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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 recent announcement of RFK Jr.’s termination of mRNA vaccine contracts is the latest effort to undermine this promising technology at the federal level. Pharmaceutical companies and private investors must fill the gap and ensure that research into this critical resource continues.
Here are five oral obesity candidates that, according to Mizuho’s Graig Suvannavejh, could change the weight loss game.
Arguably the FDA’s most anticipated decision this month is for a subcutaneous induction formulation of Biogen and Eisai’s Alzheimer’s drug Leqembi, which, according to Eisai, could “help reduce the burden on healthcare professionals and patients.”
After exiting the FDA less than two weeks ago for unclear reasons, Vinay Prasad is once again director of the Center for Biologics Evaluation and Research, HHS confirmed to several outlets Saturday.
Under PreCheck, the FDA will communicate more frequently with pharmaceutical companies, helping them as they establish or expand manufacturing sites in the U.S.
In December 2024, Dewpoint Therapeutics CEO Ameet Nathwani said the biotech’s cash runway would last until the third quarter of 2025.
The U.S. Preventive Services Task Force makes recommendations for preventive services—including Gilead’s twice-yearly HIV PrEP Yeztugo—that insurers must cover. A recently postponed meeting has raised concerns that Health Secretary RFK Jr. could abolish or overhaul the group.
There is no certainty that the buyout will come to pass, according to The Financial Times, which first reported the rumors.
From the price of forthcoming weight loss pill orforglipron, to Most Favored Nation drug pricing and the market battle with Novo Nordisk, pricing was the number one issue for Eli Lilly on its second quarter earnings call.
Higher competition for fewer roles remains the status quo for biopharma professionals, based on BioSpace data. Additionally, the U.S. Bureau of Labor Statistics has reported that recent job growth is lower than previously believed.