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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 20, 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 Nick Paul Taylor For Sangamo, last week is probably one to forget. Late on Friday, the gene-based therapy biotech revealed it had lost two partners in quick succession, with Biogen and Novartis walking away from partnerships collectively worth billions of dollars in milestones within days of each other. |
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By Angus Liu Under David Ricks’ leadership, Eli Lilly’s stock price reached a record high in 2022. But the CEO’s pay decreased slightly last year. |
By Andrea Park Since its humble beginnings back in 2012, the Fierce 15 has made a point of spotlighting the most exciting startups in medtech—those not only challenging the limits of both the tech and healthcare industries but also making real progress toward their lofty goals. The companies on this year’s list—which kicks off the second decade of Fierce Medtech’s Fierce 15—are setting the bar even higher. |
By Fraiser Kansteiner Ozempic, which has been in short supply for some six months, is once again available in two common, lower doses, while a third higher dose will maintain limited availability through the end of the month, according to the U.S. Food and Drug Administration’s drug shortage database. Novo Nordisk confirmed the restocking in an emailed statement. |
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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 Andrea Park In the week since Carl Icahn sent an open letter to Illumina shareholders to drum up support for a proxy battle, the fight between the billionaire activist investor and sequencing giant has only continued to heat up. |
By Gabrielle Masson As Athenex’s cash dries up, the FDA has slapped a clinical hold on its phase 1 trial assessing a CAR-NKT cell therapy for neuroblastoma in the wake of a patient death. |
By Ben Adams AstraZeneca has been reprimanded by the U.K. drug marketing authority for a series of breaches of its code of conduct across its website for its respiratory franchise. |
By Max Bayer Gilead has selected the first fruit borne from a 2019 collaboration with Nurix, taking on an IRAK4 degraded to tackle inflammatory diseases. Gilead is paying up to $445 million to exclusively license the med. |
By Andrea Park The FDA cleared a pair of tests this week both aimed specifically at improving diagnoses of women’s health conditions. |
By Zoey Becker While UCB waits for the FDA's approval decision on bimekizumab in psoriasis, the company is touting new data in another indication. The company presented 48-week data in hidradenitis suppurativa at the American Academy of Dermatology's 2023 meeting. |
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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