| Today’s Big NewsOct 25, 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 Angus Liu Roche has already settled a patent infringement lawsuit that it filed against Biogen in July. The case surrounded Biogen’s biosimilar version of Roche’s blockbuster rheumatoid arthritis therapy Actemra. |
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By Gabrielle Masson Rachel King said few things would bring her out of retirement. Leading the Biotechnology Innovation Organization—the largest biotech advocacy body in the world—just happened to be one of those things. |
By Andrea Park The recall—which represents a product correction, rather than a removal of the machines from the market—began in late 2022, but it wasn’t until this month that the FDA handed down its classification. |
By Annalee Armstrong MADRID—Daiichi Sankyo started off ESMO with a mic drop moment: a $4 billion upfront deal giving Merck & Co. rights to the Japanese ADC powerhouse’s next three prospects. |
By Kevin Dunleavy Five months after becoming the first company to secure FDA approval for a respiratory syncytial virus (RSV) vaccine, GSK is taking steps toward expanding its label for Arexvy. The company has revealed that a study investigating Arexvy’s effectiveness in adults ages 50 to 59 has achieved its two primary objectives. The results could pave the way for the shot to be approved for this age group. The FDA has already endorsed it for people 60 and older. |
By Conor Hale During the Transcatheter Cardiovascular Therapeutics conference in San Francisco, both Medtronic and Edwards Lifesciences presented clinical outcomes from landmark trials of their TAVR systems in patients with severely narrowed aortic valves who fell in the low-risk category for traditional surgery. |
By Nick Paul Taylor Araclon Biotech has provided early evidence that its Alzheimer’s disease vaccine is effective, linking the candidate to a 38% slowdown in disease progression compared to placebo in an exploratory analysis of phase 2 data. |
By Zoey Becker The FDA previously uncovered evidence of forged emails and trial misconduct in the company's phase 3 Alzheimer's disease agitation study. Now, with a third-party audit in hand, BioXcel looks to push forward with the drug. |
By Conor Hale A head-to-head, randomized study examined the two leading heart implants worldwide for reducing the risk of stroke among people with atrial fibrillation. |
By Max Bayer Mediar is parterning up with Pfizer's Ignite program to help expand R&D capabilities ahead of two phase 1 trials. The smaller biotech says it will retain all decision-making authority and full rights, though financial details weren't disclosed. |
Fierce podcasts Don’t miss an episode |
| In this episode of "The Top Line," Fierce's Fraiser Kansteiner engages in a conversation with Alexander Scott, senior vice president of integrity at Eisai, to discuss the full approval of Leqembi and what it means for Eisai and, most importantly, for Alzheimer's patients. |
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