Fierce Pharma
APRIL 4, 2024
Amylyx Pharmaceuticals is keeping a promise by pulling the amyotrophic lateral sclerosis (ALS) therapy Relyvrio off the market after the drug failed in a confirmatory trial. | Amylyx is keeping a promise by pulling the amyotrophic lateral sclerosis (ALS) therapy Relyvrio off the market after the drug failed in a confirmatory trial. And 70% of the company's staff will soon lose their jobs.
MedCity News
APRIL 4, 2024
Implementing diverse and sustained strategies to empower frontline workers should be the cornerstone of any modern healthcare workforce management program. The post Frontline Burnout in Healthcare: A Growing Crisis Demands Action appeared first on MedCity News.
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Fierce Pharma
APRIL 4, 2024
With a new order clarifying several terms of the patents at the center of Arbutus Biopharma and Genevant Sciences’ infringement suit against Moderna, the companies are one step closer in | A Delaware judge sided with Arbutus and Genevant's proposed constructions of the patent claims in question, strengthening their case against Moderna and its COVID-19 vaccine Spikevax.
MedCity News
APRIL 4, 2024
The MedCity INVEST conference is scheduled for May 21-22 at the Ritz Carlton hotel in Chicago. In addition to panel discussions around some of the hottest topics in healthcare transformation, there is also a startup pitch contest, a presentation on government funding for startups and networking opportunities. The post Boutique Healthcare Investment Event in Chicago Highlights AI, Government Funding, Value-Based Care.
Fierce Pharma
APRIL 4, 2024
As Teva advances its Pivot to Growth strategy under CEO Richard Francis, the company is making good on its pledge to beef up its biosimilar pipeline through outside deals. | Teva has unveiled a fresh in-licensing accord with Spain’s mAbxience to chip in on an investigational biosimilar spanning multiple oncology indications. Under the deal, Teva will oversee regulatory duties and marketing for the biosimilar, while mAbxience is on the hook to continue developing and manufacturing the drug at its
MedCity News
APRIL 4, 2024
Employers are struggling with point solution fatigue, but does that mean new startups shouldn’t be selling to them anymore? Experts have mixed opinions. The post Should New Entrants Bother With Selling Point Solutions To Employers? appeared first on MedCity News.
Pharma Rep Focus brings together the best content for pharma rep professionals from the widest variety of industry thought leaders.
MedCity News
APRIL 4, 2024
Quantum Health CEO Zane Burke and Imagine360 CEO Jeff Bak highlighted the significance of the partnership, what it means for their respective businesses, and the industry at large, in response to emailed questions. The post Ardent Health Opts for New Employee Benefits and Employee Experience with Quantum Health and Imagine360 appeared first on MedCity News.
Fierce Pharma
APRIL 4, 2024
Fifteen years after Basilea's antibiotic ceftobiprole sustained a rejection from the FDA, the company has finally won over the U.S. regulator and done so in triplicate. | Fifteen years after Basilea's antibiotic ceftobiprole sustained a rejection from the FDA, the company has finally won over the U.S. regulator and done so in triplicate. The FDA has approved Basilea’s Zevtera for three different kinds of infections.
MedCity News
APRIL 4, 2024
LLMs bring great potential to help the healthcare industry center care around patients’ needs by improving communication, access, and engagement. However, LLMs also present significant challenges associated with privacy and bias that also must be considered. The post How Large Language Models Will Improve the Patient Experience appeared first on MedCity News.
Fierce Pharma
APRIL 4, 2024
Sanofi has agreed to settle approximately 4,000 personal injury claims from users of its heartburn drug Zantac, resolving litigation in all U.S. | Sanofi has agreed to settle approximately 4,000 personal injury claims from users of its heartburn drug Zantac, resolving litigation in all U.S. state courts besides Delaware, the company confirmed on Thursday.
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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.
pharmaphorum
APRIL 4, 2024
A small study of Sanofi’s lixisenatide has suggested that the GLP-1 agonist could slow down the progression of Parkinson’s disease, pointing to another potential use for the fast-growing drug class.
Fierce Pharma
APRIL 4, 2024
Fierce Pharma Asia—Eisai's subQ Leqembi delay; Legend and J&J's supply deal with Novartis; China's Ozempic biosimilar aliu Thu, 04/04/2024 - 16:14
MedCity News
APRIL 4, 2024
Chicago-based Prenosis gained FDA clearance for its sepsis detection technology this week, marking the first time the agency has cleared an AI diagnostic tool for sepsis. The post FDA Grants Its First-Ever Clearance for Sepsis Detection AI appeared first on MedCity News.
Fierce Pharma
APRIL 4, 2024
Sanofi pledges to keep polio vaccine supplies afloat in India after new approval fkansteiner Thu, 04/04/2024 - 16:04
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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
pharmaphorum
APRIL 4, 2024
Healthcare system Providence has spun out a new company, Praia Health, focused on a platform to build and sustain connections between patients and health providers. The new company starts life with $20 million in Series A funding and a mission to develop the Praia Health Identity and Engagement Platform, which was launched within Providence’s digital innovation group (DIG) incubator in 2022 and already handles around 3.5 million user accounts.
