Wed.Oct 16, 2024

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Rising Pharmaceutical Costs: A Major Challenge for Managed Healthcare

Drug Patent Watch

One issue continues to loom large in healthcare: the skyrocketing costs of pharmaceuticals. This challenge has become a significant hurdle for managed healthcare organizations, patients, and policymakers alike.

Drugs 110
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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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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 242
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FDA puts Novavax flu vaccine trials on hold

Bio Pharma Dive

The hold, which was made in response to a serious adverse event report, could impact the company’s plans to start a Phase 3 trial of a combination shot for COVID-19 and influenza.

Trials 286
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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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Remote monitoring: Upgrading chronic care and addiction management in Scotland

Pharmaceutical Technology

A new generation of remote monitoring devices in Scotland is helping to reduce the burden on healthcare systems and improve patient care.

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GSK claims Moderna infringed mRNA vaccine patents

Bio Pharma Dive

The pharma’s lawsuit focuses on scientific work that helped clear the path for creating mRNA vaccines to fight the COVID-19 pandemic.

Vaccine 278

More Trending

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Novocure wins FDA approval for electric field device in lung cancer

Bio Pharma Dive

Alongside immunotherapy or chemo, the wearable device helped patients live longer in a trial, though the results are somewhat controversial.

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Eli Lilly will ‘build new way of doing science’ in UK amid £297m pledge to government

Pharmaceutical Technology

Lilly’s senior VP of information and R&D IT Ramesh Durvasula said Lilly will use AI and tech to transform the company.

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October 16, 2024: Testing of Behavior Change Interventions, in This Week’s PCT Grand Rounds

Rethinking Clinical Trials

Dr. Alexander Fanaroff In this Friday’s PCT Grand Rounds, Alexander Fanaroff of the University of Pennsylvania will present “Rigorous Testing of Behavior Change Interventions: Lessons From the BE ACTIVE Randomized Clinical Trial.” The Grand Rounds session will be held on Friday, October 18, 2024, at 1:00 pm eastern. Fanaroff is an assistant professor of medicine at the University of Pennsylvania.

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bit.bio defends European patent for ‘novel’ opti-ox technology

Pharmaceutical Technology

bit.bio’s method for pluripotent stem cell (PSC) programming, opti-ox, was deemed sufficiently novel and inventive.

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

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With Gilead coming fast, GSK bolsters case for long-acting HIV PrEP drug Apretude

Fierce Pharma

With Gilead sprinting to a likely approval next year for its long-acting pre-exposure | With GSK girding for competition from Gilead Sciences, the company has presented strong results from three real-world studies of its bi-monthly injection for HIV prevention.

Drugs 126
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Radiopharm and AtomVie partner on radioantibody development

Pharmaceutical Technology

Radiopharm Theranostics (RAD) and AtomVie have announced a partnership for the development and manufacturing of 177Lu-BetaBart.

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HBC Immunology shares promising results for prostate cancer co-therapy

Pharma Times

There are around 55,100 new prostate cancer cases in the UK every year

Hormones 125
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Synedgen partners with BARDA for MIIST305 development

Pharmaceutical Technology

Synedgen has announced a partnership with the Biomedical Advanced Research and Development Authority (BARDA) to develop MIIST305.

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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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Pfizer sticks $1.5bn on Triana's molecular glue tech

pharmaphorum

Pfizer partners with US biotech Triana Biomedicines in a deal focusing on molecular glue degraders that could be worth $1.

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FDA accepts UroGen’s UGN-102 NDA for bladder cancer treatment

Pharmaceutical Technology

UroGen Pharma has received the NDA acceptance from the US FDA for UGN-102 (mitomycin) to treat bladder cancer.

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NIH study backs Bavarian Nordic mpox jab for adolescents

pharmaphorum

NIH study finds Bavarian Nordic's mpox vaccine is effective in adolescents, a particularly vulnerable group amid the ongoing outbreak

Vaccine 116
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COPD market expected to grow to $30.8bn in the 7MM by 2033

Pharmaceutical Technology

The chronic obstructive pulmonary disease (COPD) market in the seven major markets (7MM: US, France, Germany, Italy, Spain, UK, and Japan) is set to grow from sales of $11.5bn in 2023 to $30.8bn in 2033.

Marketing 130
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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Decentralized Clinical Trials Back in the Spotlight Thanks to New FDA Guidance

ACRP blog

Just when it seemed as if decentralized clinical trials (DCTs) were in danger of becoming “yesterday’s news” in light of all the attention being paid lately to applications of artificial intelligence in the clinical research enterprise, the tables have turned, if perhaps only briefly, thanks to the release of finalized new U.S. Food and Drug Administration (FDA) regulatory guidance on DCTs.

