| Today's Big NewsApr 13, 2023 |
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July 18-19, 2023 | Jersey City, NJ Hear the latest industry trends from leaders in the field, and developed with input from our esteemed advisory board, to ensure you have a sound plan for your company, brands, and yourself. Save $500 when you Register Today!
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| By Gabrielle Masson In the first quarter of 2023, 56 biopharmas laid off staff—an 87% jump compared to 2022, when 30 companies reported layoffs for the same period, according to a Fierce Biotech analysis. |
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By Fraiser Kansteiner In its “skinny label” legal saga with Teva, GSK has hit back following the U.S. Solicitor General’s call for the Supreme Court to rehear the yearslong case. GSK argues the U.S. took a myopic view of the arguments. |
By Andrea Park In the wake of CFO Karen Parkhill’s February announcement that Medtronic would deliver “significant expense reductions” in the final months of its 2023 fiscal year—which closes out at the end of April—the medtech giant is closing a California facility, resulting in a round of layoffs. |
By Nick Paul Taylor Pharma has overtaken tech to become the second-largest industry for ad spending in 2023. That is one of a wealth of insights from the latest look at the data from SMI, which found pharma is dialing up spending on established mediums such as linear TV while simultaneously expanding quickly in digital video and podcasts. |
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Thursday, April 20, 2023 | 11am ET / 8am PT In this presentation, we highlight key study design challenges and considerations for rare disease CGT trials and discuss the potential for leveraging in silico approaches for generating synthetic control arms that enable a control-based comparative assessment of efficacy. Register now.
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By Max Bayer Novavax has cut $50 million in costs in the first quarter, which may just be the tip of the iceberg, according to an interview with new CEO John Jacobs in Reuters. |
By Angus Liu Vertex and CRISPR Therapeutics’ gene editing-based exa-cel and bluebird bio’s gene replacement therapy lovo-cel can be priced up to $1.93 million to be cost-effective, the Institute for Clinical and Economic Review said in a draft report. |
By Conor Hale The former Fierce Medtech Fierce 15 winner's spring-loaded Misha implant cushions the thigh and shin bones of people suffering from painful osteoarthritis. |
By Nick Paul Taylor Prothena has enlisted an ally to boost its pursuit of Biogen and Eisai in Alzheimer’s disease. Working with Walgreens, the biotech aims to accelerate enrollment in an early-phase clinical trial of a potential rival to Leqembi. |
By Andrea Park The FDA is feeling the heat. Just in time for summer, the agency has cleared an adhesive patch from Candesant Biomedical that’s designed to reduce excessive underarm sweating for several months after just a few minutes of wear. |
By James Waldron The string of recent clinical successes for the antibody zolbetuximab has not only been welcome good news at AstraZeneca and Astellas, it has also buoyed biotechs working on their own Claudin-targeting therapies. |
By Eric Sagonowsky Seeking a new approval to curb agitation in Alzheimer's patients, Lundbeck and Otsuka Pharmaceutical are gearing up for an important test Friday. And it appears the FDA is open to a potential nod for their atypical antipsychotic Rexulti. |
By Ben Adams Horizon Therapeutics is reaching for the sky as it becomes the highest ranked pharma on Fortune’s annual Best Companies To Work For list for the second year in a row. |
By Andrea Park On the heels of a small NIH-backed study showing that its neurostimulation technology could improve upper limb mobility in people partially paralyzed by stroke, Reach Neuro has grabbed the FDA’s attention. |
Fierce podcasts Don't miss an episode |
| This week on "Podnosis," we discuss Medicaid redeterminations and the long-term outlook for the misunderstood program. We also talk about colorectal cancer and what stakeholders can do to tackle this disease. |
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Thursday, May 4, 2023 | 11am ET / 8am PT Join industry experts for this insightful webinar to learn more about enzyme inhibition studies. We’ll explore how these studies drive informed decisions for drug developers, frequently asked questions from sponsors, recommendations for achieving successful regulatory submission, and more. Register now. |
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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 |
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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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