September, 2023

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New RSV vaccines can be powerful tools, but rollout poses test

Bio Pharma Dive

Public health officials, as well as drugmakers, are trying to raise awareness of RSV among older adults at risk, and convince them to get an additional respiratory shot alongside those for COVID and flu.

Vaccine 328
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ADDF invest in BrainScope for Alzheimer’s prediction biomarker

Pharmaceutical Technology

The neurotech will receive the investment in Series B equity financing round to invest in Alzheimer’s disease research.

Research 324
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Bioanalysis through automation: Our top four takeaways

Worldwide Clinical Trials

Our team has been working diligently to find a way to revitalize how we use automation, and during WRIB this year, we presented a poster on “Revolutionizing Bioanalysis through Automation: Overcoming Challenges and Unlocking Potential.” In case you missed it, we’ve highlighted the top four takeaways: 1. Instrument Integration: At both hardware and software levels, our integration of multiple bioanalytical instruments created a total laboratory automation (TLA) system for ligand bindi

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Grand Rounds September 22, 2023: Integrating Community Health Workers into Team-Based, Early Childhood Preventative Care (Tumaini Rucker Coker, MD, MBA)

Rethinking Clinical Trials

    Speaker Tumaini Rucker Coker, MD, MBA Professor of Pediatrics Division Head for General Pediatrics University of Washington Department of Pediatrics Seattle Children’s Hospital Slides Keywords Pediatrics, Preventive Medicine, Community Health, Well Child Care Key Points There are 10 preventive care visits from ages 0-3, usually scheduled as 15-20 minute visits with a pediatrician.

Trials 214
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From Diagnosis to Delivery: How AI is Revolutionizing the Patient Experience

Speaker: Simran Kaur, Founder & CEO at Tattva Health Inc.

The healthcare landscape is being revolutionized by AI and cutting-edge digital technologies, reshaping how patients receive care and interact with providers. In this webinar led by Simran Kaur, we will explore how AI-driven solutions are enhancing patient communication, improving care quality, and empowering preventive and predictive medicine. You'll also learn how AI is streamlining healthcare processes, helping providers offer more efficient, personalized care and enabling faster, data-driven

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Neuroplast spinal cord injury study milestone

Pharma Times

The trial analyses the impact of its ‘Neuro-Cells’ among patients with traumatic spinal cord injuries - News - PharmaTimes

Trials 161
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Pfizer, Moderna score FDA nods for next round of seasonal COVID-19 vaccines

Fierce Pharma

Out with the old and in with the new: Monday, the U.S. | The FDA has approved Pfizer and Moderna’s separate vaccine formulations that target current variants of the disease. Each company’s shot is approved for people ages 12 and up and emergency authorized for patients 6 months old to 11 years old.

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More Trending

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Generative AI-focused biotech startup Evozyne raises $81m

Pharmaceutical Technology

The company’s algorithms put proteins through millions of years of simulated evolution to identify potential functional candidates.

Protein 317
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Oregon Project Extends Benefits of Clinical Trials to More Hispanics/Latinos

ACRP blog

With observations of National Hispanic Heritage Month kicking off on September 15, this year’s events will have special resonance for a team of Oregon Health & Science University (OHSU) researchers who are working to bring the benefits of clinical trials to more persons in underserved communities. Eneida R. Nemecek, MD, MS, MBA, an endowed professor of pediatrics and medical oncology and Medical Director of Clinical Research at the Knight Cancer Institute of OHSU, recently received a $625,00

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September 27, 2023: This Friday’s PCT Grand Rounds to Highlight PROTEUS Consortium

Rethinking Clinical Trials

In this Friday’s PCT Grand Rounds, Claire Snyder of Johns Hopkins University and Norah Crossnohere and Anne Schuster, both of Ohio State University, will present “Navigating the Use of Patient-Reported Outcomes in Research and Practice: The PROTEUS Consortium.” The Grand Rounds session will be held on Friday, September 29, 2023, at 1:00 pm eastern.

