| Today’s Big NewsNov 16, 2023 |
| By Kevin Dunleavy Vertex and CRISPR Therapeutics have scored authorization in the U.K. for their exa-cel gene therapy to treat patients with sickle cell and transfusion-dependent beta thalassemia. Despite the excitement for the anxiously awaited drug—which Vertex said will potentially open the treatment up to 2,000 patients in the U.K.—a key question remains: Because of its steep price, will it ever be commercialized in England? |
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By Annalee Armstrong Almost a year to the day after Roche revealed that its Alzheimer's drug gantenerumab failed a phase 3 trial, the data are appearing in The New England Journal of Medicine, giving scientists a chance to reflect on what was learned. |
By Annalee Armstrong Fierce Biotech investigates a biotech caper after Takeda's TAK-279 poster mysteriously went missing from the late-breaker poster session at ACR in San Diego this week. |
By Andrea Park In its second and third such notices this week, the FDA doled out its most serious label to recalls of syringe devices used in medication delivery. |
By Angus Liu Watch out, Pfizer and Roche. Thanks to an acquisition and now an FDA approval, Bristol Myers Squibb is entering a niche lung cancer market. |
By Gabrielle Masson Merck & Co. is running out of time to get the first chronic cough medicine to market. So far, its path has been wrought with delays and the future appears no different as the FDA expresses new doubt about the pharma’s candidate gefapixant. |
By Conor Hale The over-the-counter Simple 2 test is sold by LetsGetChecked—a former Fierce 15 winner that made a name for itself in remote testing during the COVID-19 pandemic. |
By Nick Paul Taylor Astellas has shared a detailed look at the four deaths in its AT132 gene therapy clinical trial. Writing in The Lancet Neurology, the drugmaker explained that the liver toxicity seen in the trial differs from cases linked to other therapies—and made the case that the drug can provide transformative clinical benefits. |
By Fraiser Kansteiner The Gates Foundation blessed Micron with a $23.6 million grant to built out a commercial manufacturing facility for the company’s dissolvable, microarray-based drug and vaccine delivery tech. |
By Conor Hale According to the San Francisco-based company, sepsis contributes to more than one third of all in-hospital deaths—more than 350,000 annually in the U.S. |
By Andrea Park Less than a year after absorbing fellow virtual reality-based digital therapeutics maker OxfordVR, BehaVR is bulking up its business through yet another merger. |
Fierce podcasts Don’t miss an episode |
| In this week’s episode of "Podnosis," you'll hear from two journalists from the Fierce Healthcare team: Paige Minemyer, senior editor of Fierce Health Payer, and Dave Muoio, a staff writer for Fierce Healthcare. Together, they guide you through their key insights from the inaugural Fierce Health Payer Summit in Austin and dive into the latest earnings updates from the largest health plans and health systems. |
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