Roche lands approval to slash Gazyvaro infusion time in EU, bringing treatment in line with MabThera Russian team gets green light to trial nasal COVID-19 vaccine but lacks funding to start study Oyster Point, with AbbVie and Novartis in its sights, wins first FDA approval for nasal spray to treat dry eye disease Corium, bouncing back from FDA rejection, snags PDUFA date for weekly Alzheimer's patch Medtronic to leap ahead in diabetes race with $300M Triple Jump purchase: report Featured Story | By Nick Paul Taylor Roche has cleared a barrier to the use of Gazyvaro over biosimilar copies of its collapsing blockbuster MabThera. Gazyvaro, known as Gazyva in the U.S., is now cleared for use over the same accelerated 90-minute infusion time as MabThera in follicular lymphoma patients in the EU. read more |
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Top Stories By Nick Paul Taylor Russia has joined the ranks of COVID-19 vaccine developers exploring nasal delivery. Having originally developed Sputnik V for intramuscular administration, Russian researchers are now set to study the effects of giving two doses to volunteers via nasal delivery—if they can get funding for the trial. read more By Nick Paul Taylor Oyster Point Pharma’s bet that the path to a better dry eye disease treatment goes through the nose has come good, with the FDA approving its Tyrvaya for use in a broad population of patients. read more By Nick Paul Taylor Corium is having another crack at getting its weekly patch treatment for Alzheimer’s disease to market, securing a March PDUFA date a little more than one year after the FDA rejected its first try. read more By Andrea Park Amid back-to-back expansions of two Class I recalls pertaining to the MiniMed insulin pump technology it acquired two decades ago, Medtronic is reportedly eyeing a purchase of another insulin pump maker. read more Resources Sponsored by: Thermo Fisher Scientific Learn how to develop a high-performing supply chain for cGMP chemicals used throughout your biologics workflow. Download the free whitepaper from Thermo Fisher Scientific Sponsored by: Thermo Fisher Scientific Learn how to develop a high-performing supply chain for cGMP chemicals used throughout your biologics workflow. Download the free whitepaper from Thermo Fisher Scientific Sponsored by: Thermo Fisher Scientific Learn how to develop a high-performing supply chain for cGMP chemicals used throughout your biologics workflow. Download the free whitepaper from Thermo Fisher Scientific 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: Bioclinica This whitepaper addresses where AI can make the biggest impact in clinical trials. 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. 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 Pharma Meeting Pros Summit November 3-4, 2021 | Atlantic City, NJ & Virtual Learn how to develop and get regulatory approval for medical devices November 3-4, 2021 | Live & Online 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 | 