MORE►
FDA
[Image: sudok1/istockphoto]
Alpha Cognition Gets FDA Acceptance of New Alzheimer’s Drug Application
by David Seeley | Dec 13, 2023
Based in Vancouver with a North Texas office in Frisco, Alpha Cognition said its novel oral tablet ALPHA-1062 is designed for the treatment of people with mild to moderate Alzheimer's disease. The company was honored at the recent BioNTX iC3 Summit as one of eight "Rising Stars."
by David Seeley |
Dec 11, 2023
On Friday, the first CRISPR-based gene-editing therapy to win FDA approval was announced. CASGEVY holds "the potential of a functional cure" for sickle cell disease—and Medical City Children’s is one of only nine hospitals in the U.S. in its initial network of authorized treatment centers.
MORE►
by Quincy Preston |
Jul 18, 2023
Parker Health's cloud Health Management System is the first in the U.S. to build on the Fast Healthcare Interoperability Resources—or FHIR—standard to create an interoperable, affordable, and compliant cloud-based platform. The Parker Suite aims to unify patient-centric data, biometrics, diagnostic tools, patient outcomes, care delivery, practitioner engagement, and pharmaceuticals for the healthcare ecosystem.
MORE►
by Lance Murray |
Jun 5, 2023
Dallas-based Trinity Hunt Partners announced a majority investment in Centricity Research, a clinical research services provider specializing in conducting Phase I-IV clinical trials across more than 40 therapeutic areas.
The amount of the investment was not disclosed.
“We are confident that Trinity Hunt’s expertise in partnering with growing healthcare services companies and its shared commitment to providing an empowering team environment will help us drive innovation and make significant strides as we continue to expand,” Centricity President Dr....
MORE►
[Image: istockphoto]
Nanoscope Therapeutics Accelerates Sight-Restoring Drug Development with New Gene Therapy Manufacturing Partnership
by Kevin Cummings | 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.
MORE►
by Dallas Innovates | Staff Report |
Oct 17, 2022
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.
MORE►
by Kevin Cummings |
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.
Meet Powell and six other startup leaders.
MORE►
by David Seeley |
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."
MORE►
From left, AyuVis Senior Research Scientist Sumita Behera with CEO and Founder Suchi Acharya. [Image: AyuVis]
Fort Worth Immunotherapy Startup Gets $1.8M Grant Ahead of First Clinical Trials
by Kevin Cummings | 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."
Founder Suchismita Acharya calls the timing "perfect."
MORE►
by Kevin Cummings |
Apr 18, 2022
Frisco-based InspectIR received the FDA emergency use authorization on Friday for its breathalyzer test, which tests for organic compounds associated with COVID-19 in a person's breath. According to a study, the tests are more effective than the rapid antigen tests available for free from the U.S. government.
MORE►
by David Seeley |
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.
MORE►
by Alex Edwards |
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.
MORE►
Ken Judd and Joe Hansen of Tyme Bank. [Photo: Michael Samples]
North Texas De Novo TYME Bank Withdraws Application With the FDIC
by Quincy Preston | 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.
MORE►
by Lance Murray |
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.
MORE►
by Blair Welch |
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.
MORE►
