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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Bridging Innovation & Patient Care: The Growing Role of AI

Speaker: Simran Kaur, Co-founder & CEO at Tattva Health Inc.

AI is transforming clinical trials—accelerating drug discovery, optimizing patient recruitment, and improving data analysis. But its impact goes far beyond research. As AI-driven innovation reshapes the clinical trial process, it’s also influencing broader healthcare trends, from personalized medicine to patient outcomes. Join this new webinar featuring Simran Kaur for an insightful discussion on what all of this means for the future of healthcare!

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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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Scientists Discover a New, Unexpected Way That Cancer Cells Spread

AuroBlog - Aurous Healthcare Clinical Trials blog

One of the challenges in treating cancer is stopping it from metastasizing, and a new study reveals one of the fundamental mechanisms through which this happens. Now we know about this mechanism, perhaps we can stop it. Key to this newly discovered process is GRP78, and it’s what’s known as a chaperone protein.

Scientist 246
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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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Teva reveals critical Ajovy data

Pharma Times

Therapy has been developed to reduce the frequency, duration and severity of migraine attacks - News - PharmaTimes

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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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Moderna mounts 2 new patent lawsuits against mRNA rivals Pfizer, BioNTech: report

Fierce Pharma

Caught in a litigation crossfire, Moderna has reportedly opened two new fronts in its COVID-19 vaccine patent war with Pfizer and BioNTech. | Moderna has lodged two new lawsuits at the High Court in Dublin, Ireland, and the Brussels Commercial Court in Belgium, Juve Patent first reported. This adds to a complex web of ongoing mRNA patent litigation.

Vaccine 134
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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 287
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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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This Drug Might Offer Hope For Those With Difficult-to-Treat Depression

AuroBlog - Aurous Healthcare Clinical Trials blog

Ketamine might be better known as a recreational drug or anesthetic. But there’s growing evidence for its use for people with hard-to-treat depression. An Australasian study out today [July 14] showed some positive results for people with treatment-resistant depression when they had ketamine injections.

Drugs 246
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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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July 27, 2023: NIH Collaboratory Hosts Onboarding Session for Newest Demonstration Projects

Rethinking Clinical Trials

Leaders of the NIH Pragmatic Trials Collaboratory hosted an onboarding meeting for the program’s 3 newest Demonstration Projects. The projects joined the program under the UG3 cooperative agreement mechanism to support a 1-year planning phase in preparation for potential transition to a UH3 implementation phase. Access the complete materials from the onboarding session.

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GSK’s Arexvy authorised by MHRA

Pharma Times

Therapy is the first respiratory syncytial virus vaccine specifically developed for older adults - News - PharmaTimes

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Novo Nordisk brings new round of lawsuits against compounded versions of Ozempic and Wegovy

Fierce Pharma

As demand skyrockets for GLP-1 drugs that can trigger significant weight loss, unauthorized versions of the treatments have started to fill pharmacies. | In late May, the FDA warned of illegal knockoffs of Novo Nordisk’s Ozempic and Wegovy. And now, the Danish company has filed its second wave of lawsuits against pharmacies in the U.S. that are producing the copycats.

Pharmacy 125
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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 287
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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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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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WHO Declares Aspartame Possibly Carcinogenic. Here’s What It Means For Your Diet Soda

AuroBlog - Aurous Healthcare Clinical Trials blog

The International Agency for Research on Cancer (IARC), which is the specialized cancer agency of the World Health Organization, has declared aspartame may be a possible carcinogenic hazard to humans.

Research 246
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July 26, 2023: In Friday’s PCT Grand Rounds, Carl Bergstrom to Share Tools to Fight Misinformation in Medicine

Rethinking Clinical Trials

Professor Carl Bergstrom In this Friday’s PCT Grand Rounds, Professor Carl Bergstrom of the University of Washington will present “How Can Researchers Fight Misinformation About Medicine?” The Grand Rounds session will be held on Friday, July 28, 2023, at 1:00 pm eastern. Bergstrom is a professor of biology at the University of Washington.

Medicine 130
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King’s College London and Pioneer Group in incubator link-up

Pharma Times

Collaboration aims to revitalise two empty sites on the South Bank of London by providing several laboratories - News - PharmaTimes

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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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Teva weighs sale of $2B API business as CEO Richard Francis embarks on 'Pivot to Growth' strategy: reports

Fierce Pharma

Less than two months into its "Pivot to Growth" strategy under a new CEO, Israeli-American generics giant Teva Pharmaceutical could be weighing a major shake-up of its key drug ingredients business | Teva is looking at strategic options for its active pharmaceutical ingredient unit, with a potential sale on the table, BNN Bloomberg and Benzinga have reported.

Sales 123
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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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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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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 246
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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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July 19, 2023: IMPACt-LBP Study Team Will Share Early Lessons in This Friday’s PCT Grand Rounds

Rethinking Clinical Trials

From left: Dr. Christine Goertz and Dr. Adam Goode of the IMPACt-LBP Demonstration Project In this Friday’s PCT Grand Rounds, Dr. Christine Goertz and Dr. Adam Goode of Duke University will present “Implementing New Care Pathways for Low Back Pain in Academic Healthcare Systems: Early Lessons From IMPACt-LBP.” The Grand Rounds session will be held on Friday, July 21, 2023, at 1:00 pm eastern.

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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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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.