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January 24, 2020___

Today's Rundown

Featured Story

Ipsen's $1B bet on the ropes after interim phase 3 analysis

Ipsen has paused a phase 3 trial of palovarotene after an interim analysis found it is unlikely to meet its primary efficacy endpoint. The setback is another blow for the retinoic acid receptor gamma agonist, which has run into safety and efficacy problems since Ipsen acquired it in a $1.3 billion (€1.1 billion) takeover of Clementia Pharmaceuticals.

Top Stories

Gilead mulls repositioning failed Ebola drug in China virus 

Gilead is considering repositioning NUC inhibitor remdesivir as a treatment for the coronavirus now sweeping across parts of China. The antiviral last made headlines when Gilead tested it, with little success, as a treatment for Ebola virus.

PwC report sees pharma-biotech deals 'to be extremely active in 2020'

A report out this week by PwC thinks that biotech could be in for a good year for deals as it sees the momentum from 2019 growing, although don’t expect many megadeals.

Summit Therapeutics loses R&D president after BARDA funding boost

What a difference a day makes in biotech: Yesterday, antibiotics player Summit Therapeutics was riding high after an $8.8 million cash infusion from the U.S. Biomedical Advanced Research and Development Authority.

ATAI, DemeRx pursue 'neurochemical reset' for addiction in $22M JV

ATAI Life Sciences and DemeRx are setting up a joint venture to develop a one-and-done treatment for opioid use disorder that works by giving people a “neurochemical reset.” Ibogaine has previously been sold as a stimulant and antidepressant in France and has been studied in other countries as a treatment for addiction.

Repurposing non-oncology drugs to treat cancer

Scientists at the Broad Institute and the Dana-Farber Cancer Institute screened thousands of existing drug compounds and unexpectedly found 49 they believe could be repurposed for treating cancer. They also identified novel targets that could aid in the development of new cancer drugs.

Epizyme scores FDA nod for rare cancer med Tazverik, but prices it for a future indication: analyst

Patients with epithelioid sarcoma previously had no targeted treatment options, but that'll change with Epizyme's approval for Tazverik. The FDA signed off on the drug Thursday, and the company plans a launch within 10 business days. Epizyme priced its rare cancer drug at $15,500 per month.

EuroBiotech Report—Roche SMA data, iOnctura, PDC*line, Targovax and Bayer

In this week's EuroBiotech Report, Roche's risdiplam clears another phase 3 SMA trial, Merck KGaA spinout raises cash and Korean VCs back PDC*line.

FiercePharmaAsia—Amgen-Astellas JV; Hengrui's new chairman; coronavirus vaccine development

Amgen is taking full control of a Japanese joint venture it formed with Astellas. Jiangsu Hengrui's Sun Piaoyang has stepped down as chairman but still retains control of the Chinese drugmaker. Moderna partners with NIH to develop an mRNA-based vaccine against the new coronavirus from China. And more.

Chutes & Ladders—Lonza seeking experience in CEO successor

Lonza looking for replacement for former CEO Funk; Hengrui's longtime chairman Piaoyang set to step aside; Vyaire taps Agarwal as CEO.

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

[Whitepaper] Assessing the Financial Impact of Translational Pharmaceutics®

Tufts Center for the Study of Drug Development (CSDD) white paper sharing study results that indicate Quotient Sciences’ Translational Pharmaceutics® platform reduces development times by more than 12 months and lowers R&D costs by more than $100 million per approved new drug, compared to traditional multi-vendor development paradigms.

[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.

[Whitepaper] What to Look for in an Informatics Platform for Large Molecule R&D

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