| Editor's Note: Fierce Biotech is monitoring the FDA's advisory meeting for Sarepta Therapeutics' DMD gene therapy. Check our website this evening for the latest news. |
Today's Big NewsMay 12, 2023 |
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Choosing the best eCOA platform that considers the needs of patients, site staff and data requirements are all critical factors. But it takes more to reach success. Download your eCOA Technology Guide.
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| By Nick Paul Taylor GSK has shared pivotal data that could help fend off Pfizer’s attack on its blockbuster vaccine franchise. The phase 3 results show the five-in-one meningitis vaccine is immunologically effective against the most common strains, keeping GSK tucked in behind Pfizer in the race to market. |
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By Nick Paul Taylor Revive Therapeutics has extinguished its phase 3 COVID-19 trial after an interim look at the data showed it was on course to fail. But the biotech still thinks it can resuscitate the drug program, telling investors it believes the data could support talks with the FDA about the next steps. |
By Annalee Armstrong Algorithm Sciences is no longer planning to set up a base on Hoth Therapeutics, as the two small biotechs terminate a planned merger. |
Sponsored by ValGenesis Inc. Cell and gene therapies hold great promise but can also carry serious risks. Applying a risk-based approach during development and manufacturing increases patient safety and product quality. Read more. |
By Gabrielle Masson ‘Tis the season—earnings season that is. A time of pipeline culls, project delays and partnership terminations—and this quarter has been no exception, with two more biotechs reporting changes today. |
Sponsored by Precision for Medicine Discover Sofia Baig's vision for clinical research, data-driven insights & patient centricity at Precision for Medicine! |
By Gabrielle Masson NYBC Ventures has unveiled as one of the first venture funds to focus solely on advancing new blood and cell-based therapies, with $50 million in hand from the New York Blood Center. |
By Helen Floersh Novo Nordisk’s Ozempic and Wegovy may have benefits beyond helping patients shed pounds: They appear to reverse the impairments in cancer-fighting natural killer cells seen in people with obesity, independent of weight loss. |
By Max Bayer,Gabrielle Masson Pablo Cagnoni, M.D., former CEO of Flagship-founded Rubius Therapeutics, is headed to Incyte to serve as president and head of R&D. |
By Angus Liu Roche and Eisai each bought a HER2 drug from separate Chinese companies. Takeda will lay off 186 staffers across Massachusetts. EQRx has returned three drugs it previously licensed from two Chinese biotechs. And more. |
By Zoey Becker As GSK's former consumer health unit Haleon nears its one-year mark of independent operations, its former parent company is shedding 240 million shares. |
By Heather Landi The end of the PHE has significant operational, financial and compliance impacts for providers, payers, states and suppliers. As the healthcare industry moves into a post-pandemic world, here are the biggest changes to track and what lies ahead for the next two years. |
By Ben Adams Around 40% of liver disease posts on social media site TikTok contain misinformation in a worrying trend doctors want to reverse. |
By Phil Taylor Last year, Healthy.io claimed FDA approval for the first smartphone-based, at-home diagnostic that can be used to screen people for chronic kidney disease. Now, Boehringer Ingelheim has come on board to see how the test might be used more widely to improve patient care. |
Fierce podcastsDon't miss an episode |
| | This week on "The Top Line," we're concluding our miniseries on Narcan the nasal spray. It is the first naloxone product to be approved for use without a prescription. |
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July 18-19, 2023 | Jersey City, NJ Our speaking faculty features leaders from big pharma, small-mid size pharma, biotechs, and more. Save $500 when you. Register Today!
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| 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 |
| Research What 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 |
| Whitepaper How can eConsent provide a more flexible approach to informed consent? Sponsored by: YPrime |
| 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 |
| 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 |
| 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 |
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