Sat.Sep 24, 2022 - Fri.Sep 30, 2022

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Maximising outsourcing models beyond time and cost

Drug Discovery World

In this listicle, SAMDITech outlines the benefits of outsourcing models in the pharmaceutical industry, looking past perceived costs to the value outsourcing can bring. . Many biotech and pharmaceutical companies now rely on contract research organisations (CROs) for drug discovery services. CROs offer an established infrastructure to develop, initiate, execute, and progress drug discovery programs towards the clinic.

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The importance of health literacy

Antidote

Since 1999, October has been recognized as Health Literacy Month. The goal, as defined by the Institute for Healthcare Advancement , is to raise awareness about the importance of understandable health information — but what is health literacy and why is it important?

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New patent for Pharmacyclics Inc drug IMBRUVICA

Drug Patent Watch

Annual Drug Patent Expirations for IMBRUVICA Imbruvica is a drug marketed by Pharmacyclics Inc and is included in two NDAs. It is available from one supplier. There are forty patents…. The post New patent for Pharmacyclics Inc drug IMBRUVICA appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 97
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Drug Channels News Roundup, September 2022: Patients vs. SaveonSP, PBMs’ Oncology Exclusions, Medicare Advantage Winners, HRSA’s 340B Reveal, and New DCI Offerings

Drug Channels

Autumn is here! Please savor these Drug Channels acorns that we’ve squirrelled away for you: One patient’s troubling experience with SaveonSP PBMs ramp up formulary exclusions for oncology drugs The mega-players dominating Medicare Advantage My 340B FOIA efforts yield change at HRSA! Plus, two new resources from Drug Channels Institute. P.S. Join my 32,000 LinkedIn followers for daily links to neat stuff.

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How Machine Learning Drives Clinical Trial Efficiency

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.

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T cell therapy for melanoma shows promise 

Drug Discovery World

New trial data has shown that using a patient’s own immune cells could be a powerful immunotherapy for metastatic melanoma, an aggressive skin cancer. . The TIL (tumour-infiltrating lymphocytes) trial compared T cell therapy to standard immunotherapy with the checkpoint inhibitor ipilimumab. . The results of the trial were presented at the 2022 annual congress of the European Society for Medical Oncology (ESMO) in Paris. .

Therapies 130
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OPDP Outlines New Research

Eye on FDA

FDA published notice recently that the Office of Prescription Drug Promotion (OPDP) was proposing some new research related to the promotion of medicines by pharmaceutical companies. The research was new (kind of) but the direction was more of the same old focus – direct-to-consumer advertising (DTC). First, just a note on why the research is of importance at all.

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Informed Consent Writing Tip Sheet

Advarra

Informed consent is one of the central protections the regulations provide to research subjects. This tip sheet outlines the regulatory requirements for research informed consent forms (ICFs). The regulatory requirements for informed consent will vary depending upon which regulations apply to the conduct of a particular study. Note: Individual institutional review boards (IRBs) may have their own specific policies regarding how ICFs should be formatted, how to address certain regulatory criteri

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Comment: Join the science revolution at Drug Discovery 2022 

Drug Discovery World

ELRIG CEO Sanj Kumar tells readers how they can access the most exciting research and find the latest technologies to propel their projects forward at this year’s Drug Discovery 2022 . At ELRIG, our purpose is to support researchers in the life sciences and drug discovery communities to learn, share, innovate, connect, and collaborate. We understand that you find it difficult to keep up with the latest research and technological developments across the industry, from cell and gene therapy advanc

Science 130
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What is EoE and how is it treated?

Antidote

Though it has only been identified since the early 1990s, Eosinophilic Esophagitis (EoE) has come to be known as a major cause of gastrointestinal illness. Though there are still a lot of unknowns surrounding EoE, ongoing research hopes to provide patients and medical professionals with more insights in the future.

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New patent for Serenity Pharms drug NOCTIVA

Drug Patent Watch

Annual Drug Patent Expirations for NOCTIVA Noctiva is a drug marketed by Serenity Pharms Llc and is included in one NDA. There are two patents protecting this drug. Drug patent…. The post New patent for Serenity Pharms drug NOCTIVA appeared first on DrugPatentWatch - Make Better Decisions.

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Deliver Fast, Flexible Clinical Trial Insights with Spotfire

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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Wearable Sensor Promises More Efficient Early Cancer Drug Development

NIH Director's Blog: Drug Development

Wearable electronic sensors hold tremendous promise for improving human health and wellness. That promise already runs the gamut from real-time monitoring of blood pressure and abnormal heart rhythms to measuring alcohol consumption and even administering vaccines. Now a new study published in the journal Science Advances [1] demonstrates the promise of wearables also extends to the laboratory.

