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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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While MBAs can reflect positively on job applicants, work experience can often be more valuable, depending on the area.
For people with, or at risk for, SOD1-ALS, the FDA’s approval of Qalsody is an important step toward advancing gene-specific research for this uniformly fatal disease.
Vowst, the first-ever oral fecal microbiome-based therapeutic, is indicated for preventing C. diff recurrence in adults following antibacterial treatment.
Merck and AstraZeneca are seeking broad approval for Lynparza in mCRPC regardless of BRCA status.
During its Q1 earnings call Tuesday, Biogen announced a handful of program pauses and cuts and touted the potential of anticipated approvals.
Orbital will use Series A funds to advance RNA-based vaccines, immunomodulators and protein replacement therapies.
The proposed drug pricing legislations follow the Inflation Reduction Act, passed in August 2022.
Novartis is scaling back its pipeline to focus on higher-value assets with stronger commercial potential.
The regulatory filing puts the company alongside Vertex and CRISPR, which also await FDA approval for their SCD gene therapy.
Vedanta will use the funds to advance its lead asset VE303 in clostridioides difficile infection and support the development of another candidate in ulcerative colitis.