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AstraZeneca and SAS link up on AI and analytics

Pharma Times

Collaboration will enable teams across the organisation to increase clinical research innovation - News - PharmaTimes

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

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Novo, Lilly set to dominate $71B GLP-1 drug market by 2032: J.P. Morgan

Fierce Pharma

Demand is so strong for Novo Nordisk’s obesity drugs that the only limitation on sales—in the short term—seems to be the company’s ability to produce them. | Promising heart data for Novo Nordisk's Wegovy are a "paradigm shift," according to J.P. Morgan, which has doubled its market projection for GLP-1 diabetes and obesity treatments to $71 billion for 2032.

Marketing 139
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FDA approves updated COVID boosters from Pfizer, Moderna

Bio Pharma Dive

Pfizer and Moderna, which have seen slowing demand for their coronavirus vaccines, expect to make the reformulated shots available in the U.S. in the coming days.

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Nestlé divests peanut allergy treatment Palforzia to Stallergenes Greer

Pharmaceutical Technology

Nestlé has sold its peanut allergy drug Palforzia to Swiss biopharma Stallergenes Greer harma, concluding a year-long strategic review.

Allergies 299
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Ann Marie Hall, SR Clinical Trial Manager, Site Management, shares her story about why World Alzheimer’s month is so important to her.

Worldwide Clinical Trials

In September, as we observe World Alzheimer’s month and focus attention on how far we have come in raising awareness of the disease and research being done to find more effective treatments, I think back to when my grandmother was first diagnosed and how heart wrenching it was to watch her loose herself over the years. When my mother was diagnosed, it was not a surprise, as I had already been witnessing those early changes and knew what was coming.

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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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September 20, 2023: This Friday’s PCT Grand Rounds Explores the Role of Community Health Workers in Early Childhood Well-Child Care

Rethinking Clinical Trials

In this Friday’s PCT Grand Rounds, Tumaini Rucker Coker of the University of Washington and Seattle Children’s Hospital will present “Community Health Workers in Early Childhood Well-Child Care.” The Grand Rounds session will be held on Friday, September 22, 2023, at 1:00 pm eastern. Coker is the chief of general pediatrics and a professor of pediatrics at the University of Washington School of Medicine and Seattle Children’s Hospital.

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Brainomix’s e-Lung enters TIPAL trial

Pharma Times

The company will use its AI technology during a sub-study to analyse the effect of lansoprazole - News - PharmaTimes

Trials 155
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Merck and Eisai's Keytruda-Lenvima combo chalks up 2 more losses, this time in non-small cell lung cancer

Fierce Pharma

Merck and Eisai’s Keytruda-Lenvima tag team can’t seem to catch a break. | Merck and Eisai’s Keytruda-Lenvima tag team can’t seem to catch a break. Following a series of trial shortfalls this year in melanoma, colorectal cancer and head and neck squamous cell carcinoma, the duo has missed the mark in yet another set of clinical trials—this time in non-small cell lung cancer.

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Daiichi Sankyo, with new data, to seek FDA approval of lung cancer drug

Bio Pharma Dive

The HER3-targeting treatment could become the next antibody-drug conjugate to emerge from Daiichi Sankyo’s laboratories, after the AstraZeneca-partnered Enhertu.

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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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FDA accepts Takeda’s NDA resubmission for eosinophilic esophagitis therapy

Pharmaceutical Technology

The US FDA has accepted Takeda’s NDA resubmission for TAK-721 for the short-term treatment of eosinophilic esophagitis (EoE), for review.

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Repurposing the anthelmintic drug Niclosamide

Pharma Mirror

Niclosamide is an anthelmintic medication that has been used for decades to treat various types of parasitic infections in humans and animals. Niclosamide works by disrupting the energy metabolism of the parasitic worms, specifically by interfering with their ability to generate adenosine triphosphate (ATP), which is essential for their survival. This disruption ultimately leads to the death of the parasites.

