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November 09, 2017

Today's Rundown

Featured Story

Sage soars as postpartum depression phase 3 trials hit goals

Sage Therapeutics’ brexanolone has cleared the bar of efficacy in two phase 3 trials in women with postpartum depression. The trials linked the intravenous formulation of allopregnanolone to statistically significant improvements on a depression scale, teeing Sage up to file for approval next year and sending its stock up 44%.

Top Stories

Otonomy’s renaissance starts as Ménière’s disease drug clears trial

Just weeks after a phase 3 setback caused it to slash staff and R&D programs, Otonomy has bounced back with a positive late-stage trial for its lead candidate Otividex in Ménière’s disease.

Sanofi pays $40M, commits $765M more for preclinical MS drug

Sanofi has committed up to $805 million to license multiple sclerosis drug PRN2246 from Principia Biopharma. The French Big Pharma is paying $40 million upfront to pick up the preclinical asset, with $765 million more to follow if it passes all the milestones that await.

[Sponsored] Are You Prepared to Address International Pediatric Plan Requirements?

Did you know pediatric plans are a requirement for virtually all new medicines, not just those identified as available for children? Gain insights from Dr. Dehlinger-Kremer, chair of the EFGCP and EUCROF on this requirement.

After asthma success, AstraZeneca and Amgen’s tezepelumab misses in atopic dermatitis

AstraZeneca and Amgen’s tezepelumab missed the primary endpoint in a phase 2a atopic dermatitis trial, raising doubts about the prospects of the thymic stromal lymphopoietin antagonist making a mark in a congested field featuring Sanofi, Pfizer and Novartis.

Chasing Alexion, Apellis hits the start button for $150M IPO

Flush with recent clinical trial wins, Apellis has moved quickly ahead with an initial public offering that it hopes will raise $150 million and give it the reserves needed to take its lead complement drug through the next phases of clinical development.

Editas backer Partners taps Lilly to help raise $171M fund

Partners HealthCare System has grown its early-stage fund into a $171 million investment vehicle. The Boston-based hospital network achieved the jump in scale by turning to outside backers including Eli Lilly, which collectively pumped $66 million into the fund.

Improving cancer immunotherapy by harnessing new technology

Checkpoint-inhibiting drugs like Merck’s Keytruda and Bristol-Myers Squibb’s Opdivo have transformed the treatment of some cancers, but they don't work for some patients, and for others they cause dangerous autoimmune responses. Two new ideas for improving these drugs were proposed this week.

NIH recruits Fitbit for Precision Medicine Initiative program

The National Institutes of Health has tapped Fitbit to provide 10,000 devices for the All of Us research program, which seeks to collect health data from more than 1 million people as part of the Precision Medicine Initiative.

Resources

[Whitepaper] Modernize Quality Management

Gain a complete, real-time view of quality and streamline operations. Incorporate partners into processes for critical oversight and 30% greater efficiency, and transform cross-functional processes like change control.

[Whitepaper] DSM Looks to Challenge Traditional Stent Graft Materials with its Dyneema Purity® Membrane Edit

Discover DSM's Dyneema Purity® membrane, an effective and efficient material to construct stent grafts used in minimally invasive surgeries to treat both cardiovascular and peripheral arterial diseases.

[Whitepaper] Accessing Scientific Literature Doesn’t Have To Be Like Scaling A Mountain

SO CLOSE AND YET SO FAR. Is that how many documents seem to you? Getting what you want—when, where, and how you want it—can be a real pain. That’s why we created this concise guide to getting around the obstacles that stand between you and the information your organization needs. Download the whitepaper to learn more.

[Whitepaper] Meeting the Challenge of Appropriate Safety Report Distribution

As clinical trials become more complex, safety document distribution to investigative sites has reached the point that demands a solution.

[Webinar] Tips to escape the Vacancy Trap and avoid it entirely

Join this webinar to discover tested and proven solutions to manage vacancies. Presented by Tyler Cowan, VP, Client Solutions, Ashfield US, you’ll learn how to maintain and build momentum in field sales despite turnover.

[Whitepaper] Veeva 2017 Annual CRO Report: CROs lead the drive to a unified clinical model

CROs are leading an industry wide shift to modernize clinical systems and clinical trial processes.

[Webinar] Validating a 7 Day Membrane Filtration Sterility Test using Celsis®

Join us as we discuss how Charles River Celsis® helped Labor L+S AG validate a 7-day membrane filtration sterility test using existing protocols.

[Infographic] Evolution of Flexible Commercial Biologics Manufacturing

Learn how Catalent Biologics is paving the way for flexible biologics development and manufacturing through advanced technologies and fully integrated multi-product facility.

[eBook] Developing Site-specifically Modified ADCs: Using a Chemoenzymatic Approach

Download the eBook to get articles from various Elsevier journals highlighting developments in ADC technology.

[Article] Optimizing titer and use of a specific enzyme for generating a fully processed antibody

Learn how cell development and process scale-up can be optimized for antibodies requiring additional processing.

[Webinar] Within-Subject Clinical Trials: Intro to New Methods & Stat. Models

In this webinar, we will introduce the rapidly-evolving within-subject clinical trial (WSCT) methods for early phase evidence generation that require fewer people, less time, and usually less funding than traditional early phase methods.

Events

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