WELCOME TO FIERCE LIFE SCIENCES WEEKLY DIGEST Vertex proves that small can be mighty after an early peek at data from just one patient jump-started its shares as its cell therapy helped boost insulin in a diabetes patient. Meanwhile, UnitedHealthcare and Optum are teaming up to offer virtual-first approach where members can connect 24/7 with a personalized Optum care team. And it was tough news for Biogen and AstraZeneca, with the former failing an ALS trial and the latter seeing an FDA clinical hold slapped on its experimental blood cancer trials after a safety scare. Those stories, plus our other top reads of the week, follow below. | |
| Featured Story By Annalee Armstrong Vertex is providing an initial peek at the first patient to receive a new type of diabetes cell therapy that could prevent the need for organ transplantation. A single patient with type 1 diabetes achieved a “robust” restoration of islet cell function after receiving VX-880. Restoration of these cells could allow patients to regulate insulin or even produce it on their own. read more |
| |
---|
| | Webinar: Clinical Adjudication Survey Results Revealed Tuesday, November 2 | 1pm ET / 10am PT In a recent survey, 89% of clinical adjudication users agreed clinical adjudication provides value to clinical trials. Join two Bioclinica experts for a discussion of these and other survey results to understand how they could impact your studies. Register Now. | Top Stories Of The Week By Paige Minemyer UnitedHealthcare has unveiled a new virtual-first plan design called NavigateNOW, which was developed in collaboration with its sister company, Optum. read more By Nick Paul Taylor Stop me if you think you've heard this one before. A Biogen neurodegenerative disease prospect has failed a pivotal study, but the Big Biotech has latched onto biomarker data and “trends favoring” the treatment as it heads into talks with the FDA. Will it be enough to get the candidate to market? read more By Kevin Dunleavy After myocarditis reports in four Nordic countries, the FDA has delayed a decision on the Moderna COVID-19 vaccine for those between the ages of 12 and 17, The Wall Street Journal reports. The concerns could give Pfizer an edge in vaccine sales to children. Since May, the Pfizer shot has been authorized for those 12 and older. read more By Dave Muoio Reports are trickling out on firings and voluntary resignations as some provider organizations reach their first deadlines for partial or full COVID-19 vaccination for their workers. 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 By Kevin Dunleavy Biogen sales were sliding ahead of the controversial approval for Alzheimer's drug Aduhelm. On Wednesday morning, Biogen revealed a stunning number—$300,000—in third-quarter sales for the medicine, once hailed as a first-of-its-kind breakthrough drug. read more By Joseph Keenan Novavax, which reaped $1.6 billion from the federal government last year to develop and manufacture a COVID-19 vaccine, is reportedly struggling to meet quality standards. 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: 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, an ERT Company 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. |