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Today's Rundown

Featured Story

Regenerative medicine nears banner year with $14.1B cash infusion, regulatory milestones and a well-stocked pipeline

For a long time, gene and cell therapies were a treatment option for the future. Now, the pace of development is moving at breakneck speed, with a number of firsts and $14.1 billion in financing collected over the initial half of the year. The Alliance for Regenerative Medicine has documented the “acceleration on all fronts” in a new report looking at the first half of 2021.

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Top Stories

Vigil bags $90M to take ex-Amgen assets on path from rare diseases to Alzheimer's

Vigil Neuroscience is barreling forward with a strategy that will see it hop along steppingstones from rare diseases to Alzheimer’s. Having emerged with $50 million late last year, Vigil has gathered up an additional $90 million to validate its ex-Amgen asset in a rare, inherited neurodegenerative disease.

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Marinus tees up phase 3 for rare epilepsy med that slashes seizures in mid-stage trial

Marinus Pharmaceuticals is gearing up for a phase 3 study after its epilepsy drug curbed seizures in patients with a rare, genetic disease that causes benign tumors to grow in various parts of the body, including the brain. The treatment, ganaxolone, reduced the seizure frequency over four weeks of patients with tuberous sclerosis complex by 16.6%.

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Sponsored: Artificial Intelligence in Drug Discovery Requires Validated Data

Machine-learning-based techniques in drug and diagnostic discovery require copious amounts of biomedical data, and that data needs to be validated to ensure success.

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Jnana nets $50M to push newly unveiled PKU program, expand into more hard-to-drug targets

After years chasing a hard-to-drug group of targets called solute carriers, Jnana Therapeutics is revealing its lead program and a new $50 million financing to get it into the clinic. That program targets phenylketonuria, a rare, inherited disorder in which the amino acid phenylalanine builds up in the blood and brain.

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Bayer, Novartis-backed Immunitas secures $58M series B to push new checkpoint inhibitors past blockade

Immunitas is attempting to tackle the hurdles traditionally associated with checkpoint inhibitors, which don't work for everyone and typically require combination regimens with investigational drugs to boost their clinical potential. The biotech is now one step closer to moving its programs into the clinic.

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The CHAMP? Ranok raises $40M to show it can knockout other protein degrader technologies

Add another biotech to the list of protein degrader startups. Weeks after Pfizer’s landmark deal with Arvinas, Sino-American biotech Ranok Therapeutics has unveiled a $40 million series B round to fund work on a cancer program.

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Bristol Myers' $1.2B discovery pact with Exscientia strikes gold as first drug candidate selected

Exscientia has already found a drug candidate in its $1.2 billion partnership with Bristol Myers Squibb. The Big Pharma will pay the AI-powered drug miner $20 million for the option fee just three months after expanding their collaboration, which included a $50 million upfront payment.

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Verily logs first major buyout, folding SignalPath trial management system into Baseline platform

Making good on its pledge to expand the reach of Project Baseline, its clinical research platform, Verily is set to acquire SignalPath, developer of an eponymous platform that, like Baseline, aims to make the entire clinical trial process more efficient.

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GSK's Jemperli follows Merck's Keytruda with FDA nod to target certain tumors regardless of location

GlaxoSmithKline’s PD-1 latecomer Jemperli has scored an FDA go-ahead to expand into a larger cancer field. Once again, it’s following in the footsteps of Merck’s market leader Keytruda, but first-in-class opportunities await down the line. 

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Biden administration to invest $19M to expand telehealth in rural, underserved areas

The Biden administration is investing $19 million to expand telehealth in rural and underserved communities to help increase access to care during the COVID-19 pandemic. Among other things, the investments will provide funding for telehealth incubators to pilot new telehealth services and track outcomes in rural medically underserved areas that have high chronic disease prevalence and high poverty rates.

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Resources

Guide: Frost & Sullivan Precision Medicine Enabling Technology Guide

Download Frost & Sullivan’s enabling technologies best practices report to learn more about the four core functionalities required in successful precision medicine programs.

eBook: Accelerate recruitment with a decentralized clinical trial strategy

Learn how a decentralized clinical trial strategy improves patient recruitment, reduces drop-out rates, and ultimately streamlines the path to the next trial phase.

Whitepaper: How to build a robust packaging strategy for rapid commercialization

Learn how to build a robust packaging strategy and the key technical considerations in packaging design and operational planning to enable rapid commercialization of pharmaceuticals.

Whitepaper: Understanding the CMC regulatory landscape for cell and gene therapy products

Learn how regulations are changing and key considerations for commercializing cell and gene therapies without sacrificing quality.

Whitepaper: Navigating the Digital Transformation Journey

Uncover the real impact of “digital transformation” with practical advice to help you plan your own transformative journey to a harmonized digital ecosystem.

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.

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. 

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