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Today's Big NewsSep 28, 2022 |
Eisai and Biogen’s Alzheimer’s disease drug lecanemab slowed cognitive decline in a phase 3 trial by 27% versus placebo, teeing the companies up for a potential accelerated approval decision from the FDA this January. The surprising success once again casts the spotlight on the amyloid hypothesis for treating the neurodegenerative disease. Biogen and Eisai’s clinical results could also be positive news for Eli Lilly and Roche, which are both developing their own treatments that target the buildup of amyloid beta plaques in the brain. And while the surges in Eisai and Biogen’s respective stock prices reflect overwhelming excitement among investors, an Editor’s Corner by Fierce Pharma’s Angus Liu says the companies may still need to meet CMS halfway when it comes to winning proper reimbursement coverage for lecanemab—based on the drug’s current clinical data, plus the fresh memories of Aduhelm. - Conor Hale |
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Tuesday, October 4, 2022 | 1pm ET / 10am PT This panel will discuss leveraging technology and home health solutions to augment existing points of care between patients and their clinical care team to improve the patient experience, drive more scientific rigor to data generation and achieve timely endpoint capture. Register now. 
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| By Nick Paul Taylor,Gabrielle Masson Eisai’s phase 3 clinical trial of Biogen-partnered Alzheimer’s disease candidate lecanemab has hit its primary and key secondary endpoints. The result, which analysts called a “major surprise,” gives a big boost to the partners as they head toward an accelerated approval decision in January. |
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By Angus Liu An FDA approval now looks all but certain for Eisai and Biogen's lecanemab. But before lecanemab can clear the name of the amyloid beta theory after the fallout from Biogen's Aduhelm launch and before the drug can realize its megablockbuster sales potential down the road, there’s one major hurdle to cross—reimbursement. |
By Max Bayer Eisai and Biogen's recent phase 3 victory has once again placed the spotlight on amyloid beta. A slate of late-stage drugs, including lecanemab, are targeting amyloid plaque buildup to treat Alzheimer's. |
By Dave Muoio The "catastrophic" storm has HCA, Tampa General Hospital, AdventHealth and others taking emergency precautions. |
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Tuesday, October 4, 2022 | 2pm ET / 11am PT In this webinar we will cover the challenges that this collaboration aims to solve and how the partnership is poised to enable significant scientific outcomes. We will also take your questions live about this exciting advancement. Register now. 
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By Conor Hale After more than 430 emergency green lights for COVID-19 tests since the start of the pandemic, the FDA is beginning to wind down its expedited review programs for coronavirus diagnostics, instead urging developers to follow its traditional regulatory paths to market. |
By Kevin Dunleavy In branding its consumer health spinoff, Johnson & Johnson has gone to Scotland for inspiration. The new company will be called “Kenvue,” J&J revealed on Wednesday, explaining that in Scotland, “ken” refers to knowledge, while “vue,” of course, relates to sight. |
By Dave Muoio Ten major industry groups including the American Medical Association and American Hospital Association say providers are unprepared for, and sometimes unaware of, the Oct. 6 deadline. |
By Gabrielle Masson Context Therapeutics is “cutting all excess fat” so it can stay afloat through 2024, putting nonessential activities on hold to “focus on blocking and tackling for the time being,” CEO Martin Lehr has told Fierce Biotech. |
By Conor Hale Pfizer, AstraZeneca, Teva and Merck KGaA have backed an Israeli startup incubator looking to wield AI programs in the discovery and development of new drugs, and now they’re celebrating the launch of their first company. |
By Heather Landi Online grocery delivery company Instacart is launching a new business initiative aimed at expanding access to nutritious food for underserved communities. |
By Zoey Becker As Sanofi prepares to release third-quarter results—after a tough summer for its share price—the company says it expects a major boost from exchange rate changes. Specifically, the company said the U.S. dollar should help revenues and earnings. |
By Andrea Park Studies have shown that the Nexpowder system leads to immediate hemostasis in at least 94% of cases of upper gastrointestinal bleeding. |
By Paige Minemyer Cigna is launching a new concierge care platform that aims to harness both the strengths of its health plan and its sister company, Evernorth. |
Fierce podcasts Don't miss an episode |
| This week on "Podnosis," we talk about how AI is helping patients and what’s standing in the way of more widespread use. We also chat about how payers have invested in bringing on expertise necessary to tackle social determinants of health |
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Wednesday, October 5, 2022 | 11am ET / 8am PT This webinar will cover the needs and challenges of precision medicine from a clinical perspective, and present the economic values of employing a single cell technology for better patient stratification. Register now. 
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