Today's Rundown Featured Story | | | Thursday, December 5, 2019 Eli Lilly is revamping its cancer research unit, combining the oncology team at Lilly Research Laboratories with Loxo Oncology, the biotech it picked up for $8 billion in January—and putting a trio of Loxo execs at the helm: Josh Bilenker, M.D., Jacob Van Naarden and Nisha Nanda, Ph.D. |
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Top Stories Thursday, December 5, 2019 Sage Therapeutics’ key phase 3 trial in major depressive disorder has missed its primary endpoint. The failure of SAGE-217 to beat placebo wiped more than 50% off Sage’s share price as investors digested the implications of the data for a critical asset. Thursday, December 5, 2019 A phase 3 trial of Aurinia Pharmaceuticals’ voclosporin in lupus nephritis has hit its primary endpoint, causing the company's share price to double. The data tee Aurinia up to file for FDA approval next year and go on to address a major unmet medical need. Monday, December 2, 2019 A clinical trial is a measurement system, but too often, we fail to calibrate the most significant of measurement instruments: trial participants. Thursday, December 5, 2019 Immunomedics has had a long and troubled road in the past few years that has included losing much of its C-suite after an FDA rejection, not to mention the strange failure of a $2 billion deal with Seattle Genetics. Thursday, December 5, 2019 Insitro has snagged a new chief data officer: Serafim Batzoglou, Ph.D., who led Illumina’s applied and computational biology team, co-founded the bioinformatics and data management company DNAnexus and worked alongside insitro founder and CEO Daphne Koller in Stanford University’s computer science department. Wednesday, December 4, 2019 Aggressive castration-resistant prostate cancer can persist after treatment with standard-of-care hormone therapies targeting the androgen receptor. Now a team led by Duke University scientists has identified a cell surface receptor that drives this resistance, and a Merck drug that inhibits prostate tumor growth in mice. Friday, November 8, 2019 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. |  | Experts in our field; with 20+ years’ experience in Viral Vector & plasmid DNA (R&D, High Quality and GMP) manufacture for pre-clinical, clinical & commercial supply. Take a virtual tour of our facilities & find out more about our expansion project. |
Enrollment Showcase | | | Sponsored by: University of Florida College of Pharmacy 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. |
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Resources Sponsored by: Clarivate Analytics 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. Sponsored by: Thermo Fisher Scientific Are you facing costly delays in your API scale-up? Sponsored by: Roche and IQVIA 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. Sponsored by: Catalent Pharma Solutions 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. Sponsored by: Amazon Web Services 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 Sponsored by: Outer Edge Technology, LLC See why visionaries outsource the design and management of the infrastructure allowing their scientists to innovate. Sponsored by: Veeva Systems 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. Sponsored by: SHYFT Analytics 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. Sponsored by: IBM Watson Health 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. Sponsored by: IBM Watson Health Inpatient View and Outpatient View are powered by robust data assets and use sophisticated projection methodologies to help ensure accuracy of reporting. Sponsored by: IBM Watson Health 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. Sponsored by: ON24 Discover solutions to the most common challenges faced by medical device companies. Sponsored by: Eli Lilly and Company in partnership with Xcenda Download this complimentary paper that explores the practice of step therapy and its impact on key stakeholders in the US healthcare system. Sponsored by: Article Galaxy powered by Reprints Desk This white paper examines the skyrocketing cost of drug development and provides step-by-step guidance for executing a successful fail fast strategy. Sponsored by: Catalent 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. Sponsored by: Catalent 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. Sponsored by: Catalent Download the eBook to explore a proactive approach for clinical supply management. | 
