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IPO
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.
FEATURED STORIES
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.
FDA
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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With GLP-1 agonists slated to become the best-selling drugs in 2024, the biopharma industry is already pivoting to explore treatments that preserve muscle mass as patients shed pounds.
Humira maintained its blockbuster status and market share dominance in the first quarter of 2024, but experienced a drop in sales as biosimilar competition heated up, AbbVie reported on Friday.
Gilead on Thursday reported revenue growth in the first quarter of 2024, driven by the strong sales of its HIV, cancer and liver diseases franchises, while culling a number of candidates.
Starting in June 2024, Evernorth Health Services will offer Humira biosimilar products with no out-of-pocket cost through its Accredo specialty pharmacy.
With its lawsuit filed against Pfizer and BioNTech, the British multinational biopharma has joined the high-profile patent battle over mRNA technology used in COVID-19 vaccines.
FDA
Pfizer will go toe-to-toe with CSL Behring following the FDA’s Friday approval of its hemophilia B gene therapy Beqvez and will launch a warranty program based on the durability of response.
The genetic engineering startup, recently honored by BioSpace readers for its work environment, is downsizing as it seeks to launch its first clinical trials.
Is there a connection between Bristol Myers Squibb’s announcement that it will reduce its headcount by 6% and the company’s recent acquisitions of Karuna, Mirati and RayzeBio?
Several companies—including Roche, Curemark and Yamo Pharmaceuticals—are running clinical trials of treatments that aim to offset the myriad challenges of autism.
Sanofi is dropping its Sjögren’s syndrome candidate due to disappointing Phase II efficacy data, while AstraZeneca is stopping work on some early-stage assets amid a portfolio reprioritization.