Fri.Nov 22, 2024

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BridgeBio heart drug approved by FDA, setting up battle with Pfizer

Bio Pharma Dive

The approval of Attruby for transthyretin amyloidosis with cardiomyopathy begins a battle for control of a lucrative market that investors have been skeptical BridgeBio can win.

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Magazine: Pharma’s green shift with dry powder inhalers

Pharmaceutical Technology

Several pharmaceutical companies are advancing dry powder inhalers (DPIs) for respiratory conditions in an effort to cut down on greenhouse emissions and create a solution that is more eco-friendly than traditional pressurised metered-dose inhalers (pMDIs).

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Halozyme drops Evotec buyout bid; Patient dies in Neurogene trial

Bio Pharma Dive

Evotec appears to have rebuffed Halozyme’s $2.1 billion acquisition attempt. Elsewhere, Argenx has another blockbuster target in sight and an FDA veteran plans retirement.

Trials 143
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Novartis acquires Kate Therapeutics to advance gene therapies

Pharmaceutical Technology

Novartis has announced the acquisition of Kate Therapeutics to enhance its portfolio of gene therapies for inherited neuromuscular diseases.

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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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Johns Hopkins surgeon Makary is Trump’s pick to lead FDA

Bio Pharma Dive

A prolific medical research and author, Martin Makary criticized the FDA and CDC for their decision-making during the pandemic, although he describes himself as pro-vaccine.

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Enveda raises $130m to advance AI-driven plant based drug development

Pharmaceutical Technology

The biotech uses its AI platform to discover the therapeutic potential of plant-based molecules, advancing ten candidates with the funds.

More Trending

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Health Canada issues NOC to J&J’s CARVYKTI for multiple myeloma

Pharmaceutical Technology

Health Canada has issued a Notice of Compliance (NOC) for Johnson & Johnson’s (J&J) CARVYKTI for multiple myeloma treatment.

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Will Walgreens’ store closures disrupt its clinical trial aims?

Bio Pharma Dive

Despite plans to shutter 1,200 stores, the company’s chief clinical trials officer said the pharmacy giant remains committed to aiding drug research.

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J&J eyes FDA approval for injection-based Tremfya in ulcerative colitis

Pharmaceutical Technology

Johnson & Johnson Innovation Medicine has submitted a request to the FDA to approve Tremfya as a treatment for ulcerative colitis.

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Grand Rounds November 15, 2024: Pragmatic Randomized Trial of Smartphone-Based Nudges to Reduce Distracted Driving Among US Auto Insurance Customers (M. Kit Delgado, MD, MS)

Rethinking Clinical Trials

                         Speaker M. Kit Delgado, MD, MS Associate Professor of Emergency Medicine and Epidemiology Faculty Director, Penn Medicine Nudge Unit Slides Keywords Distracted Driving; Auto Insurance; Smartphones Key Points Distracted driving leads to over 800,000 crashes, over 400,000 injuries, and over 3,000 deaths per year.

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

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UK point-of-care production of cell therapies could arrive in 2025

Pharmaceutical Technology

The UK’s proposed regulations would provide the legal framework for POC manufacturing of cell therapies, including quality assurance.

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Global study shows depressive disorders not getting adequate treatment

Medical Xpress

A University of Queensland-led team analyzed data for 204 countries and territories, to assess global access to adequate mental health care. The study involved researchers from the University of Washington, the World Health Organization and Harvard University and was published in The Lancet Psychiatry.

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Amneal files again for FDA approval of first dihydroergotamine autoinjector

Pharmaceutical Technology

Amneal Pharmaceuticals has submitted another NDA for its DHE prefilled syringe autoinjector to treat tough-to-treat headaches.

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Cardiology collaboration advances machine learning predictions for AFib after stroke

Medical Xpress

Researchers at Penn State are using machine learning and existing electrocardiogram (ECG) data to help doctors make more accurate predictions. A team of artificial intelligence engineers, in collaboration with a team of physicians from Penn State Heart and Vascular Institute, is working to develop novel algorithms for point-of-care, in-house use and for technology licensing.

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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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“No magic wand” for Novo Nordisk, as CagriSema pen supply rumours swirl

Pharmaceutical Technology

Novo Nordisk and Ypsomed’s 2023 deal is rumoured to include an autoinjector supply for potential Wegovy successor CagriSema.

