| Today’s Big NewsSep 21, 2023 |
| By Fraiser Kansteiner Six months after Travere Therapeutics’ Filspari won an accelerated nod to treat patients with a rare kidney disease, the first-of-its-kind drug narrowly failed its confirmatory trial. While the results bode poorly for a full FDA approval anytime soon, Travere can take some solace in the fact that the drug’s removal from market looks unlikely, according to analysts. |
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By Nick Paul Taylor Mesoblast has plotted a path toward its third attempt to win approval of its off-the-shelf therapy, exiting a meeting with the FDA convinced that new potency assay data and a single-arm trial can finally get the candidate to market. |
By Conor Hale Two technologies were honored with the top prize in biomedical research: one with a history that spans more than three decades and another that made its mark in about a tenth of the time. |
By Nick Paul Taylor Inventiva and Kezar Life Sciences have found buyers for Asian rights to their lead candidates, collectively bringing in $17 million upfront in return for the chance to develop and sell assets in certain territories. |
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October 16-18, 2023 | Boston, MA Brought to you by the editors behind Fierce Biotech, this conference is a unique venue where biotech executives can network and learn how to improve their partnership and pipeline strategies. It’s the only event that covers the entire pharma R&D spectrum, from basic research through clinical trials. Countdown is on! Register today to save $200
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By Fraiser Kansteiner Looking to establish a “hub” in the cell therapy ecosystem, the Novo Nordisk Foundation is pumping 950 million Danish kroner (about $136 million) into a new clinical production site at the Technical University of Denmark (DTU) in Lyngby. |
By Andrea Park The Simplera sensor is half the size of Medtronic’s last CGM, the Guardian 4, while also being easier to apply than its predecessor—via a two-step insertion process, using the included applicator tool—and completely disposable. |
By Helen Floersh In the world of COVID variants, many mutations seem to lead to the same goal: Evade innate immunity. By pinpointing key proteins that make this "convergent evolution" possible, researchers are on the way to finding new targets for therapies. |
By Ben Adams Americans' perception of the pharmaceutical industry is at its lowest point this century, especially among Republican voters, as the initial support for COVID-related efforts has turned into disillusionment. |
By Andrea Park Researchers were able to pinpoint a shared signature among the patients’ neurological data that lined up with changes in their depression symptoms—and which could in turn be used to predict those changes ahead of time. |
By Kevin Dunleavy Aurinia has responded to criticism from some investors who believe the company has not maximized its opportunity with lupus nephritis drug Lupkynis. The company named its founder and former CEO Robert Foster to its board of directors in an agreement with major stockholder MKT Capital. |
Fierce podcastsDon’t miss an episode |
| This week on "The Top Line," we discuss the trends seen at Cannes Lions, the top compensated CEOs in the industry, and the cancer drug shortage |
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Tuesday, September 26, 2023 | 11am ET / 8am PT This webinar will focus on the latest advancements in bioprocessing for cell and gene therapies (CGTs), including the improved consistency and reduced production costs associated with closed manufacturing. Register now.
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