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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 12, 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 Annalee Armstrong The biopharmas that objected to a Texas judge’s ruling suspending the approval of the abortion drug mifepristone are not content with just a letter. The companies have now banded together to support the U.S. government’s appeal in an amicus brief. |
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By Nick Paul Taylor The evidence that drug-induced liver injury is a classwide problem for BTK inhibitors is mounting up. In the wake of its partial clinical holds on studies involving Biogen and Sanofi, the FDA has clamped down on trials of Merck KGaA’s contender in response to evidence of damage to the liver of two patients. |
By Nick Paul Taylor Junshi Biosciences has established its credentials as the next challenger for the increasingly congested Chinese PARP inhibitor market. A phase 3 trial of the candidate hit its primary endpoint, setting Junshi up to compete with products including AstraZeneca and Merck & Co.’s Lynparza for the ovarian cancer space. |
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 Andrea Park Novo Nordisk’s diabetes treatments have so far revolved around injected insulins and other medications along with a slate of insulin pen technologies to help perform those injections. Now, however, the Big Pharma is looking even deeper under the skin for its next diabetes therapeutic. |
By James Waldron Employees at Aeglea BioTherapeutics who survived the company’s previous two rounds of layoffs may be left wondering if it was worth it, as the biotech effectively throws in the towel in response to the latest data from one of its two remaining rare disease candidates. |
By Kevin Dunleavy The FDA has signed off on an expansion to Takeda's plasma-derived therapy HyQvia to treat children with primary immunodeficiency. The news comes three weeks after Takeda revealed it was building a new manufacturing facility in Japan which would increase the company’s capacity for plasma production nearly fivefold in that country. |
By Teresa Carey 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. |
By Andrea Park Elizabeth Holmes must report to prison at the end of this month as previously scheduled, the judge in her case ruled this week, shutting down the disgraced Theranos founder’s bid to delay her sentence while she appeals her conviction. |
By Nick Paul Taylor Have Sanofi and Regeneron done it again? After birthing a blockbuster eczema market with the launch of Dupixent, the partners have now seemingly repeated the trick with an eosinophilic esophagitis rollout that is going gangbusters and likely still has several years of competition-free growth to come. |
By Dave Muoio Though quit rates remain high, other metrics such as payroll adds, open position rates and wage growth are all beginning to trend in favor of healthcare employers, the ratings agency said in a recent sector update. |
By Conor Hale A study of miniaturized, leadless pacemakers found that, due to their smaller size, they could provide a promising, short-term option for certain children with abnormally slow heartbeats. |
By Angus Liu Astellas is doing some house cleaning under new CEO Naoki Okamura, booking impairments from three programs before its full-year earnings report. |
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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