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Today's Rundown

Featured Story

Meet Neumora, Arch's $500M, Amgen-partnered play for the targeted future of neuroscience R&D

Arch Venture Partners has taken the lid off its big bet on neuroscience. Having quietly put the startup together over the past 18 months, Thursday Arch unveiled Neumora Therapeutics—a biotech that starts life with $500 million, a collaboration with Amgen and a pipeline of eight prospects.  

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Top Stories

Bristol Myers Squibb's deucravacitinib flunks midphase IBD trial, raising questions about potential blockbuster

Bristol Myers Squibb’s deucravacitinib has hit its first bump in the road. After blowing Amgen’s Otezla away in psoriasis, deucravacitinib went into a phase 2 readout in ulcerative colitis flying high—only to fail to meet the primary or secondary endpoints. 

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Pfizer's development leader becomes 2nd executive to retire in early 2022

Rod MacKenzie will leave Pfizer early next year after heading up clinical development and as the company seeks expanded use of its COVID-19 vaccine. The 35-year Pfizer veteran will retire around the same time as the Big Pharma's group president John Young.

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Sponsored: The Role of Quality and Speed in Custom 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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Denali makes ALS play, hustling Sanofi-partnered drug into phase 2 and sharing early data on internal program

Denali Therapeutics has set out its play for the amyotrophic lateral sclerosis (ALS) market, revealing early-phase data on one asset and plans to move a Sanofi-partnered program into phase 2 early in 2022.

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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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Oculis snags Novartis head of ophthalmology Joanne Chang for CMO role

Joanne Chang departed Novartis after heading up worldwide medical affairs for ophthalmology for the past four years to be chief medical officer of Oculis. With a fresh set of eyes leading the medical affairs of the eye treatment biotech, Oculis will expand its presence in Hong Kong.

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Intergalactic shoots for non-viral gene therapy stars with $75M in rocket fuel

Intergalactic Therapeutics really is shooting for the stars in its audacious mission to develop a non-viral gene therapy that doesn't require cells in the manufacturing process and can be re-dosed. The biotech's incubator, Apple Tree Partners, is pumping $75 million of rocket fuel into the biotech with a clinical telescope pointed toward ophthalmology, oncology and other potential disease targets.

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AffyImmune attracts $30M with its CAR-T strategy for beleaguered solid tumor cancers

AffyImmune wants to avert the toxic side effects and other issues associated with CAR-T therapies using a "tune and track" approach that allows for affinity tuning and tracking of where the cells are in the body. ORI Capital is doubling down on its interest in the biotech with a $30 million second series A.

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Yale spinout shows how targeting cancer cells' acidic environment might enhance immunotherapy

Yale University spinout Cybrexa Therapeutics has developed a peptide-drug conjugate that, instead of aiming for a specific antigen, targets the acidic environment of cancer cells to deliver a toxic payload. The drug improved the efficacy of checkpoint inhibitors in mouse models of cancer.

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Ginkgo Bioworks 'a hoax for the ages,' says activist short seller firm

Calling its business model “hocus-pocus” and “a colossal scam,” activist short seller firm Scorpion Capital has stung Ginkgo Bioworks—the synthetic biology company that went public less than a month ago through a $1.6 billion SPAC deal.

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Chamber of Commerce, AHA press Congress to stay away from merger framework

The American Hospital Association and the U.S. Chamber of Commerce led an effort to convince lawmakers to not touch the regulatory and legal framework for reviewing mergers and acquisitions.

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Pilot launch complete: GlaxoSmithKline's malaria shot scores WHO backing for wider rollout in Africa

GlaxoSmithKline has spent many years developing and testing its world-first malaria vaccine, but even after a positive recommendation from European regulators in 2015, the shot still isn't widely deployed. That's set to change with the World Health Organization's blessing for the vaccine.

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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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