To view this email as a web page, click here

Today's Rundown

Featured Story

AstraZeneca files for FDA green light of COVID-preventing antibody

AstraZeneca has taken another step toward bringing its COVID-19 antibody cocktail to market, filing for emergency use authorization of the long-acting candidate in coronavirus prophylaxis in the U.S. 

read more

Top Stories

Collins, after 12 years at the NIH helm, will exit by year-end

The search is on for a new director of the National Institutes of Health as long-serving Francis Collins, M.D., Ph.D., announced his decision to retire by the end of 2021.

read more

Gemini axes CSO and 20% of staff to focus on late-phase plans

Gemini Therapeutics is betting it all on its clinical-phase eye disease prospect. Having built up early-stage activities in gene therapy and other areas, Gemini is now sweeping those programs aside to focus on the lead program.

read more

Sponsored: Speed to Data Without Quality Compromise in Custom Mouse Model Generation

Pressure to get results in drug discovery and development is unprecedented and the need for genetically engineered custom mouse models is greater than ever. Innovative thinking is getting these critical models into researchers hands faster.

read more

BioMarin snags Vertex VP as CMO a month after clinical snafu in gene therapy trial

BioMarin Pharmaceutical hired Harold Bernstein as chief medical officer and senior vice president after leading translational medicine work at Vertex. The California biotech also snagged Ganesh Vedantham from Amgen to fill the role of senior vice president of technical development.

read more

Sponsored: Accelerating Outcomes with a Pancreatic Cancer Adaptive Platform

PanCan utilised Almac's IRT expertise to accelerate their adaptive platform outcomes and improve patient care. Find out how here.

read more

MoonLake over the moon with $230M SPAC deal for llama antibodies to challenge Novartis' Cosentyx

Just five months after debuting with a nanobody licensed from Merck KGaA, MoonLake Immunotherapeutics is headed to Wall Street. The Swiss biotech is linking arms with blank-check company Helix Acquisition in a SPAC deal that will give MoonLake $230 million in proceeds.

read more

Novartis-backed Exo Therapeutics secures $78M to reprogram enzymes sans side effects

Already backed by Novartis, Exo Therapeutics has added $78 million to the bank to fund preclinical development of four potential drug candidates that target exosites. The goal is for the small molecules to be more selective and less toxic in potentially treating various cancers and inflammatory diseases.

read more

Eli Lilly-backed IpiNovyx Bio emerges with $10M for 2023 clinical entry

IpiNovyx Bio is launching with $10 million in seed funding from Eli Lilly, Viva Biotech's incubator and other venture capital firms, aiming to take its first candidate into the clinic in 2023. The company is going after inflammatory and autoimmune diseases.

read more

UCSF's customized 'pacemaker for the brain' successfully treats severe depression

The brain stimulation system includes a small device implanted on the patient’s brain that continuously monitors neurological activity and instructs two leads in separate areas of the brain to emit pulses if abnormal activity is detected.

read more

CMS: Employer plans can't deny benefits to unvaccinated customers but can offer premium discounts

Employer health plans cannot deny benefits to customers who don't get vaccinated for COVID-19 but they can offer premium discounts for getting vaccinated, new CMS guidance says.

read more

AstraZeneca underpaid hundreds of female and Hispanic sales reps, feds say

AstraZeneca has already faced one high-profile personnel issue this year in a case that resulted in a $2.4 million jury award for a former sales manager. Now, the company is paying up to resolve allegations of race- and gender-based pay discrimination for hundreds of sales reps.

read more

Resources

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?

Paid Marketplace: Online Graduate Programs Designed for Your Career

Drexel University’s online graduate programs in biomedicine, clinical research, drug discovery, and molecular medicine were developed with working professionals in mind, providing you with the education, practical skills, and competitive edge you need to be successful in your career. Learn more.

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.

eBrief: Drug Product Process Development: Ensuring a Consistent, High-quality Biologic

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.

Whitepaper: Achieving a Successful Drug Product Technology Transfer

Get insights on key considerations for a successful tech transfer process for manufacturing a biologic drug product, including a case study on overcoming challenges in a process transfer for a sterile diluent.

Events