Food and Drug Administration

Radius Health Business Update

Tuesday, July 27, 2021 - 1:00pm

To date in 2021, 80+% of our top 50 TYMLOS prescribers are fracture / bone health focused, a trend we see accelerating.

Key Points: 
  • To date in 2021, 80+% of our top 50 TYMLOS prescribers are fracture / bone health focused, a trend we see accelerating.
  • Radius plans to move forward with a seamless Phase 2/3 pivotal trial for PWS.
  • Radius goal: through the pivotal trial and subsequent data readout, demonstrate efficacy and safety for FDA approval, and to help patients living with PWS.
  • Radius is a commercial biopharmaceutical company committed to serving patients with unmet medical needs in endocrinology and other therapeutic areas.

FDA Awards REI System $400M SIRCE IT Modernization Contract

Tuesday, July 27, 2021 - 12:00pm

The FDA engaged REI Systems to address new legislative mandates, emerging health concerns, and leverage opportunities presented by evolving technologies through more efficient, reliable, and secure systems.

Key Points: 
  • The FDA engaged REI Systems to address new legislative mandates, emerging health concerns, and leverage opportunities presented by evolving technologies through more efficient, reliable, and secure systems.
  • The FDA selected REI Systems based on the company's success with complex application modernization throughout the federal government, unique Agile and DevSecOps capabilities, and a successful track record with previous technology transformations at FDA, including the Foreign Inspection Planning and Scheduling System.
  • REI Systems' CEO Shyam Salona said, "We are very pleased to expand our relationship with the FDA.
  • We take a Mindful Modernization approach in providing Application Modernization, Government Data Analytics, Grants Management Systems and Products, and Advisory Services.

LifeSignals receives FDA 510 (k) Approval for LifeSignals LX1550 Multiparameter Remote Monitoring Platform

Tuesday, July 27, 2021 - 12:00pm

FREMONT, Calif., July 27, 2021 /PRNewswire/ -- LifeSignals Inc., today announced it has received FDA Class II 510 (k) approval for the LifeSignals LX1550 Multiparameter Remote Monitoring Platform.

Key Points: 
  • FREMONT, Calif., July 27, 2021 /PRNewswire/ -- LifeSignals Inc., today announced it has received FDA Class II 510 (k) approval for the LifeSignals LX1550 Multiparameter Remote Monitoring Platform.
  • Clinicians and Care Providers can access the cloud-based remote monitoring dashboard to view patient physiological data and manage alert settings.
  • The Remote Monitoring Platform is designed to enable healthtech companies to rapidly enhance their product and service portfolios to provide vital sign monitoring to the widest possible patient base, from any location.
  • "This FDA 510 (k) approval marks another major milestone in the company's development and mission.

Day One Receives FDA Rare Pediatric Disease Designation for DAY101 for the Treatment of Pediatric Low-Grade Glioma

Tuesday, July 27, 2021 - 12:00pm

In addition to FDA Rare Pediatric Disease Designation, DAY101 has been granted Breakthrough Therapy designation by the FDA for the treatment of patients with pLGG harboring an activating RAF alteration who require systemic therapy and who have either progressed following prior treatment or who have no satisfactory alternative treatment options.

Key Points: 
  • In addition to FDA Rare Pediatric Disease Designation, DAY101 has been granted Breakthrough Therapy designation by the FDA for the treatment of patients with pLGG harboring an activating RAF alteration who require systemic therapy and who have either progressed following prior treatment or who have no satisfactory alternative treatment options.
  • In addition, DAY101 has received Orphan Drug designation from the FDA for the treatment of malignant glioma and orphan designation from the European Commission for the treatment of glioma.
  • The FDA has also granted Rare Pediatric Disease Designation to DAY101 for the treatment of low-grade gliomas harboring an activating RAF alteration that disproportionately affects children.
  • In addition, DAY101 has received Orphan Drug designation from the FDA for the treatment of malignant glioma and orphan designation from the European Commission for the treatment of glioma.

Harrow Health Acquires Patented Ophthalmic Surgical Drug Candidate from Sintetica

Tuesday, July 27, 2021 - 12:00pm

Sintetica intends to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in late 2021.

Key Points: 
  • Sintetica intends to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in late 2021.
  • Harrow Health will have marketing rights for the U.S. and Canada, while Sintetica will retain the marketing rights in other countries.
  • Harrow Health also holds equity positions in Eton Pharmaceuticals, Surface Ophthalmics and Melt Pharmaceuticals, all of which started as Harrow Health subsidiaries.
  • Harrow Health also owns royalty rights in four clinical stage drug candidates being developed by Surface Ophthalmics and Melt Pharmaceuticals.

