| Today's Big NewsJun 16, 2023 |
| By Angus Liu Less than a month after AbbVie and Genmab won FDA approval for Epkinly, Roche has crossed the finish line with its bispecific answer to large B-cell lymphoma, though with a narrower label. |
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By Nick Paul Taylor GSK is going to have to wait a little longer to start delivering a return on its $1.9 billion cancer bet. The FDA has delayed its ruling on the blood cancer candidate momelotinib by three months to provide time to review recently submitted data. |
By Andrea Park As 2022 drew to a close, Siemens Healthineers announced that it would be embarking on a yearslong cost-cutting campaign within its diagnostics division that would include swaths of layoffs and a slimmed-down product portfolio. The medtech giant still hasn’t disclosed the total number of positions that will be affected by the layoffs, but several dozen are now on the chopping block in New Jersey. |
By Nick Paul Taylor Bavarian Nordic has identified a “concern” with its investigational COVID-19 vaccine. With phase 3 data imminent, the Danish drugmaker has reported weakened immune responses against the omicron variant XBB.1.1 in a midstage study. |
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Wednesday, June 28, 2023 11:00am ET / 8:00am PT Join us for this this insightful webinar to learn how antibody profiling has been used to successfully identify novel diagnostic, prognostic, therapeutic, and predictive biomarkers in melanoma, prostate cancer, breast cancer, ovarian cancer, and rare cancers, yielding promising results.
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By Zoey Becker After scoring accelerated approval to treat HER2-positive stomach cancer in 2021, the drug has now shown it can stave off tumor progression in patients with PD-L1 positive tumors. |
By Andrea Park While many wearable devices currently available to people with Parkinson’s disease focus mainly on tracking the condition, the latest iteration of Cala Health’s externally worn technology is aiming to effectively treat the tremors associated with the disease. |
By Max Bayer Coherus is doubling down on its immuno-oncology pipeline with a $65 million deal to buy Surface Oncology. |
By Phil Taylor BearCare has issued a voluntary recall of a wearable thermometer product after reports of “minor to severe” skin burns and irritation with the device. |
By Kevin Dunleavy Hello again to a monovalent COVID-19 vaccine. Goodbye to the bivalent shot. That was the message Thursday from an FDA advisory committee, which decided unanimously that COVID vaccines this fall should not provide coverage against the original, wild-type coronavirus and that protection only is needed against an XBB strain. |
By Phil Taylor Transcranial magnetic stimulation pioneer Neuronetics has picked up a new FDA clearance that builds its position in obsessive compulsive disorder (OCD), a major new application of the technology. |
By Gabrielle Masson,Max Bayer After nearly 20 years away, Paul Burton, M.D., Ph.D., is set to return to Amgen. Francis deSouza cedes control of Illumina after Carl Icahn proxy battle. A new nomination to Biogen's board stirs up controversy. |
Fierce podcastsDon't miss an episode |
| | This week on "The Top Line," we discuss the the top news from this year's annual BIO meeting, plus a COVID lawsuit, an FDA-approved app and the rest of the week's headlines. |
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Monday, June 26, 2023 | 11:00 am ET Join us for a webinar on “The RESTORE Trial: First-Ever Lab-Grown RBCs” where Dr. Ashley Toye will talk about the first-ever clinical trial conducted for the transfusion of lab-grown red blood cells. Register now. |
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| WhitepaperAutoantibody 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 |
| 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 |
| 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 |
| eBookSee how clinical trial sponsors can build stronger strategies to address challenges across the patient enrollment funnel, starting with four necessary steps. Sponsored by: OneStudyTeam |
| 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 |
| 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 |
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