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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 27, 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 Andrea Park Seemingly undeterred by reports earlier this month that the FDA had rejected an early 2022 request from Neuralink to begin a clinical trial of its brain implant, Elon Musk's brain-computer interface company is reportedly plowing ahead with plans for human testing. |
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By Fraiser Kansteiner Looking to tackle issues ranging from climate change to cell therapy production, the Biden Administration has issued a panoply of biomanufacturing targets. |
By Max Bayer The latest R&D budget rankings looks a lot like the 2021 list, but Sanofi cracked the list this year and shifts in positions occurred, like Merck reaching the podium after jumping Pfizer for third place. |
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. |
By Max Bayer Historically known for developing a handful of cystic fibrosis treatments, Vertex is now going deeper into diabetes and its work with CRISPR Therapeutics in a new $330 million deal. |
By Angus Liu Novartis' highly anticipated NATALEE trial reported a positive readout, showing Kisqali could pare back disease recurrence in an early breast cancer population that's broader than Eli Lilly's Verzenio. |
By Nick Paul Taylor AbbVie is 10 years old. To get the message out, the Big Pharma has turned to its critical resource: its employees. Across a blog post and social media updates, AbbVie has made employees the primary voice of the campaign to enable them to “express their pride” and show what it’s like to work at the company. |
By James Waldron Only two weeks after crashing Redx Pharma’s planned reverse merger into Jounce Therapeutics, Concentra Biosciences’ unsubtle tactics appear to have paid off as it walks home with Jounce. |
By Conor Hale The FDA has laid down a path for the developers of COVID-19 tests and other pandemic-focused medical devices to finally make the transition to the foreseeable regulatory future, where the coronavirus will be treated as more endemic than emergency—and the agency is urging companies to get their paperwork in ASAP. |
By Eric Sagonowsky Even as Novo Nordisk rides the momentum of Rybelsus' hot launch, the company is testing higher-dose versions of the diabetes drug that could broaden its reach in a competitive market. Now, as part of the effort, the company is declaring a late-stage win. |
By Andrea Park Only a few months after it quietly conducted a reduction in force, iCad is once again laying off another chunk of its workers. |
By James Waldron More than a year after Gamida Cell slimmed down its workforce, the biotech has again resorted to laying off staff to keep the long-delayed plans for its blood cancer treatment omidubicel on the road. |
By Andrea Park An artificial-intelligence-powered screening tool could make it easier for doctors to decide on the best treatment route for patients with certain types of brain tumors, according to a newly published study. |
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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