FDA

Nanoscope Therapeutics Accelerates Sight-Restoring Drug Development with New Gene Therapy Manufacturing Partnership

by | Oct 18, 2022
Dallas-based Nanoscope Therapeutics is accelerating the development of therapies that could restore sight in patients with the help of a publicly traded firm. The retinal degenerative diseases-focused biotech company announced a new gene therapy manufacturing partnership with contract research organization Charles River Laboratories International.
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Fort Worth’s Lucid Hearing Launches Over-The-Counter Hearing Aids as New FDA Rule Kicks In
Today is the first day that over-the-counter hearing aids can be sold without a prescription. It’s a moment that Fort Worth-based Lucid Hearing has been eyeing for years.
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Dallas Medical Device Company Wins Top Prize at Dell for Startups Pitch Competition
by | Aug 9, 2022
“Opioids are diabolical, because they actually change the structure and function of your brain; they change the way your reward system works,” said Daniel Powell, CEO at Spark Biomedical.

Meet Powell and six other startup leaders.
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Dallas’ Berkshire Biomedical Gets NIH Research Grant for Home Methadone Dispensing System
by | Aug 2, 2022
Berkshire's COPA System delivers automated at-home methadone doses to treat people with opioid use disorder. The computerized device offers biometric screening and real-time remote monitoring as it "accurately and securely" dispenses the medication. This can help patients avoid having to travel to clinics and wait in line for their treatment—often every single day. "These are people who want to get over their addiction," says president and CEO John Timberlake, who believes COPA can "help these patients maintain their jobs and get back into society."
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Fort Worth Immunotherapy Startup Gets $1.8M Grant Ahead of First Clinical Trials

by | May 12, 2022
AyuVis, an immunotherapy startup, is set to get a $1.8 million Small Business Innovation Research grant from the Eunice Kennedy Shriver National Institute of Child Health and Human Development. The funding will support the pre-clinical research of its drug candidate to treat the second-leading cause of death in premature babies.

Founder Suchismita Acharya calls the timing "perfect."
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Westlake’s Virbac Announces Availability of New Dog Cancer Treatment Across the U.S.
by | Aug 16, 2021
Stelfonta received FDA approval last November to treat dogs with non-metastatic, skin-based mast cell tumors (MCTs)—the most common malignant skin tumor in dogs. The injection is now available at vet clinics across the U.S., with an 88% "satisfactory experience" rate to date.
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Berkshire Biomedical Raises $3M to Continue Developing Its Virtual Care and Prescription Drug Management System
by | Jan 28, 2021
Successful medical outcomes rely heavily on medication adherence, according to a Berkshire Biomedical. That's why the Dallas startup is developing tech that can dispense secure medication with a dosage specific only to the intended user. The system is currently under review with the U.S. Food and Drug Administration for market clearance.
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tyme bank

North Texas De Novo TYME Bank Withdraws Application With the FDIC

by | Jul 28, 2020
One of just two de novo applications in Texas last year, the withdrawal is a casualty of “the uncertainty caused by the COVID-19 pandemic.” But founders of the proposed locally owned community bank are looking at options to refile in the near future.
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research COVID-19
Discovery: UTSW Studies Existing Drugs to Fight COVID-19, UTA Researches Economic Abuse
by | Mar 20, 2020
Check out our weekly roundup on research and development activities by North Texas organizations to stay up-to-date on the important work.
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Fatal Yeast: Carrollton Startup MycoDART Steps Up to Fight Infections in Hospitalized Patients
by | Apr 30, 2019
MycoDART, which was named one of Health Wildcatter's six startup healthcare accelerators, has a new test that may have cracked the code on Candida auris, a type of yeast that can cause severe sickness in hospitalized patients.
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