| Today's Big NewsApr 20, 2023 |
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An ideal home for reshoring. U.S. manufacturers gain greater control of and visibility into their supply chains, as well as access to a robust STEM talent pool, by setting up operations in Puerto Rico. 
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| By Fraiser Kansteiner Not one, not two, but three of the industry's top diabetes players last month slashed prices on their competing insulins. After Eli Lilly's move, the strategy was quickly picked up by Novo Nordisk and Sanofi, drawing praise from lawmakers and advocacy groups alike. So, what was behind the sudden change? |
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By Conor Hale Distalmotion’s Dexter robot, currently used in Europe, offers what the Swiss company describes as an on-demand, hybrid approach to procedures. |
By Max Bayer Abdera is unveiling with $142 million in combined series A and B cash to build out a new wave of radiopharmaceuticals. The biotech is planning to ask the FDA to enter clinical trials with a lead asset in 2024. |
By Zoey Becker Amgen has scored a legal victory to protect its key immunology drug Otezla for several more years. An appeals court backed a previous ruling preventing generics from Sandoz and Zydus from entering the market until 2028. |
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Tuesday, May 23, 2023 | 2pm ET / 11am PT Clinical trials are complex, time-consuming, and costly. But what if you could use simulation to guide your decisions and optimize your trial design? In this webinar, we'll discuss the power of simulation-guided trial design (SGTD) and explain its benefits to clinical development strategies. Register now to join us. 
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By Andrea Park Less than a year after putting down $240 million to acquire Ivenix and its sensor- and software-backed infusion pump, Fresenius Kabi is recalling more than 1,500 of the systems. |
By Nick Paul Taylor Bristol Myers Squibb is getting deeper into antibody-drug conjugates, paying Tubulis $22.8 million upfront to access technology designed to create more stable drugs with improved risk-benefit profiles. |
By Angus Liu After a regulatory scare, Roche can now officially kick off work on changing nearly 20 years of clinical practice for previously untreated diffuse large B-cell lymphoma. |
By Andrea Park A neurostimulation-based approach from Noctrix Health is aiming to bridge the gap in treatments for restless leg syndrome. |
By Nick Paul Taylor The nine-year wait for new clinical data on Promore Pharma’s ensereptide has ended in disaster, with the failure of the polypeptide to reduce scarring in a midphase trial wounding the biotech’s share price. |
By Kevin Dunleavy Veru sold its drug for enlarged prostate, Entadfi (finasteride and tadalafil), to Blue Water Vaccines. The deal is for $20 million up front, plus an additional $80 million if sales milestones are met. Blue Water is also renaming itself to Blue Water Biotech. |
Fierce podcasts Don't miss an episode |
| This week on "The Top Line," we discuss how this year is chock-full of blockbuster drugs headed for the patent cliff, besides the well-known patent cliff for AbbVie's Humira. We also cover Johnson & Johnson's talc settlement offer and more of this week's top headlines. |
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Wednesday, April 26, 2023 | 12pm ET / 9am PT Our speakers will explore how science-based organizations are producing more data than ever before, and why digital transformation strategies to leverage this data, like AI and machine learning, require the right infrastructure of connected, searchable, and harmonized data. Register now. |
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Research Strategies for Optimal Site Selection and Feasibility Research in Novel Therapies and Geographies Sponsored by: H1 |
Whitepaper How can eConsent provide a more flexible approach to informed consent? Sponsored by: YPrime |
Whitepaper The preclinical hematotoxicity screening method that helps clients eliminate bad players earlier in the drug development process Sponsored by: ReachBio | The Cell Biology Experts™ |
Whitepaper We’ve identified four must-have tools to manage today’s scientific information chaos. How many are you utilizing? Sponsored By: CCC |
Whitepaper How advanced medicines commercial readiness differs and the resources needed to maximize potential. Sponsored by: Herspiegel Consulting |
Whitepaper This paper outlines an approach that digital health / therapeutics companies can use when developing a go-to-market strategy for the complex US market. Presented by Blue Matter, strategic consultants in the life sciences |
Whitepaper Preparation 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 |
Whitepaper Explore 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 Discover 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 |
Whitepaper For 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 |
Whitepaper Learn 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 |
Whitepaper How 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 |
Whitepaper Planning 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 |
Whitepaper Explore 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 |
| May 1-3, 2023 | Jersey City, NJ |
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