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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.
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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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The recent FDA decision will likely mean more Medicare patients gain access to the blockbuster weight loss drug, experts say. Meanwhile, results continue to roll in for GLP-1 agonists for conditions beyond diabetes and obesity.
Politics can be a touchy subject, especially during a presidential election year. How should you engage in political discussions at work?
Looking for remote quality-control jobs in the life sciences industry? Check out this BioSpace list of five top jobs that are remote.
In advance of a March 21 PDUFA date, Italfarmaco on Tuesday reported that its drug candidate givinostat met the primary endpoint for treating Duchenne muscular dystrophy.
The contract manufacturer plans to expand its U.S. footprint with a former Roche facility in Vacaville, California, which Lonza contends is one of the largest biologics manufacturing facilities in the world by volume.
A string of rejections prompt some to look beyond research roles in the biopharma industry as they seek to launch a career.
Bristol Myers Squibb secured another late-phase immuno-oncology victory Wednesday, showing that the combination of Opdivo and Yervoy improved overall survival in a patient population served by rival checkpoint inhibitors from AstraZeneca and Roche.
Two days after winning FDA approval, Orchard Therapeutics on Wednesday provided its U.S. launch plans for metachromatic leukodystrophy gene therapy Lenmeldy, which has a wholesale acquisition cost of $4.25 million for the one-time treatment.
Under the European Union’s proposed regulations, companies will have data protection for at least seven-and-a-half years preventing competitors from accessing their product data.
Novo Nordisk’s investment of more than half a billion dollars is meant to expand its production capabilities in China and help it meet the global drug demand.