July, 2023

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Pfizer backs CRISPR biotech Caribou in latest cell therapy investment

Bio Pharma Dive

Five years after helping launch Allogene Therapeutics, Pfizer is backing another developer of “off-the-shelf” cell therapies in a deal that gives the drugmaker the chance to acquire a multiple myeloma treatment.

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Digital health tech: a solution to substance use disorders?

Pharmaceutical Technology

Substance use disorders leave people with long-term negative mental and physical health implications and can lead to death.

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Disturbing New Finding Links Cognitive Decline to Dental Hygiene

AuroBlog - Aurous Healthcare Clinical Trials blog

Researchers in Japan found a connection between tooth loss, gum disease, and shrinkage in a region of the brain involved in memory and Alzheimer’s disease called the hippocampus.

Research 246
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July 6, 2023: NIH Pragmatic Trials Collaboratory Welcomes 2 New Demonstration Projects: BEST-ICU and Remote Tai Chi

Rethinking Clinical Trials

Dr. Michele Balas and Dr. Eduard Vasilevskis The NIH Pragmatic Trials Collaboratory is excited to add 2 new Demonstration Projects to its portfolio of innovative pragmatic clinical trials embedded in healthcare systems. BEST-ICU (or Behavioral Economic and Staffing Strategies to Increase Adoption of the ABCDEF Bundle in the ICU) is supported by the National Heart, Lung, and Blood Institute (NHLBI).

Trials 189
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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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DigitalHealth.London’s Accelerator programme selects Aide

Pharma Times

Project aims to boost the adoption of technology across London’s NHS and help patients manage conditions - News - PharmaTimes

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Bernie Sanders proposes price caps on drugs developed with federal funds

Fierce Pharma

After becoming chairman of the powerful Senate Health, Education, Labor and Pensions Committee earlier this year, Sen. | After becoming chairman of the powerful Senate Health, Education, Labor and Pensions Committee earlier this year, Sen. Bernie Sanders, I-Vermont—a longtime opponent of Big Pharma—has become even more ubiquitous in his efforts to reduce drug prices.

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Eli Lilly’s retatrutide sets new record for weight loss in obesity space

Pharmaceutical Technology

Pipeline developments within the obesity space have recently garnered interest following recent results published on Eli Lilly’s retatrutide.

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AI May Have Found The Most Powerful Anti-Aging Molecule Ever Seen

AuroBlog - Aurous Healthcare Clinical Trials blog

Finding new drugs – called “drug discovery” – is an expensive and time-consuming task. But a type of artificial intelligence called machine learning can massively accelerate the process and do the job for a fraction of the price.

Drugs 243
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July 31, 2023: NIH Announces Funding Opportunity for Pain Management Collaboratory Pragmatic Trials

Rethinking Clinical Trials

The NIH this month published notice of a funding opportunity to support the next round of pragmatic clinical trials within the NIH-DoD-VA Pain Management Collaboratory (PMC). Read the full notice of funding opportunity (RFA-AT-24-004). The PMC was established in 2017 with an initial cohort of 11 pragmatic trials. The new funding opportunity leverages the experience, expertise, and leadership of the PMC Coordinating Center with a new round of pragmatic trials evaluating nonpharmacologic solutions

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FDA grants Eisai’s Leqembi full approval, opening door to wider use of Alzheimer’s drug

Bio Pharma Dive

The broader approval is expected to push insurers, namely Medicare, to increase coverage of so-called amyloid-targeting therapies.

Drugs 290
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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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With new data, J&J steps forward in growing race for oral autoimmune drugs

Bio Pharma Dive

Phase 2 results show a pill the company is developing is competitive with other oral medicines in testing against psoriasis, among them the TYK2 inhibitors that have drawn significant industry interest.

Medicine 290
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Rationing strategies proliferate with cancer drugs in short supply

Pharmaceutical Technology

While drug shortages have been a major cause for concern over the past few years, medications to treat cancer are in particularly short supply.

