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Datamonitor Healthcare

NASH Disease Coverage Extract

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.   

Topic Drug development landscape Diseases

In Vivo

Six of the Greatest Therapeutic R and D Challenges

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.  

Topic Drug development landscape

In Vivo

MedTech Forum 2019: The Future Is Here But Industry Still Needs A Long-Term Vision

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

Hikma Snaps Up Insys Sprays As Part Of US Drive Towards Differentiation

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

An AdComm After All: Amarin's Vascepa Labeling Update Now Delayed By FDA

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

Taltz Tops Tremfya In Head-To-Head Psoriasis Study On Complete Skin Clearance

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

Novartis' Zolgensma Had Manipulated Data In Application, US FDA Says

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

Chirag Patel And Chintu Patel Return As Co-CEOs Of Amneal

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

Compliance Corner: FDA Investigator Sees These 4 Common Sterilization Problems When Inspecting Facilities

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

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