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January 17, 2020___

Editor’s Note: FierceBiotech will not publish on Monday in observance of Martin Luther King Jr. Day, but we’ll be back in your inbox on Tuesday, Jan. 21.

Today's Rundown

Featured Story

Frazier closes $617M life sciences fund, creating scope for bigger bets

Frazier Healthcare Partners has closed a $617 million life sciences fund, setting it up to place another set of bets spanning from company creation through public investments. Two-thirds of Frazier Life Sciences X will go into seed and series A rounds. 

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

Top Stories

Durect's painkiller gets evenly split decision from expert panel

A FDA advisory committee has issued an evenly split decision on Durect’s extended-release formulation of bupivacaine. Durect’s share price fell 12% after half of the panel of painkiller experts recommended against approving Posimir on the basis of the available evidence.

JPM: Biotech, VC execs on where the industry should look beyond cancer

SAN FRANCISCO—Oncology is clearly a major medical and societal issue: a major killer that, while predominately affecting the older population, can strike the young through a mixture of environmental factors or a genetic lottery. It’s no wonder we struggle to even call it by its name, preferring just the "big C."

After closing one of China's biggest-ever raises, I-Mab Biopharma nabs $104M Nasdaq IPO

China-based cancer and autoimmune disease biotech I-Mab Biopharma has raised $104 million on the U.S. Nasdaq composite.

This immune checkpoint could be a new target against cancer, autoimmune diseases

Inhibitors against PD-1 and CTLA-4 have become well-established anti-cancer treatments. Now, a research team led by Dartmouth College suggests another immune checkpoint, which acts as a “brake” on naive T cells' activation, could also serve as a therapeutic target for cancer and autoimmune diseases.

Foxconn backs digital X-ray startup Nanox’s $26M round

Nanox, an Israeli medical imaging company, has raised $26 million to help fuel the development and commercialization of its Star Trek-inspired digital X-ray bed.

EuroBiotech Report—MorphoSys-Incyte, Adaptimmune deal, Galapagos, BioNTech and Ipsen

In this week's EuroBiotech Report, MorphoSys lands Incyte deal, Adaptimmune teams with Astellas and Galapagos bags fibrosis options.

FiercePharmaAsia—Astellas' cell therapy deal; Takeda's €398M tax bill; Lilly-shared PD-1 in NSCLC

Astellas teamed up with Adaptimmune to develop CAR-T and TCR therapies. Takeda faces a surprising Irish tax bill linked to the Shire breakup fee AbbVie paid years ago. Innovent's Eli Lilly-partnered PD-1, Tyvyt, hits its goal in a phase 3 frontline non-small cell lung cancer trial in China. And more.

Chutes & Ladders—Bluebird picks up Heffron as European chief

Bluebird Bio taps Heffron as Euro chief; Hildemann joins struggling Ipsen as CMO; Ivenix names Hansen 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