Pfizer calls in the lawyers to block would-be rival to extended-release Xeljanz Entera advances oral challenger to Lilly's Forteo, posting midphase data and heading to pivotal trial Eyes itching from allergies? Ocular's Dextenza wins FDA approval as first monthly implant Timber posts data on topical Accutane, readies for pivotal trial FDA warns against using over-the-counter lip and facial fillers with unauthorized needle-free devices Featured Story | By Nick Paul Taylor Sinotherapeutics wants to start selling a generic version of Pfizer’s extended-release JAK inhibitor Xeljanz XR. Pfizer has other ideas, prompting it to file a lawsuit setting out its objections to the plan. read more |
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Top Stories By Nick Paul Taylor Entera Bio has posted midphase data on its oral challenger to Eli Lilly’s injectable osteoporosis drug Forteo, setting it up to begin a phase 3 registration study of the hormone formulation next year. read more By Angus Liu Patients with itchy eyes caused by allergic inflammation often take eye drops multiple times per day. Thanks to an FDA approval, a monthly insert into the canaliculus of the eye will soon be available. read more By Nick Paul Taylor Timber Pharmaceuticals has posted midphase trial data on its topical Accutane treatment for the rough, dry and scaly skin of congenital ichthyosis patients, setting it up to start a pivotal study next year. read more By Andrea Park The FDA’s crackdown on online sales of unauthorized medical devices and substances rages on. The latest to be placed on the chopping block are dermal fillers sold over the counter and the at-home, needle-free devices used to inject them—none of which have been cleared by the FDA. read more Resources Sponsored By: Unlearn AI Read Unlearn’s whitepaper to learn about how novel trial designs with Digital Twins enable more efficient clinical trials, with higher power and smaller required sample sizes. Sponsored By: Bioclinica This whitepaper addresses where AI can make the biggest impact in clinical trials. Sponsored By: Trial Interactive Check out the eTMF Implementation Quick Guide to see a checklist TMF experts developed to help you reduce risks, maintain compliance, and establish effective processes in your eTMF. Sponsored by: Thermo Fisher Scientific Looking to accelerate your biotech company, but not sure where to start? Sponsored by: Oracle Health Sciences New research indicates an accelerated adoption of decentralized clinical trials due to COVID-19. Sponsored by: LabVantage Solutions Shift from data collection to data science. Add advanced analytics to your lab informatics platform to yield valuable, action-ready insights from LIMS and other data. Sponsored by: Thermo Fisher Scientific Integrate supply chain simulation into your early clinical trial planning to minimize risk in an uncertain supply chain environment, improve supply chain outcomes, and help streamline time-to-market for innovative therapies. Sponsored by: WCG Every biopharma sponsor faces the challenge of initiating, running and closing trials on time, but oncology studies pose several unique hurdles. Sponsored by: Box Read Get to Know Cloud Content Management for Life Sciences and learn how to eliminate silos across all workflows, from R&D to commercialization. Sponsored By: Remarque Systems Remarque Systems consolidates data, then layers on visualization and automated metrics to generate consistent, actionable data insights in real-time. Click here for more info. Sponsored by: Catalent Learn about drug product process development challenges and risks, the difference between innovator and biosimilar drug product process development, and more during the drug product process development phase. Virtual U.S. Healthcare Compliance Certificate Program October 11 – 14, 2021 Fierce Biotech Cell & Gene Therapy October 19, 2021 | Virtual Event Learn what it takes to get a drug developed and approved October 20-21, 2021 | Live & Online TMF Summit October 25-27, 2021 | New Orleans, LA Fierce Health Payer Summit Virtual Event | October 26, 2021 Learn how to develop and get regulatory approval for medical devices November 3-4, 2021 | Live & Online Pharma Meeting Pros Summit November 3-4, 2021 | Atlantic City, NJ & Virtual Diversity, Equity, & Inclusion Summit November 9–10, 2021 | Virtual Event Learn impact of pricing, competitive assessment, epidemiology November 17-18, 2021 | Live & Online Drug Development Boot Camp® 2021 Onsite and VIRTUAL in real time November 17-18, 2021 | Register now! Pre-Boot Camp preparation is now available. Learn how therapeutics are successfully launched and commercialized December 1-2, 2021 | Live & Online | 