| Today's Big NewsJun 7, 2023 |
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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 Kevin Dunleavy Legend Biotech and Johnson & Johnson have filed with the FDA for expanded use of Carvykti. After gaining approval 16 months ago for the CAR-T to treat multiple myeloma patients following four or more lines of therapy, the companies hope to get the U.S. regulator to sign off on its use at an earlier stage of treatment. |
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| San Diego, CA |  |
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By Eric Sagonowsky As Alzheimer's partners Eisai and Biogen lay the groundwork for a wider launch of Leqembi, their efforts center on winning a full FDA approval. On Wednesday, that vision came into better focus as the FDA released a document showing how the agency views the drug. |
By Max Bayer Back in January, Moderna set a planned mpox vaccine on the back burner as the immediate outbreak waned, but now the shot has slid into the priority lane, with entry to the clinic likely a “month or so” away, according to a top vaccine developer and strategist at the company. |
By Gabrielle Masson Venture Capital has long been a man’s game. But the rules are changing. |
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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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By Andrea Park Two years after its cartridge-based diagnostic became the first COVID-19 test given emergency use authorization by the FDA for non-prescription, at-home use, Cue Health has now scored the agency’s first regular-use clearance for an at-home COVID test. |
By Angus Liu Fierce Pharma is asking you, the dedicated employees working in the biopharma industry, to tell your stories of the pandemic—in photographs. |
By Joseph Keenan Global CDMO giant Catalent, which has been struggling through difficult financial times, added more biologic processes to its OneBio platform, which features capabilities for antibody and recombinant proteins, cell and gene therapies, and messenger RNA. |
By Nick Paul Taylor Horizon Therapeutics has teed up yet another sporting partnership, chipping in support for the KPMG Women's Irish Open ahead of the start of the golf tournament at the end of this summer. |
By Andrea Park People ages 18 and up with ADHD can now access a version of Akili's Endeavor video game-based digital therapeutic without requiring a prescription. |
By Gabrielle Masson Astellas is busy. Very busy. With three oncology approvals expected in the next year—two of which are label expansion approvals and one entirely new treatment—it's enough to add a few extra gray hairs. |
Fierce podcasts Don't miss an episode |
| This week on "The Top Line," we discuss the need to democratize access to medications like emergency contraception, plus Elizabeth Holmes, the state of Alzheimer's research, and the rest of the week's headlines. |
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Tuesday, June 27, 2023 | 2:00pm ET / 11:00am PT In this webinar we will discuss the growing complexity of clinical research, examples of how eClinical tools can reduce human effort, streamlining the time to approval, current challenges and gaps in eClinical tech, and more. Register now. 
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Whitepaper Autoantibody screening is promising for early cancer detection with the potential to improve the whole treatment decision tree, providing a less invasive, powerful approach. Sponsored by: Sengenics |
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 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 |
eBook See how clinical trial sponsors can build stronger strategies to address challenges across the patient enrollment funnel, starting with four necessary steps. Sponsored by: OneStudyTeam |
Whitepaper This 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 |
Whitepaper ChatGPT 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 |
Whitepaper Learn 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 |
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 |
| July 18-19, 2023 | Jersey City, NJ |
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