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Listicle: Maximising outsourcing models beyond time and cost

Drug Discovery World

Challenges in outsourcing drug discovery. In this listicle, SAMDITech outlines the benefits of outsourcing models in the pharmaceutical industry, looking past perceived costs to the value outsourcing can bring. . The goal of drug discovery is clear: Identify the most promising leads in the shortest amount of time. Many companies have several projects ongoing simultaneously, which can limit internal resources (space, lab equipment, personnel) and delay progress.

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Supporting Needed Research on Recovery

National Institute on Drug Abuse: Nora's Blog

Supporting Needed Research on Recovery mfleming Tue, 09/27/2022 - 13:33 Nora's Blog September 28, 2022 National Recovery Month (Recovery Month), which started in 1989, is a national observance held every September to promote and support new evidence-based treatment and recovery practices, the nation’s strong and proud recovery community, and the dedication of service providers and communities who make recovery in all its forms possible.

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New patent expiration for Organon drug CLARINEX D 24 HOUR

Drug Patent Watch

Annual Drug Patent Expirations for CLARINEX+D+24+HOUR Clarinex D 24 Hour is a drug marketed by Organon and is included in one NDA. There are two patents protecting this drug. This…. The post New patent expiration for Organon drug CLARINEX D 24 HOUR appeared first on DrugPatentWatch - Make Better Decisions.

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Clinical Data Like You´ve Never Seen It Before: Why Spotfire Is the Leading Tool for Clinical Analytics

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

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Antidote’s database engagement capabilities [one-pager]

Antidote

At Antidote, we believe that getting to know patients is about more than making an initial connection. As a digital patient engagement company with a database of 400,000 users, we know a lot about finding patients — but we also know how to keep them engaged.

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LC-MS Analysis for (Bio)pharmaceutical Research

Drug Discovery World

In the seventh eBook of the Hamilton series “LC-MS Analysis for (Bio)pharmaceutical Research”, we discuss: The role of LC-MS in the drug development process. The drivers behind the need for LC-MS sample prep automation in biopharma. The modules and full liquid handling automation solutions that Hamilton offers for LC-MS sample preparation.

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Keys to Unblocking the Innovation Bottleneck in Research

Advarra

Is the clinical research industry winning or failing at innovation? It probably depends on who you ask and likely full of nuance. In the past decade, trials have evolved to include not just traditional drugs and medical devices, but also innovations like cell and gene therapies, wearables, and more. As exciting as that growth may be, it invites more complexity.

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New patent for Vertex Pharms drug ORKAMBI

Drug Patent Watch

Annual Drug Patent Expirations for ORKAMBI Orkambi is a drug marketed by Vertex Pharms Inc and is included in two NDAs. It is available from one supplier. There are twenty…. The post New patent for Vertex Pharms drug ORKAMBI appeared first on DrugPatentWatch - Make Better Decisions.

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Thoughts on a Vaccine Act MDL

Drug & Device Law

Bexis recently returned from speaking at the 2022 National Vaccine Law Conference. As a veteran of both the DTP and thimerosal vaccine litigations, he was generally interested in vaccine-related product liability issues, so he stayed for the entire conference. He was most interested in learning more about the compensation systems provided by the National Childhood Vaccine Injury Act and the PREP Act.

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eBook – LC-MS Analysis for (Bio)pharmaceutical Research

Drug Discovery World

This is the seventh eBook of the Hamilton series “LC-MS Analysis for (Bio)pharmaceutical Research” This ebook covers: The role of LC-MS in the drug development process. The drivers behind the need for LC-MS sample prep automation in biopharma. The modules and full liquid handling automation solutions that Hamilton offers for LC-MS sample preparation.

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Webinar: Introduction into Fragment Based Drug Discovery

Drug Discovery World

Fragment-based drug discovery (FBDD) is one strategy of hit identification (hit ID) in the drug discovery process. Register now to attend the free webinar, Introduction into Fragment Based Drug Discovery, hosted by DDW and supported by WuXi AppTec. The event will take place on Thursday, October 13 at 3PM BST, 4PM CET, 10AM EST, 7AM PDT. Key Learning Objectives:?

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Up to 8 recipients to be awarded grants for genomic research

Drug Discovery World

Beckman Coulter Life Sciences has released a call for registrations for its SPRI Grants for Genomic Research, which the company describes as part of its commitment to the next generation of researchers and scientists. . Reinforcing its dedication to providing streamlined genomic workflow solutions, the company will award up to eight grants in 2022.

Research 130
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Latest DDW eBook – Analysis in the lab: Advancing drug discovery 

Drug Discovery World

The latest DDW eBook reveals the critical role analytical tools and equipment have in helping to advance drug discovery research. It is sponsored by Sartorius. . This ebook covers: . Opinions on the major trends in lab analytics. . Measuring the pharmacokinetics of monoclonal antibodies. . Best practices in cell line development. . You can read this entire book as a holistic approach or jump straight to the section that is most relevant to your needs, from an elaboration on how bioelectroni

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Malaria specialists secure $1.5m investment round  

Drug Discovery World

US biotechnology start-up LivFul has secured a $1.5m investment to expand its work saving lives from malaria and other insect-borne diseases, and to support the company’s growth plans. . The company’s major markets are now opening up following the pandemic, with interest in Livful’s Enhanced Insect Repellent ramping up. Livful is currently focussing its business development initiatives on Australia, the United States, Uganda, Nigeria, Indonesia and the Philippines. .