Drugs 130
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September 5, 2023: NIH Pragmatic Trials Collaboratory Announces Grand Rounds Series on Design and Analysis of Pragmatic Clinical Trials

Rethinking Clinical Trials

The NIH Pragmatic Trials Collaboratory is launching a special Grand Rounds series to share advances in the design and analysis of pragmatic clinical trials. Join us on the first Friday of each month, October through January, to hear the latest best practices and explore emerging questions with experts from the program’s Biostatistics and Study Design Core.

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Intelligent OMICS partners with Janssen on AI-driven research

Pharma Times

The AI platform and expertise will be combined to discover novel targets for haematological cancers - News - PharmaTimes

Research 153
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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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Novartis targets first-line use for radiotherapy Lutathera with trial win in neuroendocrine tumors

Fierce Pharma

More than five years after an initial FDA approval, Novartis is touting positive trial results for its radiotherapy Lutathera as a first-line therapy against the rare cancer that killed Apple co-fo | More than five years after an initial FDA approval, Novartis is touting positive trial results for its radiotherapy Lutathera as a first-line therapy against the rare cancer that killed Apple co-founder Steve Jobs.

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Startup AIRNA emerges from stealth to bring RNA editing to a rare disease

Bio Pharma Dive

AIRNA is one of several biotechs to debut plans for target alpha-1 antitrypsin deficiency in recent years, with competitors such as AlveoGene, Wave Life Sciences and Arrowhead Pharmaceuticals.

RNA 317
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Signal: Illumina leads $15m investment in Broken String Biosciences

Pharmaceutical Technology

Embattled biotech giant Illumina has led series A funding into genomics mapping company Broken String Biosciences.

Genomics 290
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Patient-Centric Marketing in the Life Science Industry: Putting the Focus on Patient Needs

Pharma Mirror

by Nataliya Andreychuk, Co-founder and CEO of Viseven Many pharma brands still shy away from marketing directly to patients, depending on conversion through healthcare providers (HCPs). And it is not hard to see why. Compliance with complex laws and regulations, like Direct-to-Consumer Advertising (DTCA) Rules or the Health Insurance Portability and Accountability Act (HIPAA), can be quite daunting.

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2022 Research: The Rapid Rise of Ocean Freight Visibility

A research study conducted by The Journal of Commerce and FourKites surveyed hundreds of international shippers, exploring how their usage of global supply chain visibility technology has evolved since the onset of global disruptions caused by COVID-19. For international shippers, ocean freight visibility has evolved from optional to essential and satisfaction with visibility varies greatly depending on how it is obtained and delivered.

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Clinical trial phases: What’s the difference?

Antidote

Clinical trials are how researchers advance their knowledge about potential new treatments, including medications, medical devices, and lifestyle interventions. Clinical trials are divided into phases , each with a distinct duration, purpose, and number of volunteers needed. Before any new treatment becomes available on the market, it must go through this process, as required by the FDA.

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NICE nod for Darzalex with lenalidomide and dexamethasone

Pharma Times

Therapy has been developed to treat adult patients with newly diagnosed multiple myeloma - News - PharmaTimes

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Patent cliffs, divestitures and maturing biotechs all point to more pharma M&A: analysts

Fierce Pharma

Biopharma M&A is on an uptick compared to the post-pandemic doldrums of the last two years. | Biopharma M&A is on an uptick compared to the post-pandemic doldrums of the last two years. Analysts anticipate that the trend will continue in 2023 and into 2024 as companies attempt to beef up their portfolios.

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Flagship-backed Generate raises $273M as its first drugs move to the clinic

Bio Pharma Dive

Since 2019, Generate has raised nearly $700 million in private financing and has now brought a monoclonal antibody into Phase 1 testing.

Antibody 317
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An Innovative & Creative Problem Solver Approach to Selling in the Medical Device Space

Speaker: Steve Goldstein, Sales Leader

Are you currently in sales, or involved in a business that depends on strong sales results? What about the extremely competitive world of medical device sales? What are some of the top challenges your customers face and how do you approach understanding what’s most important to them? Join Steve Goldstein, Sales Success Coach, Motivational Speaker and Medical Device Sales Leader from Gold Selling LLC., to discover critical strategies and approaches you can take to engage your customers, achieve g