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December 01, 2017

Welcome to FierceLifeSci Weekly Digest, your roundup of the biggest and most popular stories from each of our publications.

Featured Story

New Teva CEO shakes up structure and executive ranks as major layoffs loom

New Teva CEO Kare Schultz is getting down to business—and quickly. Monday, the troubled Israeli drugmaker unveiled a new structure and changes to its leadership team, and it promised its restructuring plan would arrive earlier than expected, too. The company will put its generics and specialty products together under one commercial roof, with segments in North America, Europe and Growth Markets.

Top Stories Of The Week

Takeda spins off cancer assets to incubated startup  

A team of ex-Takeda scientists has struck out on its own with cancer assets licensed from the drugmaker. The resulting biotech, Chordia Therapeutics, starts life with multiple oncology drugs, lab space at a Takeda site and funding from the Japanese firm and a VC syndicate.

Medicare Part D rule change would be another win for pharma’s lobbyists, analyst says

Pharma stands to prevail again in Washington, D.C., if a new Part D rule proposal from the Centers for Medicare & Medicaid Services comes to fruition. Last week, the agency put out potential changes to solicit feedback, with a drug pricing tweak one area under consideration.

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.

Roche's prospects look sunnier, thanks to blockbuster-boosting data for Hemlibra, Tecentriq

Two of Roche's new generation of drugs—including the just-approved hemophilia therapy Hemlibra—racked up new data Monday that bolster their case for blockbuster sales. That's good for the drugmaker, whose top-selling cancer meds are facing a growing threat from biosimilars.

Lilly makes big push into devices to protect diabetes sales

Eli Lilly has unveiled its device-driven strategy for weathering the competitive and pricing pressures faced by its diabetes unit. The Big Pharma is working on insulin delivery devices that move it onto Medtronic’s turf and has teamed up with Dexcom to add continuous glucose monitoring systems to its arsenal. 

Sanofi takes €100M charge after Dengvaxia analysis leads it to seek smaller label

After an analysis showed that Sanofi's highly touted dengue vaccine could lead to more serious infections if used in the wrong setting, the company is requesting a label change that will likely lead to fewer eligible recipients. With the development, Sanofi is taking a €100 million ($119 million) charge in the fourth quarter.

Identifying new ‘template’ for potent vaccine against HIV

Scientists at the International AIDS Vaccine Initiative and the Scripps Research Institute have identified viral changes and antibody features that could provide a possible template for HIV vaccine design that tackles the virus's diversity and evasiveness.

Fresenius Kabi to invest $100M, add 445 jobs in North Carolina as U.S. investments now top $5B

With plans for a major expansion of its North Carolina site, Fresenius Kabi's investments aimed primarily at the U.S. generics market now top $5 billion as the German drugmaker bets on growth in sterile injectables.

Gilead taps X-Chem’s DNA-encoded libraries for drug discovery

Gilead Sciences has teamed up with privately held X-Chem, which will screen its DNA-encoded libraries containing over 120 billion small molecules, in the hope of finding new drugs in antiviral and other therapeutic areas.

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] 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

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

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.

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