To view this email as a web page, click here

   Home

Subscribe

Advertise

 

 

 

 

December 07, 2017

Today's Rundown

Featured Story

1-year data set Spark on track with hemophilia B gene therapy

Patients with hemophilia B have seen their symptoms controlled for up to a year with a single dose of a gene therapy developed by Spark Therapeutics, almost entirely eliminating the need for treatment with clotting factors.

Top Stories

Sage wows with phase 2 depression data, sending stock to new highs

Sage Therapeutics has scored another big win in the clinic. SAGE-217 triggered near-immediate, fairly durable improvements in patients with major depressive disorder, sending its stock on a tear for the second time in the past month.

FDA opens door to multiarm, multicompany clinical trials

The FDA has outlined how developers of drugs targeting rare pediatric diseases can streamline their clinical development programs by collaborating. Officials want drug developers to consider teaming up to test multiple candidates in single trials, thereby cutting the number of patients who need to receive placebos. 

Metabolic biotech Metacrine gains $22M for NASH tests

We’ve spoken a lot about NASH this week—this year in fact. Yet Metacrine is seeing us talk about it again after completing a series B as it aims to combat the fatty liver disorder.

Juno strikes 3 deals to advance multiple myeloma combo treatment

Juno Therapeutics, which dumped its lead CAR-T program in March, has inked license agreements with Eli Lilly, OncoTracker and Fred Hutch.

Activating the hedgehog pathway protects mice from obesity

Boosting a protein signaling pathway in the body known as "hedgehog" prevented weight gain in mice, a team from Washington University in St. Louis found. The method, which stops fat cells from growing larger, targets a common cause of obesity in adults.

Augmented reality startup Apprentice bags $2.5M cash to build on uptick in biopharma interest

Apprentice has raised money to build out its biopharma-focused augmented reality business. The startup provides smart glasses applications that enable hands-free data capture, remote problem solving and other tasks at drug research and manufacturing facilities.

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

.