October, 2024

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GSK takes mRNA patent fight to Moderna, suing over vaccines for COVID and RSV

Fierce Pharma

Nearly six months after lodging a similar complaint against Pfizer and BioNTech over the partners’ COVID shot Comirnaty, GSK is targeting Moderna in a pair of lawsuits alleging the Massachusetts-ba | GSK is targeting Moderna in a pair of lawsuits claiming the mRNA specialist violated multiple patents with its vaccines Spikevax and mRESVIA. In the complaints, GSK says it hopes to recover a “reasonable royalty” tied to Moderna’s vaccine sales, plus damages.

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RNA editing: emerging from CRISPR’s shadow

Bio Pharma Dive

Early study data from Wave Life Sciences suggests how editing RNA may yield viable medicines. Large and small drugmakers say such results are just the start.

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Pharma companies must adapt to keep pace with AI developments, say experts

Pharmaceutical Technology

At the Outsourcing in Clinical Trials Conference, key opinion leaders shared predictions for workflow changes due to AI.

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Lilly touts new Kisunla regimen that reduces side effects

pharmaphorum

Eli Lilly says a new starting dose regimen for its Alzheimer's disease therapy Kisunla reduces the risk of side effects that have stood in the way of approvals and reimbursement decisions for drugs in its class.Simply shifting one vial of the anti-amyloid antibody from the first infusion to the third infusion of the titration phase of dosing – the period used to achieve therapeutic levels in the body – is enough to lower the incidence of a potentially serious side effect known as ARIA-E, accordi

Antibody 106
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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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AAO 2024: Nanoscope Therapeutics’ MCO-010 RESTOREs vision in RP patients

Pharmaceutical Technology

This trial investigated the potential of Nanoscope Therapeutics' MCO-010 to restore vision in patients with retinitis pigmentosa (RP).

Trials 246
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Imitation Ozempic Is Flooding The Market: Here’s What You Need to Know

AuroBlog - Aurous Healthcare Clinical Trials blog

(Abdullah Durmaz/Getty Images) In just a few years, brand-name injectable drugs such as Ozempic, Wegovy, Mounjaro and Zepbound have rocketed to fame as billion-dollar annual sellers for weight loss as well as to control blood sugar levels and reduce the risk of heart disease.

Marketing 203

More Trending

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Wave sees RNA editing validation in early trial results

Bio Pharma Dive

The results provide the first clinical evidence of RNA editing, a burgeoning field that's drawn interest from biotechs and pharmaceutical companies alike.

RNA 358
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October 3, 2024: JAMA Commentary Highlights Gap Between Research Results and Implementation Decisions

Rethinking Clinical Trials

In a JAMA Viewpoint published online this week, leaders from the NIH Pragmatic Trials Collaboratory discuss the discordance between the results of pragmatic clinical trials and the implementation of those results in healthcare settings, even in settings that championed the work. Coauthors Richard Platt, Hayden Bosworth, and Gregory Simon posit that, to provide evidence that healthcare systems leaders will actually use, changes are necessary: Trials need to be faster (2 to 3 years) Trials should

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Insilico Medicine reports positive results for idiopathic pulmonary fibrosis therapy

Pharma Times

ISM001-055 shows promise in improving lung function among patients

Medicine 155
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NUHS’s CD7 CAR-T cell therapy shows promise for leukaemia

Pharmaceutical Technology

The CD7 CAR)-T cell therapy has demonstrated potential in treating patients with relapsed or refractory T-cell leukaemia.

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

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Does Stress Really Turn Your Hair Gray?

AuroBlog - Aurous Healthcare Clinical Trials blog

(juanma hache/Getty Images) When we start to go gray depends a lot on genetics. Your first gray hairs usually appear anywhere between your twenties and fifties. For men, gray hairs normally start at the temples and sideburns. Women tend to start graying on the hairline, especially at the front.

Genetics 199
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Innovation in Autoimmune and Bone Health Research: Driving Progress for Better Patient Outcomes

Worldwide Clinical Trials

Autoimmune diseases and bone health conditions are not just medical challenges – they’re personal battles that millions of people fight every day. From the unpredictability of lupus flare-ups to the silent progression of osteoporosis, patients face daily struggles that can significantly impact their quality of life. Fortunately, advances in clinical research are providing hope for better treatments and outcomes.

Research 147
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An Alzheimer’s drugmaker is accused of data manipulation. Should its trials be stopped?

Bio Pharma Dive

An experimental Alzheimer’s therapy from Cassava Sciences is still being tested in two Phase 3 studies, even as the company has come under regulatory scrutiny.

Trials 360
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October 9, 2024: In This Week’s PCT Grand Rounds, Early Diagnosis and Treatment of COPD

Rethinking Clinical Trials

Dr. Shawn Aaron In this Friday’s PCT Grand Rounds, Shawn Aaron of the University of Ottawa will present “Early Diagnosis and Treatment of Asthma and COPD.” The Grand Rounds session will be held on Friday, October 11, 2024, at 1:00 pm eastern. Aaron is a professor of medicine at the University of Ottawa and the director of the Canadian Respiratory Research Network.

