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December 11, 2019___

Today's Rundown

Featured Story

SABCS: AstraZeneca, Daiichi's ADC keeps breast cancer at bay for 16 months

AstraZeneca and Daiichi Sankyo’s antibody-drug conjugate staved off cancer for a median of 16.4 months and shrank tumors in 61% of patients with HER2-positive breast cancer. The treatment could become an option for patients whose cancer worsens despite undergoing HER2-targeted therapies.

Top Stories

Correvio Pharma shows heart drugs aren't always an easy sell at FDA

After Novartis’ near $10 billion buyout of The Medicines Company, and with it the biotech’s leading heart drug hopeful, many thought cardiovascular therapies were hot again.

Leo's Dupixent rival hits all endpoints in pivotal program

Leo Pharma’s tralokinumab has hit all the primary and secondary endpoints in its three pivotal trials. The data position Leo to file for approval of the Dupixent rival in atopic dermatitis next year, but the lack of numbers shared publicly make it impossible to gauge whether tralokinumab is a threat to Sanofi and Regeneron’s blockbuster incumbent.

SABCS: Seattle Genetics hails 'stunning' tucatinib breast cancer data

Seattle Genetics has shared more of the tucatinib data it hopes will win it approval in HER2-positive breast cancer. The pivotal trial linked the tyrosine kinase inhibitor to reduced risk of progression and death in patients with and without brain metastases, leading Seattle Genetics CEO Clay Siegall to hail the data as “stunning.”

SABCS: MacroGenics' margetuximab posts OS gains in specific metastatic breast cancer patients

MacroGenics presented new, phase 3 breast cancer data from its HER2-targeting antibody margetuximab as it works to put the finishing touches on the drug’s approval application to the FDA in the final weeks of this year.

Sanofi to restructure its Onduo, Verily partnership alongside diabetes exit

As its new CEO begins to move Sanofi away from new diabetes research, the drugmaker—and producer of one of the world’s top-selling insulins—will also look to pull back from its three-year-old relationship with Verily and their virtual diabetes clinic, Onduo.

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] 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.

Events