Today's Rundown Novartis sells phase 3 rare disease drug to Pharming Deciphera soars as phase 3 cancer data tee up FDA filing Regeneron, Ridgeback Ebola meds beat ZMapp, prompting early end for Congo study Xontogeny's Landos Biopharma reels in $60M to ramp up IBD program Boehringer, MD Anderson build out 'virtual R&D center' for cancer research Datavant, PCORnet to build real-world data network spanning 60M patients Novartis Form 483 puts into question who knew what, and when, about Zolgensma data manipulation Featured Story | | | Tuesday, August 13, 2019 Pharming has licensed late-phase rare genetic disease treatment leniolisib from Novartis for $20 million (€17.9 million) upfront. The immunomodulator could come to market in activated PI3K-delta syndrome in the second half of 2021. |
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Top Stories Tuesday, August 13, 2019 A phase 3 trial of Deciphera’s ripretinib in gastrointestinal stromal tumors has hit its primary endpoint. The data sparked a surge in the company's stock price, even though details of the results leave scope to question ripretinib’s prospects. Tuesday, August 13, 2019 Investigators ended a study testing Ebola treatments from Gilead, Regeneron and the NIH because the latter two drugs beat ZMapp, another unapproved drug that had been used in previous outbreaks. Tuesday, August 13, 2019 Landos Biopharma was the first biotech to come out of Xontogeny, the accelerator started by former Sarepta chief Chris Garabedian. Now, the company has picked up $60 million to propel its lead program into phase 2 for inflammatory bowel disease. Tuesday, August 13, 2019 German pharma Boehringer Ingelheim and The University of Texas MD Anderson Cancer Center have joined forces to create a new “virtual” R&D hub so the pair can work on cancer drugs. Tuesday, August 13, 2019 The People-Centered Research Foundation tapped Datavant to help it de-identify and coordinate the sharing of data across its national clinical research network covering over 60 million patients. Tuesday, August 13, 2019 Novartis, which last week was publicly shamed by the FDA for manipulating data tied to the application of its gene therapy Zolgensma, has said that it launched an investigation in March as soon as it learned of the issue. But records from the lab where the manipulation arose, suggest that the company’s investigation may not have been as deep or wide as the Swiss drugmaker has proclaimed. Resources Sponsored by: Wesco Pharmaceutical Solutions and WBR Insights The regulations and managing processes for hazardous, controlled and rare chemicals and biologics necessary for drug discovery are a huge distraction for R&D labs. Learn from the perspectives of industry executives the pain points and improvements they want in their processes for chemicals and biologics in pharmaceuticals R&D. Sponsored by: Kinaxis Download this life sciences industry spotlight to discover how concurrent planning can help you overcome complex supply chain challenges to drive down costs and improve efficiency. Sponsored by: Patheon, by Thermo Fisher Scientific Patheon, part of Thermo Fisher Scientific, offers advanced API manufacturing technologies such as continuous processing and continuous analytics to deliver high-quality products with well-defined features to meet your timelines and volume requirements. Sponsored by: ICON Understanding the challenges for formulary decision makers and manufacturers. Sponsored by: Veeva This white paper details how leveraging new reporting capabilities, live UAT feedback sessions, and an agile design approach to study builds will save them time and money. 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: 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: 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! | 