| Editor’s Note: Fierce Biotech will not publish Monday, Feb. 20 in observance of Presidents' Day. We’ll be back in your inboxes Tuesday, Feb. 21. |
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While typically required for a product’s marketing approval, in some situations conducting a randomized controlled trial is unethical or impractical. Often in these scenarios, the solution is to use an in silico method to construct a virtual patient control arm. Download our guide to learn how in silico approaches can be used to evaluate drug candidates before clinical trials or in single-arm clinical trials.
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Today's Big NewsFeb 17, 2023 |
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Learnings from three IQVIA case studies. Accelerate your trials with these strategies: contract execution to go-live in 3 months, 50% timeline reduction in study build and 95% patient compliance. On-Demand Now.
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| By Annalee Armstrong Moderna checked off two influenza A strains in a phase 3 clinical trial for a new flu shot candidate, but the vaccine struggled against two B strains in the same test, marking a mixed readout for the famed mRNA biotech. |
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By Nick Paul Taylor Pfizer and Valneva’s phase 3 Lyme disease vaccine clinical trial has gone badly wrong. After discovering good clinical practice violations at some trial sites, the partners have removed around half of the enrolled participants from the study. |
By James Waldron Rather than racing to get an “off-the-shelf” CAR-T into the clinic or going all-in on a solid tumor strategy, GSK executives told Fierce Biotech they believe the Big Pharma's genetics expertise will offer the smoothest path to market success. |
By Helen Floersh Most patients with EGFR-mutated NSCLC will go on to develop drug-resistant tumors, even after a successful initial treatment course. Now, scientists have found a way to wipe out leftover EGFR-mutated NSCLC cells before they develop complete resistance. |
By Andrea Park A year after Charles River Laboratories teamed up with artificial intelligence developer Valo Health to build an AI-powered drug discovery and development platform, the contract research organization is putting that tech to work. |
By Kevin Dunleavy Madrigal’s resmetirom fared better than Intercept’s Ocaliva in a study by ICER assessing cost-effectiveness in non-alcoholic steatohepatitis (NASH). There are no approved treatments for the disorder which affects between 1.5% and 6.5% of adults in the United States. |
By Robert King Senators decried the lack of transparency in the PBM industry during a hearing Thursday, as lawmakers have sought to jump-start reforms to the controversial market. |
By Kevin Dunleavy A survey by social media network Sermo shows that 77% of physicians do not favor pharmacists having the power to switch patients from reference products to biosimilars. Only 19% say that financial savings to patients is a consideration in deciding whether to prescribe biosimilars. |
By Andrea Park In a full-year earnings report published Thursday, Labcorp reported a 7.7% year-over-year drop in revenues in 2022, thanks almost entirely to a COVID diagnostics haul that weighed in at less than half the size of the previous year’s. |
By Robert King The Senate HELP Committee is launching a new effort to shore up the healthcare workforce shortage that has been roiling the industry since the start of the COVID-19 pandemic. |
By Angus Liu Takeda's Iclusig beat Novartis' Gleevec in a type of acute lymphoblastic leukemia. Biogen has returned a BTK inhibitor to China's InnoCare Pharma. Astellas made its first ad appearance during the Super Bowl. And more. |
By Gabrielle Masson,Max Bayer Sanofi's head of global R&D John Reed, M.D., Ph.D., has left for a spot at rival Big Pharma Johnson & Johnson, where he'll serve as executive vice president of pharmaceutical R&D. |
Fierce podcastsDon't miss an episode |
| | This week on "The Top Line," we discuss the intense patent fight between Moderna and Pfizer-BioNTech around the mRNA technology used in their COVID-19 vaccines. We also talk about negotiating vaccine contracts via text messages, one of the biggest medtech deals of the year and other top headlines from this week. |
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| ResearchLike many top 10 and global pharma companies, an H1 client needed to diversify both its patient outreach and site investigator profiles for upcoming trials. Sponsored by: H1 |
| Whitepaper Discover the Power of Small with NanoplasmidTM – the next-generation plasmid for manufacturing today’s cell and gene therapies. Sponsored by: Aldevron |
| WhitepaperThis paper explores the cost drivers behind gene therapies and how they are likely to evolve in the coming years. Sponsored by: Blue Matter |
| WhitepaperExploring the biology of G Protein-Coupled Receptors (GPCRs) and outlining a novel approach for developing therapeutics against previously undruggable GPCRs Sponsored by: Orion Biotechnology |
| WhitepaperLearn more about critical success factors for your next launch based on the experience of 100+ pharma product launches. Sponsored by: Herspiegel Consulting |
| Whitepaper What makes nucleotides suitable for current good manufacturing practices? Sponsored by: Thermo Fisher Scientific |
| WhitepaperWhat are key considerations for intranasal delivery in the treatment of acute and chronic conditions? Sponsored By: Catalent |
| Research Learn more on Catalent’s step-wise approach for the definition and execution of Process Characterization for the production of a monoclonal antibody for late phase process characterization and development. Sponsored by: Catalent |
| 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 |
| 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 |
| WhitepaperDiscover key considerations that every trial sponsor should know when navigating the complex clinical supply distribution landscape across Asia-Pacific. 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 |
| Research Learn more on an approach for process characterization for the production of a monoclonal antibody, which will improve the efficiency and effectiveness of the process by targeting the right design and number of experiments. 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 |
| 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 |
| Case Study Learn more on an approach for process characterization for the production of a monoclonal antibody, which will improve the efficiency and effectiveness of the process by targeting the right design and number of experiments. Sponsored by: Catalent |
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