Today's Rundown Analyst: Biogen's aducanumab is not getting approved absent a deus ex machina Cyrus, the Broad team up to make in vivo CRISPR use safer IFM gets new CEO, bags another $55M to launch incubator, new subsidiaries [Sponsored] Thwarting Subjectivity in Clinical Trials Kodiak bags $225M in exchange for $1B-plus in future royalties From Covance CEO to short-lived LabCorp diagnostics lead, Ratliff lands at AMRI How an abandoned Pfizer NASH drug gave rise to a Novartis-teamed follow-on Featured Story | | | Monday, December 2, 2019 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. |
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Top Stories Monday, December 2, 2019 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. Monday, December 2, 2019 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. 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. Monday, December 2, 2019 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. Monday, December 2, 2019 John Ratliff’s position has changed three times this fall, but now, much like the falling leaves, he looks to have settled. Wednesday, November 27, 2019 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. | | 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. FierceBiotech Executive Breakfast at the J.P. Morgan Healthcare Conference 2020 January 14, 2020 | The Fairmont Hotel | San Francisco, CA 4th Annual Gene Therapy for Rare Disorders March 30 – April 2, 2020 | Boston, MA Drug Development Boot Camp® 2020 November 18-19, 2020 | Register now and begin Pre-Boot Camp Preparation. | Take your new medicine development skills to the next level. | 