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January 19, 2018

Welcome to FierceLifeSci Weekly Digest, your roundup of the biggest and most popular stories from each of our publications.

Featured Story

Message to Trump: Alnylam CEO proud to be a ‘shitholer’

Describing a country as a "shithole" isn’t going to endear you to anyone, but President Trump’s latest alleged outburst has struck a nerve with one particular biotech leader.

Top Stories Of The Week

Merck's Keytruda nabs new data to rival Bristol-Myers' Opdivo at fending off melanoma's return

Merck & Co. and Bristol-Myers Squibb have been head-to-head competitors in melanoma ever since their two immuno-oncology treatments, Keytruda and Opdivo, both won their first FDA approvals. Now, with its latest data, Keytruda can play catch-up with its rival for another new use.

Juno stock jumps as reports suggest Celgene wants a buyout

After a $7 billion biobucks deal for Impact Biomedicines at the J.P. Morgan Healthcare Conference last week, Celgene is lining up another deal for CAR-T biotech Juno Therapeutics, according to several media reports.

Merck extends all-important lung-cancer lead with phase 3 Keytruda combo win

Skittish investors grew increasingly concerned last year that Merck & Co. couldn’t replicate its Keytruda-chemo combo success in a phase 3 trial of previously untreated patients. But on Tuesday, the pharma giant silenced its doubters.

FDA slams Becton Dickinson for 510(k) failing, GMP violations in hard-hitting warning letter

The FDA has hit Becton Dickinson with a warning letter over unauthorized changes to devices and other regulatory violations. Inspectors identified a slew of violations at the company's site in New Jersey but have allowed the blood collection tubes at the center of the investigation to remain on the market.

AbbVie's silent IBD awareness ad sparks angry backlash but also draws support

One of AbbVie's latest TV ads for IBD awareness doesn't use any words, but that hasn't stopped it from creating controversy with patients divided over whether the imagery of parents missing out on their children's lives is insulting or empowering.

Decoding cancer-linked enzyme could lead to better EGFR cancer drugs

NIH scientists have modeled the 3D structure of DHHC enzymes, which modify nearly 1,000 human proteins, including EGFRs, a family of receptors that are implicated in a range of cancers.

Google, Sequoia back Oxford universal flu vaccine developer Vaccitech

On its way to developing a universal flu vaccine, University of Oxford spinout Vaccitech has raised £20 million in series A financing, backed by Google parent company Alphabet’s venture capital arm GV, Sequoia China and Oxford Sciences Innovation.

Charles River buys immunology player KWS BioTest for $20M

Charles River Laboratories has snapped up British CRO KWS BioTest for about $20 million, a deal that will enhance its offerings in immuno-oncology and inflammatory and infectious diseases.

Celltrion's Seo says company will build next plant outside of South Korea

Celltrion Chairman Seo Jeong-jin has confirmed that the South Korean drugmaker has decided to build its third plant outside of South Korea and expects to start construction by year-end.

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

[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] 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.

[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] 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.

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