Virus 130
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How AI in pharma can live up to the hype 

Drug Discovery World

Ben Folwell, Principal Consultant at Citeline, maps out how AI, swarm learning and open access to clinical data could revolutionise drug discovery. . Artificial intelligence (AI) is notorious for its industry hype, touted to revolutionise the way multiple sectors operate over the next five to 10 years. Its application in pharma, most commonly in drug discovery, has been steadily growing with global partnerships between tech vendors and pharma companies becoming more commonplace.

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Platform enables cell therapy commercialisation

Drug Discovery World

Terumo Blood and Cell Technologies (BCT) has launched the Quantum Flex Cell Expansion System, a bioreactor platform that supports process development through to commercial manufacturing for the cell and gene therapy (CGT) sector. . Responding to the industry’s need for earlier automation to potentially limit additional and time-consuming steps such as bridging studies and technology transfers, Terumo BCT says that Quantum Flex allows developers to complete their early process development

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Analysis in the lab: Advancing drug discovery

Drug Discovery World

Learn about the critical role analytical tools and equipment have in helping to advance drug discovery research in this DDW ebook sponsored by Sartorius. This ebook covers: Opinions on the major trends in lab analytics. Measuring the pharmacokinetics of monoclonal antibodies. Best practices in cell line development. Access the eBook here. The post Analysis in the lab: Advancing drug discovery appeared first on Drug Discovery World (DDW).

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Ori Biotech and CTMC partner to accelerate novel cell therapy delivery 

Drug Discovery World

Ori Biotech and the Cell Therapy Manufacturing Center (CTMC) have partnered to accelerate process development, clinical implementation, and commercialisation of novel cell therapies. . The partnership will combine Ori’s technology platform with CTMC’s manufacturing capabilities and, in the first instance, will focus on a cell therapy invented by Dr Sattva Neelapu, Professor of Lymphoma/Myeloma at MD Anderson.

Therapies 130
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UMC Utrecht receives grant for microbiota-boosted cancer therapy 

Drug Discovery World

UMC Utrecht and its partners have received a research grant to unravel how the intestinal microbiota can be exploited to boost cancer immunotherapy and limit therapy side-effects. . Close to €800,000 was awarded by Health~Holland to a public-private partnership between UMC Utrecht, Artizan Biosciences, Inc. (USA) and MicroViable Therapeutics (Spain). .

Therapies 130
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Highs and lows of drug repurposing 

Drug Discovery World

DDW Editor Reece Armstrong explores the rise of drug repurposing and the benefits and disadvantages it brings to drug discovery and development. . Drug repurposing, the act of finding new clinical targets for both approved and unapproved drugs, has emerged as a viable alternative to traditional drug discovery approaches. . It’s common knowledge that drug discovery and development is costly, lengthy and has no guarantee of success.

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First and only biologic approved in the EU in patients with severe asthma 

Drug Discovery World

AstraZeneca’s Tezspire (tezepelumab) has been approved in the European Union as an add-on maintenance treatment in patients 12 years and older with severe asthma who are inadequately controlled with high dose inhaled corticosteroids plus another medicinal product. . The approval by the European Commission was based on results from the Pathfinder clinical trial programme, which included the pivotal Navigator Phase III trial in which Tezspire demonstrated superiority across every primary and key

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Law and order

Drug Discovery World

DDW Editor Reece Armstrong takes a look at the recent Covid-19 patent battles involving key players in the pharmaceutical sector. . There’s no doubting that when the time came for the life sciences industry to step up during the Covid-19 pandemic, it delivered. From diagnostics to PPE and eventually the launch of Covid-19 vaccines – within a never-before-seen expedited timeframe – the life sciences industry was the beating heart behind getting the world back on track.

Vaccine 130
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New patent for Vertex Pharms drug TRIKAFTA (COPACKAGED)

Drug Patent Watch

Annual Drug Patent Expirations for TRIKAFTA+%28COPACKAGED%29 Trikafta (copackaged) is a drug marketed by Vertex Pharms Inc and is included in one NDA. It is available from one supplier. There are…. The post New patent for Vertex Pharms drug TRIKAFTA (COPACKAGED) appeared first on DrugPatentWatch - Make Better Decisions.

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New patent expiration for APGDI drug MYRBETRIQ GRANULES

Drug Patent Watch

Annual Drug Patent Expirations for MYRBETRIQ+GRANULES Myrbetriq Granules is a drug marketed by Apgdi and is included in one NDA. It is available from one supplier. There are four patents…. The post New patent expiration for APGDI drug MYRBETRIQ GRANULES appeared first on DrugPatentWatch - Make Better Decisions.

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