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February 02, 2018

Today's Rundown

Featured Story

Moderna raises $500M to move mRNA drugs deeper into human tests

Moderna has raised $500 million from private investors. The huge series G round equips Moderna to gather more data on its pipeline of mRNA candidates and build out its manufacturing capabilities ahead of its long-anticipated IPO.

Top Stories

AstraZeneca stops monotherapy study at centerpiece of $500M buyout

AstraZeneca has stopped monotherapy development of a PD-1 drug it acquired in a $500 million (€400 million) biotech buyout. The candidate, MEDI0680, was the centerpiece of AstraZeneca’s takeover of Amplimmune.

Arcturus Therapeutics ousts CEO Joseph Payne

Arcturus Therapeutics VP Mark Herbert will take over as interim president after the company’s board opted to terminate President and CEO Joseph Payne.

New insights into dopamine release could mean better weapons against addiction

Harvard scientists discovered that neurons transfer dopamine to each other more quickly and specifically than previously thought. This new understanding could shed light on how dopamine signaling goes wrong in brain disorders, and it could lead to improved treatments for addiction, Parkinson's disease and more.

Apple eyes FDA approval filing for investigational heart device

Apple has told participants in its heart study that their data will be used to seek FDA approval for an investigational device, MobiHealthNews reports. The study is using Apple Watch sensors and related algorithms to identify irregular heart rhythms.

EuroBiotech Report—Sanofi-Ablynx, COPD data, EMA move, AstraZeneca and Roche

In this week's EuroBiotech Report, Sanofi is set to buy Ablynx, AstraZeneca posts COPD data, the EMA move gets complicated, plus more need-to-know news from Europe's biotech industry.

FiercePharmaAsia—Lantus biosimilar, Takeda’s Zika vaccine, Celltrion warning letter

Mylan and Biocon won an EU recommendation for approval of a Lantus biosimilar, Takeda’s Zika vaccine candidate won FDA fast-track status, Celltrion's South Korean plant was slapped with a warning letter, and more.

Chutes & Ladders—Hugin to retire from Celgene. Could Senate be next?

Legendary Bob Hugin might run for the Senate after retiring from Celgene as executive chairman, Voyager founder and CEO will step aside to executive science adviser, Boehringer Ingelheim U.S. chief Fonteyne will retire, plus more hirings, firings and retirings throughout the industry.

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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