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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.
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Scientists in New Zealand have found that mRNA-based COVID-19 vaccines produce greater antibody levels compared to adenovirus vector-based ones across major COVID-19 variants.
ShouTi believes many targets addressed by biologic and peptide therapeutics can be reached by innovative, rationally-designed, best-in-class small molecules that don’t need refrigeration or injection.
Cytokinetics filed with the SEC reporting that the FDA planned to hold an advisory committee meeting to review its New Drug Application (NDA) for omecamtiv mecarbil.
Avrobio presented clinical data on Tuesday at the 25th Annual Meeting of the American Society for Gene and Cell Therapy (ASGCT) from its trial of AVR-RD-04, and preliminary results are promising.
Moderna held its first in-person Science and Technology Day since 2019. Notably, the company shared information about its new inhalable lipid nanoparticles (LNPs).
Vertex Pharmaceuticals dedicated a new site in Boston’s Seaport. But the company seemed to say, “But wait! There’s more!” and announced it plans to build another facility in the area.
RQ Biotechnology has officially launched, with the financial backing of AstraZeneca. The move strategically increases the availability of monoclonal antibodies at a time of ever-increasing demand.
Idera Pharmaceuticals has stopped patient enrollment early for its Phase II trial on a candidate melanoma drug after interim data delivered impressive results.
As Scholar Rock prepares to move forward with its experimental assets for spinal muscular atrophy, it has terminated 25% of its staff and also announced the loss of its chief medical officer.
CRISPR Therapeutics tapped Amgen veteran Phuong Khanh (P.K.) Morrow, M.D., FACP, as its new chief medical officer.