Pharmaceutical Technology
JUNE 16, 2023
Flamingo Therapeutics has received a research grant of €1.7m from Flanders Innovation & Entrepreneurship (VLAIO) to further advance its oncology portfolio targeting RNA. The grant will help Flamingo to support its translational research in a Phase II study of its lead clinical programme, danvatirsen, to treat head and neck squamous cell carcinoma.
Bio Pharma Dive
JUNE 16, 2023
The approval of Columvi adds another “bispecific antibody” to the market, highlighting the fast research progress for drugs that target two proteins rather than one.
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Pharmaceutical Technology
JUNE 16, 2023
Roche Group member Genentech has secured approval from the US Food and Drug Administration (FDA) for its Columvi (glofitamab-gxbm) to treat adults with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL). The approval has been granted for patients with R/R DLBCL not otherwise specified or large B-cell lymphoma (LBCL) caused by follicular lymphoma, after two or more systemic therapy lines.
Bio Pharma Dive
JUNE 16, 2023
The expert panel recommended coronavirus vaccines be tailored to target an omicron subvariant known as XBB, which Pfizer, Moderna and Novavax said they’re prepared to do.
Pharma Mirror
JUNE 16, 2023
The Hague — Plans to develop FIP-UNESCO UNITWIN centres for excellence for pharmacy education across the world have been bolstered by a renewed agreement between the International Pharmaceutical Federation (FIP) and the United Nations Educational, Scientific and Cultural Organization (UNESCO) concerning the UNITWIN Network on Global Pharmacy Education Development, the federation announced today.
Bio Pharma Dive
JUNE 16, 2023
Best known for its work in biosimilars, Coherus will acquire two drugs in human testing for various solid tumors through a roughly $65 million buyout of Surface Oncology.
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Bio Pharma Dive
JUNE 16, 2023
GSK said it remains confident in its application supporting the myelofibrosis medicine momelotinib, which it bought in last year’s deal for Sierra Oncology.
Pharma Mirror
JUNE 16, 2023
Maintaining optimal tablet tooling is paramount for achieving effective production outcomes. Inadequate handling and aftercare methods are responsible for 85% of punch and die problems. To address this critical issue, I Holland, leader in the manufacture of tablet tooling for the pharmaceutical and nutraceutical markets, has developed Safestore and tool tray racking, an innovative system designed to securely store tooling.
Pharmaceutical Technology
JUNE 16, 2023
Belgium-headquartered ANeuroTech is participating in a Series B round, which will raise up to $150m to power the pivotal programme of its lead candidate ANT01 for use as an adjunctive treatment for major depressive disorder (MDD). This includes the company’s upcoming Phase IIIb trial, but also another Phase III study and a long-term safety trial, said ANeuroTech CEO Eric Buntinx in an interview with Pharmaceutical Technology.
Fierce Pharma
JUNE 16, 2023
In the battle for superiority in the field of next-gen diabetes and obesity treatments, Novo Nordisk holds the lead as the developer of the metabolism-regulating treatment semaglutide. | In the battle for diabetes and obesity superiority, Novo Nordisk holds a head start as the original developer of the metabolism-regulating treatment semaglutide. But Eli Lilly is quickly gaining ground and is primed to become the market leader with its GLP-1 treatment Mounjaro, according to GlobalData.
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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
Pharmaceutical Technology
JUNE 16, 2023
Artificial intelligence (AI)-driven commercial optimisation platform provider Verix has purchased start-up.ai for an undisclosed sum, boosting its life science AI capabilities. start-up.ai is a group of AI specialists that helps enterprises improve their processes through AI and machine learning. The company will be merged with Verix’s AI lab, and start-up.ai co-founder and CEO Shahar Cohen will become Verix’s CTO.
Fierce Pharma
JUNE 16, 2023
Merck’s cancer star Keytruda could be on its way to an updated label in HER2-positive stomach cancer after showing it can stave off tumor progression in a combination study. | After scoring accelerated approval to treat HER2-positive stomach cancer in 2021, the drug has now shown it can stave off tumor progression in patients with PD-L1 positive tumors.
Pharmaceutical Technology
JUNE 16, 2023
The Abu Dhabi Department of Health (DoH) in the UAE has made a declaration of collaboration with Mass General Brigham’s (MGB) International Center for Genetic Disease (iCGD) to advance life sciences. The deal is aimed at advancing life sciences across three strategic areas: clinical and translational research, capacity building and technology transfer, and in the area of commercialisation.
Fierce Pharma
JUNE 16, 2023
Less than a month after AbbVie and Genmab won FDA approval for Epkinly, Roche has crossed the finish line with its bispecific answer to large B-cell lymphoma. | Less than a month after AbbVie and Genmab won FDA approval for Epkinly, Roche has crossed the finish line with its bispecific answer to large B-cell lymphoma, though with a narrower label.