Drugs 279
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Lifera, Sanofi and Arabio boost vaccine manufacture in Saudi Arabia

Pharmaceutical Technology

Lifera, Arabio and Sanofi have signed a memorandum of understanding (MOU) to bolster manufacturing of vaccines in Saudi Arabia.

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Sarepta sells FDA fast pass earned from Duchenne gene therapy approval

Bio Pharma Dive

The deal enables Sarepta to quickly cash in on the clearance of Elevidys, with $102 million in new funds to help bankroll its drug research.

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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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Incyte’s non-segmental vitiligo treatment approved in UK

Pharmaceutical Technology

Following FDA approival and CE marking for Incyte’s JAK-inhibiting cream Opzelura (ruxolitinib), the MHRA has followed suit in the UK.

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Abeona Therapeutics raises funds to launch cell therapy

Pharmaceutical Technology

Abeona Therapeutics has raised $25m from its current select investors to launch and commercialise its cell therapy, EB-101.

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Generative AI – beyond the hype

Pharmaceutical Technology

2023 started with a buzz around ChatGPT, and more generally around the immense potential that generative AI (GenAI) holds.

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Removing snags in cell and gene therapy manufacturing processes with robotics

Pharmaceutical Technology

Deploying robots in pharmaceutical manufacturing will remove snags in cell and gene therapies and enable breakthroughs

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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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Personalised mRNA cancer vaccines: Moderna and Merck & Co versus BioNTech and Roche

Pharmaceutical Technology

While messenger ribonucleic acid (mRNA)-based cancer vaccines have been in development for decades, their development had languished.

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AstraZeneca buys Pfizer’s early gene therapy work for up to $1B

Bio Pharma Dive

The British pharma is deepening its investment in genetic medicine through a deal for a group of Pfizer’s gene therapy delivery tools, while the New York giant cuts back.

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NS Pharma scores breakthrough therapy status for DMD therapy

Pharmaceutical Technology

NS Pharma’s candidate would be the first to target Duchenne Muscular Dystrophy (DMD) patients amenable to exon 44 skipping therapy.

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Gene editing biotech Homology hits reset and seeks a sale

Bio Pharma Dive

The company will lay off 87% of its workforce and halt further research, including for a gene editing therapy to treat the rare disease PKU.

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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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Biogen to acquire rare disease drugmaker Reata for $7.3B

Bio Pharma Dive

The deal is a major bet by Biogen and its new CEO Chris Viehbacher, who’s reorganized R&D, cut costs and laid off staff since becoming company head last year.

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Moderna, Merck advance cancer vaccine into late-stage test

Bio Pharma Dive

The companies are enrolling people with melanoma in a Phase 3 trial aimed at testing whether the shot can prevent disease recurrence.

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Rx Machina: How AI is transforming pharma sales

Pharmaceutical Technology

Pharma sales have undergone a seismic transformation after Covid-19, with the adoption of artificial intelligence tools.

Sales 246
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Bavarian Nordic to scrap RSV vaccine after study setback

Bio Pharma Dive

The shot failed to meet a key goal of Bavarian Nordic’s Phase 3 study, a finding that separates it from marketed vaccines developed by Pfizer and GSK.

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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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Hunting Host Cell Proteins (HCPs) with mass spectrometry

Bio Pharma Dive

Regulators are recognizing mass spectrometry as a powerful tool in Host Cell Protein analysis. Are you ready to implement HCP-MS?

Protein 246
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Cell and gene therapy is coming of age

Bio Pharma Dive

Outsourcing in the cell and gene therapy industry is booming and no longer considered just a “trend.

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Gilead drug acquired in $5B buyout fails key blood cancer trial

Bio Pharma Dive

Treatment with magrolimab proved ineffective in a Phase 3 study in myelodysplastic syndrome, adding to doubts about so-called CD47 inhibitors as well as Gilead’s deal strategy.

Trials 246
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Boehringer, Lilly secure EC approval for Jardiance to treat adults with CKD

Pharmaceutical Technology

Boehringer Ingelheim and Eli Lilly have secured approval from the EC for Jardiance to treat adults with chronic kidney disease (CKD).

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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