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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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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
Ipsen bolsters rare disease portfolio with acquisition of liver disease specialist Albireo.
The FDA approved Eisai and Biogen’s lecanemab (Leqembi) Friday afternoon. It is the second anti-amyloid antibody to be approved for Alzheimer’s disease in two years.
PCN-101, a ketamine-based candidate for treatment-resistant depression being developed by Atai’s Perception Neuroscience, fell short in a Phase II trial.
Thursday, Fate Therapeutics announced it terminated the 2020 collaboration agreement with Johnson & Johnson’s biopharma subsidiary Janssen.
Graphite Bio announced it is voluntarily pausing the Phase I/II study of its lead candidate nula-cel in sickle cell disease.
Moderna and CytomX ink a cancer partnership.
In another early high-value deal, Amgen inked a licensing agreement with Synaffix for the development of next-generation antibody-drug conjugates.
NovoCure’s novel cancer-fighting platform hits the mark in non-small cell lung cancer.
Metagenomi announced a Series B extension financing round led by Moderna, Leaps by Bayer and several others.
A letter published Wednesday in the NEJM links a stroke patient’s death to lecanemab. Eisai investigators respond.