News
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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Read our takes on the biggest stories happening in the industry.
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.
THE LATEST
Elicio Therapeutics published data on the preprint server bioRxiv, describing preclinical research into its cancer vaccine that shows a lot of promise.
Alnylam Pharmaceuticals shared 18-month results from its phase III Helios-A clinical study demonstrating that vutrisiran improves clinical cardiac symptoms in patients with hATTR.
Two experimental drugs from Seres Therapeutics and Vera Therapeutics celebrate clinical trial wins in hard-to-treat disease areas.
The compact and portable nasal spray means it can be used directly before an anxiety-provoking trigger or at the beginning of an episode.
The approval marks the first for EoE, a chronic, progressive type 2 inflammatory disease that damages the eosinophilic esophagitis and prevents it from working properly.
BridgeBio Pharma and its affiliate Phoenix Tissue Repair announced positive data from their Phase II clinical trial for the treatment of recessive dystrophic epidermolysis bullosa (RDEB).
Celebrities’ struggles with breast cancer are bringing new awareness to the importance of screening - particularly because new therapies like Radius Health’s elacestrant are on the horizon.
The hold follows a serious adverse event in which a study participant died after developing possible differentiation syndrome.
A study conducted by Athersys’ partner Healios on a potential treatment for ischemic stroke failed to meet the primary endpoint as its stock dropped 43%.
The 25th Annual Meeting of the American Society of Gene and Cell Therapy wrapped up on Thursday. BioSpace looks at some of the highlights.