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Datamonitor Healthcare
16 Aug 2019
Datamonitor Healthcare recently surveyed 60 gastroenterologists in the US and five major EU markets after the approval of the first disease-specific therapies for the treatment of non-alcoholic steatohepatitis (NASH). The market for these treatments will exceed $21bn in 2027.
In Vivo
16 Aug 2019
Explore the six biggest therapeutic R&D challenges facing the industry today with a free infographic from In Vivo. This snapshot view of the major issues facing R&D is packed with data and insights about everything from drug resistance to diagnostics challenges.
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.
Scrip
12 Aug 2019
With the continuation of the US-China trade standoff, the rapid increase in R&D costs and a gruelling centralized bidding process, foreign pharma firms have a lot on their plates in China. Gain insight on these key challenges through this Scrip article pack
Topic Business strategies
Trialtrove
12 Aug 2019
Get a visual snapshot of how the industry pipelines are faring with our 2018 Completed Trials snapshot. This graphic analysis paints a clear picture of the state of clinical trial completions, while pointing to some important changes that are emerging.
Pink Sheet
By Neena Brizmohun 09 Aug 2019
The stakes are extremely high for companies called before EU or US regulators and scientific experts to answer queries about their new drug applications at the later stages of the review process. How they perform is critical. Consultant Kate Dion has a raft of helpful tips for companies facing this daunting situation. Neena Brizmohun reports.
Topic Drug approval
Pink Sheet
By Cathy Kelly 09 Aug 2019
Investigation may help define when rebate arrangements seeking to protect a brand against biosimilar competition are anticompetitive.
Topic Policy and regulation
Pink Sheet
19 Aug 2019
Scrip
19 Aug 2019
Scrip
19 Aug 2019
Pink Sheet
19 Aug 2019
Scrip
19 Aug 2019
Scrip
19 Aug 2019
In Vivo
19 Aug 2019
Scrip
19 Aug 2019
Medtech Insight
19 Aug 2019
Medtech Insight
19 Aug 2019
Medtech Insight
19 Aug 2019
Medtech Insight
19 Aug 2019
Medtech Insight
19 Aug 2019
Pink Sheet
19 Aug 2019
Pink Sheet
19 Aug 2019
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