategic partnership. The two companies have been working together since 2019 on digital health interventions to provide support to people with cancer, focusing initially on tools for patients undergoing cancer immunotherapy.

Nurses 137
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Pfizer to acquire Biohaven in $11.6B bet on biotech's migraine drugs

Bio Pharma Dive

The rest of Biohaven's pipeline, which includes drugs for ALS and obsessive compulsive disorder, will be spun out into a new company led by the biotech's current CEO and retaining its name.

Drugs 334
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International Nurses Day 2022

Deltaclinical

On May 12, we celebrate Nurses Day! Sometimes it seems that we have forgotten the past 2 years. Because even after a pademic, nurses are there for us day and night. And they do this with a clear goal in mind: making other people better and taking care of those in need. It is therefore more than deserved to put all nurses in the spotlight today! THANK YOU to everyone who provides warm and professional care every day!

Nurses 130
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“Growing end” of inflammation discovered

Scienmag

Redness, swelling, pain – these are signs of inflammation. It serves to protect the body from pathogens or foreign substances. Researchers from the Universities of Bonn and Cologne were able to show that inflammatory reactions of an important sensor protein proceed in a specific spatial direction. This finding has the potential to conceivably stop inflammation […].

Protein 104
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Roles and Responsibilities of Specialized Clinical Supply Experts

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.

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SparkRx: The first digital therapeutic for adolescents

pharmaphorum

Mental health issues among teens and young adults have risen dramatically over the past decade. Jessica Lake, chief science officer at Limbix, tells us about SparkRx, a digital therapeutics app aimed to help treat adolescent depression. . SparkRx is designed to decrease depression in individuals aged 13 to 22 by providing a multi-week programme based on cognitive behavioural therapy (CBT) and behavioural activation protocols.

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Clay Siegall, founding Seagen CEO, takes leave amid domestic violence accusation

Bio Pharma Dive

The company's board is investigating the allegation, which Siegall, who has led Seattle's largest biotech for 24 years, denied. Chief Medical Officer and former Merck executive Roger Dansey was named interim CEO.

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International Nurses Day 2022

Deltaclinical

On May 12, we celebrate Nurses Day! Sometimes it seems that we have forgotten the past 2 years. Because even after a pademic, nurses are there for us day and night. And they do this with a clear goal in mind: making other people better and taking care of those in need. It is therefore more than deserved to put all nurses in the spotlight today! THANK YOU to everyone who provides warm and professional care every day!

Nurses 130
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Modifying the body’s immune system to help treat Type 1 diabetes

Scienmag

In a new study, a team of researchers from the University of Missouri, Georgia Tech and Harvard University has demonstrated the successful use of a novel Type 1 diabetes treatment in a large animal model. Their approach involves transplanting insulin-producing pancreas cells — called pancreatic islets — from a donor to a recipient, without the […].

Insulin 102
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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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Pfizer: Pharma needs a business strategy for a digital world

pharmaphorum

The unprecedented rate of digital acceleration seen in the first two years of COVID-19 has set in train an age of digital transformation. In my last article, I outlined the inflection point facing the pharmaceutical industry in digital health and the digital transformation of its clinical and commercial operations. This time I’m going to focus on one company and its view on pharma’s digital commercial strategy.

Doctors 131
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J&J ends hepatitis B, HPV vaccine work with Bavarian Nordic

Bio Pharma Dive

The companies' hepatitis B program never reached clinical testing, while J&J said it would no longer develop an HPV vaccine because of the "widespread uptake" of effective shots from other companies.

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Cytiva opens Swiss manufacturing facility and Center of Excellence for cell and gene therapies

BioPharma Reporter

Cytiva is opening a new 7,400m manufacturing facility in Grens, Switzerland this month: which will serve as a center of excellence for the companyâs cell and gene therapy business as well as a being a base for European customer training programs.

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Scripps Research scientists explain what makes COVID-19 antibody “J08” so potent

Scienmag

LA JOLLA, CA—Last year, scientists at Scripps Research and Toscana Life Sciences studied the blood of 14 COVID-19 survivors to find the most potent antibodies against the SARS-CoV-2 virus. One of the leading molecules that emerged—now in stage II/III trials in Italy—was an antibody dubbed J08, which seemed to be capable of both preventing and […].

Antibody 100
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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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Wearable tracks health by measuring skin gas emissions

pharmaphorum

Researchers in the US have developed a wearable monitor that could be used to monitor metabolic diseases through gases released from a person’s skin. It’s a spin on the use of monitors that detect chemicals in sweat using electrical signals and has the key advantage that it does not need substantial amounts of sweat to get a reading, according to the team from Ohio State University.

