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BioWorld - Tuesday, July 5, 2022
Home » Topics » Regulatory

Regulatory
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Product regulatory actions for Sept. 12, 2019

Sep. 13, 2019
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Health of U.S. patent system in the eye of the beholder

Sep. 13, 2019
By Mari Serebrov
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Depending on who's talking, the U.S. patent system may, or may not, be in dire need of reform. In a Senate Judiciary subcommittee hearing Wednesday on the bipartisan STRONGER Patents Act, Sen. Chris Coons (D-Del.) stressed the need to undo the precedent set by the Supreme Court's 13-year-old eBay decision that weakened injunctive relief in infringement cases and to resolve some of the unintended consequences of the 2011 America Invents Act (AIA).
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Product regulatory actions for Sept. 11, 2019

Sep. 12, 2019
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Budget restrictions on the way for medical devices in France

Sep. 11, 2019
By Bernard Banga
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Regulatory front

Sep. 11, 2019
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Product regulatory actions for Sept. 10, 2019

Sep. 11, 2019
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Regulatory front

Sep. 10, 2019
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Product regulatory actions for Sept. 9, 2019

Sep. 10, 2019
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Sonivie's PAH treatment scores FDA breakthrough device designation

Sep. 10, 2019
By Meg Bryant
No Comments
The FDA has granted breakthrough device designation to Sonivie Ltd.'s Therapeutic Intra-Vascular Ultrasound (TIVUS) system for the treatment of pulmonary arterial hypertension (PAH). Early clinical studies suggest that the catheter-based system could stabilize or reduce pressure in the pulmonary vasculature of PAH patients, a population with an average survival rate of five years.
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Regulatory front

Sep. 9, 2019
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