Featured Story | By Fraiser Kansteiner Novartis and Genentech want to put their injectable asthma drug Xolair directly into patients' hands—and they've filed their prefilled syringe version for FDA approval to do just that. If the agency grants a green light, Xolair could be administered at home, a convenience made even more important by the COVID-19 pandemic. read more |
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Top Stories By Fraiser Kansteiner Researchers have come up with a high-tech way to test medicated gum: A set of robotic jaws that closely mimic human chewing patterns and even release artificial saliva. In a study that compared the chewing bot with human subjects, the jaws triggered drug release from xylitol-infused gum on par with human subjects. read more By Eric Sagonowsky Treatment for neuromyelitis optica spectrum disorder has transformed over the last year with FDA approvals for Alexion‘s Soliris and Viela Bio’s Uplizna, but now pharma giant Roche is entering the fray. Enspryng, formerly known as satralizumab, has scored an FDA approval. read more By Fraiser Kansteiner In July, diabetes drugmaker Xeris Pharmaceuticals launched its Gvoke HypoPen, a glucagon auto-injector approved to treat severe hypoglycemia. With some quick pandemic footwork and strong early adoption, HypoPen has soared during its first month at market; now, at least one group of analysts are hailing it as an "Epipen" for diabetes patients. read more By Ben Adams Medtronic is buying up leading smart insulin pen and connected phone app maker Companion Medical as it looks to shore up its growing weakness in the pump market. read more |  | Get insights on key considerations for a successful tech transfer for manufacturing a drug product, including a case study on overcoming challenges in a process transfer for a sterile diluent. Download this Catalent Biologics eBook. |
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Resources Sponsored by: Oracle Health Sciences Patient-facing digital technologies are playing an important role in clinical trials for new drugs and medical devices, to the point where conducting virtual trials is becoming mainstream. But terms like remote trials, direct-to-patient trials, hybrid trials, decentralized trials, and more all add to the confusion of what makes a trial "virtual." Sponsored by: Oracle Health Sciences The research conducted here is to help understand and solve the top challenges in clinical operations, to remove barriers that are slowing down our ability to bring new drugs to market as quickly as possible to patients waiting in need. Sponsored by: Thermo Fisher Scientific How to select the right dosage form for your Phase I clinical supply. Sponsored by: Thermo Fisher Scientific Quality by Design (QbD) reduces risk within drug development, while bringing therapies to market quicker. 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: Cardinal Health 3PL Services Identifying opportunities to simplify channel strategies and business processes for biopharma companies, their customers and patients. 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: 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: Phlow Corp. Interested in putting patients, people, and planet over profit in a fast-paced environment? Please Apply: VP of Integrated Supply Chain and VP of Manufacturing, Science, & Technology Sponsored by: PRA Health Sciences Collaboration across the industry will be key to meeting the demands of the RACE Act and ensuring pediatric patients receive the care and treatments they need. Sponsored by: InterSystems Accurate, timely insights are everything. Whatever the question, the answers demand real world data you can trust. Healthy data advances reliable insights, and takes the error out of AI. Healthy data is not just useable, but invaluable. Healthy data starts with InterSystems. | 