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Exelixis stock rises as key drug Cabometyx withstands patent challenge

Fierce Pharma

A federal judge in Delaware has ruled in favor of Exelixis in its Cabometyx patent fight with MSN Laboratories, effectively pushing the earliest generic entry out to 2030. | A federal judge in Delaware has ruled in favor of Exelixis in its Cabometyx patent fight with MSN Laboratories, effectively pushing the earliest generic entry out to 2030.

Drugs 116
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Analyzing the impact of biosimilars on biologic drug development pipelines

Drug Patent Watch

Biosimilars, which are biologic drugs that are highly similar to an already approved biologic drug, are transforming the pharmaceutical industry. As patents for original biologic drugs expire, biosimilars are becoming increasingly important, offering more affordable treatment options for patients and healthcare systems.

Drugs 115
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Access to genomic surveillance: Open science and public health

pharmaphorum

The pandemic served as a catalyst for a revolution in genomic surveillance for tracking pathogens. The technology proved vital in aiding understanding of the evolution of and spread of virus in real time to inform public health measures, ultimately accelerating drug and vaccine development.

Genome 115
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The New Age of Decentralized Clinical Trials

This new white paper defines and details the impact of Decentralized Clinical Trials on the Pharmaceutical industry and how the impact can be measured along with steps companies can take to ensure adoption.

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CDMO SpectronRx homes in on completion of European plant to crank out key isotope for radiotherapies

Fierce Pharma

While radiopharmaceuticals have attracted significant interest in recent years thanks to their cancer-fighting prowess, the unique makeup of the meds has presented a host of production challenges f | SpectronRx has inked an agreement to complete its first European radiolabeling plant at the Belgian Nuclear Research Center in Mol, Belgium. The facility will initially focus on the labeling of Actinium-225-based radiopharmaceuticals.

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Hympavzi (Marstacimab): FDA Approves First Once-Weekly and Pfizer’s Second Hemophilia Therapy

XTalks

Pfizer’s Hympavzi (marstacimab-hncq) has received approval from the US Food and Drug Administration (FDA) for treating hemophilia A or B in adults and adolescents aged 12 and older with factor VIII deficiency (hemophilia A) or factor IX deficiency (hemophilia B), who do not have inhibitors to these factors. Hympavzi is the first anti-tissue factor pathway inhibitor (anti-TFPI) approved in the US for hemophilia A or B, and it’s also the first hemophilia therapy to be administered via a pre-

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Scilex Holding looks to separate Scilex Pharma through potential spinout, IPO

Fierce Pharma

Scilex Pharma may soon flee the nest after its parent company Scilex Holding’s board of directors granted permission to explore routes to maximize the company’s value. | Scilex Pharma may soon flee the nest after its parent company Scilex Holding’s board of directors granted permission to explore alternative routes for the drugmaker.

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Strategies for commercialising oncology treatments for young adults

pharmaphorum

Discover effective strategies for commercialising oncology treatments for young adults with cancer, and learn how these targeted approaches can improve patient outcomes and access to innovative therapies.

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Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research

Planning on running clinical trials in Japan? How can you reliably supply these studies? Discover Catalent’s clinical supply packaging facility in Shiga, Japan. Strategically located between Tokyo and Osaka, and one of largest in Japan, this 6,000 square meter facility offers comprehensive services including primary and secondary clinical packaging and labelling, comparator sourcing, cold chain storage, local and global distribution, local language support and white glove service to support stud

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Innovative Approaches to Antiviral Drug Development

XTalks

In this episode, Vera spoke with Dr. Sam Lee, Co-Chief Executive Officer and President of Cocrystal Pharma, a clinical-stage biotech company focusing on antiviral drug development with a unique structure-based drug discovery platform. With over 25 years of experience in anti-infective drug discovery, Dr. Lee brings a wealth of knowledge to the discussion on the urgent need for innovative antiviral therapies.

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FDA set to decide on GSK's gepotidacin antibiotic in March

pharmaphorum

The FDA starts priority review of GSK's gepotidacin, vying to become the first new-class antibiotic for uncomplicated urinary tract infections in over 20 years

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Maximizing the Power of Central IRBs Prior to the FDA’s sIRB Mandate

WCG Clinical

Get ahead of the impending single Institutional Review Board (sIRB) mandate and optimize your clinical trials by tuning into this recorded webinar. The Food and Drug Administration’s (FDA’s) impending sIRB mandate will streamline processes by requiring multi-site studies to partner with one IRB reviewer. While the date is not set on when this mandate will go into effect, it is crucial to prepare your studies and processes now.

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Head and neck cancer trials 'becoming less diverse'

pharmaphorum

Despite efforts to raise diversity in clinical trials, a study in head and neck cancer found the trend in the US is going in the other direction.

Trials 85
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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.