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Regulatory
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FDA approves Adakveo to reduce vaso-occlusive crises in patients with sickle cell disease

Nov. 18, 2019

Regulatory front for Nov. 19, 2019

Nov. 18, 2019
The latest global regulatory news, changes and updates affecting medical devices and technologies.
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Child reading eye chart

Coopervision wins FDA nod for first contact lens to slow advance of myopia in children

Nov. 18, 2019
By Meg Bryant
The U.S. FDA has given its final approval to Coopervision Inc.'s Misight 1 day, the first contact lens designed to slow the progression of myopia, or near-sightedness, in children. The single use, disposable, soft contact lens is indicated for children who are diagnosed with myopia and begin Misight treatment at an early age. Specifically, the FDA indication said that "Misight (omafilcon A) daily wear single use soft contact lenses are indicated for the correction of myopic ametropia and for slowing the progression of myopia in children with non-diseased eyes, who at the initiation of treatment are 8-12 years of age and have a refraction of -0.75 to -4.00 diopters (spherical equivalent) with ≤ 0.75 diopters of astigmatism. The lens is to be discarded after each removal."
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Regulatory front for Nov. 18, 2019

Nov. 18, 2019
The latest global regulatory news, changes and updates affecting medical devices and technologies.
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Final guidance retains restrictions to devices exported from U.S.

Nov. 18, 2019
By Mark McCarty
The U.S. FDA draft guidance for appeals for denial of certificates for export indicated that the scope was limited to devices exported from physical locations in the U.S. This provision appears in the final guidance as well – despite arguments that it flies against the text of the Food and Drug Administration Reauthorization Act of 2017 (FDARA)
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Deep Bio wins CE marking of AI-based prostate diagnosis software

Nov. 18, 2019
By Jihyun Kim
HONG KONG – South Korean biotech Deep Bio Inc. has won CE marking for its artificial intelligence (AI)-powered medical software DeepDx-Prostate Connect.
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Regulatory front for Nov. 18, 2019

Nov. 18, 2019
The latest global regulatory news, changes and updates affecting biopharma.
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CHMP nods through five applications as EMA gets the keys to its new HQ

Nov. 18, 2019
By Cormac Sheridan
DUBLIN – Friday marked an important milestone for the EMA as its settles into its new home in Amsterdam. The Dutch authorities formally handed over to the agency the keys to its new building, which is located in the Zuidas district of the city.
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Novartis wins early FDA approval of P-selectin binder Adakveo in SCD

Nov. 18, 2019
By Randy Osborne
About two months ahead of the priority review action date, Novartis AG scored FDA clearance for Adakveo (crizanlizumab), previously known as SEG-101, to reduce the frequency of vaso-occlusive crises (VOCs), or pain crises, in adult and pediatric patients ages 16 and older with sickle cell disease (SCD).
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FDA approval of Shionogi antibacterial sets stage for move into new market

Nov. 18, 2019
By Michael Fitzhugh
Adults with complicated urinary tract infections (cUTIs) and limited or no alternative treatment options could soon receive Shionogi & Co. Ltd.'s cefiderocol following FDA approval for the antibacterial. The approved indication also included kidney infections caused by susceptible gram-negative microorganisms. The new therapy, to be marketed as Fetroja, is expected to be available in early 2020.
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