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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 28, 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 Annalee Armstrong Novartis has hopped on Bicycle Therapeutics’ radio-conjugates ride with a $50 million upfront payment and a further $1.7 billion possible down the road. |
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By Andrea Park For the first time in at least a decade, the head of Johnson & Johnson’s medtech division is among the company’s highest-paid executives. |
By Kevin Dunleavy The FDA has identified a date for its long-awaited advisory committee meeting to discuss whether Perrigo’s birth control medication Opill can be used without a prescription. The joint meeting of the Nonprescription Drugs Advisory Committee (NDAC) and the Obstetrics, Reproductive and Urologic Drugs Advisory Committee (ORUDAC) has been set for May 9-10. |
By Max Bayer Ferring Pharmaceuticals is closing up a U.S. research wing, laying off 89 employees as a result. The Ferring Research Institute has been in business since 1996 and just wrapped up a new expansion project. |
By Fraiser Kansteiner Short seller Scorpion Capital was all venom in a new report rebuking Harmony Biosciences and its narcolepsy drug Wakix. The firm branded Harmony’s rollout one of the most “thoroughly corrupt healthcare schemes in recent years.” |
By Andrea Park Masimo’s first smartwatch gathers data every second. Its second caters to those who may be wary of where, exactly, those 86,400 daily measurements go. |
By Nick Paul Taylor Boehringer Ingelheim has spied an opportunity to seize the holy grail of immuno-oncology: turning cold tumors hot. In return for $10 million upfront and up to $471 million milestones, the German drugmaker has tasked Covant Therapeutics with discovering covalent candidates against an emerging cancer target. |
By Fraiser Kansteiner Amicus Therapeutics' Pombiliti—which combines a long-term enzyme replacement therapy with the oral enzyme stabilizer miglustat—has been approved by the European Commission as Pombiliti in adults with late-onset Pompe disease. Now, the company must wait on the European Medicines Agency’s Committee for Medicine Products for Human Use to deliver a verdict on miglustat specifically. |
By Conor Hale The deal includes single-use oxygen delivery systems and devices for opening the patient’s airway, such as positive-pressure ventilation masks and tubing. The financial terms of the transaction were not disclosed. |
By James Waldron With its lead chronic pouchitis treatment stuck in limbo as the company searches for a phase 3 partner, it looks like Applied Molecular Transport has finally thrown in the towel. |
By Zoey Becker Milestone payments can be hard to come by when two partners can't agree on trial results. Now, Esperion slapped its Nexletol partner Daiichi Sankyo with a lawsuit after the latter refused a $300 million payout. |
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 |
| 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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