June, 2024

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AI Enables Individualized Cancer Vaccines

BioSpace

The use of artificial intelligence in the development of cancer vaccines allows for individualized therapy, but the prospect of an ever-changing product poses new challenges for drug developers and regulators.

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These microscopic tunnels are a goldmine for new medicines

Bio Pharma Dive

A growing cohort of biotechs, from Biohaven to Neurocrine to Jazz, hope research on ion channels will bring them new drugs and big business — much like it has done for Vertex.

Medicine 344
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Novavax seeks FDA approval for updated Covid-19 vaccine

Pharmaceutical Technology

Novavax has sought US FDA approval for an updated JN.1 version of its Covid-19 vaccine, NVX-CoV2705, for individuals aged 12 years and above.

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Watch out, GSK. Gilead’s twice-yearly PrEP drug shows 100% efficacy for HIV prevention

Fierce Pharma

For the first time, an HIV PrEP drug candidate has shown zero infections in a phase 3 trial. | For the first time, an HIV PrEP drug candidate has shown zero infections in a phase 3 trial. For Gilead, it serves as one of two pieces for a potential FDA filing. For GSK, it means a major competitor could be looming around the corner.

Drugs 144
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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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Daiichi’s lung cancer ADC rejected by FDA in blow to first project under Merck partnership

Fierce Pharma

In the second setback for the HER3 field in days, the FDA has rejected Daiichi Sankyo’s Merck & Co.-partnered antibody drug conjugate (ADC) patritumab deruxtecan. | In the second setback for the HER3 field in days, the FDA has rejected Daiichi Sankyo’s Merck & Co.-partnered antibody drug conjugate patritumab deruxtecan.

Antibody 135
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There’s a Strange Link Between Depression And Body Temperature, Study Finds

AuroBlog - Aurous Healthcare Clinical Trials blog

(VioletaStoimenova/Getty Images) To better treat and prevent depression, we need to understand more about the brains and bodies in which it occurs. Curiously, a handful of studies have identified links between depressive symptoms and body temperature, yet their small sample sizes have left too much room for doubt.

More Trending

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New data showcase promise, growing pains of CAR-T in autoimmune disease

Bio Pharma Dive

One expert described trial results presented at EULAR last week as “unprecedented.” But reports of relapses in some patients drew questions about the therapies’ ultimate potential.

Trials 349
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Novavax seeks EMA approval for updated JN.1 Covid-19 vaccine

Pharmaceutical Technology

Novavax has sought EMA approval for its updated JN.1 Covid-19 vaccine, NVX-CoV2705, for people aged 12 years and above.

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June 17, 2024: This Week’s PCT Grand Rounds to Feature Trial of Electronic Cigarettes for Smoking Cessation

Rethinking Clinical Trials

Dr. Reto Auer In this Friday’s PCT Grand Rounds, Reto Auer of the University of Bern will present “Efficacy and Safety of Electronic Cigarettes for Smoking Cessation: Keeping a Trial on a Polarizing Topic Running Under Regulatory and Epidemic Changes.” The Grand Rounds session will be held on Friday, June 21, 2024, at 1:00 pm eastern.

Trials 173
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New study reveals how brain cell communication is linked to Alzheimer’s disease

Pharma Times

Two support cells, microglia and astrocytes, were found to communicate with each other

Research 150
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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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The Blood of Exceptionally Long-Lived People Reveals Crucial Differences

AuroBlog - Aurous Healthcare Clinical Trials blog

(Bloomberg Creative/Getty Images) Centenarians, once considered rare, have become commonplace. Indeed, they are the fastest-growing demographic group of the world’s population, with numbers roughly doubling every ten years since the 1970s. [link] How long humans can live, and what determines a long and healthy life, have been of interest for as long as we know.

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Exploring the Future of Oncology with ADCs and TILs: Key Insights From ASCO  

Worldwide Clinical Trials

The 2024 ASCO Annual Meeting from the American Society of Clinical Oncology is a fantastic platform for clinical researchers to discuss the latest advancements and challenges in oncology research. Worldwide Clinical Trials attends each year to hear from the research community, connect with our sponsors and sites, and explore potential partnerships to drive forward novel treatments.

Antibody 162
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Duchenne approval exposes FDA rift over Sarepta gene therapy

Bio Pharma Dive

Peter Marks’ decision to override the objections of agency staff and broaden use of Elevidys could have a “lasting impact” on gene therapy as well as the FDA, one analyst wrote.

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AstraZeneca’s Tagrisso receives approval in Japan for lung cancer

Pharmaceutical Technology

AstraZeneca has received Japanese approval for Tagrisso plus chemotherapy as first-line treatment for non-small cell lung cancer (NSCLC).

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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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June 5, 2024: This Week’s PCT Grand Rounds to Feature PCORnet-Based COVID-19 and Diabetes Assessment (CODA) Study

Rethinking Clinical Trials

Dr. Russell Rothman and Dr. Jason Block In this Friday’s PCT Grand Rounds, Russell Rothman of Vanderbilt University Medical Center and Jason Block of Harvard Medical School will present “The NIH COvid-19 and Diabetes Assessment (CODA) Study: Leveraging PCORnet for a Novel Cohort Study.” The Grand Rounds session will be held on Friday, June 7, 2024, at 1:00 pm eastern.

