Sage: Three days to treat depression?

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Today's Rundown

Featured Story

Pfizer tears up gene therapy timelines, revealing a series of phase 3 delays that end vision of a banner 2022

Pfizer’s vision for a banner 2022 in gene therapies is over. Having previously expected to post interim data on a trio of phase 3 programs next year, Pfizer has now delayed all the readouts, setting back its plans in hemophilia and Duchenne muscular dystrophy.  

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Top Stories

Fleet of Flagship biotechs will get up to $110M for new cystic fibrosis treatments

The Cystic Fibrosis Foundation will give $20 million upfront and up to another $90 million to Flagship Pioneering-founded biotechs to work on potential new treatments. The deal is part of the foundation's $500 million pledge to find a cure for the disease that causes severe damage in the lungs.

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Sage tweaks primary endpoint for zuranolone depression trial, leaving key durability question unanswered

Sage Therapeutics has slightly tweaked the primary endpoint for a phase 3 trial of the Biogen-partnered depression drug zuranolone, a move analysts say is likely designed to avoid a miss on the original goal and one that could complicate the drug's real-world use.

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Sponsored: A New Reference Model for Clinical Trial Recruitment, Enrollment and Retention Success

Rare diseases demand a modern recruitment approach grounded in uncovering the ideal, medically-eligible patient population with the highest propensity for study enrollment and retention.

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Antios, months after series B, raises a further $75M to fuel pursuit of hepatitis B cure

Antios Therapeutics is going full throttle in pursuit of a curative hepatitis B therapy, raising $75 million just months after its previous round to accelerate phase 2b development of its lead prospect.

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Sponsored: Intranasals in Clinic Now Positioned for $71 Billion Nasal Delivery Market

Australia’s Avance Clinical: how intranasal biotechs can expedite trials with rapid approval processes - including no IND and a 43.5% incentive rebate - to tap $71 billion market

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PhaseBio’s Brilinta reversal agent wins midstage test as biotech awaits key data on emergency patients

PhaseBio’s Brilinta reversal drug has scored a mid-stage win without any adverse events or blood clot issues, layering on the data to support the therapy that’s already pushing through phase 3.

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Cara chief hands keys to former LEO head Posner, months after first approval in its 17-year history

It took 17 years to get its first FDA greenlight. Three months later, Cara Therapeutics founding CEO Derek Chalmers exits the top perch as LEO Pharma's U.S. CEO and president enters the role.

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Bristol Myers Squibb-backed Clade nabs a meaty $87M series A for cell therapy 2.0

It still feels as if the use of cell therapy is a fresh innovation, but inertia is the enemy of progress, and next-gen approaches are already here.

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Race, ethnicity of trial patients 'highly correlated' with staff of site investigators: study

About one-third of staff at clinical trial sites in U.S. academic medical centers and community hospitals are representative of minority populations, according to a new study by Tufts University. That figure is higher, at nearly half, for personnel who work in private practices, and Europe lags behind at just 10% representation.

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By unanimous vote, CDC advisory committee endorses Pfizer COVID-19 vaccine for kids 5-11

By a unanimous vote, CDC vaccine advisers have blessed the Pfizer-BioNTech COVID-19 vaccine with no restrictions for children ages 5 to 11, setting up the shot to be distributed in the U.S. later this week. The recommendation now moves forward to CDC Director Rochelle Walensky.

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Intuity launches all-in-one, push-button blood glucose monitor

The company has launched its Pogo Automatic monitoring system following years of development, with an FDA-cleared blood glucose reader equipped with cartridges that provide up to 10 fingerstick tests with the quick push of a button.

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Humana posts $1.5B profit based on Medicare Advantage growth but cuts 2021 outlook

Humana posted $1.5 billion in profit for the third quarter of the year thanks in part to its Medicare Advantage growth but cut its financial outlook for the rest of 2021.

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Resources

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2021 Report: Clinical Trial Management in a Post-Pandemic World

New market research provides valuable insight into the impact of adaptations made in clinical trials during the pandemic.

Whitepaper: A Checklist for eCOA Solution Deployment

Every detail is important when selecting a new eCOA solution; learn more about the current eCOA landscape, best practices, and crucial considerations for successful eCOA solution deployment in this white paper.

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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.

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.

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