| This week's sponsor is Ajinomoto Bio-Pharma Services. | | | |
Today's Rundown Eli Lilly cancer chief Levi Garraway replaced by Loxo CEO Josh Bilenker (for now) as Big Pharma rings the changes Moderna chugs along, moving a second program into phase 2 Neon CBO Robert Ang jumps ship to take the helm at Vor Biopharma XyloCor hires Reinhardt as CMO to lead gene therapy programs Rhythm’s genetic obesity drug hits primary endpoint in phase 3 Parexel keeps up recruiting pace, nabbing ex-BioClinica CIO FDA ready to crack down as Novartis reveals manipulated Zolgensma data Featured Story | | | Wednesday, August 7, 2019 Amid a series of change-ups to its top executive team this morning, Eli Lilly has moved its biotech buy’s CEO, Josh Bilenker, into its oncology division, as Levi Garraway hits the exit. |
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Top Stories Wednesday, August 7, 2019 Moderna has pushed another four mRNA programs into phase 1 and started a phase 2 study of its Merck-partnered personalized cancer vaccine for patients with melanoma, the company said on its second-quarter earnings call. Wednesday, August 7, 2019 After four years at Neon Therapeutics and a career that’s shown him the many faces of biopharma, Robert Ang is ready to take the plunge and run his own company: Vor Biopharma, a biotech working on engineered stem cell therapies for blood cancers. Wednesday, August 7, 2019 XyloCor Therapeutics has named Rickey Reinhardt as CMO. Reinhardt, who helped GlaxoSmithKline get a gene therapy to market, joins XyloCor to take genetic treatments for cardiovascular diseases through clinical development. Wednesday, August 7, 2019 Phase 3 trials of Rhythm Pharmaceuticals’ setmelanotide in patients with genetic obesity have met their primary endpoints. Rhythm plans to use the data to complete a rolling submission to the FDA around the end of the year, positioning it to bring the drug to market in 2020. Wednesday, August 7, 2019 Parexel has been on a recruiting spree of late, delving into FDA to beef up its regulatory offerings. Now, it’s turned to fellow biopharma services provider BioClinica for a more digital role. Tuesday, August 6, 2019 The FDA is weighing penalties for Novartis over revelations that its application for gene therapy Zolgensma contained manipulated data. Resources 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: 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: 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! | 