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February 14, 2018

Today's Rundown

Featured Story

Bristol-Myers Squibb makes history with major multibillion-dollar Nektar drug pact

Bristol-Myers Squibb is paying Nektar Therapeutics $1 billion to develop NKTR-214 in combination with Opdivo and Yervoy. All told, Bristol-Myers is committing $3.6 billion to a deal that gives Nektar the lion’s share of NKTR-214 profits and leaves it some freedom to develop the drug in combination with other assets.

Top Stories

Merck BACE1 drug fails in prodromal Alzheimer’s phase 3

Merck has stopped a phase 3 trial of BACE1 inhibitor verubecestat in prodromal Alzheimer’s patients following an interim review. News of the setback comes 12 months after Merck pulled the plug on a trial in patients with more advanced forms of the disease after seeing similarly lackluster data.

Aradigm executives jump ship after FDA snub

Strapped for cash after an FDA rejection, Aradigm is hemorrhaging executives. CEO Igor Gonda, Chief Medical Officer Juergen Froehlich and Chief Financial Officer Nancy Pecota are all bidding the troubled biotech farewell.

Astellas pledges $102.5M for universal donor cell company

Astellas has bought out a U.S. biotech that promises to do away with the testing needed to ensure cell therapy products aren’t rejected by a patient’s immune system.

Tetraphase’s eravacycline misses endpoints in phase 3 flop

Tetraphase's lead candidate, eravacycline, failed to best Merck’s ertapenem in the treatment of complicated urinary tract infections. The candidate is currently under FDA and EMA review for complicated intra-abdominal infections.

Novartis, Gates Foundation pen tropical disease drug pact

The Bill & Melinda Gates Foundation has teamed up with big pharma Novartis and its experimental drug for certain diarrheal diseases.

DIY DNA sequencing for $2 a gene

UCLA scientists were frustrated by the prospect of paying up to $100 per gene from commercial vendors that sell gene sequences for scientific experiments. So they decided to invent a gene-synthesis technology that would allow scientists anywhere to make their own genes quickly and efficiently.

Axovant COO McCourt jumped from sinking biotech right into Regeneron's top commercial post

Axovant announced Monday that President and COO Marion McCourt would exit “to pursue another opportunity” as part of a major executive shakeup at the beleaguered biotech. Turns out, that opportunity is with Regeneron.

Resources

[Whitepaper] How Life Sciences Companies Use Box for Regulated Content in the Cloud

Learn how biopharma and medical device companies can now collaborate on, manage and distribute regulated clinical, lab and manufacturing content in Box. That means all of your content is standardized on a single content repository that meets regulatory and compliance standards, so you can eliminate inefficient silos, enable seamless collaboration and accelerate the validation process.

[Whitepaper] CFO's, Is This Part Of Your Corporate TO DO List?

Employee stock option trading & administration, Restricted stock transactions (Rule 144), Affiliated trading plans (10b5-1), Directed share plans, Equity comp plan administration — private to public

[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.

[On Demand] 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. Watch this webinar to learn how to prevent, identify, and implement a successful clinical trial rescue.

[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 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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