Manufacturing and Production

2020 Veeva Unified Clinical Operations Survey

Published on 24/02/20 at 05:01pm

Every year, Veeva asks clinical professionals to take part in the Veeva Unified Clinical Operations Survey to help the industry better understand the current challenges.

Last year’s survey findings had shown that sponsors and CROs are making progress in unifying clinical systems, streamlining end-to-end processes, and aligning stakeholders to improve trial performance.

THE ORPHAN DRUGS & RARE DISEASES CONFERENCE

Monday, June 3, 2019 - Tuesday, June 4, 2019
London, United Kingdom
Event Type: Conference

Industry veteran Dr David Setboun joins BrainStorm as Executive VP and COO

Published on: 03/04/20

BrainStorm Cell Therapeutics, a firm developing cellular therapies to tackle neurodegenerative diseases, has named industry Big Pharma veteran Dr David Setboun as its new Executive Vice President and Chief Operating Officer.

Dr Setboun has served for two decades at some of the biggest names in pharma. His most recent role was Vice President of Corporate Development, Strategy & Business at Life Biosciences, where he helped drive development of a range of vital commercial, operating and funding milestones.

Dr John C. McKew promoted to Chief Operating Officer at Lumos Pharma

Published on: 03/04/20

Lumos Pharma, Inc. has promoted Dr John McKew to the position of Chief Operating Officer effective 1 April 2020.

McKew is already Chief Scientific Officer and he will do both roles simultaneously. With his new role, he will lead Lumos’s clinical development plan as the company looks toward adding additional assets to its pipeline.

Steven T Gill returns to Alimera as VP, Thought Leader Engagement

Published on: 03/04/20

Ophthalmology specialist Alimera Sciences has announced that Steven T Gill is to return to the company in the newly created role of Vice President, Thought Leader Engagement.

Gill had previously served at Alimera as its Senior Director, Thought Leader Liaison, before leaving the company for Novartis, where he most recently held the position of Associate Director, Thought Leader Liaison at Novartis US.

The April 2020 issue of Pharmafocus is available to read free online now!

The latest monthly edition of Pharmafocus, the April 2020 issue, is available to read for free online now!

There’s one big story on everyone’s mind, and with the whirlwind of information (and misinformation) around the COVID-19 pandemic, it’s easy to get disorientated. The latest issue of Pharmafocus aims to cut through that by providing a blow-by-blow account of some of the key milestones on the journey to where we are today.

Axsome’s late-stage study of experimental depression drug misses main trial goal

Photo by Tom Varco

Axsome Therapeutics reported on Monday that its Phase 3 study of its experimental depression drug missed its main trial goal.

It’s drug AXS-05 (dextromethorphan/bupropion) failed to significantly improve depression symptoms compared to bupropion, in patients with treatment-resistant depression (TRD). However this treatment for people with major depressive disorder (MDD) remains on track in its trial phase.

Johnson & Johnson selects lead COVID-19 vaccine candidate and targets September Phase I study

Photo by Open Grid Scheduler

Johnson & Johnson announced that it has selected a candidate for a COVID-19 vaccine from potential constructs it has been investigating since January, and is targeting a Phase 1 study for September.

Paul Stoffels, Chief Scientific Officer at the company, said: “Supported by the global production capability that we are scaling up in parallel to this testing, we expect a vaccine could be ready for emergency use in early 2021.”

Bayer's Nubeqa combo approved in Europe for non-metastatic castration-resistant prostate cancer

The European Commission has given the green light to Bayer’s non-steroidal androgen receptor inhibitor Nubeqa (darolutamide), jointly developed with Orion, in the treatment of non-metastatic castration-resistant prostate cancer (nmCRPC) in men who are at high risk of developing metastatic disease.

Phase 3 data supporting the approval showed that Bayer’s drug, in combination with androgen deprivation therapy (ADT), improved metastasis-free survival by a median of 40.4 months compared to just 18.4 months with placebo plus ADT, meeting the trial’s primary goal.

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