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As Sangamo runs out of cash, Eli Lilly and Astellas have emerged as stalking horse bidders for key assets, including a Fabry gene therapy currently being submitted for potential FDA approval.
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Former FDA, CDC and NIH leaders convene at the BIO International Convention to discuss the dismantling of the Department of Health and Human Services under the Trump administration—and where we go from here.
If cell and gene therapy makers are going to achieve their mission to improve patients’ lives, the industry must come together to share information across stakeholders, from regulators to manufacturers to payers.
While drugmakers and other stakeholders want to see faster approvals, experts say the FDA’s Commissioner’s National Priority Voucher program is still bereft of important details, with candidate selection and interference from the agency’s senior leaders topping the list.
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Read our takes on the biggest stories happening in the industry.
UniQure’s planned third-quarter submission for its Huntington’s disease gene therapy may be a harbinger of a more flexible FDA under acting commissioner Kyle Diamantas—but how long will it last? And how can companies be sure these positive decisions won’t just be reversed?
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The Inflation Reduction Act, “march-in rights” to take back patents and M&A were among the issues discussed at a Sunday panel in San Francisco ahead of Monday’s start of the J.P. Morgan conference.
A day after inking an AI deal with Alphabet’s Isomorphic Labs, Novartis is back at it, acquiring Calypso Biotech and tying up with Shanghai Argo in two RNA-i-focused pacts.
Brand pharmas not only leverage ancillary patents but sometimes hide or misrepresent information to the U.S. patent office in order to extend market exclusivity and high prices.
The IPO window is starting to crack open this year, with Metagenomi and ArriVent making their offerings ahead of the J.P. Morgan Healthcare Conference.
The multimillion-dollar collaboration will develop small molecule drugs against undisclosed targets.
The patient deaths were deemed unrelated to Vertex’s investigational islet cell therapy, but the study will be halted while regulatory authorities and an independent data monitoring committee review the findings.
The state must submit additional information about the drugs it intends to import before the first shipments are sent to the U.S.
The therapeutic targets of many of our top startups are also reflected in recent big biopharma acquisitions and partnerships.
In a major pivot, Allogene Therapeutics will no longer focus on two of its studies testing blood cancer therapy cema-cel in an effort to extend its financial runway into 2026.
While initial public offering activity was light in 2023, the new year has recorded the first IPO plan—from California-based CG Oncology.