Fierce Pharma
MAY 17, 2023
Regulatory tracker: Another China-made PD-1 starts FDA journey as Elevar, Hengrui target big cancer type aliu Wed, 05/17/2023 - 09:41
MedCity News
MAY 17, 2023
Five companies will take part in the showcase with technologies addressing mental health, care coordination, aging in place, physical therapy and more. Register for INVEST, scheduled for May 22-24, at the Ritz Carlton in Chicago!
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Fierce Pharma
MAY 17, 2023
Intercept's latest NASH bid in jeopardy after FDA questions drug's efficacy, safety aliu Wed, 05/17/2023 - 12:29
MedCity News
MAY 17, 2023
Suki recently announced one of its biggest partnerships to date: it is integrating its voice assistant into Epic’s EHR. The startup’s assistant can be thought of as like Apple’s Siri or Amazon’s Alexa — but for doctors.
Fierce Pharma
MAY 17, 2023
AZ's Tagrisso maintains winning streak in EGFR-mutated lung cancer—this time with some help fkansteiner Wed, 05/17/2023 - 09:35
MedCity News
MAY 17, 2023
Lucem Health recently closed a $7.7 million Series A funding round. The startup’s platform takes in the data required to fuel AI algorithms that give clinicians insights to improve patient care.
Pharma Rep Focus brings together the best content for pharma rep professionals from the widest variety of industry thought leaders.
MedCity News
MAY 17, 2023
Blue Cross Blue Shield of Massachusetts has added Eden Health, On Belay Health Solutions and VillageMD to its primary care network. The physician groups will provide both virtual and in-person care to members.
Fierce Pharma
MAY 17, 2023
Does FTC attempt to block Amgen's Horizon buy spell trouble for Pfizer-Seagen?
MedCity News
MAY 17, 2023
PTC Therapeutics plans to talk to regulators about regulatory submissions for sepiapterin after the drug met the main goal of a Phase 3 study. The small molecule is a potential treatment for phenylketonuria, a rare enzyme deficiency.
Fierce Pharma
MAY 17, 2023
At Gilead's CAR-T unit Kite, Roche vet Cindy Perettie takes the baton from Christi Shaw kdunleavy Wed, 05/17/2023 - 07:14
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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.
Pharmaceutical Technology
MAY 17, 2023
Chinook Therapeutics and Ionis Pharmaceuticals have entered a partnership to develop an antisense oligonucleotide (ASO) therapy to treat a rare, severe chronic kidney disease. The collaboration aims to discover, develop and commercialise an ASO therapy. It will use the precision medicine approach, as well as the deep expertise of Chinook Therapeutics in nephrology and knowledge of Ionis Pharmaceuticals in RNA-targeted therapeutics.
Fierce Pharma
MAY 17, 2023
The Digital Health Continuum – Connecting Clinical Trials to Care Delivery mteefey Wed, 05/17/2023 - 17:25
Pharmaceutical Technology
MAY 17, 2023
The US Food and Drug Administration (FDA) has accepted and granted priority review to Takeda ’s biologics licence application (BLA) for its enzyme replacement therapy, TAK-755, to treat congenital thrombotic thrombocytopenic purpura (cTTP). By replacing the missing or deficient ADAMTS13 enzyme, TAK-755 offers targeted therapy for addressing an unmet medical need for thrombotic thrombocytopenic purpura patients.
Medgadget
MAY 17, 2023
Researchers at the University of Hawaii at Manoa have developed a wearable that can take multiple sweat samples and which also supports on-board colorimetric biomarker analysis. Unlike many sweat collecting methods, which often involve a simple absorbent pad that must be removed and analyzed once wet with sweat, the ‘sweatainer’ employs a complex microfluidic architecture to take multiple sweat samples over time and store them in different compartments for later analysis. 3D printing was the key
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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
MedCity News
MAY 17, 2023
CVS Health is winding down its clinical trials business, with a full exit expected by December 31, 2024, the company confirmed to MedCity News. But decentralized clinical trials still have an important role to play, said Brian Weiss, CEO of Carebox.
