| | Working on an early phase oncology trial? Your trial design can make or break it. Targeted therapies are a cornerstone of precision medicine and how you design your trial is a critical factor. Download our guide to stay on the path to success. |
Bayer inks $425M upfront KaNDy buyout to challenge Astellas for menopause market Spark Therapeutics nabs CMO from new owner Roche Life after R&D death: Halozyme CEO Helen Torley on the company's pivot and path to profitability Perceptive debuts LianBio with $115M, cancer and heart disease programs Fulcrum’s losmapimod fails interim analysis in muscle wasting trial New insight into Down syndrome genes could inspire treatments for solid tumors Featured Story | By Nick Paul Taylor Bayer has struck a $425 million upfront deal to buy KaNDy Therapeutics in the belief its treatment for menopause-related hot flashes has blockbuster potential. KaNDy recently completed a phase 2b trial of neurokinin-1,3 receptor antagonist NT-814, teeing it up to start a pivotal study next year. read more |
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| | CROs rely on data analytics to provide sponsors with continuous clinical insight of trends that could predict safety, and more importantly, efficacy for investigational products. Learn more about strategies for data analytics and evaluation from our free white paper. |
Top Stories By Ben Adams After its recent $4.8 billion buyout of gene therapy specialist Spark Therapeutics, Roche is now handing over one of its execs to help lead its new acquisition’s R&D. read more By Amirah Al Idrus Halozyme CEO Helen Torley has always been frank about what would happen if the company’s foray into drug development failed: the two-pillar company would ditch its internal pipeline and focus solely on providing its drug delivery technology to pharma partners. Now, that transparency has turned out to be key in keeping the company alive—and profitable. read more By Amirah Al Idrus After working in stealth since October, Perceptive Advisors is unveiling its latest biotech: LianBio, which serves the dual mission of bringing much-needed new drugs to China and helping U.S. biotech companies expand their operations into Asia. It launches with $115 million, as well as a trio of assets licensed from MyoKardia and BridgeBio Pharma companies Navire Pharma and QED Therapeutics. read more By Nick Paul Taylor Fulcrum Therapeutics’ losmapimod has performed no better than placebo in an interim analysis of data from a phase 2 clinical trial in patients with facioscapulohumeral muscular dystrophy (FSHD). Despite the setback, Fulcrum hailed the data as “very encouraging,” zeroing in on results from a pre-specified sensitivity analysis to make its case for an upbeat reading of the interim analysis. read more By Arlene Weintraub Researchers at Chicago's Lurie Children's Hospital found that under-active genes that cause heart problems and poor muscle movement in Down syndrome may also impede the growth of solid tumors by creating an inhospitable tumor microenvironment. Many of the abnormal genes were related to cell motion. read more | | Experts in our field with 20+ yrs. experience in Viral Vector & Plasmid DNA (R&D, High Quality, GMP) manufacture for pre-clinical to commercial supply. Now part of the Cognate BioServices family, Cobra has rebranded – look around our updated website. |
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Resources Sponsored by: Evotec Two informative webcasts will present practical and methodological approaches to preclinical drug abuse liability assessment Sponsored by: Catalent Pharmaceutical and biotech companies are spending years developing drugs or promising new biologics, all with the hopes of saving or enhancing patients’ lives. It’s a “race to the finish” in some cases, and the quicker a company can get its product to patients, the better. Sponsored by: Acorn AI by Medidata, a Dassault Systèmes company Case Study: Oncology-focused pharmaceutical company strengthens product launch by identifying hundreds of high-value physicians with Acorn AI. Sponsored by: Paysign Download the whitepaper for a solution designed to connect manufacturers, pharmacists, and patients. In this special guide, you will learn not just about the law but about the portal platform designed to change the entire process for all. Sponsored by: Cardinal Health 3PL Services Identifying opportunities to simplify channel strategies and business processes for biopharma companies, their customers and patients. Sponsored by: Catalent In a BioPharma Dive industry survey, planning and forecasting were identified as top concerns for trial sponsors. In response to this need, the CSM team at Catalent has developed a methodology for identifying, evaluating, and proactively managing the inherent risks involved in clinical trial supply chain management. Sponsored by: PRA Health Sciences Drug developers and stakeholders must find ways to collaborate, rather than compete, as the RACE Act prompts the need for more pediatric research. Sponsored by: Lonza Pharma & Biotech A novel spray-dried dispersion platform has been developed to faciliate high drug load applications Sponsored by: Catalent Learn about a real-world example of how clinical supply management expertise was applied to overcome inventory challenges for a complex, global study. Sponsored by: Catalent Whether a study is simple or highly complex, forecasting and simulation reports serve as data driven communication tools to help minimize risks and keep the study on track. Learn more about forecasting solutions for informed decision making and supporting contingency planning for clinical study. Sponsored by: Catalent Learn how to drive excellence within the forecasting process and utilize forecasting throughout the clinical study to better plan clinical supply budgets and project timelines. Explore how to identify potential supply-related issues before they can negatively impact your study. Drug Development Boot Camp® 2020 November 18-19, 2020 | Register now! Pre-Boot Camp training ongoing now. | COVID19 provisions – training will be on-site as normal. | New – may be possible for some individuals to access the training virtually in real time. | 