Medicine 173
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New paediatric blood test to prevent sudden death from hereditary heart condition

Pharma Times

Hypertrophic cardiomyopathy is a rare condition that affects up to 1,000 children in the UK

Research 148
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Scientists Pinpoint Where Extreme Moods of Bipolar Disorder Exist in Brain

AuroBlog - Aurous Healthcare Clinical Trials blog

Moods and emotions play an important role in our day-to-day life. They even influence how we experience things – for instance, whether we start the day feeling hopeful and energised or grumpy and lethargic. This can affect whether we interpret events in a positive or negative light.

Scientist 203
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Kansas AG accuses Pfizer of misrepresenting COVID vaccine, hiding safety risks in lawsuit

Fierce Pharma

Kansas Attorney General is accusing Pfizer of "misrepresenting" its vaccine's safety and efficacy in a 179-page civil suit.

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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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In review of Lilly Alzheimer’s drug, FDA staff focus on safety, patient selection

Bio Pharma Dive

The agency is seeking input from an advisory panel on whether donanemab is effective across different groups of Alzheimer's patients, and on an unusual dosing strategy used by Lilly.

Drugs 334
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Johnson & Johnson submits BLA to FDA for lung cancer drug

Pharmaceutical Technology

Johnson & Johnson has filed a BLA with the US FDA seeking approval for SC amivantamab for the treatment of non-small cell lung cancer.

Drugs 283
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June 13, 2024: Burgess to Present Results of LAMP Trial, Precursor of NIH Collaboratory’s RAMP Trial

Rethinking Clinical Trials

Dr. Diana Burgess Diana Burgess, a co–principal investigator of the NIH Pragmatic Trials Collaboratory’s RAMP trial, will present the results of the precursor LAMP trial as part of the Veterans Affairs (VA) Health Systems Research Cyberseminars series. The Learning to Apply Mindfulness to Pain (LAMP) trial is a multisite pragmatic clinical trial that compared 2 approaches for delivering mindfulness-based interventions via telehealth for veterans with chronic pain.

Trials 162
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US study suggests BMS’ cancer drug could target Parkinson’s-causing protein

Pharma Times

The progressive neurodegenerative condition affects more than ten million people worldwide

Protein 144
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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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Your Body’s Internal Clock May Boost Cancer Treatments, Scientists Say

AuroBlog - Aurous Healthcare Clinical Trials blog

(Peter Dazeley/The Image Bank/Getty Images) Our body’s circadian clock affects everything from sleepiness to metabolism – and it might also influence how effective certain cancer treatments are, according to recent research.

Scientist 198
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After 33 years, Geron finally crosses FDA finish line with blood cancer med Rytelo

Fierce Pharma

Once hailed as an anti-aging magic bullet, telomerase has failed to live up to the hype as it was profiled in a | The FDA has approved Geron Corporation's Rytelo (imetelstat) to treat a group of bone marrow disorders called myelodysplastic syndrome (MDS). The approval is the first for the 33-year-old California biotech.

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After ‘sobering’ FDA panel, psychedelics supporters wonder what’s next

Bio Pharma Dive

A vote against MDMA-assisted therapy set back a high-profile treatment. Proponents argue the panel offered few solutions to longstanding problems, making the path forward unclear.

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NIH AI tool predicts cancer patients’ immunotherapy outcomes

Pharmaceutical Technology

Scientists at the NIH have introduced an AI tool to predict the response to immune checkpoint inhibitors for cancer patients.

Scientist 281
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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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June 18, 2024: NIH Pragmatic Trials Collaboratory to Hold Virtual Workshop July 15-16 Featuring NIH Director as Keynote

Rethinking Clinical Trials

The NIH Pragmatic Trials Collaboratory will hold a virtual workshop July 15-16, 2024, on “Going From Zero to 100: Generating Evidence Through Pragmatic Research to Address Pressing Healthcare Issues.” Dr. Monica Bertagnolli, director of the NIH, will deliver the keynote presentation exploring how to identify high-priority healthcare issues that require the effort, time, and funding of a trial.

Trials 150
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Leuko device to remotely monitor cancer patients during chemotherapy

Pharma Times

Cancer was estimated to be responsible for more than 18 million cases worldwide in 2020

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This Rare Gene Variant Seems to Protect You From Alzheimer’s Disease

AuroBlog - Aurous Healthcare Clinical Trials blog

A woman in Colombia with rare genetic resistance to Alzheimer’s disease may have more company than scientists thought.

Gene 196
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Europe taps CSL Seqirus to produce bird flu vaccines for pandemic preparedness efforts

Fierce Pharma

Right after signing on to help with bird flu pandemic preparedness efforts in the U.S., CSL Seqirus has agreed to do the same in Europe through a vaccine supply pact. | The vaccine maker will deliver 665,000 doses of its avian flu-matched pre-pandemic vaccine. Under a 4-year contract, authorities can purchase up to 40 million doses.

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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