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BioWorld - Monday, December 16, 2019
Home » Topics » Regulatory

Regulatory
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TED talk: Briefing docs, buzz presage fairly smooth adcom on Horizon

December 12, 2019
By Randy Osborne
No Comments
Hitches for Horizon Pharma plc seem unlikely in the upcoming FDA advisory panel to mull the BLA for teprotumumab in thyroid eye disease (TED), though regulators did take issue with the clinical activity score (CAS) as calculated by the company.
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Regulatory front for Dec. 12, 2019

December 12, 2019
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The latest global regulatory news, changes and updates affecting medical devices and technologies.
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Regulatory front for Dec. 13, 2019

December 12, 2019
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The latest global regulatory news, changes and updates affecting biopharma.
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FDA gives nod for Orthogrid’s intraoperable PhantomMSK Trauma application

December 10, 2019
By Meg Bryant
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Orthogrid Systems Inc., of Salt Lake City, has received a green light from the U.S. FDA for the latest application on its intraoperable PhantomMSK platform, this one for use in orthopedic trauma cases. The new PhantomMSK Trauma application, which Orthogrid plans to formally roll out next spring, joins currently available applications for total hip and hip preservation. The Trauma application is an orthopedic surgical software that helps surgeons achieve and confirm the alignment of bone fractures and improves intraoperative efficiency via artificial intelligence-trained and augmented reality-based decision support and assistance for the placement of surgical instruments.
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Equillium tell: Fast track for itolizumab shows FDA faith that CD6 targeter could hit mark in lupus nephritis

December 10, 2019
By Randy Osborne
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Shares of Equillium Inc. (NASDAQ:EQ) closed at $4.75, up 69 cents, or 17%, after trading as high as $5.25 as Wall Street hailed the FDA’s granting of fast track status to itolizumab – the first clinical-stage anti-CD6 therapy – for the treatment of lupus nephritis (LN). 
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DC district court hands FDA a product jurisdiction loss in barium sulfate suit

December 10, 2019
By Mark McCarty
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The FDA has lost a product jurisdiction case in DC district court to Genus Medical Technologies LLC over its barium sulfate contrast agent. The judge in the case ruled that the agency violated the Administrative Procedures Act in ruling that the product is a drug, but the FDA will have another crack at the matter as the application for the product has been remanded to the FDA.
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Regulatory front for Dec. 10, 2019

December 10, 2019
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The latest global regulatory news, changes and updates affecting medical devices and technologies.
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Regulatory front for Dec. 10, 2019

December 10, 2019
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The latest global regulatory news, changes and updates affecting biopharma in Asia-Pacific.
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Novel technologies may drive tighter controls for ethylene oxide sterilization

December 9, 2019
By Mark McCarty
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The U.S. Environmental Protection Agency (EPA) has posted an advanced notice of proposed rulemaking for control of ethylene oxide emissions (EtO), which would update a 2006 final rule that declared no additional controls for EtO were necessary. However, the agency’s latest proposed rule makes note of several technological advances that allow for greater control of EtO, a fact that could drive a greater regulatory requirement for containment and destruction of EtO emissions at medical device sterilization plants.
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Brinavess: Is there light at the end of the tunnel?

December 9, 2019
By Peter Winter
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Vancouver, British Columbia-based Correvio Pharma Corp. is hoping that it will receive a positive response from the FDA’s Cardiovascular and Renal Drugs Advisory Committee, which meets tomorrow to consider the U.S. approvability of Brinavess (vernakalant hydrochloride, I.V.), its antiarrhythmic drug for the rapid conversion of adult patients with recent onset atrial fibrillation (AF).
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