European Pharmaceutical Review
MAY 17, 2023
An engineered oncolytic virus (DNX-2401) targeting glioblastoma (GBM) cells combined with subsequent immunotherapy using intratumoural delivery , gave a 52.7 percent 12-month overall survival (OS) rate for patients with recurrent GBM. According to the Phase I/II trial results published in Nature Medicine , this is higher than the prespecified efficacy threshold of 20 percent.
Medgadget
MAY 17, 2023
Researchers at the University of Illinois at Urbana-Champaign have developed a bioinspired implant coating that is designed to be implanted along with devices such as spinal implants. The technology has been inspired by dragonfly and cicada wings that contain tiny pillars that can skewer bacteria, providing mechanical anti-microbial action. Unlike current approaches that use antibiotics that are gradually released by the implant, the mechanical approach will not become depleted over time or caus
European Pharmaceutical Review
MAY 17, 2023
A market report has shown that to improve efficiency, quality and to reduce costs in drug manufacturing , Pharma has been adopting automated quality management systems, digitalisation of processes and integration of data analytics. The data observed the global pharmaceutical quality management systems (QMS) market is expected to reach a value of $4.44 billion by 2031.
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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.
Medgadget
MAY 17, 2023
Researchers at Ecole Polytechnique Fédérale de Lausanne (EPFL) in Switzerland have created a machine learning approach to scan millions of protein fragments and assess their structure and binding properties. Based on the surface chemistry and geometry of a protein, the developed software can determine a ‘fingerprint’ for each protein and predict how they might bind to various protein fragments.
Copyright Clearance Center
MAY 17, 2023
The post What Sets Ringgold Solutions Apart appeared first on Copyright Clearance Center.
PharmExec
MAY 17, 2023
Biotech company to receive $55 million upfront, per terms of the deal.
Pharmaceutical Technology
MAY 17, 2023
Precision oncology company Boundless Bio has raised $100m in a Series C financing round for advancing extrachromosomal DNA (ecDNA)-directed therapies for oncogene-amplified cancer patients. Co-led by Leaps by Bayer and RA Capital Management, the Series C round saw the participation from new investors Piper Heartland Healthcare Capital and Sectoral Asset Management.
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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.
PharmExec
MAY 17, 2023
When deciding on the right commercialization model, organizations must consider multiple factors, including the asset or platform they possess, the launch timing, the funding required, and staffing expertise.
PharmaTimes
MAY 17, 2023
Dosing optimisation technology will be incorporated alongside anti-hypertensive drugs
Healthcare Success
MAY 17, 2023
We’ve written about branding over the years, everything from strategy and concepts to tactics and execution. This time I’d like to focus on what happens when your strategy is said and done. You can now create great content, right? Well, not exactly. You need a brand style guide that communicates your strategy in a guidebook. Without this guide, you can end up with off-brand content.
PharmaTimes
MAY 17, 2023
Partnership will provide a healthcare boost across in low and middle-income countries
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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
PharmaTech
MAY 17, 2023
Dr. Erika Lüthi, R&D Senior Chemist at Valsynthese, the Fine Chemical Unit of Société Suisse des Explosifs Group, will take you through the evolution of Nitroglycerin, from its explosives origins to pharmaceutical applications. Nitroglycerin has been produced at SSE for over 125 years in a safely way and adapting its use to increasingly noble purposes.
Salesforce
MAY 17, 2023
Can you imagine ecommerce without written content? Picture it: Product listings without descriptions. Photography without context. Landing pages without information. A brand without a heart. (Okay, okay… as a content writer, maybe I’m a little bit biased.) But don’t take my word for it: Businesses in every industry see the value of quality ecommerce content, and they’re throwing their weight behind it.
PM360
MAY 17, 2023
Digital Health Networks , a global leader in healthcare-focused original content production and OTT streaming, announces the inaugural CINEHEALTH International Film and Video Festival where “The CINEHEALTH Awards” will be presented in the following categories: Feature Films, TV episodic series, short-form videos, social media, and TikTok reels. The festival is the first and only international film festival focusing exclusively on health and wellness.
Pharmaceutical Technology
MAY 17, 2023
The Inflation Reduction Act, which became US law in August 2022, has invited its fair share of critics and supporters over its drug pricing provisions. At a lively panel at Financial Times US Pharma and Biotech Summit on May 16, panellists were at odds over whether the new legislation would improve treatment affordability or stifle pharma innovation.
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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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