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November 08, 2017

Today's Rundown

Featured Story

Roche, Calico vet Hal Barron takes GSK R&D hot seat, as Vallance out

Former Roche and Calico vet Hal Barron has become the new CSO and research chief at GlaxoSmithKline amid a shake-up from its new CEO Emma Walmsley.

Top Stories

Kerrisdale predicts failure for Prothena rare disease medication in short attack

Sahm Adrangi’s Kerrisdale Capital Management, known for its activist short positions, has given Elan spinoff Prothena the unwanted title of the “next big biotech blowup.”

Gottlieb: Don’t take away FDA’s drug/device approval remit for soldiers

FDA Commissioner Scott Gottlieb has hit back at plans that could see the Pentagon take control over the approval of some experimental drugs and devices for soldiers.

[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.

Amgen makes regenerative medicine play, backing $25M Fortuna round to move neural stem cells into the clinic

Amgen’s VC wing has invested in Fortuna Fix to help move autologous neural stem cells into the clinic. The $25 million series B sets regenerative medicine startup Fortuna to move candidates against Parkinson’s disease and spinal cord injury to clinical trials next year.

Boehringer gets deeper into NASH, RNA with MiNA pact

Boehringer Ingelheim has entered into its second RNA therapeutics NASH deal in as many weeks. The new pact sees Boehringer commit to up to €307 million ($356 million) to work with MiNA Therapeutics on up to three targets relevant to NASH and other fibrotic liver diseases.

QuintilesIMS no more. Say hello to IQVIA

About a year after QuintilesIMS was born from a megamerger between Quintiles and IMS Health, the contract research giant has decided to turn the page and rebrand as IQVIA, pronounced as “I-Q-via.”

FDA loosens rules on consumer genetic health tests

The FDA has cleared the way for more direct-to-consumer genetic health tests to come to market. If finalized, the approach will allow certain manufacturers to bring genetic tests to market without undergoing premarket review.

Resources

[Whitepaper] Modernize Quality Management

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

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[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] 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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