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Carol Nacy

50 Over 50 2021: Vision

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Carol NacyArmed with brilliant ideas, experience and a determination to disrupt, these 50 women are making an impact on society and culture through healthcare, robotics, music, dance, and so much more. It’s the third chapter of our 50 Over 50 project, launched in June and produced in partnership with Mika Brzezinski’s Know Your Value initiative.

 

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Sonosa Medical Spins Out of the MDC Studio

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Sonosa

The MDC Studio is pleased to announce the spin-out of the company, Sonosa Medical, Inc., as an independent entity. Founded in 2019, Sonosa Medical is developing next-generation devices poised to transform the diagnosis and treatment of obstructive sleep apnea (OSA). The company is led by Dr. Stephen Restaino as Chief Executive Officer, Dr. Jeffrey Wolf as Medical Advisor, and Dr. Gil Blankenship as Chairman of the Board. Dr. Restaino and his team have been developing novel technology for the detection and treatment of OSA using a wearable device. Their work has been funded by a $3.35 million Phase II Small Business Innovation Research (SBIR) award from the Defense Advanced Research Projects Agency (DARPA).

 

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NCI Technology Transfer Center (TTC) Communications for Industry Partners

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Public reporting burden for this collection of information is estimated to average 10 minutes per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden to: NIH, Project Clearance Branch, 6705 Rockledge Drive, MSC 7974, Bethesda, MD 20892-7974, ATTN: PRA (0925-0642). Do not return the completed form to this address.

 

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FZata Announces First-in-Class “Live Biologics In A Pill” Platform Entering Manufacturing Phase · BioBuzz

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NewImage

FZata, Inc. is developing our ground-breaking “Live Biologics In A Pill” platform for oral delivery of live biologics. Live Biologics In A Pill will open up a new route of oral administration for innovative live biologic therapeutics. FZata is pleased to announce that our lead drug, FZ002, has advanced to manufacturing stage and IND-enabling studies. FZ002 is a first-in-class live biotherapeutic product (LBP) yeast for the treatment of Clostridioides difficile (C. diff) infection.  C. diff bacteria can cause life-threatening diarrhea. Infections occur most often in people who have taken antibiotics for other conditions. It is the most common healthcare-associated infection and the CDC has labeled it at the highest urgent threat level.

Image: https://biobuzz.io

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FDA new drug applications to cost more than $3M in 2022

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FDA Logo

Starting in 2022, drugmakers filing new drug applications with clinical data will have to pay the FDA $3.1 million.

The FDA’s fee for new drugs with clinical data has risen from a little more than $2 million in 2017 to $3.1 million in 2022.

The 2022 fee for FDA approval applications not requiring clinical data will be about $1.6 million in 2022, which is about $200,000 more than the previous two years.

Drugmakers pay these fees to ensure the FDA responds to applications within 10 months for standard applications and within six months for expedited reviews.

 

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Notification Center

How A Disconnected Biohealth Ecosystem Became The Next Big Thing – YouTube

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Notification Center

Jeff Galvin, CEO of American Gene Technologies and Rich Bendis, CEO and President of BioHealth Innovation, Inc. have a fireside chat about the rapid evolution of the BioHealth Capital Region.

On the heels of Silicon Valley’s branding as one of the world’s largest tech hubs, the BioHealth Capital Region aims to brand the DMV region as one of the most prominent BioHealth clusters in the Mid-Atlantic. BioHealth Innovation, Inc. was founded 11 years ago in an effort to drive ideas from labs into markets through innovation-driven economic development organizations and initiatives.

Galvin and Bendis discuss the abundance of opportunities for growth within the region as it is home to a wide variety of research institutions, top scientists, and annual grants. Additionally, they discuss how BioHealth Innovation, Inc. cultivates success for companies within the competitive region.

 

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