| Today's Big NewsFeb 24, 2023 |
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Tuesday, March 14, 2023 | 2pm ET / 11am PT Join this webinar to hear industry experts across the clinical research space share their perspectives on inefficiencies in the current clinical research space, how to prioritize change, where to begin, how to measure success, and considerations when evaluating and selecting enabling technology. Register now.
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| By Nick Paul Taylor Novartis is nixing a nonalcoholic steatohepatitis candidate amid a narrowing of its therapeutic focus, walking away from a Pliant Therapeutics program it paid $50 million for back in 2019. |
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By Angus Liu Drug reviewers at the European Medicines Agency have recommended an approval for the combination of Zejula and Zytiga for metastatic castration-resistant prostate cancer. But only patients with BRCA1/2-mutated tumors will be eligible for the fixed-dose combo. |
By Andrea Park For all of 2022, Insulet took in $1.3 billion, an increase of more than 18% over the previous year’s $1.098 billion total, according to an earnings report published Thursday. |
By Eric Sagonowsky Moderna and the U.S. government are putting one patent dispute to bed. Under a licensing deal inked late last year, the mRNA specialist recently paid a $400 million "catch-up payment." |
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Tuesday, March 21, 2023 | 11am ET / 8am PT Today’s clinical trials are longer and more complex than ever. Sponsors, sites, and patients need technology that is practical, easy to use, and strengthens studies’ scientific integrity. This webinar will explore how approaches from B2B and consumer technologies can be leveraged to streamline processes, deliver quality outcomes data, and more. Register now.
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By Teresa Carey This week on "The Top Line," we discuss a checklist that the Society for Immunotherapy of Cancer released last October. The guidelines are designed to maximize the value of phase 3 immuno-oncology combination trials. We also cover the top headlines from this week. |
By Andrea Park Under the terms of the acquisition, Olympus will hand $255.5 million to Taewoong in cash as soon as the deal closes, then will mete out up to $114.5 million more if and when Taewoong’s business hits certain milestones. |
By Annalee Armstrong Fulcrum Therapeutics’ sickle cell disease therapy has been placed on a clinical hold by the FDA, capping off a tough week for drug development for the condition that saw three separate treatments discontinued. |
By Zoey Becker Sanofi and partner Sobi are coming back to the hemophilia A market with a vengeance after Roche’s Hemlibra ate up sales of their aging Eloctate. The duo expects the once-weekly Altuviiio to be commercially available in April. |
By Nick Paul Taylor Nektar Therapeutics’ hopes of rebuilding its battered business around lupus lie in tatters. The key phase 2 clinical trial of rezpegaldesleukin missed its primary endpoint, prompting partner Eli Lilly to drop plans for further development in lupus and reassess its next steps in atopic dermatitis. |
By Andrea Park Spinal cord stimulators were first approved to treat chronic pain in 1989, but in more recent years, researchers have begun studying the technology’s potential to address other conditions including those affecting movement. |
Fierce podcastsDon't miss an episode |
| This week on "The Top Line," we discuss a checklist that the Society for Immunotherapy of Cancer released last October. The guidelines are designed to maximize the value of phase 3 immuno-oncology combination trials. We also cover the top headlines from this week. |
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Wednesday, March 29, 2023 | 2pm ET / 11 am PT Attendees will come away with a deeper understanding of how genetic counseling and genetic services workflows can help biopharma organizations more effectively identify patients that qualify for their clinical trials and/or commercial therapeutics, the value of customized genetic services workflows in optimizing clinical trial/sponsored testing program ROI, and more. Register now.
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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 |
| On-Demand Webinar See how high-throughput DNA synthesis combined with antibody engineering expertise provides end-to-end antibody discovery solutions. Sponsored by: Twist Bioscience |
| WhitepaperWhat are key considerations for intranasal delivery in the treatment of acute and chronic conditions? 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 |
| 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 |
| 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 |
| WhitepaperDiscover key considerations that every trial sponsor should know when navigating the complex clinical supply distribution landscape across Asia-Pacific. Sponsored by: Catalent |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
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