Sage’s depression drug off to FDA
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Today's Rundown

Featured Story

Unwelcome surprise for Vertex as FDA slaps hold on phase 1/2 diabetes cell therapy study

Vertex’s new diabetes cell therapy has brought many surprises: first, the rush of excitement that followed new data from a single patient last year. And now, an FDA clinical hold on a phase 1/2 trial.

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Top Stories

Gilead follows Big Pharma peers to Dragonfly's pond in $300M deal for natural killer cell engagers

Gilead has become the latest Big Pharma to find a gem from Dragonfly Therapeutics, entering a $300 million upfront deal to work together on cancer and inflammatory disease.

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Sage, Biogen get rolling on FDA submission for depression med

Sage Therapeutics and Biogen’s zuranolone is heading off to the FDA for consideration in treating major depressive disorder as a two-week, once-daily drug to bridge the time it takes for traditional therapies to kick in.

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Sponsored: Progress with Promise with Ibex® Design’s 11-month DNA to IND guarantee

Exactly what you need from your DNA to IND partner to succeed. A unique guarantee of speed and quantity, backed by Lonza’s 35 years of experience in biologics, for a fixed price.

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Eyelid mites no match for Tarsus eye drop, as phase 3 data spurs drive to FDA

Tarsus Pharmaceuticals says mites are no match for its novel eye drop, posting positive phase 3 data that the company intends to ride all the way to regulators later this year. 

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Sponsored: With the makings of a hub, NYC primed to be life sciences leader

With a $1 billion public investment, diverse talent and science, space, and funding, NYC emerges as a global leader in life sciences.

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Stealth stumbles again as age-related macular degeneration joins list of clinical trial flops

Stealth BioTherapeutics’s elamipretide has flopped again. The latest setback saw the mitochondria-targeted peptide fail to beat placebo in a phase 2 clinical trial in geographic atrophy, an advanced form of dry age-related macular degeneration.

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After posting midphase data, Rezolute banks $130M to take treatment for rare disease into pivotal trial

Rezolute has made its pitch to challenge Zealand Pharma for the congenital hyperinsulinism (CHI) space. The biotech linked its candidate to a 75% reduction in severe low blood sugar events in children, emboldening it to raise $130 million to support a push into phase 3.

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Seeing green: Breakthrough Properties raises $3B to build in biotech

Dollar signs aren’t the only green thing at Breakthrough Properties. A joint venture of biotech investment firm Bellco Capital and real estate developer and investor Tishman Speyer, Breakthrough’s $3 billion fund will go to buying and building biotech facilities in the U.S. and Europe, with a focus on sustainability.

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Cedars-Sinai AI catches pancreatic cancer in CT scans years in advance: study

The AI was trained to analyze CT images to look for certain changes in texture on the surface of the pancreas that are potentially linked to the molecular changes that occur while pancreatic cancer is developing.

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Anti-aging for the liver? Researchers find way to de-age liver cells

The liver is the only organ with the power to regenerate itself, and now, with a little help, it could even get younger. Researchers at the Salk Institute have found a way to partially de-age liver cells, returning them to younger stages to improve tissue regeneration.

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Most influential people in biopharma—the CEOs

With great pleasure, the Fierce Biotech and Fierce Pharma teams bring you our 2022 selections for the most influential people in biopharma. Starting today and for following three weeks, we’ll release five honorees each Monday and tell you their stories. We will shed light on why they are significant players in their respective fields and why their peers are paying close attention to their moves. 

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Researchers take heart from mRNA's potential to boost recovery from cardiac attack

Messenger RNA has already proven its credentials in the race to create a COVID-19 vaccine, and researchers are investigating whether this versatile technology could also boost recovery from a heart attack.

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CVS study: Mental health concerns on the rise as pandemic drags on

Mental health concerns are on the rise across the board, and especially among Blacks, seniors, young adults and LGBTQIA people, a new survey finds.

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Rest easy—research shows gene editing could hold the key to deep sleep

A good night’s rest can often be the best medicine, which means new research into gene editing that may have unlocked the part of the brain responsible for deep sleep could lead to exciting new therapy options.

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Resources

Whitepaper: Medical Affairs Metamorphosis: Trends Driving Change & What They Mean

Recent trends are driving big changes in Medical Affairs. This paper explores why, and what MA teams can do to stay ahead of the curve.

eBook: Streamline HCP interactions management

Don’t miss these critical considerations when evaluating your HCP interactions management program.

Research: Healthcare Has No Borders: The Role of Rescue Sites in Times of Global Calamity

More than 570 clinical trials in Ukraine have been disrupted. Unanticipated disruptions to medical testing and clinical trials impede progress toward new breakthroughs and new therapies that millions of patients around the world hang their hope on. What role do rescue sites play?

Infographic: United Cargo: Providing Comprehensive Solutions For the Most Critical Shipments

The United Cargo team has made a commitment to pharmaceutical and medical partners that we are equipped to support their vaccine transportation needs safely and effectively across our expansive global and domestic network. The safety and security of these commodities is our priority, and we are proud to be a trusted partner in these efforts. Download infographic now.

Whitepaper: Uncovering the hidden value of quality in chemical supply

Learn how to position quality as a central component within your raw material sourcing strategies for the chemicals used throughout your workflows. Download the free whitepaper from Thermo Fisher Scientific.

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