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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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This summer, BioSpace will release a series of reports looking at the current state of diversity and inclusion in the life sciences.
Ocugen introduced NeoCart, which is designed to repair full-thickness lesions of the knee cartilage in adults, as a Phase III cell therapy platform technology.
A blood test to diagnose Alzheimer’s disease launched in April by Quest Diagnostics has the potential to screen patients for risk years before symptoms appear.
Genocea’s board of directors voted to wind down ongoing operations and terminate its remaining staff, except for those necessary to see the company’s closing.
Alnylam Pharmaceuticals announced Tuesday new positive results from the Phase III ILLUMINATE-C trial of lumasiran for advanced primary hyperoxaluria type 1 (PH1).
If approved, etranacogene dezaparvovec would be the first gene therapy treatment for hemophilia B.
Two months after closing its Series A financing round, KaliVir Immunotherapeutics forged an exclusive licensing and collaboration agreement with Roche.
Caladrius Biosciences announced it was suspending enrollment in its Phase IIb FREEDOM study assessing xowna for coronary microvascular dysfunction (CMD) due to supply chain issues.
Imugene and City of Hope announced that the first patient has begun treatment in a Phase I clinical trial, investigating the safety and efficacy of CF33-hNIS in adults with metastatic or advanced tumors.
Pfizer and Eli Lilly are forging ahead with ulcerative colitis (UC) research after posting positive results from their respective Phase III studies.