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Evaluating multiple doses of a candidate drug in phase 2 studies can be challenging when assessing a dose-effect signal compared to placebo. Bayesian response-adaptive design is an increasingly popular alternative to help make the process more efficient. Our blog has 5 things you need to know about this alternative design. Premier Research. Built for Biotech℠. .png)
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Today's Big NewsApr 13, 2023 |
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Insights from 450+ sponsors, CROs, and sites on the trends shaping clinical trials in 2023. Learn more. .png)
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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 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 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. |
Sponsored by Parexel Biotech Where is clinical R&D heading? And to what extent are biopharmas using and applying new approaches such as adaptive designs, DCTs, and ECAs? 33 biopharma executives share their insights. |
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 Nick Paul Taylor Pyramid Biosciences’ current pipeline is built around the kinase TRK. But the biotech has now struck a deal that will take it down a new path, paying $20 million upfront and betting $1 billion in biobucks for the ex-greater China rights to a would-be challenger to Gilead’s ADC Trodelvy. |
By Gabrielle Masson,Max Bayer,Annalee Armstrong Alongside the new year, we've launched a new Fierce Biotech Fundraising Tracker to keep the pulse on the industry's financing. |
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 Joseph Keenan Ora has brought on industry expert Paul Colvin as its new chief operating officer to help lead the ophthalmology CRO’s global growth. |
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 Joseph Keenan IMA Clinical Research’s parent IMA Group has acquired Accelemed Research Institute for an undisclosed price, continuing the clinical trial site company’s expansion march across the U.S. |
By Robert King A federal appeals court has partially stayed a lower court's ruling that suspended FDA approval of the abortion drug mifepristone. |
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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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 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 Discover key considerations that every trial sponsor should know when navigating the complex clinical supply distribution landscape across Asia-Pacific. 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 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 |
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 |
| May 1-3, 2023 | Jersey City, NJ |
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