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February 05, 2018

Today's Rundown

Featured Story

Nektar Therapeutics reportedly considering a sale

Nektar Therapeutics could join the growing list of biotechs opting for a takeover, according to a Bloomberg report that it is exploring strategic options for the business.

Top Stories

After FDA setback, Bellicum bolsters R&D team with ex-Genentech executive

Just a few days after the FDA placed a clinical hold on its lead cell therapy for cancer, Bellicum Pharma has added new R&D leadership by appointing ex-Genentech executive William Grossman, M.D., Ph.D., as its chief medical officer.

British biotech ReViral hits goals in early RSV test

ReViral has hit its primary and secondary endpoints in a small midstage trial testing its experimental medication against the respiratory syncytial virus (RSV).

[Sponsored] Can emerging technology help biopharma improve the returns on R&D?

While biopharma companies are investing more than ever to develop innovative therapies, returns are not keeping pace. How can emerging technologies help improve productivity? Learn more from Deloitte’s annual ROI analysis.

Charles River to accelerate hit discovery with AstraZeneca high-throughput deal

Charles River Laboratories has strengthened its high-throughput screening capabilities by gaining access to technologies available at AstraZeneca’s Centre for Lead Discovery in Cambridge, U.K.

Months after FDA rejection, Intarcia cuts 60 jobs and halts 2 late-stage trials

Intarcia slashed 60 jobs in a restructuring scheme following the FDA's rejection of its drug-device treatment for Type 2 diabetes.

With Celgene buyout, Juno CEO Hans Bishop set for monster payout of $287M

After ushering Juno Therapeutics through early fundraising, an IPO, clinical setbacks and more, CEO Hans Bishop is set to take home up to $287 million when the CAR-T player seals its buyout with Celgene.

Bristol-Myers' Opdivo-Yervoy team scores coveted win in first-line lung cancer

Bristol-Myers Squibb finally got its win in first-line lung cancer—and it’s a success that not only helps confirm one immunotherapy combo approach that has been in doubt, but puts forward a diagnostic biomarker that could apply to other cancer types.

Resources

[Marketplace] Is This Part Of Your Corporate TO DO List?

Guiding corporate executives through regulatory complexities, while delivering an array of sophisticated investment options. Learn more.

[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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