Bio Pharma Dive
SEPTEMBER 23, 2024
The company’s technology, which enables it to target viral proteins in their “prefusion” shape and skip a manufacturing step, could lead to vaccines that are more potent and easier to produce, said CEO Emmanuel Hanon.
Pharmaceutical Technology
SEPTEMBER 19, 2024
An innovative approach to healthcare, precision medicine is a new medical model that takes into account individual differences in genes, environments, and lifestyles to drive better outcomes through medicine.
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Bio Pharma Dive
SEPTEMBER 20, 2024
The decision against Syfovre’s approval follows efforts by Apellis to have reviewers reevaluate clinical evidence multiple times and, according to an analyst, will lead to a restructuring of the company’s operations in Europe.
AuroBlog - Aurous Healthcare Clinical Trials blog
SEPTEMBER 16, 2024
(Francesco Carta Fotografo/Moment/Getty Images) Migraines and headaches affect billions of people worldwide, and a new study suggests the drug ubrogepant can put a stop to the pain even before a migraine has fully kicked in.
Rethinking Clinical Trials
SEPTEMBER 16, 2024
Researchers in Australia examined the feasibility of implementing an enhanced version of the TSOS collaborative care intervention for patients at risk of persistent posttraumatic stress disorder (PTSD) and pain symptoms after major traumatic injury. They found the intervention was highly valued by most participants and could be implemented at low cost in the trauma system in Victoria, Australia.
Fierce Pharma
SEPTEMBER 18, 2024
With its latest acquisition, women’s health outfit Organon is bringing its dermatology business to the U.S. with a potential blockbuster in tow. | Organon is set to acquire Roivant’s immuno-dermatology subsidiary Dermavant for up to $1.2 billion, the companies announced Wednesday. The crown jewel of the deal is undoubtedly Vtama, Dermavant’s steroid-free cream for plaque psoriasis, which is looking at a major expansion opportunity in eczema.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Pharmaceutical Technology
SEPTEMBER 16, 2024
While Lykos Therapeutics’ MDMA therapy was rejected by the FDA, psychedelic therapy advocates remain optimistic about the sector.
AuroBlog - Aurous Healthcare Clinical Trials blog
SEPTEMBER 18, 2024
(Niklas Hamann/Unsplash) Most of us will be all too familiar with that dopey, groggy feeling of being tired after a restless night. Some social media users have taken tiredness to the extreme, however, by taking part in what they call a “no-sleep challenge.
Rethinking Clinical Trials
SEPTEMBER 18, 2024
Dr. John Fortney In this Friday’s PCT Grand Rounds, John Fortney of the University of Washington will present “Similarities and Differences Between Pragmatic Trials and Hybrid Effectiveness-Implementation Trials.” The Grand Rounds session will be held on Friday, September 20, 2024, at 1:00 pm eastern. Fortney is a professor of psychiatry and behavioral sciences in the University of Washington School of Medicine and a senior research career scientist in the HSR Center of Innovat
Fierce Pharma
SEPTEMBER 20, 2024
The hits just keep on coming for Bristol Myers Squibb staffers amid the company's cost-savings program. | Bristol Myers Squibb is laying off an additional 79 staffers in Lawrenceville, New Jersey. The cuts will be effective between Dec. 12 and May 30 of next year and are part of BMS's $1.5 billion cost reduction program.
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White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations
Bio Pharma Dive
SEPTEMBER 17, 2024
The funding will support mid-stage testing of a drug the company believes to have the potential to treat a range of neurodegenerative conditions.
Pharmaceutical Technology
SEPTEMBER 20, 2024
The growth of AI in the healthcare sector is already having real-world impacts and promises a step-change in future care.
AuroBlog - Aurous Healthcare Clinical Trials blog
SEPTEMBER 22, 2024
(Richard Jones/Science Photo Library/Getty Images) Scientists have discovered hundreds of genes that could potentially promote cancer, new research shows. Cancer is typically triggered by some kind of change to our genetic coding that interferes with a cell’s ability to manage its growth.
Drug Discovery World
SEPTEMBER 20, 2024
A new multinational clinical trial will investigate whether a novel treatment can help slow the progression of chronic kidney disease (CKD). The EASi-KIDNEY trial will evaluate whether vicadrostat, also known as BI 690517, improves clinical outcomes when it is given in combination with existing treatments. The trial will run in 15-20 countries around the world, with around 11,000 people expected to participate.
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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.
Fierce Pharma
SEPTEMBER 19, 2024
From truckloads of torn documents to avian incursions in the production plant, Granules India’s recent manufacturing reprimand from the FDA is alarming no matter which way you look at it. | Earlier this month, Granules was slapped with a Form 483 following an inspection of its Telangana facility in India that ran from Aug. 26 to Sept. 6. The FDA’s report cites six observations around poor quality control procedures, subpar cleaning, cross-contamination risks and more.