Engineer 130
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Moderna's finance head is out as former employer conducts investigation

Bio Pharma Dive

Jorge Gomez, who officially took the CFO reins Monday, lasted one day on the job. His departure comes as Gomez's previous company, Dentsply Sirona, looks into financial allegations against current and former executives.

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Packaging Solutions for Pharmaceuticals & Medical Devices: Insights and Considerations

XTalks

A container closure system consists of all the packaging components that contain and protect a pharmaceutical product. It includes both primary components, which are materials that are in direct contact with the product, as well as secondary packaging components that provide additional protection but are not in direct contact with the product. Packaging components include the raw materials, auxiliary packaging, as well as containers and closures, and the combination of products are referred to a

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Time to Benefit of Intensive Blood Pressure Control in Older Adults

JAMA Internal Medicine

This secondary analysis of randomized clinical trials estimates the time needed to potentially derive clinical benefit from intensive blood pressure treatment in patients 60 years and older.

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The New Age of Decentralized Clinical Trials

This new white paper defines and details the impact of Decentralized Clinical Trials on the Pharmaceutical industry and how the impact can be measured along with steps companies can take to ensure adoption.

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Game used to track symptoms in children with cancer

pharmaphorum

A study has shown that a mobile game can be used to gather symptom data from children undergoing treatment for cancer, and potentially might also be used to provide personalised management of their care. That is the conclusion of a small US study looking at the role of Color Me Healthy, a gaming app developed through a collaboration between children, game designers and clinical staff.

Nurses 129
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Against a historic market downturn, Moma Therapeutics raises $150M for precision cancer research

Bio Pharma Dive

The biotech's Series B round, which kicked off early this year, should be able to fuel its work on "molecular machines" until at least 2024, according to CEO Asit Parikh.

Marketing 284
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Voyage Foods is Taking the Cocoa out of Chocolate, Peanuts out of Peanut Butter and Beans out of Coffee

XTalks

Voyage Foods, a California-based startup that has reverse-engineered chocolate, peanut butter and coffee, recently closed a $36 million Series A investment round, bringing the company’s total funding to $41.8 million. Co-led by UBS O’Connor and Level One Fund, the latest funds will help Voyage Foods scale up and become a bigger player in what it calls the ethical food market.

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Superdrug launch comprehensive perimenopause screen service

Pharma Times

High street service has been launched to support those experiencing symptoms potentially connected to the menopause

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Accelerating Clinical Supply Through Integrated Drug Development

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.

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Novo Nordisk forges close ties with biotech VC Flagship

pharmaphorum

Danish drugmaker Novo Nordisk has traditionally generated its pipeline mainly from internal R&D, but a new alliance with venture capital firm Flagship Pioneering signals another departure from that strategy. The partnership with Flagship will bring Novo Nordisk into closer contact with the VC’s portfolio of 41 biotech companies, with the aim of creating a portfolio of “transformational” medicines for cardiometabolic and rare diseases.

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Key Bristol Myers drug holds up in long-term psoriasis study

Bio Pharma Dive

Deucravacitnib, forecast by Bristol Myers to hit $4 billion in peak sales, is under FDA review with an approval decision due by September. The agency's view of its safety will be key to its future.

Sales 278
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GoodPop Expands Better-For-You Dessert Line with Frozen Oat Milk Fudge Squares

XTalks

GoodPop is expanding its line of better-for-you frozen desserts with the introduction of Fudge n’ Vanilla Squares, which the company claims are the first plant-based and gluten-free frozen dessert squares. The Austin, Texas-based brand combined creamy vanilla oat milk ice cream with a chocolate fudge shell for its latest “cleaned up classics” product.

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New patent expiration for Purdue Pharma drug TARGINIQ

Drug Patent Watch

Annual Drug Patent Expirations for TARGINIQ Targiniq is a drug marketed by Purdue Pharma Lp and is included in one NDA. There are fifteen patents protecting this drug. Drug patent…. The post New patent expiration for Purdue Pharma drug TARGINIQ appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 98
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Deliver Fast, Flexible Clinical Trial Insights with Spotfire

Clinical research has entered a new era, one that requires real-time analytics and visualization to allow trial leaders to work collaboratively and to develop, at the click of a mouse, deep insights that enable proactive study management. Learn how Revvity Signals helps drug developers deliver clinical trial data insights in real-time using a fast and flexible data and analytics platform to empower data-driven decision-making.