| Today's Big NewsJul 31, 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 Angus Liu GSK has won the first FDA approval for an immunotherapy to treat certain patients with newly diagnosed endometrial cancer. But the industry-first go-ahead is tempered with a label limitation. |
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By Max Bayer The FDA's Peter Marks, M.D., Ph.D., thinks gene editing—specifically base editing—could be a "game changer," but progress has been slow, likely due to discouragement with the regulatory process. |
By Conor Hale An update from the FDA has linked four deaths to collisions between the Impella heart pumps developed by J&J's Abiomed division and TAVR implants. |
By Zoey Becker U.S. Bankruptcy Judge Michael Kaplan ruled that J&J's LTL Management subsidiary didn't establish immediate financial distress when it applied for bankruptcy protections. The filing was therefore made in "bad faith," according to the judge. |
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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 Gabrielle Masson While facing a mutiny led by former CFO Christopher Riley, Nymox Pharmaceutical is claiming that Riley attempted to swindle the company of 100,000 stock shares and tried to promote one of the “very worst offers” the company has seen. |
By Conor Hale Listed for sale on the clinical testing giant's website, the AD-Detect beta amyloid test retails for $399. |
By Kevin Dunleavy A study of FDA advisory committee meetings between 2010 and 2021 shows that the regulator leaned heavily toward approval. When a panel recommended approval, the FDA agreed 97% of the time. When a panel recommended a thumbs-down, however, the FDA complied only 67% of the time. |
By Nick Paul Taylor Sumitomo Pharma and Otsuka’s plan to turn ulotaront into a blockbuster growth driver is on the ropes. A pair of phase 3 schizophrenia clinical trials of the candidate missed their primary endpoints, leaving the partners looking to a “high placebo response” for evidence that the asset has a future in the disease. |
By Andrea Park Surgalign, which was founded more than two decades ago and once boasted annual revenues of more than a quarter of a billion dollars, is now set to be sold for parts for a total of less than $6 million. |
By Angus Liu Takeda's targeted non-small cell lung med Exkivity has failed in a phase 3 trial in newly diagnosed patients, just days after Johnson & Johnson touted a win for its rival EGFR inhibitor. |
By Helen Floersh Researchers have identified another potential gene therapy for treating chronic pain, this time by indirectly targeting a key sodium ion channel. |
By Andrea Park True to its name, RapidAI is working quickly to build out its slate of artificial-intelligence-powered software tools designed to spot signs of stroke, aneurysm and other neurological conditions in brain CT scans. |
By Fraiser Kansteiner Viatris has successfully held its ground in a pitched battle with the Internal Revenue Service over tens of millions of dollars. The case hinges on charges Viatris accrued in patent litigation tied to its generic drug approvals in the 2010s. |
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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