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May 1 - 3, 2023 | Jersey City, NJ Connect with senior executives in Medical Affairs, MSL and IIT to share best practices. Register Today & save $200 from now until April 7th!
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Today's Big NewsMar 29, 2023 |
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Download the white paper by VeriSIM Life CSO Dr. Szczepan Baran and Peter Henstock, Machine Learning/AL Lead at Pfizer, to better integrate AI across R&D. Where to start, how to benchmark & more. Download Now.
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| By Gabrielle Masson While clinical trial activity was strong in 2022 following a pandemic-induced dip, many trends resumed their pre-COVID trajectory—including plummeting diversity in clinical trials. |
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By Fraiser Kansteiner While commercial revenue has yet to materialize in bluebird bio's earnings report, the company is flying high on the U.S. launches of its two new gene therapies Zynteglo and Skysona. |
By Andrea Park The FDA's new cybersecurity requirements went live Wednesday, as a $1.7 trillion federal omnibus spending bill took effect. |
By Max Bayer Johnson & Johnson is 'exiting' a late-stage respiratory syncytial virus program amid a large-scale overhaul of its infectious disease unit. |
By Fraiser Kansteiner The U.S. FDA blessed Emergent BioSolutions' 4mg Narcan nasal spray with a nonprescription nod, teeing up over-the-counter sales for the opioid overdose reversal treatment at places like drug stores, convenience stores, supermarkets and gas stations. |
By Conor Hale ICU Medical has placed itself in the running to serve as the new corporate home of Medtronic’s patient monitoring and hospital ventilator businesses, according to a report from Reuters. |
By Annalee Armstrong Blueprint Medicines’ solid tumor med BLU-222 is back from the drawing board after the FDA lifted a partial clinical hold that has been in place since mid-February. |
By Zoey Becker Vanda Pharmaceuticals has scored a legal win over the FDA. A D.C. District Court ruled that the agency must turn over records relating to its 2018 rejection of the company's Hetlioz in jet lag disorder. |
By Fraiser Kansteiner A major makeover is underway at a former AbbVie biologics plant in Liverpool, which Pharmaron bought in 2021. The work is supported by a U.K. government grant, the Chinese CDMO said. |
By Andrea Park Only a month after Getinge announced that the CE marks allowing it to sell its heart-lung support and permanent life support systems in Europe had been suspended, the Swedish devicemaker has temporarily lost another EU approval. |
By James Waldron AstraZeneca has pulled out of a pneumonia collaboration with Aridis Pharmaceuticals, sending the biotech’s phase 3 plans into a tailspin over the company’s alleged failure to hand over the agreed upfront payment two years ago. |
By Ben Adams If it’s March, it must be #FierceMadness, Fierce Pharma Marketing’s annual take on the March Madness NCAA basketball tournament and bracket mania—with a pharma twist. |
Fierce podcastsDon't miss an episode |
| | This week on "The Top Line," we discuss Fierce Medtech’s annual Fierce 15 report and startups that made the cut. We also cover Illumina and Carl Icahn's proxy battle and more of this week's top headlines. |
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Thursday, April 6, 2023 | 11am ET / 8am PT In this webinar, we show how we used Nunchuck to make LNPs in small-volume screening runs and bulk formulations. The complete workflow will be illustrated, from the testing of flow rates in initial formulations to the final assessment of mRNA expression in multiple cell types, showing successful transfection of cells by the LNPs. Register now.
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| WhitepaperPreparation of critical process liquids and buffer components shifts resources away from core activities and can be filled with inefficiencies and risks that can increase time and costs across your workflow. Learn about the framework to help reduce your total costs beyond capital and operational expenditures and set a solid foundation for successful scale-up of buffer preparation. Sponsored by: Thermo Scientific Production Chemicals and Services |
| WhitepaperThis paper describes the key elements of good US/EU corporate governance for US-based biopharma companies in operating Europe. Sponsored by: Blue Matter, strategic consultants in the life sciences |
| Executive SummaryRead about the latest survey results from over 200 biopharma executives and the changing approaches to building biologic drug development pipelines. Sponsored by: Twist Bioscience |
| WhitepaperHave you had your questions about mRNA/saRNA manufacturing unanswered during a webinar; have no fear, we have you covered here. Sponsored by: Aldevron |
| Whitepaper Download Herspiegel Consulting’s Go-To-Market Model, based on 100+ launches, to learn the critical components, and timelines for commercial success. Sponsored by: Herspiegel Consulting |
| WhitepaperWhat are key considerations for intranasal delivery in the treatment of acute and chronic conditions? Sponsored By: Catalent |
| 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 |
| Research Learn more on Catalent’s step-wise approach for the definition and execution of Process Characterization for the production of a monoclonal antibody for late phase process characterization and development. Sponsored by: Catalent |
| Case Study Learn more on an approach for process characterization for the production of a monoclonal antibody, which will improve the efficiency and effectiveness of the process by targeting the right design and number of experiments. 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 |
| 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 |
| Research Learn more on an approach for process characterization for the production of a monoclonal antibody, which will improve the efficiency and effectiveness of the process by targeting the right design and number of experiments. 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 |
| 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 |
| 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 |
| 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 |
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