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November 11, 2019___

Today's Rundown

Featured Story

Roche's challenger for SMA market hits goal in phase 3

A phase 3 trial of Roche’s risdiplam in patients with type 2 or 3 spinal muscular atrophy (SMA) has met its primary endpoint. The results tee Roche up to file for approval to compete with Biogen and Novartis in the increasingly crowded SMA market.

Top Stories

2019's Fiercest Women in Life Sciences

More women have climbed to the top of the corporate ladder than ever before. This report recognizes 20 of them: women at the top of the life sciences field who lead the change in everything from research to business development and regulatory effort, or have outright built and run their own companies.

Nektar shows durability of Opdivo combo in 18-month update

Nektar Therapeutics has presented 18-month data on its NKTR-214-Opdivo combination in first-line melanoma. The phase 1/2 results show the efficacy seen at 12 months has persisted, providing early evidence to support Nektar’s belief NKTR-214 can drive durable, deepening responses.

AASLD: Gilead wants to move the needle for fatty liver therapies

BOSTON—Gilead’s nonalcoholic steatohepatitis (NASH) prospect selonsertib may have failed two phase 3 studies, but the company is putting the data from those studies to work. It presented three abstracts at the annual meeting of the American Association for the Study of Liver Diseases showing how noninvasive testing and machine learning could improve diagnostics and drug development for NASH.

Aslan's varlitinib hopes fade after latest failure

The chronicles of Aslan keep reading as a tragedy as the Singapore-based cancer biotech is hit with another failure for its key pipeline hope.

FierceMedTech opens nominations for the 2019 Fierce 15

Our 2018 picks for the FierceMedTech Fierce 15 showcased the innovative companies we believe can make strong, tangible impacts—not just by moving their individual needles past the limits of today’s medical technology, but by chasing breakthroughs that could move the field forward as a whole.

Bolt Bio preps clinical trials of immune-stimulating cancer drug in stubborn solid tumors

Bolt Biotherapeutics, founded by Stanford immuno-oncology veteran Edgar Engleman, is developing new class of cancer drugs called immune stimulating antibody conjugates. Backed by fresh data from animal trials of its lead drug, a tumor-targeting antibody connected to an immune stimulator, the company is preparing a phase 1 trial.

Enrollment Showcase

A Credential for the Future of Health Care

Join the future of health care with the flexibility and convenience of an online program.

Resources

[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] Q2 2019 Biopharma licensing report

18 high-value new licensing deals worth in excess of $500 million took place during the second quarter of 2019 -Get the Q2 2019 Biopharma licensing report for full details and insights.

[Whitepaper] Synthesizing Success: Six Principles For Getting Pharmaceutical Development Right From The Start

Is your API development on track?

[Infographic] Implement the Patient Voice to Build an Effective Engagement App

Get the latest data on how people are using apps to manage their health, and learn how you can leverage it in the development of your next clinical trial app.

[eBook] Customer Experience: Shaping Digital Healthcare

Report: How to design digital services that deliver value and improve outcomes for patients, healthcare professionals and the healthcare systems they serve

[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.

[Article] 8 Compelling Reasons Why Businesses Need To Be In The Cloud Now!

Companies that don’t have a cloud strategy are at a competitive disadvantage. Why? The cloud has a measurable impact on business.

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

A global landscape study of funding trends and innovations.

[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