| Today's Big NewsJun 29, 2023 |
| By Angus Liu After an initial rejection in 2020 and a review delay earlier this year, BioMarin’s Roctavian has finally got the FDA go-ahead to introduce a gene therapy for a not-so-rare disorder. |
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By Nick Paul Taylor Eli Lilly has dug into the biotech bargain bin for its latest buyout, emerging with a deal to buy its Type 1 diabetes partner Sigilon Therapeutics for $34.6 million upfront. The value of the deal could balloon if the biotech passes milestones from a first-in-human trial through to authorization in a major market. |
By Andrea Park Eisai, Gates Ventures, the University of Edinburgh, Health Data Research UK and LifeArc have formed a research collaboration, dubbed NEURii. |
By Angus Liu After growing the Institute for Clinical and Economic Review into an influential drug pricing watchdog, Steve Pearson is stepping down. |
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Wednesday, July 12, 2023 | 2pm ET/11am PT In this webinar, we will explore how critical it is for life sciences companies to use data to analyze the behavior of cancer at the individual level, uncover new targets and biomarkers for precision therapies, and increase the value of existing oncology drugs to new indications. Register now.
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By Nick Paul Taylor An FDA advisory committee voted 10 to four in favor of Ipsen’s rare disease drug palovarotene despite members of the panel expressing significant concerns with the data. The vote boosts the prospects of the French drugmaker finally starting to deliver a return on its $1 billion bet on the drug candidate. |
By Andrea Park Roche is on a roll: For the second time in less than a year, the company has scored FDA clearance for a pair of assays that can be used together to help spot signs of Alzheimer’s disease. |
By Zoey Becker After a December FDA inspection revealed a principal trial investigator skirted several study protocols, BioXCel found forged emails making it out that the site had properly adhered to reporting requirements for adverse events. On top of that, the study missed a secondary endpoint. |
By Annalee Armstrong Immunome and Morphimmune will come together as one company through a reverse merger, placing Clay Siegall, Ph.D.—who left his role as CEO of Seagen last year after being arrested for alleged domestic abuse—in the chief executive chair. |
By Kevin Dunleavy Much attention has been paid to Vertex’s efforts to develop a stem-cell therapy for Type 1 diabetes. But flying under the radar with an allogenic (donor) gene therapy for the disorder has been Chicago startup CellTrans. Thursday, the FDA signed off on CellTrans’ Lantidra (donislecel), the first cell therapy for type 1 diabetes. |
By Gabrielle Masson The Bill & Melinda Gates Foundation and Wellcome Trust are giving a combined $550 million to push forward a tuberculosis vaccine candidate formerly owned by GSK. The investigational shot holds the potential to become the first vaccine aimed at preventing pulmonary TB to enter the market in over 100 years. |
By Andrea Park After its allotted six months to regain compliance with the Nasdaq’s listing rules passed by without success, PAVmed has bought a bit of extra time to return to the stock exchange’s good graces. |
Fierce podcastsDon't miss an episode |
| This week on "The Top Line," we discuss the most expensive drugs in the U.S., plus Eli Lilly's recent acquisition, the latest company to challenge the Inflation Reduction Act, and the rest of the week's headlines. |
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Wednesday, July 12, 2023 | 11:00am ET / 8:00am PT Join us for this insightful discussion on how to unlock the full potential of liquid biopsy and be an integral part of the future of precision medicine. We’ll take a deep dive into the latest strategies and solutions designed to help overcome current challenges and empower researchers and clinicians with enhanced capabilities. Register now.
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