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Printable organic X-ray sensors may transform treatment for cancer patients

Medical Xpress

An international research team, led by the University of Wollongong (UOW), has found wearable organic X-ray sensors could offer safer radiotherapy protocols for cancer patients.

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Zai Lab and Pfizer to commercialise XACDURO in China

Pharmaceutical Technology

Zai Lab and Pfizer have entered a strategic collaboration for the commercialisation of XACDURO in mainland China.

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Social context tunes visual perception in fruit flies: Three neural circuit mechanisms linked to vision changes

Medical Xpress

Howard Hughes Medical Institute-led research has uncovered three neural circuit mechanisms that enable female fruit flies to modify their visual processing during aggressive interactions.

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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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Europe’s TCR immunotherapy licensing deals surge 123% above US in 2024

Pharmaceutical Technology

TCR immunotherapy is emerging as a promising, targeted approach for treating solid tumours and other indications.

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Researchers link snoring to behavioral problems in adolescents without declines in cognition

Medical Xpress

Adolescents who snore frequently were more likely to exhibit behavior problems such as inattention, rule-breaking, and aggression, but they do not have any decline in their cognitive abilities, according to a new study conducted by researchers at the University of Maryland School of Medicine (UMSOM).

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As other Big Pharmas face local headwinds, Pfizer doubles down on China commitment with Zai Lab antimicrobial marketing pact

Fierce Pharma

As other Big Pharmas face local headwinds, Pfizer doubles down on China commitment with Zai Lab antimicrobial marketing pact fkansteiner Fri, 11/22/2024 - 09:04

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Using principles from pest management, researchers aim to extend survival rate, quality of life for cancer patients

Medical Xpress

Just as crop-devouring insects evolve to resist pesticides, cancer cells can increase their lethality by developing resistance to treatment. In fact, most deaths from cancer are caused by the evolution of therapeutic resistance.

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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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Jazz gets first FDA nod for HER2 bispecific Ziihera

pharmaphorum

Jazz Pharma has claimed FDA approval for its HER2-directed bispecific antibody Ziihera as a treatment for biliary tract cancer

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Animal characters can boost young children's psychological development, study suggests

Medical Xpress

Children's books are full of animal characters whose antics capture the hearts and inspire the imaginations of their young readers.

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Neurogene drops high-dose arm in Rett study after death

pharmaphorum

The patient affected by a serious adverse event in Neurogene's clinical trial of Rett syndrome gene therapy has now died

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Scientists identify key mechanism in development of skin cancer

Medical Xpress

LMU researchers have discovered how the interplay between a key protein and an endolysosomal ion channel promotes tumor development in skin cancer.

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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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Obicetrapib-Ezetimibe Combo Cuts LDL-C in TANDEM Trial

XTalks

NewAmsterdam Pharma announced promising results from its Phase III TANDEM clinical trial, evaluating a fixed-dose combination of obicetrapib and ezetimibe. This therapy targets patients with high cardiovascular risk due to atherosclerotic cardiovascular disease (ASCVD), ASCVD risk factors or heterozygous familial hypercholesterolemia (HeFH). In the news release , John Kastelein, chief scientific officer of NewAmsterdam Pharma, said millions of people struggle to meet low-density lipoprotein chol

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Clinical trial: Monoclonal antibody may be an effective alternative to cisplatin in treatment of head and neck cancers

Medical Xpress

Head and neck cancers are the seventh most common type of cancer worldwide, according to the 2020 World Cancer Report. Smokers and drinkers, as well as those with HPV infections, are disproportionately affected.

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As J&J tries to wrap up talc litigation in the US, the company now faces class action in UK

Fierce Pharma

While Johnson & Johnson hopes to soon resolve more than 60,000 talc lawsuits with an $8 billion bankruptcy settlement in the United States, its baby power problems are only just beginning in th | While Johnson & Johnson hopes to soon resolve more than 60,000 talc lawsuits with an $8 billion bankruptcy settlement in the United States, its baby power problems are only just beginning in the U.K.

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Woman receives world's first robotic double-lung transplant

Medical Xpress

A 57-year-old woman with COPD has received the world's first fully robotic double lung transplant.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time