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.
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.
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.
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).
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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