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FDA Cleared TAP®️ Micro Select enables remote blood collection with HALO™️ technology, a bladeless micro-needle array delivering virtually painless, large volume collection up to 500 uL. Click now. .png)
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Today's Big NewsMay 3, 2023 |
| By Zoey Becker GSK is basking in "the golden age" of vaccine development with its newest shot, an exec said. Its next step will be to turn the recent approval into actual vaccinations, Dr. Leonard Friedland, vice president and director of scientific affairs and public health at GSK vaccines, said in an interview. |
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By Annalee Armstrong The headline number from Eli Lilly’s Alzheimer’s data showing a 36% slowing of cognitive decline may have grabbed eyes, but analysts see a more even comparison with Biogen and Eisai’s Leqembi when you dig a little deeper. |
By Andrea Park A jury was unable to come to a unanimous decision in a trial to determine whether Apple infringed on health-tracking technologies originally developed by fellow wearable maker Masimo. |
By Annalee Armstrong Eli Lilly’s Alzheimer’s disease candidate has achieved a 35% slowing of cognitive decline and a 39% lower risk of advancing to the next stage of the disease when compared to placebo. |
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Thursday, May 25, 2023 | 10:00am ET / 7:00am PT Join the webinar and discover our MVA technology platform and explore the advantages for development and manufacturing of multiple vaccines and cell and gene therapeutics. Register now. 
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By Joseph Keenan South Korea’s Daewoong Pharmaceutical plans to invest 100 billion South Korean won ($74.6 million) to build a third plant to produce its botulinum toxin product Nabota to meet increasing global demand. |
By Conor Hale Nanox has secured a long-awaited clearance from the FDA for its multi-source X-ray bed, designed to operate as a smaller, lighter imaging system in clinics and hospitals. |
By Zoey Becker In potentially the last quarter that Horizon Therapeutics will stand on its own, the rare disease drugmaker saw total sales slide by 6% as its biggest drug Tepezza falls 19% in year-over-year sales. |
By Gabrielle Masson Four years after taking the helm of Cerevel Therapeutics, Tony Coles, M.D., is stepping down, handing the reins over to Ron Renaud as the neuroscience biotech waits on seven data readouts. |
By Andrea Park Though it’s currently cleared by the FDA to lessen ADHD symptoms only in children between the ages of 8 and 12, Akili Interactive’s EndeavorRx digital therapeutic may actually be even more effective among older users. |
By Angus Liu Even though Nuerocrine Biosciences has had great success with one neurological disorder drug, Ingrezza, it has struggled with Parkinson’s disease med Ongentys. Now, the company has decided to call it quits on the latter medicine. |
By Conor Hale The proceeds are slated for further clinical development with the goal of securing a U.S. approval. |
By Nick Paul Taylor The clock is ticking down to the FDA advisory committee meeting about Sarepta Therapeutics’ Duchenne muscular dystrophy gene therapy SRP-9001. With days to go, Sarepta has set out what is expected to be asked at the meeting—and made the case that it can allay concerns about its confirmatory trial. |
Fierce podcasts Don't miss an episode |
| This week on "The Top Line," we're launching a mini-series on Narcan the nasal spray. It is the first naloxone product to be approved for use without a prescription. |
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Thursday, May 11, 2023 | 2pm ET / 11am PT Medical imaging holds a wealth of valuable data that can power R&D. Join us to learn how to overcome historical challenges such as the need for expertise in the field and a lack of comprehensive tools. We'll explore ways medical imaging data can be utilized in R&D, strategies for organizing and re-purposing legacy data, and more. Register now. 
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eBook Discover 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 |
Whitepaper This 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 |
Research Strategies 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 |
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 Discover 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 |
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 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 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 |
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 |
| May 1-3, 2023 | Jersey City, NJ |
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