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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 14, 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 Nick Paul Taylor Acelyrin is about to find out whether a once well-trodden path is still open to biotechs that need big bucks to bankroll their plans. Having raised $408 million from private investors in recent years, the immune drug developer now wants public financiers to step up and help it deliver phase 2b/3 data in three indications. |
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By Annalee Armstrong Exelixis is still feuding with Farallon Capital Management, but the biotech’s board likes at least some of the activist investor’s ideas—including two new recommended board members. |
By Angus Liu Following the surprise FDA rejection of Alzheimer’s disease candidate donanemab in January, another Eli Lilly biologic drug has been met with an FDA cold shoulder. This time, manufacturing is to blame. |
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 Nick Paul Taylor Guard Therapeutics’ RMC-035 has failed to provide the hoped-for protection in a midphase study. With an interim look at the data suggesting the clinical trial was destined to fail, the Swedish biotech called an early stop to the assessment of the molecule’s ability to prevent kidney injury in heart surgery patients. |
By James Waldron Following in the footsteps of Incyte’s Opzelura, Minghui Pharmaceutical has reported phase 2 results from its own JAK inhibitor that suggests the Chinese biotech's cream could also be effective against dermatitis. |
By Gabrielle Masson After the FDA denied approval for Soligenix’s rare cancer treatment in February, the agency has now said a second clinical trial with positive results will be required to accept another request for approval. |
By Andrea Park A year and a half into the repair-and-replace program for its far-reaching respiratory recall, Philips’ website states that 90% of the production of all needed replacement devices and repair kits has been completed, and that 2.46 million of the devices and kits have been “shipped in the U.S.”—but the FDA is taking issue with the latter figure. |
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. |
By Heather Landi Tech giants and startups are off to the races to test out the potential for LLMs and generative AI tools in medicine and healthcare use cases. |
By Gabrielle Masson,Max Bayer A little more than a month after Brent Saunders returned to helm the eye-focused Bausch + Lomb, the company is set to undergo further leadership changes. |
By Angus Liu Takeda has decided to stop preclinical work on AAV gene therapies and in rare hematology areas. The Japanese pharma company also faces an anticompetition lawsuit around gout drug Colcrys. Astellas has taken hefty impairment losses on three assets. And more. |
Fierce podcasts Don't miss an episode |
| This week on "The Top Line," we talk about biotech’s top money raisers in 2022. We also cover J&J's talc litigation, prison plans for Elizabeth Holmes 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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