| Today's Big NewsAug 3, 2023 |
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Wednesday, September 6, 2023 | 2:00 PM ET / 11:00 AM PT Attendees will learn about the latest tools for interacting with medical images, how to guide readers through labeling workflows, and streamlining adjudication and data standardization. Discussions will include real-world use cases of how pharma companies are enhancing AI development by optimizing reader workflows. Register now. 
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| By Zoey Becker The company raised its forecast for COVID-19 sales to between $6 billion and $8 billion, up from a prior estimate of $5 billion. Elsewhere, an RSV clash with pharma giants nears. |
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By Nick Paul Taylor Regeneron is rethinking development of its prostate cancer bispecific after two patients died in a clinical trial. The deaths prompted the Big Biotech to stop enrolling patients to receive REGN5678 and a full dose of its checkpoint inhibitor, but a reshaped bispecific development program is continuing. |
By Kevin Dunleavy Playing catch-up with Roche in a war of eye disease treatments, Regeneron hopes to gain an FDA decision for its recently rejected high-dose Eylea in this quarter. |
By Conor Hale In a brief announcement from the Federal Trade Commission, the agency said it “has learned” of the termination and described the move as “a win for patients,” adding that it came after cooperation with international antitrust regulators in Australia and the U.K. |
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Thursday, August 3, 2023 | 11am ET / 8am PT Join us for this insightful discussion on how to unlock the full potential of liquid biopsy and be an integral part of the future of precision medicine. We’ll take a deep dive into the latest strategies and solutions designed to help overcome current challenges and empower researchers and clinicians with enhanced capabilities. Register now. 
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By Annalee Armstrong Seagen is putting a phase 2 Merck-partnered antibody-drug conjugate on the shelf for now, nearly three years after signing on to a $1.6 billion partnership for the asset. |
By Kevin Dunleavy A Louisiana woman is suing Novo Nordisk and Eli Lilly, alleging that her use of Ozempic and Mounjaro caused her to vomit so much that some of her teeth have fallen out. Jaclyn Bjorklund, 44, says that she also has been hospitalized on "several" occasions and that the companies failed to warn patients of “severe gastrointestinal events” that can be caused by using the injected drugs. |
By Angus Liu Back in 2020, a surprise manufacturing shortfall led to an import ban of Bristol Myers Squibb’s Abraxane, sold by BeiGene, in China. Legal finger-pointing ensued, and now the two companies have decided to scrap their three-drug partnership altogether. |
By Conor Hale According to the former Fierce 15 winner, the agency’s green light makes the headset and its ClarityPro ICU monitoring software the first device to help diagnose electrographic status epilepticus. |
By Annalee Armstrong Intellia has patients lined up in the U.S. for a phase 2 trial of a CRISPR-based treatment in hereditary angioedema, but the FDA has thrown down a roadblock over a request for a new preclinical test of the therapy’s impact on a developing fetus. |
By Fraiser Kansteiner The U.S. Biomedical Advanced Research and Development Authority is handing Bavarian Nordic a new $120 million contract, primarily to cover the production of new bulk vaccine product. |
By Annalee Armstrong Gene editing biotech NeuBase Therapeutics is stopping program development and looking for a sale after its board of directors voted to close up shop and seek strategic alternatives. |
By Andrea Park Nearly four years after securing its initial clearance from the FDA, an algorithm designed to watch for signs of hypercapnia in children in intensive care has broadened its scope. |
Fierce podcasts Don't miss an episode |
| This week on "The Top Line," we discuss the chemotherapy drug shortage, plus Grail’s harassment lawsuit and the rest of this week’s headlines |
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Wednesday, August 30, 2023 | 1pm ET/ 10am PT Enzymes have long demonstrated their utility as a green alternative to metal-based catalysts, but the evolution time required can be significant. Join this webinar to learn about an extracellular strategy that reduces the evolution cycle and enables biocatalysis to be used much earlier in development. Register now. 
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Webinar Download this webinar to learn how to avoid pitfalls when characterizing CAR-T cells in your development workflow, how to save time by using one antibody to examine your entire panel of CARs, and more. Sponsored by: Cell Signaling Technology |
Whitepaper Learn more about the current challenges and issues that eClinical technology providers are facing. Sponsored by: YPrime |
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