In Vivo: 医療用医薬品・医療機器産業の経営層向けニュース

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.

Generics Bulletin

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

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.

Scrip: 世界の医療用医薬品＆製薬産業に関するニュース

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

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.

Scrip: 世界の医療用医薬品＆製薬産業に関するニュース

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. 

Pink Sheet: 世界の薬事規制と承認審査に関するニュース

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

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.

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

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.

Medtech Insight: 世界の医療機器・医療技術の最新情報

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.

Medtech Insight: 世界の医療機器・医療技術の最新情報

CMS Weighs Merits Of New Pass-Through Payments For Aquabeam System, Eluvia Stents In OPPS Proposal

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.

Scrip: 世界の医療用医薬品＆製薬産業に関するニュース

Oncology Market Leaders Maintain Their Upper Hand

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.