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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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The American Society of Clinical Oncology and the Association of Community Cancer Centers are combining their efforts to increase racial and ethnic diversity in clinical trials.
Several biopharma companies are opening the week with positive clinical trial news. Read on for updates from Cytokinetics, Concert Pharmaceuticals, Idorsia and Seagen.
Burlingame, CA-based Innoviva is buying all of Waltham, MA-based Entasis Therapeutics’ available shares at $2.20 per share. Currently, Innoviva owns about 60% of Entasis’ outstanding shares.
Biohaven Pharma’s NDA for its nasal spray zavegepant was accepted by the FDA, while Phase III results for its drug troriluzole to treat spinocerebellar ataxia were disappointing.
Lifting the clinical hold will allow Ocugen to continue to assess the vaccine in its ongoing study and potentially support its efforts to achieve EUA or full approval.
A small research study published in Jama shows people with a lower body mass index (BMI) tended to maintain immunity against COVID-19 longer.
Regeneron Pharmaceuticals shared positive results from its Phase III trial of an evinacumab for children with homozygous familial hypercholesterolemia.
Vir Biotechnology terminated a two-year-old COVID-19-related antibody collaboration with Wuxi Biologics that included sotrovimab, which lost EUA in the U.S. earlier this year.
Based on topline data, Pfizer stated that three doses of the COVID-19 vaccine met all immunobridging criteria required for EUA. The FDA’s advisory committee will meet June 15 to discuss the matter.
Sunday night, U.S. health authorities announced that they may have found the third documented case of monkeypox in a patient in South Florida.