Drug Discovery Featured Articles & Applications
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The RNA Therapeutics Race: How Can Pharma Stay Ahead Of The Wave?
12/5/2023
With more than 970 RNA therapies currently in the development pipeline, the market presents an exciting prospect. This article shares the key attributes of RNA therapies that are paving the way for personalized medicine, novel delivery mechanisms, and more.
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A Brief Guide For Vaccine Companies Working Toward FDA Approval For the First Time
11/22/2023
This article outlines best practices for expediting the FDA approval process while maintaining safety and efficacy standards. Tips are related to vaccine R&D, understanding the Emergency Use Authorization (EUA), post-approval surveillance and monitoring, and more.
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Biochips: The Small Devices With Big Promise
11/14/2023
Biochips are small medical devices with microarrays for carrying out biochemical processes. Biosensors enable the screening of different biological materials like enzymes, proteins, DNA, biological molecules, and more, and are used in drug discovery and research. They can also be implanted in the body for targeted drug delivery or to track health data.
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What We Need To Unlock Next-Generation mRNA Therapeutics
11/13/2023
mRNA is an incredibly nimble platform for drug discovery and development, but in order to truly unlock the next generation of mRNA therapeutics, we need to think outside the box (and we also need more funding).
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Baxalta v. Genentech: The Latest Case In Patenting Functionally Claimed Antibodies
11/10/2023
On Sept. 20, 2023, in Baxalta v. Genentech, the Federal Circuit invalidated patent claims directed to functionally claimed antibodies, finding that they failed to satisfy the enablement requirement. The author of this article is a patent attorney and he shares the key takeaways for biotech/pharma companies going forward.
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In Search Of The Unicorn: Do End-To-End C(x)DMOs Really Exist?
11/8/2023
Over the years, we have seen the progression of the biologics contract services go from contract manufacturing organizations (CMO) to what this expert today calls the C(x)DMO: the contract analytical/research/testing development manufacturing organization. Focusing on the mammalian biologics segment, this expert analyzed public information and a proprietary database by looking at 80 service providers supporting projects ranging from early discovery to commercial manufacturing.
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New Developments In mRNA Vaccine Efficacy Show Promise
11/1/2023
Significant caveats with the current base modification approach for mRNA vaccines still remain and need to be addressed. This article looks at activation of innate immunity, overcoming the limitations of pseudouridine, novel 3-base oligonucleotides, and more.
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Legal And IP Protection For New Biotechs
10/31/2023
Want to ensure you've got your biotech legal, IP, and patent bases covered? Join Business of Biotech host Matt Pillar and BlueSphere Bio CEO and biotech legal expert Keir LoIacono on 11/13 for the live, interactive, and FREE digital event Legal And IP Protection For New Biotechs.
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An Overview Of FDA Efforts To Encourage DHT Use In Drug & Biological Product Development
10/30/2023
The FDA issued its Framework for the Use of Digital Health Technologies in Drug and Biological Product Development earlier this year, representing the agency's road map on the topic. Digital health technologies (DHTs) may include wearable, implantable, or software applications, among other approaches. This article takes a closer look at the framework as well as related FDA efforts this year.
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Key Considerations For Cell & Gene Therapy Developers To Tap Into AI
10/24/2023
In the authors' first article in this two-part series, they discussed the opportunities for AI to assist cell and gene therapy companies. In this second article, they examine how cell and gene therapy developers can wisely harness AI, with a look at outsourcing vs. developing in-house solutions, data acquisition strategies, the three stages of managing AI/ML algorithms, and more.