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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
Pharma Times
JUNE 16, 2023
Company will gain access to a considerable pipeline of liquid products covering various disease areas - News - PharmaTimes
Intouch Solutions
JUNE 16, 2023
“How can we use this ‘gamification’ thing for our brands?” pharma clients asked their agencies a few years back. But as they came up with ways to make it work, gamification was suddenly dead in the water. Why has it been so difficult to bring healthcare and games together? Gamification occurs when game-play elements are added into non-gaming activities.
XTalks
JUNE 16, 2023
Foundation Medicine recently announced that the US Food and Drug Administration (FDA) approved FoundationOne Liquid CDx to serve as a companion diagnostic for identifying metastatic colorectal cancer patients with BRAF V600E alterations, suitable for treatment with Pfizer’s Braftovi (encorafenib) with cetuximab. FoundationOne Liquid CDx is a comprehensive pan-tumor liquid biopsy test.
Antidote
JUNE 16, 2023
Despite being relatively small organs, the kidneys are extremely important to the functioning of the human body. Their main function is to filter the blood, eliminating wastes, toxins, and excess fluids. They also are responsible for producing hormones and regulating various salts and minerals that are necessary for bodily functions.
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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.
XTalks
JUNE 16, 2023
Wholly Veggie , a trailblazing food company based in Toronto, Canada, is revolutionizing the way we consume plant-based products. Founded in 2016, the company’s mission revolves around the belief that good eating is a basic human right, and Wholly Veggie is here to make that possible with fun, creative and proactive plant-based solutions. Wholly Veggie was conceived by founders Johnathan Bonnell and David Orr Gaucher, who were both previously meat industry executives.
Pharma Times
JUNE 16, 2023
DEVOTE grant will allow acute care patient access and a supporting infrastructure for the company - News - PharmaTimes
XTalks
JUNE 16, 2023
Klinrisk, an artificial intelligence (AI)-based medical device company specializing in prognostic solutions for kidney disease, has been awarded an investment from the National Kidney Foundation’s Innovation Fund. Klinrisk’s unique approach incorporates routinely collected laboratory tests to deliver a highly accurate prognosis that is one of the most widely employed risk prediction tools in nephrology for identifying high-risk chronic kidney disease (CKD) patients. “Klinrisk&#
Fierce Pharma
JUNE 16, 2023
Hello again to a monovalent COVID-19 vaccine. Goodbye to the bivalent shot. | Hello again to a monovalent COVID-19 vaccine. Goodbye to the bivalent shot. That was the message Thursday from an FDA advisory committee, which decided unanimously that COVID vaccines this fall should not provide coverage against the original, wild-type coronavirus and that protection only is needed against an XBB strain.
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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.
Drug Channels
JUNE 16, 2023
Today’s guest post comes from Derek Berven, Senior Director of Software Engineering at AssistRx. Derek explains how to streamline patient support services with a modular, scalable technology solution. He then discusses Advanced Gateway, a technology that integrates patient, provider, and manufacturer services. Click here to learn more about how AssistRx’s Advanced Gateway can impact patient support programs.
pharmaphorum
JUNE 16, 2023
Pharmaphorum Editor in Chief Jonah Comstock spoke with Martin Vogel and Edmond Chan, EMEA leads for oncology and haematology, respectively at Janssen.
Cloudbyz
JUNE 16, 2023
Clinical trials are crucial for advancing medical research and developing innovative treatments. They generate a vast amount of valuable data, which needs to be securely archived for future reference and analysis. Effective clinical trial data archiving is essential to ensure data integrity, regulatory compliance, and seamless access. In this blog, we will delve into the overview, purpose, challenges, regulatory requirements, best practices, and digital solutions associated with clinical trial d
pharmaphorum
JUNE 16, 2023
How digital transformation can revamp product and process visibility Mike.
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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.
Drug Patent Watch
JUNE 16, 2023
Annual Drug Patent Expirations for XYREM Xyrem is a drug marketed by Jazz Pharms and is included in one NDA. It is available from two suppliers. There are eight patents… The post New patent expiration for Jazz Pharms drug XYREM appeared first on DrugPatentWatch - Make Better Decisions.
pharmaphorum
JUNE 16, 2023
Cala launches wearable to treat hand tremor in Parkinson's Phil.
Drug Patent Watch
JUNE 16, 2023
Annual Drug Patent Expirations for INVEGA+HAFYERA Invega Hafyera is a drug marketed by Janssen Pharms and is included in one NDA. It is available from one supplier. There are two… The post New patent for Janssen Pharms drug INVEGA HAFYERA appeared first on DrugPatentWatch - Make Better Decisions.
ECRG Media's Clinical Research Podcast
JUNE 16, 2023
Looking For a Job Before Medical School Don't forget to Subscribe for new content! Merch: [link] Subscribe: [link] Email: eliteclinicalgroup@gmail.com Podcast: [link] Steemit: [link] Advertise: eliteclinicalgroup@gmail.com Watch: » Industry News: [link] » All Videos: [link] » Interview Recaps: [link] » Glassdoor Reviews: [link] We do: » Insider Interviews » Resume Reviews » Question and Answer » Discuss all things Clinical Research » News and Product Reviews » Education Elite Clinical Resear
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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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