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April 20, 2017

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Today's Rundown

  1. Novartis drug development chief outlines CAR-T research commitment

  2. AbbVie PARP inhibitor veliparib flunks two phase 3 trials

  3. EU crushes U.K. hopes of retaining EMA after Brexit

  4. Tonix could get 2019 nod for breakthrough-badged PTSD therapy: analysts

  5. H3 Biomedicine boosts its cancer collab with Foundation Medicine

  6. J&J buys 3D-printing tech to create bone-healing implants

  7. KOLs underline use of remote technologies for clinical trials in new guidelines

  8. FDA document lays out issues undermining approval of AstraZeneca's ZS Pharma drug

Featured Story

Novartis drug development chief outlines CAR-T research commitment

Despite reports that linked Novartis to cutting back on its cell therapy work, the Swiss major says it is going full steam ahead for its CAR-T research as a potential approval for its candidate appears on the horizon.

Top Stories

AbbVie PARP inhibitor veliparib flunks two phase 3 trials

Two phase 3 trials of AbbVie’s PARP inhibitor veliparib have missed their primary endpoints. The studies set out to show that the addition of veliparib to chemotherapy improves outcomes in patients with non-small cell lung cancer or triple negative breast cancer but fell short of this goal.

EU crushes U.K. hopes of retaining EMA after Brexit

The European Commission has again sought to extinguish the United Kingdom’s lingering hopes of keeping the European Medicines Agency (EMA) in London after Brexit. Lead Brexiteer David Davis became the latest politician to claim London could retain the regulator earlier this week, only for a spokesperson for the commission to rubbish the idea.

Tonix could get 2019 nod for breakthrough-badged PTSD therapy: analysts

Just as global security is starting to look a bit precarious, Tonix Pharmaceuticals has started recruiting military personnel into a phase 3 trial of its drug candidate for combat-related post-traumatic stress disorder (PTSD).

H3 Biomedicine boosts its cancer collab with Foundation Medicine

Eisai’s spinoff unit H3 Biomedicine has expanded its 2015 deal with Foundation Medicine as the pair look for new cancer drivers.

J&J buys 3D-printing tech to create bone-healing implants

Johnson & Johnson has acquired 3D-printing technology from Tissue Regeneration Systems. The deal gives J&J’s DePuy Synthes Products unit technology for creating personalized bioabsorbable implants designed to aid the healing of bones.

KOLs underline use of remote technologies for clinical trials in new guidelines

An expert panel has released new guidelines for modern clinical trials, examining the importance of utilizing telehealth technologies in clinical studies.

FDA document lays out issues undermining approval of AstraZeneca's ZS Pharma drug

The FDA has twice rejected AstraZeneca’s application for a new drug to treat hyperkalemia because of manufacturing concerns. The reasons why became a little clearer Wednesday when the agency posted a document outlining the issues that have regulators furrowing their brows.

News of Note

AbbVie's experimental pan-genotypic, ribavirin-free hep C combo therapy hit a 99% SVR 12-week rate in patients with compensated cirrhosis. Release

George Church has been picked as one of Time's 100 most influential people for 2017. Time story

Bicycle Therapeutics has hit a preclinical milestone with ThromboGenics after pushing a Bicycle candidate into preclinical development in diabetic macular edema. Statement

Resources

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Training is a vital component of workplace efficiency especially when it comes to one of the most important deliverables of a clinical trial – the Trial Master File (TMF).

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[Whitepaper] Streamline Regulatory Compliance in Life Sciences with Digital Transaction Management

The U.S. Department of Justice has collected upwards of $17 billion in settlements from the healthcare industry since 2009, including more than $2 billion from a single life sciences company.

[Survey] Veeva 2017 Unified Clinical Operations Survey

Share your thoughts on the life sciences industry’s progress in reducing system and process complexity to improve study execution. The first 50 qualified respondents will receive a $10 Amazon gift card, as well as a $10 donation made to Doctors Without Borders in their name. Finish the survey today!

[Whitepaper] A Dose of Shared Services: Why Big Pharma is Turning South

As life sciences companies decide to implement shared services, a major concern is real estate costs for a facility. Download this Whitepaper to learn why Florida is gaining traction as a prime location for shared services.

Events

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