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January 11, 2018

Today's Rundown

Featured Story

With peanut allergy treatment on a roll, Aimmune details egg, milk programs

Aimmune CEO Stephen Dilly sat down with FierceBiotech to discuss the company's peanut allergy immunotherapy, its newer programs in egg and milk, and why it takes so long to come up with a starting dose for allergy treatments.

Top Stories

FDA panel shoots down Lipocine low-testosterone drug

A panel of experts convened by the FDA has come down against approval of Lipocine’s testosterone replacement therapy. The panel voted 13-6 against the risk-benefit profile of Tlando, leaving Lipocine looking down the barrel of a rejection with limited cash to mount a fightback.

Boehringer taps Adimab for antibody discovery project

Boehringer Ingelheim has enlisted the help of Adimab for a drug discovery project. The agreement tasks Adimab with turning its yeast-based antibody discovery platform against multiple targets picked out by Boehringer.

[Sponsored] INNOVATION BY DESIGN

Astellas, like many of our industry peers, prioritizes innovation. What sets Astellas apart, however, is how we function at the intersection where our “Science First” approach meets the flexibility we’ve built into our innovation infrastructure.

BioLegend licenses transcriptome tech from NY Genome Center

A technology developed at the New York Genome Center that combines protein and messenger RNA expression measurements in cells has been licensed by biotech tools company BioLegend.

Novavax veteran lines up as next president of Icon’s ClinicalRM

Icon has hired a retired colonel who is moving into the biotech sphere as new president of its subsidiary ClinicalRM. James Cummings, M.D., will lead the CRO’s unit, which helps provide research to a range of U.S. federal health agencies.

Novartis poaches Pfizer veteran Liz Barrett to lead cancer unit—and its big Kymriah and Kisqali rollouts

Novartis brought on Pfizer executive Liz Barrett to head up its oncology outfit after Bruno Strigini's retirement. One of her signature accomplishments: The rollout of Ibrance, a breast cancer drug among Pfizer's biggest recent successes—and a head-to-head competitor to Novartis' own Kisqali.

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

[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.

[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? From study delays to quality issues, sponsors can find their studies at risk with no clear solution.

[Whitepaper] Key to regulatory transformation is unified RIM

Expanding into new markets places a spotlight on inefficient processes.

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

This Agilent intact protein analysis includes:

[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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