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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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NICE recommendation for new Alexion PNH treatment

Pharma Times

danicopan shown to improve haemoglobin levels and reduce anaemia

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mRNA licensing agreements surge 800% amid GSK lawsuits

Pharmaceutical Technology

An 800% increase in licensing deal values indicates growing confidence in mRNA technology, but some vaccine producers are facing lawsuits.

Licensing 278
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Long COVID Fatigue Shows Up as Distinct Changes in Brain Scans

AuroBlog - Aurous Healthcare Clinical Trials blog

(Roxana Wegner/Getty Images) Fatigue is one of the most frequent and debilitating symptoms of long COVID, and yet it is also one of the hardest to measure objectively. A new study suggests the extreme mental and physical fatigue experienced by many long COVID patients is, in fact, observable in the central nervous system.

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Innovating in Autoimmune and Bone Health Research: Driving Progress for Better Patient Outcomes

Worldwide Clinical Trials

Autoimmune diseases and bone health conditions are not just medical challenges – they’re personal battles that millions of people fight every day. From the unpredictability of lupus flare-ups to the silent progression of osteoporosis, patients face daily struggles that can significantly impact their quality of life. Fortunately, advances in clinical research are providing hope for better treatments and outcomes.

Research 130
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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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After rejections, AbbVie secures approval for Parkinson’s drug

Bio Pharma Dive

Vyalev’s clearance is the second victory for AbbVie in Parkinson’s this year, following an April readout for a drug acquired through its Cerevel buyout.

Drugs 329
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October 2, 2024: In This Week’s PCT Grand Rounds, a Novel Health System–Public Health Partnership

Rethinking Clinical Trials

In this Friday’s PCT Grand Rounds, Tyler Winkelman of Hennepin Healthcare and the Hennepin Healthcare Research Institute, and David Johnson of Hennepin County, will present “Health Trends Across Communities – A Novel Health System-Public Health Data Partnership.” The Grand Rounds session will be held on Friday, October 4, 2024, at 1:00 pm eastern.

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WHO report highlights resurgence of tuberculosis

Pharma Times

Approximately 8.

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Cell and gene therapy approvals drive paradigm change in manufacturing

Pharmaceutical Technology

Trends in gene therapy approvals in recent years are rapidly shaping the future of manufacturing capabilities in the pharmaceutical industry.

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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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Will Water Save You From a Hangover? Science Says Probably Not.

AuroBlog - Aurous Healthcare Clinical Trials blog

(Bambu Productions/DigitalVision/Getty Images) Of all the advice on preventing hangovers, drinking water to prevent dehydration seems like the most sensible. A new study has found no evidence to support claims that drinking a generous amount of water after a night of boozing alleviates the pain the next day.

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Novartis, Apellis drop dueling datasets as they race for approval in rare form of kidney disease

Fierce Pharma

Novartis and Apellis Pharmaceuticals have rolled out detailed data on iptacopan and pegcetacoplan, respectively, as they race for the prize in a type of rare kidney disease. | Novartis and Apellis dropped new data on their respective meds, iptacopan and pegcetacoplan, in the rare kidney disease C3 glomerulopathy. While Apellis' drug seems to have an efficacy edge based on a cross-trial comparison, Novartis may have gotten the jump by filing for approvals ahead of its competitor.

Trials 129
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Roche weighs whether speedy approval path is open for latest Alzheimer’s drug

Bio Pharma Dive

In an investor presentation, executives hinted at the possibility of seeking an accelerated approval of trontinemab if it can significantly lower levels of amyloid in a Phase 3 trial.

Drugs 304
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October 22, 2024: Registration Opens for Pragmatic Trials Workshop at AcademyHealth–NIH Dissemination & Implementation Conference

Rethinking Clinical Trials

The NIH Pragmatic Trials Collaboratory will offer a full-day workshop at the 17th Annual Conference on the Science of Dissemination and Implementation in Health in Arlington, Virginia. The workshop, “Dissemination & Implementation in Embedded Pragmatic Trials: Getting the Timing Right in Real-World Research,” will introduce concepts in the design, conduct, and implementation of pragmatic clinical trials embedded in healthcare systems, with a particular focus on methods relevant t

Trials 162
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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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IRLAB’s new drug shows promise in treating apathy in Parkinson’s patients

Pharma Times

Phase 1 trial of IRL757 demonstrates good absorption and safety profile

Drugs 143
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Exscientia outline robot and AI use in drug discovery workflow

Pharmaceutical Technology

Exscientia detailed how its robotics lab in Oxfordshire, UK is increasing productivity and efficiency in developing new molecules at ELRIG 2024.

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Your Smartphone Could Soon Measure Your Blood Pressure With Just a Touch

AuroBlog - Aurous Healthcare Clinical Trials blog

(akaratwimages/Canva) High blood pressure (or hypertension) increases the risk of health problems such as heart or kidney failure, but goes undiagnosed in millions of people.

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Big Pharma's layoff wave in New Jersey rolls on with hundreds of J&J cuts, 57 at Bayer

Fierce Pharma

Johnson & Johnson is laying off 231 employees in New Jersey and Bayer is cutting 57 positions in the state, according to separate Worker Adjustment and Retraining Notification (WARN)

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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