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Today's Rundown

Featured Story

J&J's RSV vaccine offers 80% efficacy against severe illness in a race crowded by Big Pharmas

After years in development, the floodgates for RSV vaccines may open up soon, with more and more Big Pharmas piling on data. Now, Johnson & Johnson’s Janssen is adding to the fray, announcing efficacy as high as 80% in preventing severe infections in a mid-stage clinical trial.

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Top Stories

Amgen reveals midphase eczema data behind its $400M bet

When Amgen splashed $400 million upfront on Kyowa Kirin’s anti-OX40 antibody, the world was yet to see midphase data on the prospect. Amgen and Kyowa lifted the lid on the data over the weekend in a presentation of phase 2 results in eczema patients.

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J&J spends $100M upfront, with $1.2B in biobucks, to join Roche and Regeneron in bispecific blood cancer race

The race to use bispecifics to treat blood cancers is heating up, with Johnson & Johnson paying $100 million upfront to challenge Regeneron and Roche in a field that looks set to be highly competitive.

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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.

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Enanta pulls plug on NASH, seeks to offload assets for combos

Enanta Pharmaceuticals is tearing up its NASH strategy. After getting a look at interim phase 2b data, the biotech has decided to stop the monotherapy trial and seek to outlicense its candidates for use in combinations. 

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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.

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Takeda taps Selecta for $1.1B gene therapy research pact

After a tough pre-pandemic rout that saw it slash staff, steer around a cash crunch and face a bitter setback in the clinic, Selecta Biosciences is bouncing back with a major new biobucks pact with Japan’s Takeda.

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Magenta poaches Constellation CMO Humphrey after 5-month search, setback to blood cancer trial

Five months after former Chief Medical Officer John Davis, M.D., said he'd hit the exit, Magenta Therapeutics has found a replacement in Constellation CMO Jeffrey Humphrey. The new hire comes after Magenta was able to clear a phase 1/2 clinical trial in blood cancer last month following a setback in July.

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New insights into the ‘second brain’ in the gut could inspire treatments for intestinal diseases MSU team reports

Michigan State University researchers discovered that glial cells actively modify electrical signals in the gut to maintain normal functions like motility. They believe the findings could inspire new treatments for common conditions like inflammatory bowel disease and other motility disorders.

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Providers cry foul over new surprise billing rule's arbitration process

Providers are united in opposition to the Biden administration's latest surprise billing rule, claiming it tilts a dispute resolution process in payers' favor.

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FDA approves Abbott's latest implant for closing holes in the heart leftover from childbirth

The Talisman device builds off the company’s previous Amplatzer occluder for treating a patent foramen ovale, a gap that forms during fetal development and allows blood to pass through the heart’s right and left atria.

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The 2021 Fierce Pharma Marketing Awards

After a year when it seems like creativity should have hit a pause, the Fierce Pharma Marketing Award winners are proof of just the opposite.

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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.

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