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December 01, 2017

Today's Rundown

Featured Story

Shire snaps up Bayer’s Andreas Busch a day after he leaves the German pharma

Bayer was keeping mum on where its R&D vet Andreas Busch, Ph.D., was heading yesterday after it announced a big change-up in its research unit (and his exit), but early this morning Shire announced it was the company he was heading for.

Top Stories

Astellas buys DMD drug in $450M mitochondrial takeover

Astellas has acquired its partner Mitobridge in a deal worth up to $450 million. The takeover gives Astellas full control of a phase 1 Duchenne muscular dystrophy (DMD) drug in return for $225 million upfront and the same again down the line.

Active Bio and Teva’s laquinimod strikes out again, this time in progressive MS

Active Biotech and Teva’s laquinimod—once billed as a successor to multiple sclerosis blockbuster Copaxone—has hit yet another snag after failing a phase 2 trial in primary progressive MS.

[Sponsored] What makes a modern-day biotech?

Blue Latitude Health interviews 6 biotech leaders to reveal the commercial challenges and opportunities in 2018 and beyond, including big data, FDA approvals, combination therapies, empowered patients and the skills crisis.

ValiRx shares yo-yo on fundraising and pipeline update

ValiRx is approaching a pivotal point in its development as it waits for clinical results from two lead programs that it hopes will net it a development partner.

Foundation Medicine gets FDA, CMS nods for pan-cancer genomic test

Foundation Medicine has brought its pan-cancer test through the parallel review process, securing FDA approval and a likely coverage by Medicare. The approval is the first time the FDA has signed off on such a broad test.

EuroBiotech Report—Merck-Brexit, Innate-BMS, UCL-Synpromics, MorphoSys and Auris

In this week's EuroBiotech Report, Merck bets on post-Brexit Britain, Innate rocked by lirilumab setback, UCL inks gene therapy pact and more.

FiercePharmaAsia—Takeda’s assets spinoff, AstraZeneca’s China JV, Biocon’s biologics plant

Takeda transferred some early cancer candidates to a startup it's incubating, AstraZeneca put its R&D capabilities in China in the hands of a newly formed joint venture, Biocon has resolved FDA concerns of a plant crucial to potential approval of its Herceptin biosimilar, and more.

Chutes & Ladders—Teva rejigs C-Suite amid major restructuring

Teva CSO Hayden will leave with two other executives amid a major structural overhaul, Bayer R&D reorg saw Moeller in and Busch out for Shire, Shire and Biogen get experienced CFOs, plus more hirings, firings and retirings throughout the industry.

Resources

[Whitepaper] How biopharma companies are bolstering R&D pipelines through deal-making

Sourcing research externally seems to be the preferred path for biopharma companies to strengthen their R&D pipeline.

[Whitepaper] 5 Steps to Managing Quality Globally

Read this guide if you’re a global life sciences company - conducting clinical trials across several countries, or manufacturing and distributing products in multiple regions - to learn five steps to align and improve quality oversight, as well as avoid common mistakes in harmonization initiatives.

[Whitepaper] Growing Regulatory’s Strategic Value: The Value of a Holistic RIM Capability

Read Deloitte Consulting's whitepaper on the value of a holistic RIM capability, covering the potential cost savings and revenue gains from doing RIM right.

[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] 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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