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January 14, 2020___

Today's Rundown

Featured Story

Just a year in and $25M down, Eli Lilly abruptly exits NextCure pact

Eli Lilly has killed off its deal with immuno-oncology biotech NextCure after spending $25 million upfront on the pact just over a year ago.

Thank you to Rho for sponsoring this year's JPM 2020 coverage.

Top Stories

Astellas teams with Adaptimmune to create CAR-T, TCR therapies

Astellas has teamed up with Adaptimmune to develop allogeneic chimeric antigen receptor T-cell (CAR-T) and T-cell receptor (TCR) therapies. The agreement sees Astellas pay $50 million (€45 million) upfront and commit to many times as much in milestones to work with Adaptimmune to identify targets and develop cell therapies against them.

Acasti blames phase 3 lipid-lowering flop on placebo response

A phase 3 trial of Acasti Pharma’s omega-3 drug CaPre has missed its primary endpoint, denting its hopes of challenging Amarin’s Vascepa for the hypertriglyceridemia market. Yet, Acasti still thinks its drug has a chance, pointing to the reduction in triglyceride levels in the placebo group to explain the failure.

JPM: Esperion tees up to launch cholesterol-busting meds—at affordable prices

SAN FRANCISCO—With approvals looming for two cholesterol-busting drugs, Esperion is building a team of 300 sales reps to make sure doctors know to prescribe the new drugs to patients who struggle to control their cholesterol. And it plans to sell the drugs at a price that ensures patients prescribed them can actually afford them.

JPM: Synlogic CEO Brennan on lessons learned and what's up in 2020

SAN FRANCISCO—Last August, Synlogic pulled the plug on its lead program: a “synthetic biotic,” or living microbe medicine, aimed at lowering ammonia levels in the intestine. Now, CEO Dr. Aoife Brennan is sharing what the company learned from that failure and what it means for Synlogic’s future.

Ex-Merck Serono CMO takes up medical role at struggling Ipsen in its evolving C-suite

Steven Hildemann, M.D., Ph.D., is set to join Parisian biotech Ipsen as its new executive vice president and chief medical officer as the company looks to overturn a clinical hold and steady the ship under a new CEO.

JPM Monday roundup: No deals, but drug-pricing startup causes the biggest noise

SAN FRANCISCO—Well, let’s start with the obvious, a pattern that has been set for a good few years now: There were no M&A deals on the so-called Merger Monday that typically kick-started the J.P. Morgan Healthcare Conference of old.

JPM: Roche, Illumina unveil 15-year cancer diagnostic tie-up

SAN FRANCISCO—Roche has inked a 15-year partnership with Illumina in oncology, which will include collaborating on new companion diagnostic indications for the DNA sequencing giant’s pan-cancer assay.

JPM: Novartis teams up with NHS England in 'world-first' access deal for PCSK9 hopeful inclisiran

Novartis CEO Vas Narasimhan and British health officials have struck a deal to get the drugmaker's as-yet-unapproved cholesterol drug, inclisiran, to thousands of NHS patients. The "population-level" agreement, unveiled Monday at JPM, could pose a threat to PCSK9 rivals Repatha and Praluent while heralding a reimbursement scheme for other payers, too.

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Resources

[Whitepaper] Simplify 21 CFR Compliance Documentation

A digital transformation is taking place in the life sciences industry, from research laboratories to manufacturing facilities. But there has always been a gap in these technologies. Download the whitepaper to learn how this challenge was addressed.

[Whitepaper] Consent and the GDPR: An Essential Guide

This paper discusses some of the challenges that the GDPR will introduce, with a particular focus on its requirements for obtaining verifiable, unambiguous consent.

[Whitepaper] Solutions Overview: 10 Digital Prescriptions for Life Sciences

Download this paper to learn how you can fully digitize all paper processes. By doing so, you will see shorter cycle times, reduced development costs, and greater customer satisfaction.

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As emerging modalities transform the needs of life science R&D, how can biotech and pharma companies use modern software approaches to increase productivity and reach breakthroughs faster?

[Presentation] Flexible Manufacturing Strategies

Get expert insights on strategies to implement flexible manufacturing and different technologies that are easily scalable and reproducible.

[Executive Summary] Overcoming Manufacturing Challenges for Accelerated Drug Development

Regardless of the assigned FDA expedited approval designation and approach, the key action items should be: the assurance of a detail-oriented plan and the adaption of a “forward-thinking” approach that will assist in any future challenges and opportunities for growth of each project.

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

The beginning of this digital transformation is well underway and is likely to accelerate. Read our white paper, “Digital Disruption in Biopharma: How Digital Transformation can reverse declining ROI on R&D,” to learn more.

[Whitepaper] Telemedicine: Facilitating Clinical Trial Participation

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.

[Whitepaper] Are We Transforming in the Right Way? Why Launches Can’t Be Distracted By Empty Promises.

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

[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] Why Partner with CSP’s to Validate Mission Critical Apps in the Cloud?

Why companies leverage the expertize of industry focused cloud service providers to design and build quality systems and facilitate the FDA Validation of Mission Critical Apps in the Cloud.

[Whitepaper] How to Protect your Supply Chain from Security and Compliance Threats Utilizing On-Dose Authentication Technologies

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.

[Executive Summary] Clinical Supplies - Made to Order

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.

[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.

Events