| Today's Big NewsMay 31, 2023 |
| By Kevin Dunleavy In the rush to supply prescriptions of Novo Nordisk’s popular diabetes and weight loss meds, some pharmacies are making unauthorized versions of Ozempic and Wegovy, the FDA warned on Tuesday. Some compounding pharmacies are using unauthorized versions of semaglutide, according to the FDA. |
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By Nick Paul Taylor More than 20 years after a pre-merger Biogen and Idec independently raised safety concerns about the mechanism, the French drugmaker has presented phase 2 data that suggest its second-generation drug candidate may be safe and effective in multiple sclerosis. |
By Zoey Becker As drug shortages persist nationwide, the director of the FDA Oncology Center of Excellence, Richard Pazdur, M.D., talked about the root cause of the problem and the agency's response. One cause, he says, is that manufacturers haven't invested enough to build capacity. |
By Andrea Park A recent warning letter from the FDA may have iRhythm Technologies changing its tune. |
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Wednesday, Jun 14, 2023 | 10:00am ET / 7:00am PT Targeting proteins for degradation therapeutically, as an alternative to inhibiting them, holds great promise for treating diseases in which pathogenic proteins are considered "undruggable" due to a lack of active sites for conventional small molecules. Register now.
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By Max Bayer Precision BioSciences has landed on an ideal patient population for its lead off-the-shelf cell therapy to treat blood cancer, and it’s, well, precise. |
By Ben Adams Novo Nordisk has lit the tinder of a new megablockbuster market with Saxenda and Wegovy as new, branded anti-obesity drugs are set to haul in $44 billion by this decade’s end. |
By Annalee Armstrong There are, at this moment, 187 clinical trials for the neurodegenerative disease underway, the highest ever on record, according to a new report from the Alzheimer’s Association. |
By Kevin Dunleavy The U.K.'s National Institute for Health and Care Excellence has recommended approval of Pfizer's Nurtec (Vydura) but with lots of restrictions. |
By Nick Paul Taylor Yuhan Corporation has bought its way into a cancer space targeted by Boehringer Ingelheim and Takeda, wagering up to $325 million to get its hands on a preclinical HER2 tyrosine kinase inhibitor. |
By Andrea Park A year after its neuromodulation device became the first non-drug treatment cleared by the FDA to relieve chronic pain associated with fibromyalgia, NeuroMetrix is one step closer to adding another first-of-its-kind indication to the technology. |
Fierce podcastsDon't miss an episode |
| | This week on "Podnosis," we discuss why generative AI can be "game-changing" in healthcare. We also take a second look at an episode on gender-affirming healthcare |
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Thursday, June 15, 2023 | 11am ET / 8am PT In this era of personalized medicine, biomarkers can provide important insights at every stage of drug discovery and development. By advancing our understanding of cancer pathophysiology and tumor profiling, they play a critical role in the rational development of novel therapies. Register now to learn more.
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| WhitepaperThis paper outlines various market archetypes and key considerations leaders must address when prioritizing new potential markets for gene therapies. Sponsored by: Blue Matter, strategic consultants in the life sciences |
| WhitepaperChatGPT shows promise in drug discovery for information extraction, scientific text authoring, hypothesis prediction, and chemical entity prediction. This whitepaper explores its potential to streamline research, delving into its technology, applications, and limitations. Sponsored by: Elucidata Corp., Cloud SAAS in Life Sciences R&D |
| WhitepaperLearn how a GPCR-focused library with a cell-based biopanning strategy led to the discovery of 13 high-affinity and selective anti-GLP-1R antibodies with highly developable therapeutic properties. Sponsored by: Twist Bioscience |
| eBookDiscover a game-changing approach to clinical research with Hybrid and Decentralized Clinical Trials (DCTs). Learn about the benefits, challenges, and key elements for success. Sponsored by: EvidentIQ |
| ResearchWhat role do the Library and Legal teams play in the drug development pipeline at Lilly? An import one – find out how. Sponsored by: CCC |
| WhitepaperThis paper focuses on stakeholder engagement and how Medical Affairs teams’ responsibilities, goals, tools, and techniques are changing. Sponsored by: Blue Matter, strategic consultants in the life sciences |
| ResearchStrategies for Optimal Site Selection and Feasibility Research in Novel Therapies and Geographies Sponsored by: H1 |
| 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 |
| 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 |
| 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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