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In Vivo
By Ashley Yeo 16 Aug 2019
In a world where national economies are beset by conflicting spending priorities, health care is oftentimes too low on the agenda, health care observers say. One of these is Boston Scientific senior vice-president Eric Thépaut, who understands the dilemmas, but says that health care will soon force its way up the priority list. He has advice for future-ready medtech innovators.
Topic Medtech Business strategies
Generics Bulletin
By Aidan Fry 15 Aug 2019
By acquiring global rights to epinephrine and naloxone nasal spray candidates from Insys, Hikma is following its strategy of moving its non-injectable Generics business segment in the US towards differentiated products.
Topic Business strategies
Scrip
By Mandy Jackson 15 Aug 2019
The US FDA informed the company it will convene an advisory committee meeting to review the REDUCE-IT sNDA for the proprietary fish oil pill, delaying the approval by at least three months and surprising investors.
Topic FDA Drug approval
Scrip
By Jessica Merrill 15 Aug 2019
Lilly's IL-17A inhibitor ixekizumab outperformed J&J's IL-23 inhibitor guselkumab on achieving complete skin clearance in moderate-to-severe psoriasis patients at 12 weeks in a head-to-head trial.
Topic Clinical trials
Pink Sheet
By Derrick Gingery 14 Aug 2019
Gene therapy should remain on the market, FDA says, but Novartis could face civil or criminal penalties. Firm knew of problems before approval.
Topic FDA Company analysis
Generics Bulletin
By David Wallace 14 Aug 2019
Chirag Patel and Chintu Patel have returned to being co-CEOs of Amneal, just over a year after the firm completed its merger with Impax. Rob Stewart – who was president and CEO of Amneal – and executive chairman Paul Bisaro have resigned from the roles.
Topic Company analysis
Medtech Insight
By Shawn M. Schmitt 14 Aug 2019
Phil Pontikos, who is also the US agency's national device expert, explains how device-makers can avoid running afoul of the FDA's rules and expectations for sterilization activities.
Topic FDA
Medtech Insight
By Sue Darcey 14 Aug 2019
The US Medicare agency has been scrutinizing two new devices that have generated some buzz within the industry for pass-through payment status under its proposed 2020 Outpatient Prospective Payment System (OPPS) rules. The devices are Procept BioRobotic’s AquaBeam System for removal of prostate tissue in men with urinary tract symptoms, and Boston Scientific’s Eluvia drug-eluting stent for treatment of peripheral artery disease.
Topic Medtech
Scrip
By Jessica Merrill 14 Aug 2019
Drugs like Ibrance and Lynparza show that in the cancer market, it can be hard for new entrants to catch early standouts.
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