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FDA Cleared TAP®️ Micro Select enables remote blood collection with HALO™️ technology, a bladeless micro-needle array delivering virtually painless, large volume collection up to 500 uL. Click now.
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Today's Big NewsMay 1, 2023 |
| By Kevin Dunleavy Chris Viehbacher, who took over as CEO at Biogen in November, collected a pay package worth $30.5 million last year, according to an SEC filing. Most of the pay came in the form of equity awards, inducing him to join the company. The figure will make him one of the highest-paid execs in the industry in 2022. |
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By James Waldron Big Pharma dealmaking may have remained relatively tepid in the first quarter, but some of the bigger European players used their earnings calls last week to suggest they may be turning on the spending taps later in the year. |
By Ben Adams Welcome to the breakdown of the top 10 biggest drug ad spenders in pharma for 2022 as we reveal who funneled the most cash into their campaigns. |
By Conor Hale When linked to Ypsomed’s pump and an app developed by University of Cambridge spinout CamDiab, Abbott said the trio can help algorithmically manage background insulin levels in people with Type 1 diabetes. |
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Thursday, May 25, 2023 | 10:00am ET / 7:00am PT Join the webinar and discover our MVA technology platform and explore the advantages for development and manufacturing of multiple vaccines and cell and gene therapeutics. Register now.
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By Angus Liu A panel of external experts for the FDA voted 11 to 1 in support of a narrow approval for AstraZeneca and Merck's Lynparza in metastatic castration-resistant prostate cancer (mCRPC). A comment from FDA's oncology chief Rick Pazdur, M.D., likely played a crucial part in Friday's vote outcome. |
By Nick Paul Taylor The multibillion-dollar biotech buyouts keep on coming. Astellas Pharma is the latest drugmaker to get in on the act, agreeing to pay $5.9 billion to buy Iveric Bio and establish itself as a player in an emerging eye disease niche. |
By Conor Hale The new Elevage Medical Technologies will follow the approach of Patient Square’s Enevate Sciences—which made its debut nearly a year ago to the day. |
By Zoey Becker After the FDA threw a wrench in Ascendis' plans for a hypoparathyroidism drug approval by flagging deficiencies in its application, the agency has now issued a complete response letter. |
By Max Bayer Sanofi is betting up to $750 million to license a phase 2-ready treatment for Pompe disease from Maze Therapeutics. The deal includes $150 million in upfront cash and equity. |
By Conor Hale According to the company, the the Micra AV2 and VR2 can offer up to 40% more battery life over their predecessors. |
By Sharon Klahr Coey Moderna’s new TV spot, “Welcome to the mRNAge," is here to let people know that messenger RNA vaccines are not just a one trick (COVID-19) pony. |
By Max Bayer Ovid Therapeutics has taken another leap forward in its quest to treat seizures and rare brain disorders, buying into a clinical-stage Rock2 inhibitor from a biotech led by Sam Waksal, Ph.D. |
By Joseph Keenan Aldevron, a subsidiary of Danaher, unveiled plans to expand its mRNA manufacturing operations to include lipid nanoparticle (LNP) encapsulation and aseptic fill-finish capabilities. |
Fierce podcastsDon't miss an episode |
| | This week on "The Top Line," we're launching a mini-series on Narcan the nasal spray. It is the first naloxone product to be approved for use without a prescription. |
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Thursday, May 11, 2023 | 2pm ET / 11am PT Medical imaging holds a wealth of valuable data that can power R&D. Join us to learn how to overcome historical challenges such as the need for expertise in the field and a lack of comprehensive tools. We'll explore ways medical imaging data can be utilized in R&D, strategies for organizing and re-purposing legacy data, and more. Register now.
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| eBookDiscover a game-changing approach to clinical research with Hybrid and Decentralized Clinical Trials (DCTs). Learn about the benefits, challenges, and key elements for success. Sponsored by: EvidentIQ |
| ResearchWhat role do the Library and Legal teams play in the drug development pipeline at Lilly? An import one – find out how. Sponsored by: CCC |
| WhitepaperThis paper focuses on stakeholder engagement and how Medical Affairs teams’ responsibilities, goals, tools, and techniques are changing. Sponsored by: Blue Matter, strategic consultants in the life sciences |
| ResearchStrategies for Optimal Site Selection and Feasibility Research in Novel Therapies and Geographies Sponsored by: H1 |
| WhitepaperHow can eConsent provide a more flexible approach to informed consent? Sponsored by: YPrime |
| WhitepaperThis 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 |
| 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 |
| 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 |
| 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 |
| 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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