Bio Pharma Dive
MAY 13, 2024
The deal gives the pharma partial rights to a medicine GSK once developed for heart disease but could soon become the first therapy for facioscapulohumeral muscular dystrophy.
Pharmaceutical Technology
MAY 13, 2024
As the debate over using tau levels to guide patient treatment persists, the landscape for Alzheimer’s diagnostics continues to move ahead.
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Bio Pharma Dive
MAY 13, 2024
Goldman Sachs and Eli Lilly are among those backing the startup, which claims its prospect could be more potent than the myelofibrosis therapies that have come to market in recent years.
AuroBlog - Aurous Healthcare Clinical Trials blog
MAY 13, 2024
The Subject Expert Committee (SEC), which advises the Central drug regulator regarding clinical trials and approvals of drugs, has recommended approval for additional indication of Zydus Lifesciences’ inactivated trivalent influenza vaccine in children above six months with clinical trial waiver subject to condition.
Bio Pharma Dive
MAY 13, 2024
The deal — worth $100 million up front and potentially billions more later on — gives Takeda an exclusive option to license an Alzheimer’s vaccine and other “active immunotherapies.
Rethinking Clinical Trials
MAY 13, 2024
May 9-10, 2024 | Bethesda, MD Main Purpose Day 1 : Hear from the newest NIH Collaboratory Trials; share challenges and lessons learned to promote successful trial conduct; discuss the evolution and current state of the NIH Collaboratory ecosystem; identify gaps and areas of opportunity for expanding the ecosystem of embedded pragmatic clinical trials (ePCTs).
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Rethinking Clinical Trials
MAY 13, 2024
May 9-10, 2024 | Bethesda, MD Main Purpose Day 1 : Hear from the newest NIH Collaboratory Trials; share challenges and lessons learned to promote successful trialconduct; discuss the evolution and current state of the NIH Collaboratory ecosystem; identify gaps and areas of opportunity for expanding the ecosystem of embedded pragmatic clinical trials (ePCTs).
Pharmaceutical Technology
MAY 13, 2024
Takeda will pay $100m upfront and up to $2.1bn in milestone-based payments for licencing AC immune’s amyloid beta-targeting immunotherapy.
Rethinking Clinical Trials
MAY 13, 2024
An ongoing funding opportunity from the National Institutes of Health (NIH) is supporting dissemination and implementation research in health. The purpose of the funding opportunity is “to support studies that will identify, develop, and/or test strategies for overcoming barriers to the adoption, adaptation, integration, scale-up, and sustainability of evidence-based interventions, practices, programs, tools, treatments, guidelines, and policies.” Posttrial sustainment and deimplemen
Pharmaceutical Technology
MAY 13, 2024
The approval was supported by the TRIDENT-1 trial studying Augtyro in TKI-naïve and TKI-pretreated patients with ROS1-positive NSCLC.
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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
MAY 13, 2024
As commercial momentum builds, coverage incentives for the Medicare market are expected to favor biosimilars in 2025.
Pharmaceutical Technology
MAY 13, 2024
Almost 12 months after the South American Summit, advancing pharma trade and raising disease response standards remains a priority.
Bio Pharma Dive
MAY 13, 2024
Examine why adaptive trials that consider comorbidities are critical for a successful trial outcome.
Pharmaceutical Technology
MAY 13, 2024
Fulcrum entered an exclusive global licence deal with GSK for rights to the oral small-molecule drug losmapimod in April 2019.
Bio Pharma Dive
MAY 13, 2024
Explore the four most important qualities for choosing a dependable outsourcing partner in pharma.
Pharmaceutical Technology
MAY 13, 2024
Regeneron and Sanofi’s injection saw sales of $11.59bn in 2023 as it gets a step closer to another indication.
pharmaphorum
MAY 13, 2024
Takeda has made a strong play for a stake in the Alzheimer’s disease market, paying $100 million upfront for an option on AC Immune’s amyloid-targeting immunotherapy. The option fee could be followed by another up to $2.1 billion in potential milestones if Takeda takes global rights to the programme, currently headed by ACI-24.060 which is in a phase 1b/2 trial with new data due in the next few weeks.