European Pharmaceutical Review
APRIL 4, 2024
A new £17.9 million initiative announced on 21 March is set to accelerate advanced therapy development in the UK. The scheme aims to support UK advanced therapy medicinal product (ATMP) clinical trials. UK Health Minister Andrew Stephenson commented on the news, stating that the investment “reaffirms the UK’s position as a global leader in clinical research”.
pharmaphorum
APRIL 4, 2024
Amylyx confirmed today that it will withdraw its amyotrophic lateral sclerosis (ALS) therapy Relyvrio/Albrioza from the market in the US and Canada, shortly after the drug failed a clinical trial. The company said that it was stopping access to the drug for new patients immediately, while those already taking it would be able to continue on it via a free drug programme, after consultation with their doctors – a move that has garnered praise from across the biopharma industry.
European Pharmaceutical Review
APRIL 4, 2024
US radiopharmacy network RLS Radiopharmacies is expanding its radiopharmaceutical contract development and manufacturing (rCDMO) capabilities by establishing a partnership with global isotope technology company Eckert & Ziegler. As part of the agreement, all 31 of RLS’ radiopharmacies will be produce Gallium-68-based (Ga-68) radiopharmaceuticals by the end of June, the company confirmed.
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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.
Eversana Intouch
APRIL 4, 2024
MM+M recently named Teva Pharmaceuticals’ AUSTEDO XR campaign as their Campaign of the Week! AUSTEDO XR helps treat tardive dyskinesia (TD), a side effect of taking medications for mental illness. It’s estimated that some 85% of TD cases go undiagnosed. To help patients and HCPs recognize TD, our team partnered with Teva on two new TV spots focusing on two different journeys of characters who have TD.
MedCity News
APRIL 4, 2024
The voluntary removal of ALS drug Relyvrio from the market comes with a corporate restructuring that turns Amylyx Pharmaceuticals’ focus to other neurodegenerative diseases. But the company also has another ALS drug candidate set to begin clinical testing this year. The post Amylyx Withdraws ALS Drug From Market; Restructuring Will Slash 70% of Staff appeared first on MedCity News.
European Pharmaceutical Review
APRIL 4, 2024
The European Commission (EC) has expanded the approval of Reblozyl ® (luspatercept) to include the first-line treatment of adults with transfusion-dependent anaemia due to very low, low and intermediate-risk myelodysplastic syndromes (MDS ). This indication expansion of Reblozyl covers all EU member states, excluding Great Britain. Bristol Myers Squibb stated that this makes it the fourth authorised indication in Europe for Reblozyl.
PharmaTimes
APRIL 4, 2024
The fatal, progressive neurological condition currently affects around 5,000 people in the UK
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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.
Pharmaceutical Technology
APRIL 4, 2024
Discover how F. Hoffmann-La Roche's patented system uses nanopores to identify nucleic acid bases, increasing confidence in base identification. Explore the innovative approach in genomics and personalized medicine.
PharmaTimes
APRIL 4, 2024
The project will assist researchers and companies in training the technology for healthcare settings
pharmaphorum
APRIL 4, 2024
Researchers in the UK will soon start trialling blood tests that promise to diagnose dementia at clinics across the country in the hope of having them in routine NHS use within five years. Two teams from University College London and the University of Oxford are spearheading a pair of studies that will recruit around 5,000 volunteers at more than 50 memory clinics in the UK.
Pharmaceutical Commerce
APRIL 4, 2024
The latest news for pharma industry insiders.
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Clinical development organizations face a wide array of challenges when it comes to data, many of which can impact the operational effectiveness of their clinical trials. In this whitepaper, experts from Revvity Signals explore how solutions like TIBCO® Spotfire® enable better, more streamlined studies. The whitepaper also features a success story from Ambrx, a leading biopharmaceutical company, detailing how it has leveraged Spotfire to tackle data quality and collaboration challenges in clinic
PharmaVoice
APRIL 4, 2024
As its FDA filing approaches, Verastem Oncology CEO Daniel Paterson wants to go from “The Little Engine That Could” to a major oncology player.
Clarivate
APRIL 4, 2024
The prevalence and co-occurrence of immune-mediated inflammatory diseases (IMIDs) like inflammatory bowel disease and rheumatoid arthritis varies by race and ethnicity among U.S. adults. That’s the upshot of a retrospective cohort study of 10.8 million U.S. adults performed by Clarivate researchers using claims and electronic health record data, data often referred to as real-world data (RWD).
Pharmaceutical Technology
APRIL 4, 2024
Discover Chiesi Farmaceutici's innovative patent for a specialized pharmaceutical formulation aimed at enhancing drug delivery efficiency for Parkinson's disease treatment. Learn about the unique composition and processes involved in this groundbreaking intraduodenal administration solution.
Rep-Lite
APRIL 4, 2024
The medical device industry is a dynamic and ever-evolving landscape. Sales representatives play a crucial role in connecting healthcare facilities with innovative technologies that improve patient care. While the rewards can be significant, carving a successful path in this field requires a unique blend of technical knowledge, interpersonal skills, and a commitment to ethical practices.
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As the development pipeline for new drugs continues to grow, biopharmaceutical companies are re-evaluating how to best manage and balance resources across an increasing number of development projects and complex clinical trials. There are two approaches that can be used to speed a drug from development to clinic faster: timeline compression and parallel processing, but only one that considers the benefits of integrating clinical supply into the overall drug development process.
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