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Today's Big NewsSep 30, 2022 |
Florida healthcare organizations reported that thousands of patients have been moved or are still in the process of being evacuated two days after Hurricane Ian made landfall and crossed the center of the state. While most hospitals have not seen significant damage, the larger challenges have been disruptions to electrical grids and water supplies. After a long road filled with scrutiny and uncertainty, Amylyx’s drug for ALS has finally scored FDA approval. Dubbed Relyvrio, it's the first treatment that showed significant slowing in both disease progression and functional decline, and it extended survival in a randomized clinical trial. Now, for only the cost of a few dozen cheeseburgers, you could have a fully sequenced human genome. Illumina is rolling out a new line of DNA analyzers that it says can read a person’s entire genetic code for about $200. - 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 Dave Muoio Utility interruptions and long-term shortages of downstream care capacity are among the top concerns for the head of the Florida Hospital Association. |
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By Zoey Becker After a long and winding road filled with AdComms, the FDA has finally approved Amylyx's ALS drug, Relyvrio. In an interview with Fierce Pharma, the company's co-founders say there is more research to be done and more drugs to be made to meet the unmet needs of ALS patients. |
By Conor Hale Now, for only the cost of a few dozen cheeseburgers, you could have a fully sequenced human genome. |
By Max Bayer Nearly six months after slashing more than a third of its workforce, Solid Biosciences is hoping to get on firmer footing through addition, not subtraction. The company is acquiring fellow gene therapy developer AavantiBio and raking in $75 million in new financing. |
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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 Max Bayer Merck's Keytruda has dazzled since first nabbing approval in 2014, earning billions of dollars in revenue and expanding its reach to more than a dozen cancers. But as the drug's patent expiration nears, can Merck manufacture a second clinical lightning strike? |
By Heather Landi Google's cloud division has teamed up with Fitbit to roll out a new service to help hospitals integrate and analyze wearables data. |
By Max Bayer Just a month after two top executives announced their departure, Scandion posted a phase 2 flop of its sole asset. The company says SCO-101 failed to produce a high enough tumor reduction rate to pass the trial's primary endpoint. |
By Angus Liu The path to a potential NASH drug approval just got bumpier for Intercept Pharmaceuticals. Just as the company plans an FDA resubmission for Ocaliva for patients with milder disease, the drug has failed in a more advanced population. |
By Robert King Congress passed a short-term spending bill which extends two key rural hospital programs through Dec. 16, but does not touch looming pay cuts to doctors set to take effect next year. |
By Nick Paul Taylor Zealand Pharma’s phase 3 short bowel syndrome study has hit its primary endpoint, delivering data that could equip it to seek approval for a challenger to Takeda’s Gattex. |
By Conor Hale The agency’s green light expands the company’s AIR Recon DL programs from 2D to 3D imaging sequences, eliminating the need to take multiple 2D scans to reach a diagnosis in certain cases. |
Fierce podcastsDon't miss an episode |
| | This week on "The Top Line," we talk with many of the Fierce 15 honorees to find out what makes them unique. We also share highlights from the Fierce Biotech Summit on gene editing innovations and battling biotech's bear market. |
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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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