Today's Rundown Pfizer Ventures helps gamma delta player ImCheck to $53M round Deerfield unveils Civetta with $53M to tackle propeller proteins in cancer Rapt edges into Asia with Hanmi I-O deal worth up to $118M [Sponsored] Thwarting Subjectivity in Clinical Trials Omeros hits endpoint in pivotal stem cell transplant study Biostage's regenerative esophagus implant placed on FDA hold ahead of clinical tests Featured Story | | | Wednesday, December 4, 2019 Pfizer Ventures has co-led a $53 million (€48 million) series B investment in ImCheck, a developer of antibodies focused on gamma delta T cells. ImCheck will use the money to move its lead candidate into the clinic in patients with solid and hematological cancers. |
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Top Stories Wednesday, December 4, 2019 Civetta Therapeutics is launching with tech from the Broad Institute and Dana-Farber Cancer Institute, as well as $53 million to develop drugs targeting beta-propeller proteins. Naturally, the company’s first focus will be cancer, but the approach could be useful in other areas, such as neurodegenerative disease. Tuesday, December 3, 2019 Rapt Therapeutics is gaining a development partner and a foothold in Asia through a partnership potentially worth $118 million. The biotech is handing Hanmi the rights to its lead cancer program in South Korea and greater China in exchange for $10 million upfront and the promise of millions more in milestones. 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. Wednesday, December 4, 2019 A pivotal trial of Omeros’ narsoplimab in hematopoietic stem cell transplant patients has hit its primary endpoint. Omeros expects to use the data to win FDA approval, although secrecy around the design of the trial means there remains scope for skepticism about the results. Wednesday, December 4, 2019 Biostage’s lab-grown replacement esophagus candidate has been placed on a clinical hold by the FDA as the company works to field questions from the agency before beginning initial human testing. | | 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. |
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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. | 