| Today's Big NewsJun 5, 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 Gabrielle Masson Johnson & Johnson has seen response rates as high as 97% in multiple myeloma before but this time, it’s not for Carvykti. No, this time the healthcare giant’s pharmaceutical unit Janssen is shining the spotlight on a combo study for talquetamab and Tecvayli. |
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By Zoey Becker The phase 4 study ended ahead of schedule after it quickly established the benefits of Andexxa. AZ now plans to seek full approvals for the drug. |
By Andrea Park The new additions bring the total number of complaints that the FDA has collected between April 2021—when Philips first began alerting customers to potential issues with some of its respiratory devices—and the end of March of this year to more than 105,000, with 385 reported deaths. |
By James Waldron Easing pain may have been one of the original goals of medicine, but the zeitgeist has long since moved on to harder-to-treat conditions. That makes Eli Lilly’s efforts to reinvigorate the space all the more intriguing. |
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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 Eric Sagonowsky Amgen and Horizon extended a prior September restraining order to Halloween as they work through the FTC litigation. Up next, the parties are set for a court hearing on September 11. |
By Andrea Park “Our data show that an enormous and even alarming number of patients are not getting genomic profiling when they get diagnosed,” Kevin Keegan, general manager of Illumina's oncology business, said in an interview at ASCO. |
By Annalee Armstrong Biogen and partner biotech Denali Therapeutics are trimming down a Parkinson’s disease clinical program that was not expected to complete until 2031 in hopes of getting some actionable data sooner. |
By Andrea Park Barely two years into its partnership with Biocorp, the French maker of “smart” connected medical devices, Novo Nordisk is upping the ante. |
By Kevin Dunleavy Johnson & Johnson’s Balversa can keep some metastatic bladder cancer patients alive longer than chemotherapy, according to a study of 266 who have fibroblast growth factor receptor (FGFR) gene mutations and had already received checkpoint inhibitors. |
By Annalee Armstrong Servier promised that interim data from a phase 3 study would “shift the treatment paradigm” for a type of brain cancer that has long been stagnant in clinical research in March. Now, we’ve got the goods. |
By Angus Liu As doctors navigate the "messy" early-stage non-small cell lung cancer landscape with various immunotherapy approaches, Merck & Co. has now unveiled new data that it hopes can establish Keytruda, used before and after surgery, as a new standard of care. |
By Andrea Park While many of the companies currently developing blood tests to help diagnose cancer or track the disease’s progression are churning out physical tests that can be sent out to labs and hospitals around the world, C2i Genomics is taking a different approach. |
By Kevin Dunleavy Six months after filing for bankruptcy, Clovis was hoping for a last gasp win for fading cancer drug Rubraca. But the FDA has rejected the company’s bid for approval of the PARP inhibitor as a first-line maintenance treatment for ovarian cancer patients who have responded to a round of chemotherapy. |
By Annalee Armstrong The FDA has signed off on an amended trial protocol for Theratechnologies’ solid tumors medicine, lifting its clinical hold and setting the Canadian biotech free to proceed. |
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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