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December 05, 2017

Today's Rundown

Featured Story

Johnson & Johnson’s JLABS looks east as it lands in Shanghai

Now well established across the U.S. and Canada, J&J’s biotech incubator system has expanded into Asia with its first center in China.

Top Stories

Special Report—2017’s fiercest women in life sciences

It feels as though we say this every year, but it bears repeating: From CEOs and COOs to division chiefs and venture capital partners, women are taking the lead and making an impact all over the life sciences industry.

Revance’s rival to Allergan’s Botox aces phase 3

A pair of phase 3 trials of Revance’s RT002 have hit all their primary and secondary endpoints. The data show the effect of the neuromodulator on wrinkles lasted for six months, suggesting it poses a threat to Allergan’s blockbuster Botox franchise.

Goldfinch poaches AstraZeneca research exec Tony Johnson for CEO

The lure of a razor-sharp therapeutic focus has enticed AstraZeneca’s head of early clinical development, Tony Johnson, to take the top job at kidney disease specialist Goldfinch Bio.

Cellectis lures ex-Servier cancer R&D chief back to industry

Cellectis has named Stéphane Depil, M.D., Ph.D., as its CMO and senior vice president of R&D. The appointment sees the former director of oncology R&D at Servier return to the industry after a spell directing the cancer immunotherapy program at a cancer center in Lyon.

Ironwood's diabetes drug posts positive phase 2 data, but shares still dip

Ironwood Pharmaceuticals unveiled promising topline data from a pair of phase 2a trials investigating its sGC stimulator in patients with Type 2 diabetes and hypertension.

Bioclinica lifts imaging and eHealth chief Herron to CEO, launches clinical adjudication service

Bioclinica named current imaging and eHealth president David Herron to succeed retiring John Hubbard, Ph.D., as CEO, and launched a cloud-based clinical adjudication platform grown out of its recent acquisition of MDDX.

LivaNova inks $225M deal for sleep apnea startup

LivaNova has struck a $225 million deal to buy ImThera Medical. The agreement will see LivaNova hand over $78 million upfront and commit to almost $150 million in regulatory and sales milestones to acquire the rest of ImThera and its neurostimulation treatment for sleep apnea.

Resources

[Whitepaper] Choosing the Right Solution: Improving the Site Feasibility Process

Selecting the right sites to conduct your clinical trials will determine the success or failure of meeting your enrollment goals.

[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] 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.

[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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