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Regulatory challenges have been even more top of mind than usual given recent upheaval at the FDA. BioSpace spoke to three industry experts about key issues, which include applying new artificial intelligence guidance. The experts also shared advice for working with regulators.
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Analysts parsed the limited data available for Pfizer’s obesity candidate on the pharma’s fourth-quarter earnings call Tuesday, looking for any nugget of additional context.
After advancing in lockstep through the pandemic, the fortunes of the biotechs have diverged as their use of COVID-19 windfalls has taken shape.
After suffering in the wake of expired tax incentives for pharmas, the island is trying to take advantage of geopolitics to grow its drug manufacturing sector.
FROM OUR EDITORS
Read our takes on the biggest stories happening in the industry.
Phacilitate’s annual event dawns as cell and gene therapies reach a new tipping point: the science has hit new heights just as regulatory and government policies spark momentum and frustration.
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Despite meeting its primary endpoint in a late-stage generalized myasthenia gravis trial, Roche and Chugai Pharmaceutical’s Enspryng did not demonstrate clinical benefit as expected, the companies announced Thursday.
Following its label expansion earlier this month, Medicare on Thursday said it will now cover the use of Novo Nordisk’s Wegovy in patients with overweight or obesity who have preexisting cardiovascular disease.
BioSpace spoke to HR leaders about how they have been supporting companies navigating a challenging economy while meeting the needs of the workforces they support.
Ubiquitous potential, possible safety advantages and the recent growth of cell and gene therapy are driving investment in a different type of genetic editing.
Imagine testing a really good drug for HER2+ breast cancer in someone with liver cancer. Would it be any surprise when that drug fails?
Mirador Therapeutics emerged from stealth Thursday with financing from ARCH Venture Partners and Sanofi, among others, to provide precision medicines for inflammatory and fibrotic diseases.
Keytruda, when used with AstraZeneca’s Lynparza, did not significantly improve overall and progression-free survival in specific patients with metastatic non-squamous non-small cell lung cancer.
Months after Johnson & Johnson turned its back on the hypertension treatment Tryvio, Idorsia has secured the FDA’s nod for the endothelin receptor blocker.
As part of a sweeping reorganization, Bayer Pharmaceuticals on Wednesday shuffled its leadership roster, which included the creation of a new unit and role changes for its executives.
A new analysis from the Congressional Budget Office predicts that Novo Nordisk’s semaglutide will likely be subjected to Medicare’s Drug Price Negotiation Program under the Inflation Reduction Act.