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Cell and gene therapies for rare diseases often present unique obstacles that can be overcome using in silico approaches. Learn how in our on-demand webinar, and meet us at BIO to discuss how Premier Consulting can advance your CGT program to its next milestone. Premier Consulting. Built for Biotech℠.
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Today's Big NewsMay 24, 2023 |
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July 18-19, 2023 | Jersey City, NJ
More panels and case studies providing real, practical experiences and solutions, including topics surrounding Investor Relations and Government Affairs. Save $500 when you Register before May 30th!
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| By Annalee Armstrong The FDA needs a wee bit more time to consider the approval of Sarepta’s gene therapy for Duchenne muscular dystrophy, however the agency has indicated an accelerated approval is likely in a restricted age group. |
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By Max Bayer Friedemann Janus, Ph.D., may, as of now, only be leading Bayer’s business development team on an acting basis, but he'd like to lose the "interim" to his title. |
By Gabrielle Masson Move over, ReNAgade. ElevateBio’s $401 million haul has already knocked the RNA company’s $300 million series A off the fundraising top spot after just one day. |
By Nick Paul Taylor PTC Therapeutics’ phase 3 Friedreich ataxia (FA) clinical trial has missed its primary endpoint. But, while the biotech is cutting other programs and reducing its head count, it thinks the FA data reveal an active drug and justify opening talks with the FDA about a path to approval in the neurodegenerative disease. |
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Explore the whole transcriptome with a prep that generates libraries in under 4.5 hours - including rRNA depletion - and delivers superior gene detection sensitivity with FFPE and low inputs. View the Data.
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By Nick Paul Taylor Apexigen’s rapid decline is nearly complete. Three years after its private megaround, and less than 300 days after going public, the biotech has accepted a $16 million buyout bid from Pyxis Oncology. |
By Helen Floersh Scientists have flipped the script on a common cancer target in an effort to regenerate nerves and protect cardiac tissue from damage. |
By Eric Sagonowsky After the recent high-profile loss of exclusivity for AbbVie's megablockbuster immunology drug Humira, industry watchers' eyes moved to Johnson & Johnson's Stelara as one of the next major drugs expected to face biosimilar competition. Tuesday, the industry got more information about when exactly that clash might occur. |
By Andrea Park After an attempt to expand its business fell apart earlier this year, Bioventus is downsizing instead. |
By Teresa Carey This week on "Podnosis," we discuss the history of 'food is medicine' and where the movement has room to grow. We also talk about our special report comparing top-paid health system execs with payer execs. |
By Kevin Dunleavy Innoviva subsidiary Entasis has captured an FDA approval for Xacduro, a treatment for hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia. Xacduro targets bacteria known as Acinetobacter baumannii, a pathogen that can cause infections in the blood, urinary tract and lungs (pneumonia). |
By Heather Landi Under this new proposal, Medicaid would have increased ability to hold drug manufacturers accountable for what Medicaid programs pay for drugs, CMS officials said. |
Fierce podcastsDon't miss an episode |
| This week on "The Top Line," we''ll discuss the recent biopharma layoff trends, plus Elizabeth Holmes, Sarepta Therapeutics, Abbott's FDA approval, and the rest of the week's headlines. |
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| WhitepaperChatGPT shows promise in drug discovery for information extraction, scientific text authoring, hypothesis prediction, and chemical entity prediction. This whitepaper explores its potential to streamline research, delving into its technology, applications, and limitations. Sponsored by: Elucidata Corp., Cloud SAAS in Life Sciences R&D |
| WhitepaperLearn how a GPCR-focused library with a cell-based biopanning strategy led to the discovery of 13 high-affinity and selective anti-GLP-1R antibodies with highly developable therapeutic properties. Sponsored by: Twist Bioscience |
| eBookDiscover a game-changing approach to clinical research with Hybrid and Decentralized Clinical Trials (DCTs). Learn about the benefits, challenges, and key elements for success. Sponsored by: EvidentIQ |
| Research What role do the Library and Legal teams play in the drug development pipeline at Lilly? An import one – find out how. Sponsored by: CCC |
| WhitepaperThis paper focuses on stakeholder engagement and how Medical Affairs teams’ responsibilities, goals, tools, and techniques are changing. Sponsored by: Blue Matter, strategic consultants in the life sciences |
| ResearchStrategies for Optimal Site Selection and Feasibility Research in Novel Therapies and Geographies Sponsored by: H1 |
| WhitepaperExplore how clinical supply can be scaled up as decentralized programs progress, and how technological solutions can accelerate trial deployment. Sponsored by: Catalent Clinical Supply |
| Whitepaper As sponsors increasingly look to CROs to support their clinical studies, making and addressing certain clinical supply considerations at the outset of the relationship can reduce the risk of potentially unforeseen impact to budget and time later. Discover key issues sponsors should consider to help their CRO or partner of choice better understand their clinical supply needs. Sponsored by: Catalent |
| WhitepaperFor sponsors, cost is a key concern when it comes to managing the supply of their clinical trials. A financial project analyst (FPA) is a specialized expert who can help control clinical supply costs and keep the project within budget. Explore the critical role that a Financial Project Analyst plays in clinical trial supply and budget management. Sponsored by: Catalent |
| WhitepaperLearn how Catalent’s extensive network across APAC can meet a wide range of clinical supply needs for sponsors conducting trials within the region. Sponsored by: Catalent |
| WhitepaperDiscover key considerations that every trial sponsor should know when navigating the complex clinical supply distribution landscape across Asia-Pacific. Sponsored by: Catalent |
| WhitepaperHow can specialized expertise help you optimize your clinical supply chain? Learn about the roles and responsibilities of unique experts such as clinical supply management, project management, and financial project analysis. Sponsored by: Catalent Clinical Supply |
| WhitepaperExplore Catalent’s newest clinical supply facility in Japan, including the comprehensive services & solutions it offers to help support trials both in-country & around the world. Sponsored by: Catalent |
| WhitepaperPlanning on using a CRO to support your next clinical study? This infographic outlines critical areas to address at the start of the relationship in order to ensure that budget and timelines keep on track for the duration of the trial. Sponsored by: Catalent |
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