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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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Astellas’ zolbetuximab hit the mark in a second late-stage trial in Claudin-18.2-positive gastric cancer.
Covalent biologic company Enlaza launches with $61M in seed financing.
Lilly digs deeper into metabolic diseases via GPCR partnership with Sosei.
BioCryst Pharmaceuticals is discontinuing the development of its Factor D inhibitor BCX9930 in paroxysmal nocturnal hemoglobinuria due to competitive factors.
AbbVie and AbCellera inked an antibody discovery deal to develop candidates for up to five targets in several indications.
Third Harmonic Bio drops its Phase 1b asset.
In a strategic reorganization announced Thursday, Axcella Therapeutics will focus its resources on its Long COVID program and slash headcount by 85%.
While showing early promise, Senolytics is a new field and most of the research is still in academic centers – most notably, the Mayo Clinic.
Vertex is kicking off a Phase I trial assessing VX-522, an mRNA therapy designed to treat the underlying cause of cystic fibrosis lung disease, while SpliSense is targeting a specific mutation.
Kymera and Sanofi shared positive results for an IRAK4 degrader for hidradenitis suppurativa and atopic dermatitis.