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November 20, 2017

Today's Rundown

Featured Story

After penning Loxo deal, Bayer signs another $1B R&D pact

Bayer has signed a new and potentially major research pact with Japan’s PeptiDream, marking the second big biobucks deal of its kind for the German pharma in the past week.

Top Stories

Acorda dumps $363M Parkinson’s drug after patient deaths

Acorda Therapeutics is scrapping its Parkinson’s disease drug tozadenant following patient deaths in its phase 3 trial. The action marks the end for an oral adenosine A2a receptor antagonist Acorda paid $363 million in cash for last year.

Biotech veteran Julian Adams takes top job at Gamida Cell

Novartis-backed biotech Gamida Cell has named Julian Adams, Ph.D.—its current chair and chief scientific officer of Clal Biotech—as its new CEO.

DBV climbs as peanut allergy safety data come in clean

DBV Technologies has posted phase 3 data suggesting safety and compliance are unlikely to scuttle its hopes of winning approval of peanut allergy treatment Viaskin Peanut. Shares in DBV rose on the back of the data, going a little way toward erasing the big drop it suffered after missing its primary efficacy endpoint.

In a first, FDA allows remote tweaking of cochlear implants

The FDA has approved the remote programming of cochlear implants via a telemedicine platform, freeing patients with severe to profound hearing loss from the need to visit specialized centers to get their devices adjusted. 

Resources

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

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[Whitepaper] How Do Sponsors Ensure Quality in Global Clinical Trials?

Global clinical trials are the trend and gaining in popularity, but running a global trial is not a straightforward process. This white paper explores some of the challenges associated with global clinical trials and considerations for ensuring that the collected data comply with the trial's overall objectives.

[Whitepaper] eClinical Landscape Study from Tufts Center for the Study of Drug Development

See the results from one of the largest, most in-depth surveys of clinical data management professionals on data management practices, performance, and challenges.

[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] 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] Discover tested and proven solutions to manage territory vacancies

December 5, 2017 | 2pm EST / 11am PST

Join this webinar to learn methods that maintain and build sales momentum 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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