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December 10, 2019___

Today's Rundown

Featured Story

8 programs to watch in NASH: Four letters and a multibillion-dollar opportunity

From Big Pharmas like Novartis and Gilead to liver specialists and one-asset biotechs, it seems like everyone in biopharma has some skin in the NASH game. This report examines the top prospects in the NASH pipeline, and why we even need a drug for nonalcoholic steatohepatitis in the first place.

Top Stories

Amgen rejigs Bay Area presence with deal for new R&D facility

Amgen has signed a lease on a 240,000-square-foot facility in South San Francisco, positioning it to join AbbVie in a new campus. The nine-story building will house Amgen’s Bay Area employees when it opens early in 2022.

ASH: Sanofi eyes FDA filing as orphan blood drug hits late-phase goal

A phase 3 trial of Sanofi’s rare blood disease drug sutimlimab has met its primary endpoint. More than half of the participants met the primary endpoint, teeing Sanofi up to file for FDA approval of the complement C1s inhibitor.

ASH: Bluebird's multiple myeloma CAR-T follow-up shows promise in phase 1

Bluebird bio offered the first glimpse of how its CAR-T follow-up is working in multiple myeloma patients who have tried several other treatments without success. Of the patients on the lowest dose of bb21217, the treatment shrank tumors in 10 out of 12—83%—evaluable patients and eliminated them in four of them.

Perceptive allies with Garabedian on $210M early-stage fund

Perceptive Advisors is moving into early-stage biotech investments in partnership with ex-Sarepta Therapeutics CEO Chris Garabedian. The $210 million fund began life by leading a $17 million series A round in Quellis Biosciences, reflecting its plans to take the lead on early-stage investments.

Flagship company Cellarity takes aim at cell behavior

Cellarity is combining artificial intelligence, a protein discovery platform and what it calls “network biology” in a drug discovery approach that it thinks will improve the success rate of drug discovery and the efficacy of drugs, as well as reduce side effects and shorten a drug’s journey to the clinic and to market.

Why do we need a NASH drug? NASH leaders weigh in

NASH leaders, including Genfit, Intercept Pharmaceuticals, Gilead and NGM Biopharmaceuticals, discuss why we need a drug for the disease and the challenges companies and doctors face in diagnosing and treating patients.

AstraZeneca brings AI to molecule building with DeepMatter deal

AstraZeneca is linking up with DeepMatter, a big data firm focused on achieving reproducibility in chemistry, to help improve the productivity of its automated compound synthesis operations.

Sanofi CEO Hudson backs away from struggling diabetes, cardiovascular areas in strategy unveiling

That didn’t take long. Sanofi CEO Paul Hudson has only been at the reins for a couple months, but on Tuesday, he unveiled a major shakeup. Going forward, the company plans to prioritize its strongest-growing products, like immunology med Dupixent and vaccines, and exit businesses where it’s not performing as well.

Resources

[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.

[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?

[Whitepaper] Innovative Funding Models for Treatment of Cancer and Other High-Cost Chronic Noncommunicable Diseases

This global landscape study identifies and assesses innovative funding models for cancer and other high-cost chronic NCDs across Africa, Asia, Europe, Latin America and Middle East. The study aims to enable readers to better understand the possibilities that innovative funding models bring to bridge the current and future funding gap, while stressing the key success factors that enable sustainability and success such as stakeholder collaboration.

[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] Why Companies Leverage the Cloud to Smooth the Path to FDA Approval

See why visionaries outsource the design and management of the infrastructure allowing their scientists to innovate.

[Whitepaper] Medical Affairs 2025 Excellence in the Era of Precision Medicine

Medical Affairs 2025 brings together leading perspectives from AstraZeneca, Bristol-Myers Squibb, Merck, Lilly, and other innovative life sciences organizations on key challenges impacting medical affairs and a roadmap for success in the coming decade.

[Whitepaper] The State of Real-World Evidence in Biopharma

This whitepaper provides a snapshot of where the biopharma industry is now, where it's heading, and how companies are allocating their resources to adapt & grow.

[Whitepaper] IBM Clinical Development: Key solutions for more efficient clinical research

IBM’s highlighted solutions reside in a security-rich cloud environment—home for capturing, managing and analyzing clinical study data with control, accuracy and confidence. These solutions lay the groundwork for further integration with IBM® Watson® cognitive technology.

[Whitepaper] How Big is the US Market for Medical Devices and Technologies?

Inpatient View and Outpatient View are powered by robust data assets and use sophisticated projection methodologies to help ensure accuracy of reporting.

[Whitepaper] The importance of early key opinion leader outreach in the biologics and biosimilars marketplace

Acknowledging various stakeholder networks, as well as recognizing variances within the regulatory environment, we believe, is essential for companies looking to uncover the right decision-makers in support of biologics or biosimilars. Learn more.

[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.

[Case Study] Clinical Supply Management

Download the case study to learn about the clinical supply management tools that helped a small sized pharma company during phase III of a multi-arm oncology study.

[Video] Demand Led Services and Clinical Supply Efficiency

Watch a short video on demand led supply model. It is designed to meet the needs of patients, clinical sites, clinical team and sponsors and results in shorter lead time, less waste, less stock out risk and no booklet labels.

[eBook] Strategies for Efficient Clinical Supply Management and Forecasting

Download the eBook to explore a proactive approach for clinical supply management.

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