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Scrip

Inclisiran’s Safety Data Suggest Game-Changing Potential In PCSK9 Market

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. 

Topic Drug development landscape Drug review

Scrip

Interview: AstraZeneca’s Pangalos on Landmark DAPA-HF Resultsv

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

Anima Biotech Lighting The Way In Protein Translation

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

Compliance Corner: 2 FDA Compliance Branch Heads Talk Regulatory Meetings – And What You Can Expect

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

Updates On The European Commission’s Medtech Agenda And Deadlines For The Rest Of 2019

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

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

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