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December 02, 2019___

Today's Rundown

Featured Story

Analyst: Biogen's aducanumab is not getting approved absent a deus ex machina

Baird analyst Brian Skorney has dismissed the chances of Biogen winning approval for its Alzheimer’s disease drug aducanumab. Skorney’s skeptical reading comes days before Biogen is due to discuss data from its phase 3 program at the Clinical Trials on Alzheimer’s Disease annual congress.

Top Stories

Cyrus, the Broad team up to make in vivo CRISPR use safer

Cyrus Biotechnology has teamed up with the Broad Institute to optimize CRISPR for use in humans. Feng Zhang, who had a hand in developing CRISPR, will serve as the Broad’s principal investigator for the collaboration. 

IFM gets new CEO, bags another $55M to launch incubator, new subsidiaries

It’s been a busy year for IFM Therapeutics. After selling off a subsidiary to Novartis and enlisting the Big Pharma as a partner for another unit, the company is promoting its R&D chief Martin Seidel, Ph.D., to CEO and reeling in $55.5 million to fund more subsidiaries, including an incubator.

[Sponsored] Thwarting Subjectivity in Clinical Trials

A clinical trial is a measurement system, but too often, we fail to calibrate the most significant of measurement instruments: trial participants.

Kodiak bags $225M in exchange for $1B-plus in future royalties

Kodiak Sciences scored $225 million in new development funding for its eye disease drug that could rival Eylea—but at a price. In exchange for the cash, the company agreed to sell a capped 4.5% royalty on net sales of the drug worldwide to Baker Bros. Advisors.

From Covance CEO to short-lived LabCorp diagnostics lead, Ratliff lands at AMRI

John Ratliff’s position has changed three times this fall, but now, much like the falling leaves, he looks to have settled.

How an abandoned Pfizer NASH drug gave rise to a Novartis-teamed follow-on

Even though Pfizer axed a phase 1 DGAT2 inhibitor to treat nonalcoholic steatohepatitis, promising clinical findings have validated the drug's mechanism of action, a new study explains. Learnings from the research have prompted the development of a follow-on candidate that's covered by a Novartis partnership.

Enrollment Showcase

Webinar, Dec. 3 | Precision Medicine Insights: Patient Safety

University of Florida precision medicine leaders highlight current knowledge and trends to advance the future of health care in this new webinar series. Register today.

Resources

[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] 5 Best Practices for Marketing Medical Devices

Discover solutions to the most common challenges faced by medical device companies.

[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.

[Whitepaper] How to succeed by failing faster

This white paper examines the skyrocketing cost of drug development and provides step-by-step guidance for executing a successful fail fast strategy.

[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.

Events