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As protein engineering and manufacturing technologies evolve, small biotech and major pharma companies alike need flexible, customized strategies that balance cost, speed and risk to accelerate drug development and approval of biotherapeutics that could address unmet medical needs. Download white paper.
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Today's Big NewsMar 22, 2023 |
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Puerto Rico is the perfect location for reshoring & securing operations. Benefit from unmatched tax incentives, USA legal framework, & world-class talent. Plus, made in Puerto Rico is made in the USA. Learn more.
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| By Kevin Dunleavy After an unsuccessful bid to get its appeal reheard in the Third Circuit Court on Wednesday, Johnson & Johnson said it will make one last appeal to the U.S. Supreme Court to legitimize its strategy to funnel more than 38,000 talc lawsuits into a company it created with the intent to declare it bankrupt. |
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By Max Bayer VistaGen's social anxiety nasal spray passed an open-label phase 3 test, showing it was safe and effective. The company said treated patients also showed improvement in a measurement of social anxiety. |
By Andrea Park As Eli Lilly inches ever closer to the finish line in its yearslong mission to bring an Alzheimer’s disease drug to the market, the company has picked up a side quest. |
By Angus Liu In what’s expected to be one of AbbVie’s “biggest new product launches” in the coming years, the company has hit a snag. The FDA rejected AbbVie’s Parkinson’s disease combo therapy over questions about its delivery pump. |
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Thursday, Apr 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.
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By Nick Paul Taylor Astellas Pharma’s zolbetuximab has gone two for two, chalking up a second phase 3 win to cement its status as the front-runner in the race to deliver a drug against one of the hottest targets in cancer today. |
By Andrea Park Medtronic and Nvidia announced a partnership this week that will see them attempt to build out an entire ecosystem of AI tools for diagnosis and other healthcare uses, using the GI Genius colonoscopy AI as a jumping-off point. |
By Gabrielle Masson Things are heating up at Flare Therapeutics, with big names like Pfizer, Eli Lilly and Novartis adding fuel to the biotech’s fire in a new $123 million financing round. |
By Fraiser Kansteiner The National Institutes of Health (NIH) rejected a petition to exercise so-called march-in authority around Pfizer and Astellas' Xtandi. The same fate befell a similar petition back in 2016 and comes after a trio of U.S. Senators last year pressed Department of Health and Human Services Secretary Xavier Becerra to move forward with the campaign. |
By Andrea Park Riding high on early clinical trial results showing that its neuromodulation headset can improve memory and cognition and slow the deterioration of white matter in the brains of people with Alzheimer’s disease, Cognito Therapeutics has now secured a flurry of funding to delve even deeper into the technology. |
By Nick Paul Taylor GSK has teamed up with Earvin “Magic” Johnson to “Sideline RSV.” Working with the former basketball star and public health advocate, GSK is raising awareness of the risks respiratory syncytial virus (RSV) poses to older adults—and laying the groundwork for its upcoming vaccine launch in the process. |
By Max Bayer Biohaven is using business development to once again bolster its pipeline, this time tacking on a brain-penetrating treatment for neuroinflammatory diseases slated to hit the clinic within a year. Biohaven has signed a $970 million agreement with Highlightll Pharma for ex-China rights to the drug. |
By Zoey Becker After Novartis in 2020 struck a partnership with England's National Health Service to study cholesterol-lowering drug Leqvio as a primary prevention med in patients with atherosclerotic cardiovascular disease, the company is changing course. |
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 the SVB failure, what to expect next and what it all meant for the biotech industry. We also cover Pfizer's big acquisition, insulin prices and more of this week's top headlines. |
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Thursday, March 30, 2023 | 1pm ET/ 10am PT Enzymes have long demonstrated their utility as a green alternative to metal-based catalysts, but the evolution time required can be significant. Join this webinar to learn about an extracellular strategy that reduces the evolution cycle and enables biocatalysis to be used much earlier in development. 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 |
| 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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