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After debuting on the public markets with $256.3 million and raking in an additional $472 million, Veradermics has emerged as one of biotech’s biggest post-IPO standouts. CEO Reid Waldman credits the weight loss craze for establishing consumer-driven channels.
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Last month, the FDA launched TrialBlazer, intended to streamline the IND path and bring early clinical trials and medical innovation home to the U.S. It’s a start, but new agency leadership must see it through.
Significant leadership instability at the FDA—compounded by continued workforce attrition—led to a slight slowdown in overall regulatory productivity in the first half of this year, but the agency has been catching up of late.
Congressional letters sent to the CEOs of Eli Lilly, Pfizer, Merck, BMS and AbbVie this week voicing concerns about the pharmas’ clinical trials in China highlight an ongoing discrepancy in how government and industry think about the rise of the Asian country’s biotech industry.
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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.
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The Alliance for Regenerative Medicine predicts up to 17 cell and gene therapy approvals this year and defends high prices, while FDA’s Peter Marks expresses concern about manufacturing costs.
Following in the footsteps of Novartis, J&J and Merck, GSK jumped into the J.P. Morgan dealmaking frenzy Tuesday, picking up respiratory and inflammation-focused Aiolos Bio.
Vertex still has an ongoing diabetes partnership with CRISPR, which gives it a non-exclusive license to the latter’s platform to develop a potential cure for type 1 diabetes.
Following the FDA’s approval of the program, PhRMA is once again suing to block Florida from importing prescription drugs from Canada.
The BioSpace team is recording from San Francisco as they bring you the the latest highlights from JPM2024.
From the rising trend of royalty financing to other adaptive funding strategies, firms think outside the box in responding to unprecedented challenges.
Harpoon has several antibodies in its pipeline that are engineered to redirect a patient’s T cells to recognize and kill cancer cells.
The pharmaceutical giant will pay $28 a share to acquire Ambrx’s pipeline of ADCs, particularly its lead candidate for prostate cancer.
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.