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A lower court had previously ruled for Sarepta in the companies’ long-running dispute, finding that REGENXBIO’s AAV patent was invalid because its elements were naturally occurring. The appeals court on Friday said that this original decision adopts a “narrow” view of the invention.
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Maintaining America’s momentum demands that policymakers resist policies that undermine research and development incentives.
Many scientists-turned-CEOs paradoxically abandon scientific principles when it comes to commercializing their innovations. But applying the scientific method to business decisions can help life science entrepreneurs avoid common pitfalls, attract investment and ultimately bring transformative technologies to market.
FDA vouchers are normally a coveted prize for biopharma companies, but a surprise rejection for Disc Medicine’s rare disease drug has biopharma reconsidering.
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Following the FDA’s refusal to review Moderna’s investigational mRNA flu vaccine last week, Commissioner Marty Makary faced questions from the U.S. president about the agency’s handling of vaccines. It’s a clear signal that the tension long brewing at the drug regulator has now gone all the way to the top.
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The FDA has asked for another well-controlled trial to establish the efficacy of reproxalap in dry eye disease.
The FDA derives just under half of its yearly funding from pharma user fees, which help support its operations and fund employee salaries. An analysis from AgencyIQ suggests that the agency is dangerously close to losing it all.
In the Phase III MITIGATE trial, Uplizna cut IgG4-related disease flares by 87% versus placebo.
Sangamo, which has been having cash problems, will receive $18 million upfront in licensing fees for its AAV capsid that in preclinical studies has shown the ability to cross the blood-brain barrier.
Bo Wang is a renowned AI scientist at the University of Toronto. He’s bringing his open-source culture and computational biology to Xaira Therapeutics in June.
An independent data monitoring board found that BeiGene’s ociperlimab was unlikely to significantly boost overall survival in patients with untreated NSCLC.
The FDA was scheduled to release its decision on Novavax’s updated, protein-based COVID-19 vaccine on April 1, but the agency’s principal deputy commissioner intervened.
Pharma’s reprieve from Donald Trump’s tariffs is expected to be temporary, with Leerink analysts anticipating possible sector-specific duties “in the next month or so.”
Although U.S. full-time employees worked an average of 42.9 hours weekly last year, according to Gallup, that wasn’t true for most BioSpace LinkedIn poll respondents. A Karius HR executive discusses a few potential reasons for the longer workweeks.
Following the dramatic late-night resignation of Peter Marks last Friday, Steele, a senior advisor to the division, takes the reins in a department inside an agency beset by cuts, layoffs, and confusion.