To view this email as a web page, click here

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

A single patient is producing insulin after treatment with Vertex's new diabetes cell therapy

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

Top Stories Of The Week

HLTH21: UnitedHealthcare, Optum collaborate on new virtual-first plan design

UnitedHealthcare has unveiled a new virtual-first plan design called NavigateNOW, which was developed in collaboration with its sister company, Optum.

read more

Biogen's ALS drug has failed phase 3. Will FDA approve anyway?

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

FDA delays decision on Moderna's COVID-19 vaccine in 12-17 age group because of myocarditis concerns: WSJ

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

How many employees have hospitals lost to vaccine mandates? Here are the numbers so far

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

Medtronic to leap ahead in diabetes race with $300M Triple Jump purchase: report

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

Biogen, with sales falling sharply, posts 'obviously disappointing' Aduhelm sales of $300K, CEO Vounatsos says

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

Novavax struggling to meet quality standards in COVID-19 vaccine production push: report

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

Whitepaper: Enhance the cost-effectiveness of your cGMP chemical supply chain

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

Whitepaper: Enhance the cost-effectiveness of your cGMP chemical supply chain

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

Research: eTMF Implementation Quick Guide

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.

Whitepaper: Modernizing Key Clinical Trial Processes with Artificial Intelligence

This whitepaper addresses where AI can make the biggest impact in clinical trials.

Free Infographic: Identifying Opportunities for Biotech Scale-Up

Looking to accelerate your biotech company, but not sure where to start?

Report: New research indicates an accelerated shift to decentralized clinical trials

New research indicates an accelerated adoption of decentralized clinical trials due to COVID-19.

Whitepaper: Transform LIMS Data into Action-Ready Insights with Advanced Analytics

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.

Whitepaper: Clinical trial simulation: Advanced modeling techniques enable data-driven supply chain planning

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.

Whitepaper: Big Challenges for Small Sponsors: Competition in Oncology Research

Every biopharma sponsor faces the challenge of initiating, running and closing trials on time, but oncology studies pose several unique hurdles.

eBook: Get solutions to market faster

Read Get to Know Cloud Content Management for Life Sciences and learn how to eliminate silos across all workflows, from R&D to commercialization.

Content Hub: Remarque Systems Resource Hub

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.