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May 04, 2018

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

Featured Story

Watch out, Gilead—Novartis got the FDA nod it needs to steal your CAR-T market

Novartis' CAR-T cancer therapy Kymriah expanded its reach with a second FDA approval Tuesday night—an approval that puts it in direct competition with Gilead's Yescarta. If the rivalry in relapsed large B-cell lymphoma comes down to price, it will be a close race.

Top Stories Of The Week

Bristol-Myers Squibb drops phase 3 trials of $800M IDO drug

Bristol-Myers Squibb has pulled two phase 3 clinical trials of the IDO1 inhibitor it acquired through an $800 million takeover of Flexus. The studies are the latest dominoes to fall following the failure of Incyte’s rival IDO drug to move the needle in a pivotal trial.

Merck lawyer's misdeeds tainted Gilead patent fight, court rules—and cost the company $200M

It's not often that one misguided phone call—and a subsequent cover-up—costs a company hundreds of millions of dollars, but that's exactly what happened in a hepatitis C patent dispute between Merck & Co. and Gilead Sciences.

AbbVie halts trial of Stemcentrx-sourced ADC for cancer

AbbVie has terminated an early-stage trial of an antibody-drug conjugate (ADC) for solid tumors, one of the candidates acquired as part of its $9.8 billion takeover of Stemcentrx in 2016.

GSK's Shingrix blows past sales projections, pushing 2018 estimates to $600M

GlaxoSmithKline's Shingrix carried high expectations, but it turns out that those ambitious projections weren't high enough. In the first quarter, the shingles vaccine generated £110 million, nearly triple analyst estimates of £40 million. And the revenue couldn't come at a better time for GSK.

Daphne Koller, A-list backers unite to create machine learning drug R&D startup

Daphne Koller has unveiled her next goal: improving drug R&D. The ex-Calico AI expert plans to enlist data and machines to address shortcomings in drug discovery and development—and she has persuaded a stellar investment syndicate to bankroll the work. 

Sermo's 'Yelp for drugs' platform chalks up 665K doctor reviews in just 1 year

Sermo’s drug ratings system by doctors for doctors is soaring. A little less than a year after its launch, the Yelp-like platform now has 655,000 ratings on more than 4,000 medications. More than half those drugs have at least 100 reviews—and 18 of them have more than 1,000.

What bats are teaching us about immunity to viruses

Bats can host several viruses without ever developing symptoms—even Marburg and Ebola, both of which can be deadly to people. So what’s the secret to the bats’ immunity, and could it point to new therapies to fight lethal viruses? Scientists from the U.S. Army are studying DNA from Egyptian fruit bats in the hopes of answering those questions.

FDA warning thrashes Indian drugmaker for filthy plant, data falsification

An Indian drugmaker has halted production of a couple of APIs for the U.S. after FDA inspectors found it was falsifying data at its manufacturing complex near Tamil Nadu, India. That was just the beginning of the problems.

Charles River expands discovery services in the U.S. and Europe

Charles River Laboratories is expanding its services into the early discovery setting, offering high-speed pharmacokinetics screening of compounds’ underlying biology to help companies identify small-molecule candidates.

Resources

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[Whitepaper] Five Tracking Spreadsheets it’s Time for Regulatory to Retire

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[Whitepaper] Regulatory Transformation at UCB

UCB took a more holistic approach to managing regulatory processes. Read how their efforts are paying off.

[Whitepaper] Risk-based Approach to Change Management of GxP Systems

Learn how to reduce change management burden, keep systems current, and maintain compliance by applying a risk-based approach to change management of GxP systems.

[Whitepaper] MSL Outlook: What is the Future of Field Medical Affairs?

Learn how leading companies, from the world’s top pharma to emerging biotechs, are empowering their medical affairs teams.

[Whitepaper] Leveraging Scientific Insights for Better Healthcare Engagement

To deliver value to key opinion leaders, medical affairs needs to tailor their engagement with deeper analytics and insights.

[Whitepaper] The Future of Life Sciences Events Management

Explore a new model for events management, and learn how to deliver more value.

[Whitepaper] Digitizing the Global Life Sciences Supply Chain: The Critical Role of Digital Transaction Management

Life science companies are experiencing a significant transformation in how they bring new products to market.

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