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January 31, 2018

Today's Rundown

Featured Story

Seattle Genetics sets $614M buyout of Cascadian and its breast cancer program

After a multibillion-dollar deal to buy Immunomedics fell through last May, Seattle Genetics has scaled down its spending as it sets up a $614 million deal for Cascadian Therapeutics.

Top Stories

FDA hits Bellicum with clinical hold after brain damage cases in T-cell therapy trial

The FDA has placed a clinical hold on Bellicum’s lead cell therapy. Bellicum suffered the setback after the FDA learned of three cases of brain damage possibly related to adjunct T-cell therapy BPX-501.

In conversation with: Laurence Reid, Warp Drive Bio CEO

Co-founded by Harvard Medical School professor of genetics and genomics expert George Church, Ph.D., Warp Drive Bio was launched by Sanofi and Third Rock Ventures back in 2012 with $125 million and a mission to “build an innovative genomics search engine to reveal nature's drugs.” Since then, it has been working to live up to its name, speeding through development and deals.

Sage expands into sleep disorders after early-phase success

Sage Therapeutics has added sleep disorders to the list of indications targeted by SAGE-217. The CNS specialist committed to initiating sleep disorder trials of the GABA receptor modulator after getting a look at data from a small study in healthy volunteers.

After years of setbacks, Vical to slash jobs, Astellas drug work

Vical has been hit with trial flop after trial flop, from cancer and herpes vaccines to a cytomegalovirus vaccine just last week. Now, the micro-cap biotech is letting go of around half its workforce.

Ohio State researchers find pacemaker-like device reduces Alzheimer’s effects

Researchers at Ohio State University say deep brain stimulation from a device similar to a cardiac pacemaker can slow the decline of problem-solving and decision-making skills in Alzheimer’s patients.

Enrollment Showcase

Online Graduate Programs Designed for Your Career

Drexel University’s online graduate programs in biomedicine, clinical research, drug discovery, and molecular medicine were developed with working professionals in mind, providing you with the education, practical skills, and competitive edge you need to be successful in your career. Learn more.

Resources

[Whitepaper] Streamline your mAb Intact Protein Characterization: Download App Note

This Agilent intact protein analysis includes:

[Marketplace] Asia-Pacific Compliance Training for Life Sciences Professionals

Don’t miss this educational program trusted by multi-national companies as part of their employee’s compliance training. Explore legal, regulatory and ethical issues faced by pharmaceutical, biotech and medical device manufacturers operating in the Asia-Pacific region. Visit event page for session topics.

[Whitepaper] Is Your In-House Strategy Ready For The Uncertainties Of Biologic Drug Development?

Download Patheon’s whitepaper to discover two main areas where a drug developer can face significant obstacles during biologics development and how by evaluating these capabilities, it can answer the critical question of whether its in-house strategy is ready for these uncertainties.

[Webinar] How to Prevent, Identify, and Implement a Clinical Trial Rescue

What do you do when timelines are missed, data is dirty, and everyone is pointing fingers? Join this webinar to learn how to prevent, identify, and implement a successful clinical trial rescue.

 

[Whitepaper] Key to regulatory transformation is unified RIM

Expanding into new markets places a spotlight on inefficient processes.

[Whitepaper] Best Practices for Managing Regulatory Processes 

Regulatory leaders share challenges and best practices from a lack of standardization, manual processes, and fragmented systems.

[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] 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] 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.

[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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