Bio Pharma Dive
SEPTEMBER 17, 2024
The FDA previously rejected patritumab deruxtecan over manufacturing issues. Tuesday's study data should boost the companies' case, however.
Pharmaceutical Technology
SEPTEMBER 18, 2024
Kisqali generated $2bn in sales last year, with broader approvals forecasting sales of over $8bn by 2030, per GlobalData analysis.
AuroBlog - Aurous Healthcare Clinical Trials blog
SEPTEMBER 17, 2024
(Andrew Brookes/Connect Images/Getty Images) The more we know about how depression takes hold in the brain, the better we can prevent and treat it, and new research has identified a brain network that seems to be twice its typical size in most people with depression.
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.
Antidote
SEPTEMBER 16, 2024
Receiving a Parkinson’s diagnosis is a life-altering event that nearly 1 million people in the United States have experienced. Parkinson’s disease symptoms can vary from person to person. Receiving a diagnosis often requires several steps. In this blog, we’ll be sharing more details about the disease and discussing opportunities for individuals to get involved in Parkinson’s research.
Fierce Pharma
SEPTEMBER 18, 2024
Since GSK’s Nucala and AstraZeneca’s Fasenra were approved two years apart to treat patients with severe asthma, the IL-5 inhibitors have engaged in a spirited market battle, with one key differenc | Locked in a spirited market battle with GSK's Nucala, AstraZeneca's Fasenra is catching up with its IL-5 inhibitor rival as the FDA signed off on its use to treat the rare autoimmune condition of eosinophilic granulomatosis with polyangiitis.
Bio Pharma Dive
SEPTEMBER 19, 2024
According to the company, the results are the first time an antiviral drug has reduced transmission of a respiratory virus in a global Phase 3 trial.
Pharmaceutical Technology
SEPTEMBER 16, 2024
Roche has secured approval from the US Food and Drug Administration for Ocrevus Zunovo with Halozyme's Enhanze drug delivery technology.
AuroBlog - Aurous Healthcare Clinical Trials blog
SEPTEMBER 19, 2024
Home Editorial Services Interview Q&A Chronicle Specials Pharma Mart ePharmail Archives Join Pharma | Login Home > TopNews you can get e-magazine links on WhatsApp.
Drug Patent Watch
SEPTEMBER 19, 2024
The generic drug market in the United States is characterized by significant price volatility and shortages, driven by the structure of the market and the incentives for manufacturers. To address these issues, several market-based proposals have been put forth to optimize generic drug cost and availability.
Fierce Pharma
SEPTEMBER 17, 2024
An FDA approval has officially lifted the curtain on a blockbuster market showdown between Novartis and Eli Lilly in early breast cancer. | An FDA approval has officially lifted the curtain on a blockbuster market showdown between Novartis' Kisqali and Eli Lilly's Verzenio in early breast cancer.
Bio Pharma Dive
SEPTEMBER 16, 2024
Legislation that passed the House of Representatives passed the Biosecure Act last week would forced U.S. biotechs to cut ties with five Chinese contract partners.
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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.
Pharmaceutical Technology
SEPTEMBER 18, 2024
Japan's MHLW has accepted for review GSK's NDA for Blenrep for patients with relapsed or refractory multiple myeloma.
AuroBlog - Aurous Healthcare Clinical Trials blog
SEPTEMBER 18, 2024
The Pharmaceuticals Export Promotion Council of India (Pharmexcil) has announced an Extra Ordinary General Meeting (EGM) scheduled for 25th September, 2024 at 3:00 pm (IST). The meeting will take place in a hybrid format, allowing both physical attendance at the Pharmexcil head office in Hyderabad and virtual participation.
pharmaphorum
SEPTEMBER 18, 2024
PBM Express Scripts has sued the FTC, claiming its recent report on the sector's role in drug pricing is defamatory and should be retracted
Fierce Pharma
SEPTEMBER 20, 2024
Amid a parade of regulatory endorsements in Europe, Apellis Pharmaceuticals’ ophthalmology prospect pegcetacoplan has been left in the cold once again. | Europe’s Committee for Medicinal Products for Human Use has confirmed its negative stance on pegcetacoplan in geographic atrophy, an advanced form of age-related macular degeneration that can lead to blindness.
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Clinical research has entered a new era, one that requires real-time analytics and visualization to allow trial leaders to work collaboratively and to develop, at the click of a mouse, deep insights that enable proactive study management. Learn how Revvity Signals helps drug developers deliver clinical trial data insights in real-time using a fast and flexible data and analytics platform to empower data-driven decision-making.
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