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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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Patients with treatment-resistant depression treated with Johnson & Johnson’s Spravato were significantly more likely to reach remission and stay relapse-free for up to 32 weeks.
Data from the Mayo Clinic shows limited eligibility for the anti-amyloid treatment. However, Michael Irizarry, Eisai’s deputy chief clinical officer, says some patients could still be eligible.
AbbVie, Amgen, Gilead, Merck and Novartis are among the 31 members that have formed the Partnership for the U.S. Life Science Ecosystem to push back against federal antitrust reforms.
The pharmaceutical giant aims to hire another 50 people by the end of this year to work on a new platform dedicated to harnessing data and AI insights in drug discovery.
The French pharma paid $500 million upfront, with up to $1 billion in future milestone payments, to co-develop and co-commercialize Teva’s Phase II anti-TL1A antibody for inflammatory bowel disease.
Its reversible nature offers the potential for RNA editing to go beyond rare diseases, eliciting excitement and buy-in from large pharmas like GSK and Eli Lilly.
In its briefing document for Thursday’s FDA advisory committee meeting, the regulator contends that the company’s confirmatory CodeBreaK 200 trial for Lumakras is not an “adequate and well-controlled” study.
The companies are expanding their long-standing CRISPR/Cas9 gene editing collaboration for the second time, now seeking to target neurological and muscular conditions.
New Phase I/II trial results show that one more type 1 diabetes patient achieved insulin independence after treatment with Vertex Pharmaceuticals’ investigational stem cell therapy VX-880.
Despite lawsuits by some companies challenging the negotiations under the Inflation Reduction Act, the manufacturers of the first 10 drugs selected for Medicare price talks will participate in the program.