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Scrip
By Joseph Haas 11 Sep 2019
The Medicines Co. unveiled Phase III safety data for inclisiran showing safety and tolerability comparable to placebo and efficacy in line with the PCSK9 inhibitor class – which should be the reassurance it needs for the oral agent.
Scrip
By Eleanor Malone 11 Sep 2019
AstraZeneca’s head of R&D spoke to Scrip about the outstanding results for dapagliflozin in heart failure regardless of diabetes status.
Topic Company analysis Diabetes
Scrip
By Jo Shorthouse 10 Sep 2019
Emerging Company Profile: With a new partner in Eli Lilly, Anima Biotech and its disruptive technology that controls protein translation is starting to make waves as it urges the industry to see the light.
Topic Clinical trials
Medtech Insight
By Shawn M. Schmitt 23 Aug 2019
US FDA Compliance Branch directors Gina Brackett and Melissa Michurski shed light on the agency's use of regulatory meetings. The FDA has been pulling enforcement punches in recent years, relying more on holding the face-to-face meetings than sending warning letters.
Topic Policy and regulation
Medtech Insight
By Amanda Maxwell 23 Aug 2019
The European Commission updates its rolling plan on progress with key document and structures toward implementation of the new medtech regulations every few months. What is new and what is still to come this year?
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
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