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Regulatory
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Illustration of cryoblation procedure in breast

Icecure wins advisory nod for Prosense system for breast cancer

Nov. 11, 2024
By Mark McCarty
Early-stage breast cancer patients in the U.S. may soon be able to access another treatment regime based on the result of a Nov. 7 FDA advisory committee for the Prosense cryoablation system by Icecure Medical Ltd. The advisory committee voted 9-5 that the benefits of Prosense outweigh the risks, although the FDA has yet to decide on the application.
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AI-generated digital horse illustration

FDA eyes generative AI in upcoming advisory committee hearing

Nov. 8, 2024
By Mark McCarty
The U.S. FDA has had its sights on artificial intelligence (AI) for some time, but an upcoming advisory hearing will review questions such as the regulatory status of a generative AI (GenAI) algorithm. This is just one of several AI-related dilemmas facing the agency in the next few years.
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DNA illustration
Neurology/psychiatric

Belief Biomed’s gene therapy for DMD designated orphan drug in US

Nov. 8, 2024
Belief Biomed Inc.’s gene therapy drug BBM-D101 has been awarded U.S. orphan drug and rare pediatric disease designations by the FDA for the treatment of Duchenne muscular dystrophy (DMD).
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Californians say yes to 340B accountability measure

Nov. 7, 2024
By Mari Serebrov
With the U.S. Congress sitting on its hands on reforms to the 340B drug discount program, states are stepping into the gap. While most state efforts have been aimed at forcing biopharma companies to give the federally mandated drug discounts to an increasing number of contract pharmacies, California is looking in a different direction. According to unofficial election results, a slim majority of the state’s voters said yes to Proposition 34, which would require certain providers that benefit from the drug discounts to spend at least 98% of their 340B revenues on direct patient care.
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Quanta Dialysis System

Quanta gets FDA clearance to use dialysis system at home

Nov. 7, 2024
By Shani Alexander
Quanta Dialysis Technologies Ltd. received the greenlight from the U.S. FDA for the use of its portable dialysis system at home. The clearance brings a much-needed option for patients with end-stage renal disease to receive their treatment in the comfort of their own homes and without a rigid dialysis schedule.
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Clinical data illustration

FDA webinar offers little insight into labeling aspects of PPI

Nov. 7, 2024
By Mark McCarty
The U.S. FDA’s new draft guidance for the voluntary incorporation of patient preference information (PPI) in device development says that PPI would be included in product labels for cleared or approved medical devices.
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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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