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New Life told FDA inspectors that they lacked the authority to enter parts of a facility where it made the GLP-1 receptor agonists semaglutide and tirzepatide.
FEATURED STORIES
With an IPO raise of $625 million, Kailera Therapeutics now holds the new record for the largest public market debut.
After receiving the FDA’s greenlight for Hunter syndrome drug Avlayah, Denali Therapeutics CEO Ryan Watts saw the culmination of 20 years of hard work unraveling the mysteries of the blood-brain barrier.
While prominent physicians can provide companies with valuable guidance during development, their perspective is limited when it comes to projecting how well or how readily a new product will be adopted. Here’s how to perform rigorous commercial diligence.
FROM OUR EDITORS
Read our takes on the biggest stories happening in the industry.
Doubling survival in pancreatic cancer, a long-fought rare disease approval, a massive IPO and ambitious biotech entrepreneurs have BioSpace Senior Editor Annalee Armstrong feeling upbeat about the biotech scene.
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Faced with the encroaching threats of patent expirations and generics, biopharma companies in 2024 invested 33% more in licensing deals, on average, than in 2023 with an eye toward enriching their pipelines with novel and potentially more effective therapies.
M&A was already on the upswing in 2024, and the new Trump administration may support that trend. But if data aren’t handled properly, acquisitions won’t reach their full potential.
With just one asset in weight loss moving through the clinic, Pfizer targets the space for potential dealmaking, as well as bringing assets over from China.
Senator Bill Cassidy voted with fellow Republicans on the Senate Finance Committee Tuesday morning to move forward the nomination of Robert F. Kennedy, Jr. for HHS secretary.
Just over a year after striking an obesity deal with Novo Nordisk, an SEC filing shows Flagship Pioneering spinout Omega Therapeutics is days away from bankruptcy and will lay off up to 17 employees.
Merck reported a 2% decline in Gardasil sales, after reaching a peak of $8.9 billion in 2023. Now with shipments to China paused, the HPV vaccine faces significant headwinds going into 2025.
Despite lackluster sales of Eylea’s high-dose formulation and Sanofi-partnered Dupixent, Regeneron beat Q4 forecasts overall thanks in part to cancer therapy Libtayo and gave shareholders a cut of the profits for the first time in the company’s long history.
The Phase IIa results continue a surge of momentum in a treatment space that last week saw the approval of Vertex’s Journavx as the first novel mechanism for acute pain in decades.
Amid growing concern of the overuse and misuse of obesity drugs, the UK’s pharmacies regulator rolled out stricter guidelines for online pharmacies selling medicines including Novo Nordisk’s Wegovy and Eli Lilly’s Mounjaro.
The Massachusetts-based biotech plans to use the funds to push its candidates into mid-stage clinical trials in a space dominated by Vertex.