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Home » Topics » Regulatory

Regulatory
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Two positive CHMP opinions in December take 2019 tally to 41

Dec. 13, 2019
By Cormac Sheridan
DUBLIN – The European Medicines Agency’s Committee for Medicinal Products for Human Use closed out its year’s work with positive opinions on two applications, Novartis AG’s Beovu (brolucizumab) in wet age-related macular degeneration and Merck & Co. Inc.’s Recarbrio for treating gram negative infections in adults.
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Regulatory front for Dec. 13, 2019

Dec. 13, 2019
The latest global regulatory news, changes and updates affecting medical devices and technologies.
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EMA takes pharmacovigilance to the next level: ‘Nearly’ real-time decision-making

Dec. 13, 2019
By Nuala Moran
LONDON – Over the next decade pharmacovigilance will move on from a sole focus on adverse drug reactions (ADRs) to encompass monitoring of the in-market efficacy of medicines, according to Guido Rasi, executive director of EMA.
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FDA’s change of heart: Sarepta’s Vyondys 53 wins surprise accelerated approval

Dec. 13, 2019
By Lee Landenberger

FDA grants accelerated approval to Vyondys 53 for DMD in patients amenable to skipping exon 53

Dec. 13, 2019

FDA approves Amarin's Vascepa to reduce CV disease risk

Dec. 13, 2019
By Michael Fitzhugh
Face with digital focus on eye

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

Dec. 12, 2019
By Randy Osborne
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

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

Dec. 12, 2019
The latest global regulatory news, changes and updates affecting biopharma.
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Health professional reviewing orthopedic imaging

FDA gives nod for Orthogrid’s intraoperable PhantomMSK Trauma application

Dec. 10, 2019
By Meg Bryant
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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