| Today’s Big NewsOct 27, 2023 |
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Wednesday, November 1, 2023 | 1pm ET / 10am PT Join us to hear about a new, fully integrated and interoperable solution for Health at Home (Remote Care Delivery), with key insights on the journey from idea to market. You'll learn about EMR integration, managing data at scale, best practices on accelerating startup innovation, and much more. Register today!
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| By Max Bayer AbbVie CEO Rich Gonzalez says the company was aware of the potential for an ADC transaction with Daiichi that Merck ultimately pounced on, electing to prioritize internal work instead. |
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By Zoey Becker The fast-growing blockbuster previously showed non-inferiority to Regeneron and Bayer's Eylea in the condition. This approval will expand the showdown between the two rival drugs. |
By Andrea Park For the second time in the last year, the U.S. International Trade Commission has determined that Apple violated a competitor’s patents in a health-tracking feature of its popular Apple Watch, setting up the devices for a potential ban in the U.S. |
By Annalee Armstrong A historic moment in pharmaceuticals will happen next week: an FDA advisory committee is set to review the first-ever CRISPR gene editing-based therapy, Vertex Pharmaceuticals and CRISPR Therapeutics’ exa-cel for sickle cell disease. |
By Angus Liu Weight loss contender Mounjaro may be getting Eli Lilly a lot of public attention these days, but the Indiana pharma giant is busy expanding in immunology, too. |
By Andrea Park As it continues to take advantage of the hole left in the CPAP market by Philips’ ongoing recall, ResMed is still fine-tuning its long-term growth strategy—a process that’s now resulting in short-term shrinkage. |
By Fraiser Kansteiner Exela is working with the FDA to recall three separate medications—injectable sodium bicarbonate, midazolam and the nutrition additive Elcys—after inspections of leftover samples flagged silicone matter in some vials. |
By Nick Paul Taylor Sanofi has reported setbacks to a trio of candidates bought in by its business development team, halting (PDF) work or posting negative data on assets picked up from Denali Therapeutics, Kymab and Principia Biopharma. |
By Kevin Dunleavy Sales of AbbVie and Johnson & Johnson’s leukemia blockbuster Imbruvica are taking a hit from BeiGene’s Brukinsa. But what about the impact of the Inflation Reduction Act? In August, Imbruvica was one of the 10 drugs identified by the CMS that will be subject to price negotiations in 2026. On Friday, as AbbVie presented its third-quarter earnings, the company said that it has recorded a $2.1 billion impairment charge based on estimates about “revised cash flows” for Imbruvica. |
By Conor Hale In a randomized, late-breaking trial presented at the TCT conference, the Esprit BTK implant bested its primary endpoints compared to standard balloon angioplasty alone. |
By Kevin Dunleavy Thursday’s FDA approval of Santhera’s Agamree (vamorolone) to treat Duchenne muscular dystrophy is just a start. The Swiss company is anxious to see how many disorders the first-in-class corticosteroid can treat. |
By Max Bayer,Gabrielle Masson Johnson & Johnson’s year of transition and restructuring is not slowing down, this time marked by the departure of a longtime key executive. |
Fierce podcastsDon’t miss an episode |
| | In this episode of “The Top Line,” we delve into the FDA's controversial approval of Aduhelm, a drug for Alzheimer's disease, despite an independent advisory committee's resounding rejection. The decision has sparked questions about potential bias within the regulatory body. |
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