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See how this AI-powered solution provided the sponsor a real-time competitive landscape evaluation for Immuno-oncology therapies with valuable insights for enhanced decision-making. Read the case study.
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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 Kevin Dunleavy In a sizable cost-cutting measure, Biogen will lay off 1,000 employees by 2025, it announced in presenting its second quarter earnings. With the company starting 2023 with 8,725 employees, that’s an 11.5% reduction of the workforce. |
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By Max Bayer Cidara Therapeutics has yet to hear whether Janssen is formally ending a collaboration on flu prophylaxis, saying it intends to trudge ahead with development until hearing otherwise. Janssen no longer lists the partnered asset in its pipeline. |
By Ben Adams We waited years for working RSV vaccines and in 2023, in the space of just a few weeks, we had two come all at once, with another on the horizon and a fresh approval for an RSV prevention med. |
By Conor Hale A regulatory affairs specialist has pleaded guilty to forging FDA documents and leading his bosses to believe they had a green light to put their medical devices on the market. |
By Fraiser Kansteiner The U.S. Food and Drug Administration has added a fourth dose of Lilly’s popular new diabetes med to its drug shortage database. The agency also expects supply issues with three other doses to persist longer than previously thought. |
By Annalee Armstrong Analysts and investors wanted the tea on the FDA review of Sage Therapeutics’ zuranolone, but Biogen CEO Chris Viehbacher wouldn’t spill it. |
By Fraiser Kansteiner Pfizer on Friday said it kicked off “immediate efforts” to provide relief and repair to the damage caused to its manufacturing facility in Rocky Mount, North Carolina. It noted crews are working around the clock to restore power, assess the structural integrity of the building and to relocate finished medicines to nearby sites for storage. |
By James Waldron Gilead’s $4.9 billion bet on Forty Seven has run into further trouble, with the Big Pharma pulling the plug on its myelodysplastic syndromes (MDS) ambitions for the lead CD47 asset from that deal in the face of a disappointing phase 3 trial. |
By Fraiser Kansteiner In a warning letter published late last week, the FDA chided Centaur for production shortfalls found during a November 2022 inspection of the company’s Maharashtra, India, drug ingredients plant. The rebuke centered on just two observations about quality deficiencies and lapses in cleaning protocols. The latter problem carried the risk of API contamination, the FDA said. |
By Helen Floersh Unexpected findings about how cell stress impacts gene expression have brought researchers a step closer to solving one of the many mysteries of cancer metastasis—and, potentially, to new ways to prevent it. |
Fierce podcastsDon't miss an episode |
| | This week on "The Top Line," we revisit an episode on Narcan the nasal spray. It is the first naloxone product to be approved for use without a prescription. |
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