Fierce Pharma
MAY 13, 2024
While much of the fanfare around COVID-19 treatments has dissipated, Shionogi has continued to press on in hopes that its Japan-approved protease inhibitor ensitrelvir could compete on a global sta | While much of the fanfare around COVID-19 treatments has dissipated, Shionogi has continued to press on in hopes that its Japan-approved protease inhibitor ensitrelvir could compete on a global stage.
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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.
FDA Law Blog
MAY 13, 2024
By Jeffrey N. Gibbs & Ana Loloei & Véronique Li, Senior Medical Device Regulation Expert — FDA has long touted the use of real-world evidence ( RWE ). Extolling RWE, FDA has said “RWE can be leveraged to bring new products to market, evaluate the safety and effectiveness of existing products for new uses, and assess the continued performance and safety of products once on the market.
Fierce Pharma
MAY 13, 2024
Another attempt at improving upon AstraZeneca’s Imfinzi in stage 3, unresectable non-small cell lung cancer (NSCLC) has gone up in flames. | Following AstraZeneca's setback in attempting to improve upon Imfinzi's efficacy in unresectable stage 3 lung cancer, a Bristol Myers Squibb endeavor has gone up in flames, as well. Now, market watchers are turning their attention to upcoming readouts from Merck & Co. and Roche.
BioSpace
MAY 13, 2024
With Monday’s agreement, AbbVie joins the industry’s growing interest in psychedelic therapies and looks to leverage Gilgamesh Pharmaceuticals’ research platform to discover novel neuroplastogens.
Fierce Pharma
MAY 13, 2024
After Johnson & Johnson's consumer healthcare spinoff last year—and its subsequent reduction in holdings in the new company—the healthcare conglomerate is once again cutting its stake in&n | Johnson & Johnson is again cutting its holdings in Kenvue. This time, it's pursuing a "debt-for-equity" offering that looks to be worth about $3.75 billion.
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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
BioSpace
MAY 13, 2024
In Tuesday’s first-quarter 2024 financial results, Bayer reported a slight drop in sales amid its sweeping companywide restructuring that resulted in workforce reductions, while lowering its full-year earnings outlook.
Fierce Pharma
MAY 13, 2024
Of all the allegations thrown at WuXi AppTec during an ongoing U.S. | Facing potential sanctions from the Department of Defense and a recent allegation that it had transferred a U.S. client's data to Beijing without consent, WuXi AppTec is again rebutting claims of its ties with Chinese authorities.
BioSpace
MAY 13, 2024
Presented at this week’s European Congress on Obesity, the two studies also demonstrate that Novo Nordisk’s Wegovy (semaglutide) provides cardiovascular benefits irrespective of starting weight and the amount of weight lost.
BioPharma Reporter
MAY 13, 2024
Regeneron Pharmaceuticalsâ gene therapy for otoferlin-related hearing loss, a genetic cause of deafness, has restored hearing to normal levels in one deaf child within just 24 weeks.
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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.
BioSpace
MAY 13, 2024
Cytokinetics released data Monday on aficamten, an oral small molecule inhibitor of cardiac myosin, showing it significantly boosted exercise capacity in patients with obstructive hypertrophic cardiomyopathy.
pharmaphorum
MAY 13, 2024
Think open-source is just for software? Think again. Learn how clinical researchers are embracing open data and tools to overhaul the drug development process.
BioSpace
MAY 13, 2024
Dynavax Technologies announced Tuesday that the FDA issued a Complete Response Letter to the company’s sBLA to include a four-dose regimen of Heplisav-B vaccine for adult hemodialysis patients.
Outsourcing Pharma
MAY 13, 2024
Sanofi, a global pharmaceutical giant, has announced a significant investment of over â1 billion ($1.08 billion) in new bioproduction capacity at three manufacturing sites in France.
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When selecting a clinical supply provider, consideration often focuses upon the manufacturing, packaging, storage and distribution capabilities available that will, at face-value, be sufficient to meet the needs of the sponsor and their trial. However, there are human-based and knowledge-driven factors that are often overlooked that go beyond these basic physical capabilities and are integral to the development and delivery of high performing clinical supply chains.
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