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January 03, 2020___

Today's Rundown

Featured Story

Incyte sinks as itacitinib fails pivotal test in acute GVHD

A phase 3 trial of Incyte’s itacitinib in treatment-naive acute graft-versus-host disease has missed its primary endpoint, wiping around $2 billion off the biotech’s market cap. The failure of the JAK1 inhibitor is another blow to Incyte’s efforts to expand its commercial portfolio beyond Jakafi.

Top Stories

Durect shares rocked by midstage psoriasis flop, shifts focus to liver disease

Durect’s stock nose-dived more than 30% yesterday on the news that its phase 2 plaque psoriasis hope failed to beat out a sham treatment.

Novan crushed by phase 3 failures of antiviral gel

Novan’s antiviral SB206 has failed to beat placebo in two phase 3 trials in patients with molluscum contagiosum. The setback wiped 74% off Novan’s value and left its cash runway looking precariously short, but the biotech plans to start another trial in the belief it still has a path to approval.

New year, new name, new CEO for synthetic biology co. Intrexon

Two years after hiving off its healthcare assets into a subsidiary, Intrexon is bringing those assets back into the fold as it changes its focus, sheds its non-healthcare work and names a new CEO.

After midstage flop, Janssen says thanks but no thanks to Provention Bio drug

Janssen will not be buying back the rights to a drug it shipped out to Provention Bio back in 2017 after it failed to move the needle in Crohn’s disease.

Illumina calls it quits after FTC blocks its $1.2B offer for PacBio

DNA sequencer makers Illumina and Pacific Biosciences of California called off their $1.2 billion merger that’s been in the works for over a year after the Federal Trade Commission challenged the transaction and described it as “monopolist.”

FiercePharmaAsia—AZ-Daiichi's fast Enhertu nod; Astellas' 2 partnered approvals, CAR-T buy

Daiichi Sankyo and AstraZeneca gained FDA nod for Enhertu just two months after a priority review tag. Astellas and Seattle Genetics won an FDA go-ahead for bladder cancer drug Padcev as Atellas' Pfizer-partnered Xtandi added a new prostate cancer indication to its label. And more.

Chutes & Ladders—AstraZeneca's Pangalos honored with knighthood

AstraZeneca R&D chief Pangalos receives knighthood; Fountain taps Zhen as new CEO; Jones joined McCann Health as creative head.

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Resources

[Whitepaper] Digital Disruption in Biopharma: How Digital Transformation can reverse declining ROI on R&D

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Download this white paper and read the expert feedback that snapIoT has gathered from industry thought leaders on the evolution, evaluation, and use of telemedicine solutions in clinical trials.

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How are your launch strategies can convert “innovation” into value for patients?

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Learn more: Best practices for defending supply chain security and compliance by efficiently managing product authentication.

[Whitepaper] The Unexpected Key to Building Value in Drug Discovery and Development

Small or emerging pharmaceutical and biotech companies pursuing novel molecules and targets have two important goals: achieve clinical success and attract new rounds of funding. While there’s never a guarantee of either, certain actions can influence the outcome in your favor.

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Learn how recent innovations in demand-led supply and direct-to-patient distribution are converging to create a next-generation clinical supply chain that is flexible, lean and most importantly patient-centric.

[Whitepaper] Digital Twins: Creating Digital Operations Today to Deliver Business Value Tomorrow

This whitepaper highlights the challenges of implementing the right digital twin strategy while providing key use cases in the manufacturing domain for which a digital twin is extremely useful and several examples of technology trends that will shape the future.

[Whitepaper] Q2 2019 Life Sciences M&A notes and trends

Get your copy of the Q2 2019 Life Sciences M&A notes and trends to understand the mergers and acquisitions (M&A) activity in the life sciences sector which drove 136 new M&A deals and provides a forward look to 2020 activity ahead.

[Whitepaper] What You Need to Know to Avoid Costly Delays in Your API Scale-Up

Are you facing costly delays in your API scale-up?

[Q&A] Embarking Upon the Commercial Manufacturing Journey for a Biologic

In this Q&A, four Catalent Biologics experts share how scale-up, regulatory expectations, demand forecasting and process validation all play a role in the success of a biologic when embarking upon the commercial manufacturing journey.

[Whitepaper] Modernizing clinical trials with Amazon Web Services (AWS)

From IoT to data management to high-performance computing and machine learning, leading life sciences organizations are using Amazon Web Services (AWS) to develop scalable, global, predictable, and secure solutions to modernize clinical trials while mitigating risks

[Whitepaper] The Impact of Step-Therapy Policies on Patients

Download this complimentary paper that explores the practice of step therapy and its impact on key stakeholders in the US healthcare system.

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