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Regulatory
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VAripulse

​FDA approval of J&J’s Varipulse ramps up PFA competition

Nov. 7, 2024
By Annette Boyle
Almost a year after U.S. FDA approval of the first pulsed field ablation device for treatment of atrial fibrillation, Johnson & Johnson secured FDA approval for its Varipulse system, intensifying competition in the rapidly growing market.
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DNA in drug capsules
BioFuture 2024

FDA eases the way for cell and gene therapy companies

Nov. 7, 2024
By Lee Landenberger
Cell and gene therapy companies are the beneficiaries of positive changes along the regulatory path that the U.S. FDA is paving for them, according to a panel of executives who spoke at the BioFuture 2024 conference in New York.
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US flag, stock market chart, White House

Cautious optimism, Street celebration greet US election results

Nov. 6, 2024
By Mari Serebrov
While uncertainty often casts a shadow on the Street, U.S. investors welcomed the presidential and congressional election results with a late-night surge that carried into the morning Nov. 6. The Dow Jones peaked at 1,380.47 points early the day after, up 3.27% from Election Day itself and hitting its highest point of the year so far. The celebration extended to the biotech sector, with the BioWorld Index, which covers more than 500 companies, up 17.06% for the year, compared with a 12.28% increase for the year on Nov. 1.
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Emma Walmsley, CEO, GSK

GSK CEO on Trump win: Watching RFK impact, US-China relations

Nov. 6, 2024
By Nuala Moran
“I think elections are like pregnancy. … Everyone puts all of the energy into D-day – the birth. We’ve had the gender reveal, but what really, really matters is what happens now and the path ahead.” That was the instant response of Emma Walmsley, CEO of GSK plc, reacting to breaking news from the U.S. that Donald Trump has won a second term in office.
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FDA lifts clinical hold on Carsgen’s CAR Ts following warnings

Nov. 6, 2024
By Tamra Sami
The FDA has lifted a clinical hold on Carsgen Therapeutics Holdings Ltd.’s. CAR T products after issuing the company a warning letter following a December 2023 FDA inspection that found the company violated good manufacturing practices at its Research Triangle Park facility in Durham, N.C.
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EU flags in front of the Berlaymont building

Regulatory consultant dismissive of EU device shortage claims

Nov. 6, 2024
By Mark McCarty
The EU’s still-new regulations for medical devices and in vitro diagnostics are often seen as drivers of current or impending shortages of these products, but Oliver Eikenberg of regulatory consultancy Pure Global is unimpressed by such claims. Eikenberg said much of the drag on the EU system is engendered by device makers that are failing to get their regulatory affairs in order – a problem neither Brussels nor the notified bodies can fix.
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Product recall concept image

GE Healthcare reports field correction for Evair compressors

Nov. 6, 2024
By Mark McCarty
The FDA announced a class I recall of Evair compressors by Chicago-based GE Healthcare due to elevated levels of formaldehyde when the devices are used with specific models of Carescape or Engstron ventilators.
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DNA in drug capsules

BioFuture 2024: FDA eases the way for cell and gene therapy companies

Nov. 6, 2024
By Lee Landenberger
Cell and gene therapy companies are the beneficiaries of positive changes along the regulatory path that the U.S. FDA is paving for them, according to a panel of executives who spoke at the BioFuture 2024 conference in New York. The agency is trying to set up cell and gene companies for success and that’s a very different agency than what it was years ago, said Paul Bresge, CEO of Ray Therapeutics Inc.
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Australia reimburses Vazkepa a decade after US approval

Nov. 5, 2024
By Tamra Sami
For the first time, Australians have access to CSL Inc.’s Vazkepa (icosapent ethyl/Vascepa) for managing cardiovascular disease more than a decade after the drug was first approved in the U.S.
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Report: Drug regulators enabling forced labor in supply chain

Nov. 5, 2024
By Mari Serebrov
Drug regulators around the world have a unique opportunity – and, in some cases, a legal mandate – to remove the taint of forced labor from the biopharma supply chain. But some of them, including the U.S. FDA and Japan’s PMDA, may be turning a blind eye to those responsibilities, according to a recent report from the nonprofit Centers for Advanced Defense Studies.
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