Idorsia announces financial results for the first half 2021 – Building momentum towards becoming a fully-fledged biopharmaceutical company

Tuesday, July 27, 2021 - 6:01am

In April and July of 2020, Idorsia reported positive results in each of the two pivotal Phase 3 studies of daridorexant in patients with insomnia.

Key Points: 
  • In April and July of 2020, Idorsia reported positive results in each of the two pivotal Phase 3 studies of daridorexant in patients with insomnia.
  • Should approval be received, the company anticipates launch in the US in the second quarter of 2022, followed by other regions thereafter.
  • A New Drug Application (NDA) to the Japanese PMDA for clazosentan was submitted on March 1, 2021.
  • Based on initial clinical pharmacology investigation with ACT-541478, the company has decided not to pursue the development of this CNS compound further.

AYVAKIT® (avapritinib) Companion Diagnostic Test Enters Priority Review and Approval Process in China

Monday, July 26, 2021 - 11:00am

The test kit is the first companion diagnostic product developed in China to go through the NMPAs accelerated review channel.

Key Points: 
  • The test kit is the first companion diagnostic product developed in China to go through the NMPAs accelerated review channel.
  • During the process, the Center for Medical Device Evaluation (CMDE) under the NMPA carries out a priority technical review, working closely with the company to expedite the process.
  • "I am very pleased that the AYVAKIT companion diagnostics test kit has entered the NMPA priority review and approval process, distinguishing itself through innovative, original technology and strong performance data.
  • I am very pleased that the AYVAKIT companion diagnostic kit has also entered the priority review process.

Aadi Bioscience Announces FDA Acceptance and Priority Review for the New Drug Application of FYARRO™ for the Treatment of Advanced Malignant PEComa

Monday, July 26, 2021 - 12:00pm

Neil Desai, Ph.D., Founder, CEO and President of Aadi, stated, We are very pleased with FDAs acceptance of our NDA with Priority Review for FYARRO in patients with advanced malignant PEComa, an ultra-rare sarcoma.

Key Points: 
  • Neil Desai, Ph.D., Founder, CEO and President of Aadi, stated, We are very pleased with FDAs acceptance of our NDA with Priority Review for FYARRO in patients with advanced malignant PEComa, an ultra-rare sarcoma.
  • If approved, FYARRO will be the first FDA-approved therapy for the treatment of patients with this disease.
  • Aadis NDA submission is based on data from the AMPECT registration trial evaluating FYARRO as a monotherapy in patients with advanced malignant PEComa.
  • FYARRO is an investigational drug that has not been approved by the FDA for commercial distribution in the United States.

Iterum Therapeutics Receives Complete Response Letter from U.S. Food and Drug Administration for Oral Sulopenem

Monday, July 26, 2021 - 12:00pm

Food and Drug Administration(FDA) for its New Drug Application (NDA) for sulopenem etzadroxil/probenecid (oral sulopenem) onJuly 23, 2021.

Key Points: 
  • Food and Drug Administration(FDA) for its New Drug Application (NDA) for sulopenem etzadroxil/probenecid (oral sulopenem) onJuly 23, 2021.
  • The FDA recommended that Iterum conduct at least one additional adequate and well-controlled clinical trial, potentially using a different comparator drug.
  • Iterum Therapeutics is advancing its first compound, sulopenem, a novel penem anti-infective compound, in Phase 3 clinical development with an oral formulation and IV formulation.
  • Iterum Therapeutics has received Qualified Infectious Disease Product (QIDP) and Fast Track designations for its oral and IV formulations of sulopenem in seven indications.

Kiromic Announces the Acquisition of InSilico Solutions Leveraging on Bioinformatics and Artificial Intelligence to Advance Clinical Development on Its Outpatient Allogeneic CAR-T for Solid Tumors

Monday, July 26, 2021 - 11:55pm

Similar data from clinical trials will be used refine our understanding of efficacy and toxicity to improve treatment protocol and patient selection.

Key Points: 
  • Similar data from clinical trials will be used refine our understanding of efficacy and toxicity to improve treatment protocol and patient selection.
  • We will continually evaluate, implement, and improve our industry leading systems that will accelerate therapeutic development, manufacturing, and clinical testing of Kiromics off-the-shelf allogeneic CAR-T for solid tumors.
  • Under the agreement terms, Kiromic acquires InSIlico through a stock-swap operation, hiring the entire staff of InSIlico and their material and immaterial assets.
  • InSilico Solutions is a bioinformatics company with a stellar 10-year track record of developing innovative software for cancer researchers.