The FierceBiotech newsletter will not be published on July 4 or July 5 in observance of Independence Day. We will be back in your inbox from Monday July 8.
Today's Rundown FDA puts Unum T cell therapy trial on hold after adverse events Purdue hires Ducharme as CSO to aid expansion beyond opioids Boehringer grabs Yuhan’s NASH prospect in $870M biobucks deal In conversation with Cydan’s Chris Adams and James McArthur Using CRISPR to eliminate HIV Chutes & Ladders—Merrimack's CEO, CFO and president abandon ship Featured Story | Wednesday, July 3, 2019 The FDA has put Unum Therapeutics’ phase 1 ACTR087-Rituxan trial on clinical hold for the second time. Unum suffered the setback after a patient experienced grade 3 and 4 adverse events including neurotoxicity and respiratory distress. |
|
| Top Stories Wednesday, July 3, 2019 Purdue Pharma has named Julie Ducharme as its CSO. Ducharme rejoins Purdue at a time when it is trying to expand beyond the opioids that built but now threaten to sink its business. Tuesday, July 2, 2019 Boehringer Ingelheim is bolstering its liver disease pipeline with yet another NASH-focused deal. This time, it is licensing a biologic from South Korea’s Yuhan for $40 million upfront and promising up to $830 million in milestone payments. Wednesday, July 3, 2019 Cydan co-founders, CEO Chris Adams and R&D chief James McArthur discuss building companies and their hunt for orphan drugs. Wednesday, July 3, 2019 In a step closer to a possible cure for the infection, a team of scientists has removed HIV from mice using the CRISPR gene-editing technology and a long-acting antiretroviral therapy. Wednesday, July 3, 2019 Merrimack's CEO, CFO and president abandon ship after canning clinical pipeline; uBiome overhauls management, again, amid FBI probe; and cue the "revolving door" criticism, as Gottlieb joins Pfizer’s board. Those moves plus more hirings, firings and retirings throughout the industry. This week's sponsor is Medrio. | | [Webinar] Accelerating Site and Patient Enrollment for Phase 1 Trials Tuesday, July 23 | 2pm ET / 11am PT This Fierce webinar will feature clinical trial site leaders and R&D executives, who will pass along the latest strategies for boosting site and patient enrollment in phase 1 trials. They will discuss best practices for communicating with both investigators and patients. Register Now! | Resources Sponsored by: United Cargo and SAVSU Technologies The combination of SAVSU technology with United Airlines’ global network has made it easier than ever to bring cell and gene therapies to destinations beyond major markets. Sponsored by: XiltriX North America Find out in this article how your pharmaceutical organization can leverage IoT technologies and informatics integration to innovate and improve overall operational efficiencies. Sponsored by: Patheon, by Thermo Fisher Scientific When a biologics company prepares to launch a new product, it must forecast the manufacturing capacity it will need. Learn more here. Sponsored by: Veradigm Patient demand for more information on their care is driving new e-prescribing regulations, and technology is evolving to help providers meet them. This report provides an overview of key areas where such regulation has emerged, and what it could mean for providers and healthcare IT companies. Sponsored by: Patheon, by Thermo Fisher Scientific Anticipate challenges in formulation early. Sponsored by: Titian Software This Essential Guide to Managing Laboratory Samples is a three-part piece exploring common problems experienced in the management of samples and how, for any scale of operation, significant efficiency and accuracy benefits can be gained using dedicated sample management software. Sponsored by: Veradigm Patients living with diabetes deserve better – Real-World Evidence for effecting/realizing change in the management of type 2 diabetes and cardiovascular/renal comorbidities. Sponsored by: AlphaSense What is agile competitive intelligence, and how can it help take market research to the next level? Sponsored by: Reprints Desk, Inc. Get 5 quick tips for faster research and better results! 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. Latin America Healthcare Compliance Certificate Program September 23-26, 2019 4th FierceBiotech Drug Development Forum October 28-29, 2019 | Boston, MA Drug Development Boot Camp® 2019 November 20-21, 2019 | Boston, MA | Register NOW and start Pre-Boot Camp Preparation! |