Today's Rundown J&J's multiple sclerosis prospect beats Sanofi drug in phase 3 Editas, Allergan kick off long-awaited in vivo CRISPR trial FDA delays AdComm for Nektar's pain drug a month ahead of decision deadline NeuroBo backs onto Nasdaq via merger with Gemphire Italian pharma Zambon takes in Breath Therapeutics through €500M deal EuroBiotech Report—GSK R&D update, Medicxi's €400M fund and Intec fails phase 3 FiercePharmaAsia—Samsung's Humira biosim; Celltrion's China JV; GenScript's new facility Chutes & Ladders—Vertex CMO Kewalramani steps into pharma's exclusive female CEO club Featured Story | | | Friday, July 26, 2019 A phase 3 trial of Johnson & Johnson’s multiple sclerosis prospect ponesimod has met its primary endpoint. The readout sets J&J up to file for approval this year, boosting its prospects of getting a return on its $30 billion takeover of Actelion. |
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Top Stories Friday, July 26, 2019 Though Editas and Allergan are not the first companies to test a CRISPR-based medicine in humans—that distinction goes to CRISPR Therapeutics and Vertex—their treatment is the first that edits DNA within the body. Friday, July 26, 2019 Two months after Nektar Therapeutics handed off its lead pain drug to a new subsidiary, the FDA is postponing an advisory panel meeting for that drug, a mu-opioid agonist designed to relieve pain without triggering euphoria. Friday, July 26, 2019 NeuroBo Pharmaceuticals is set to secure a Nasdaq listing through a reverse merger with Gemphire Therapeutics. The move comes as NeuroBo plans to start a phase 3 trial of nerve growth factor therapy NB-01 in patients with diabetic neuropathic pain. Thursday, July 25, 2019 The Italian drugmaker Zambon has bought up Breath Therapeutics, developer of a custom inhaled drug delivery platform, in a deal worth up to €500 million, or about $558.7 million U.S. Thursday, July 25, 2019 In this week's EuroBiotech Report, GSK provides a pipeline update, Medicxi raises a €400 million fund and Intec flunks a phase 3 test. Friday, July 26, 2019 Samsung Bioepis won an FDA nod for a Humira biosimilar to be sold by Merck & Co. in the U.S. Celltrion formed a JV to develop three biosimilars for China. GenScript opened a plant as it works on a commercial facility for gene and cell therapy. Friday, July 26, 2019 Vertex taps CMO Kewalramani as newest CEO; Verb Surgical brings SurgiQuest founder Azarbarzin on board; Disarm names Enzyvant head Shih to leadership role. Resources Sponsored by: BBK Worldwide The Study Voices survey challenges the myth that physicians won’t refer patients to clinical trials, and it identifies opportunities to engage physicians as partners in the enrollment process. Sponsored by: Cambrex The highest number of NCEs approved by the FDA…the fastest growing small molecule clinical pipeline reported in 20 years…these are exciting times for our industry. Sponsored by: Reprints Desk, Inc. Cut your research time in half - with an easy-to-use app for scientists that combines full-featured reference management with integrated search and on-demand document delivery. Sponsored by: Almac Group Innovative Just in Time Manufacturing solution enables sponsors full late stage customisation of clinical trial materials Sponsored by: PwC How are employer activism strategies beginning to replace the cost-sharing of the past, and improve the health of the workforce? 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: 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: 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! | 