Regulation of food and dietary supplements by the U.S. Food and Drug Administration

Genesis MedTech announces FDA Breakthrough Device designation for the J-Valve™ Transfemoral System

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Tuesday, August 1, 2023

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BURLINGAME Calif., Aug. 1, 2023 /PRNewswire/ -- Genesis MedTech, a leading medical device company, today announced that its J-Valve™ Transfemoral (TF) System has been granted Breakthrough Device designation by the U.S. Food and Drug Administration (FDA).

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BURLINGAME Calif., Aug. 1, 2023 /PRNewswire/ -- Genesis MedTech, a leading medical device company, today announced that its J-Valve™ Transfemoral (TF) System has been granted Breakthrough Device designation by the U.S. Food and Drug Administration (FDA).
J-Valve™ TF System consists of two key components including the J-Valve™ TF Bioprosthesis and the J-Valve™ TF Delivery Device.
The J-Valve™ TF System being granted a Breakthrough Device designation underscores the significance of this innovative development for cardiovascular patients.
Warren Wang, Chairman & CEO of Genesis MedTech Group shared, "We believe the Breakthrough Device designation for the J-Valve™ TF System is a testament to the innovative spirit and dedication of our team at Genesis MedTech.

Francis Medical Receives U.S. FDA Breakthrough Device Designation for Vanquish Minimally Invasive Prostate Cancer Therapy

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Tuesday, August 1, 2023

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MINNEAPOLIS , Aug. 1, 2023 /PRNewswire/ -- Francis Medical, Inc. , a privately held medical device company developing an innovative and proprietary water vapor ablation therapy for the treatment of prostate, kidney and bladder cancer, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for its Vanquish minimally invasive water vapor ablation therapy.

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MINNEAPOLIS , Aug. 1, 2023 /PRNewswire/ -- Francis Medical, Inc. , a privately held medical device company developing an innovative and proprietary water vapor ablation therapy for the treatment of prostate, kidney and bladder cancer, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for its Vanquish minimally invasive water vapor ablation therapy.
To qualify for a Breakthrough Device Designation, a device technology must show that it has the potential to provide a more effective treatment than current standards of care.
The therapy is designed to ablate cancer cells while protecting surrounding structures, lessening the likelihood of life-altering side effects common with other prostate cancer treatments.
"The goal of Francis Medical is to become the first line therapy of choice for patients with prostate cancer," said Michael Kujak, Francis Medical president and chief executive officer.

Qualigen Therapeutics Announces US FDA IND Clearance to Initiate Phase 1 Clinical Trial of QN-302 for Treatment of Advanced or Metastatic Solid Tumors

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Tuesday, August 1, 2023

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CARLSBAD, Calif., Aug. 01, 2023 (GLOBE NEWSWIRE) -- Qualigen Therapeutics, Inc. (Nasdaq: QLGN), a clinical-stage therapeutics company focused on developing treatments for adult and pediatric cancers with potential for Orphan Drug Designation, announces today that the U.S. Food and Drug Administration (FDA) has cleared the Company’s IND application for QN-302, a potential best-in-class small molecule G-Quadruplex (G4)-selective transcription inhibitor. Based on this clearance, the Company plans to initiate the Phase 1 clinical trial in the second half of 2023 and will enroll patients with advanced or metastatic solid tumors.

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Based on this clearance, the Company plans to initiate the Phase 1 clinical trial in the second half of 2023 and will enroll patients with advanced or metastatic solid tumors.
Michael Poirier, Qualigen's Chairman and CEO, commented, “This is a pivotal milestone for our therapeutics pipeline as it transitions us into a clinical-stage company.
The IND clearance for QN-302 brings us closer to our objective of developing best in class treatments that can potentially provide new therapeutic options for patients with advanced or metastatic solid tumors.
The Company anticipates the dosing of at least 24 patients in the Phase 1 trial can be completed in 2024, funded in part by proceeds received by the divestiture of the Company’s diagnostics business in July 2023.

Aspargo Laboratories, Inc. Announces Filing of Its Investigational New Drug Application for Sildenafil Oral Spray

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Tuesday, August 1, 2023

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Aspargo plans to commence the clinical studies described in the IND in the fourth quarter of 2023, pending the FDA's acceptance of the Company's filing.

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Aspargo plans to commence the clinical studies described in the IND in the fourth quarter of 2023, pending the FDA's acceptance of the Company's filing.
"Our initial product candidate, Sildenafil Oral Spray, offers a convenient, discreet option for men with erectile dysfunction.
Currently, we market Sildenafil Oral Spray in Spain and are preparing for our commercial launches in Germany, other European countries, the UK, and Central and South America.
Aspargo uses a metered-dose container that delivers the precise amount of sildenafil citrate per push based on patient need.

Actuate Therapeutics Receives FDA Orphan Drug Designation for Elraglusib for Treatment of Pancreatic Cancer

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Tuesday, August 1, 2023

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CHICAGO and FORT WORTH, Texas, Aug. 01, 2023 (GLOBE NEWSWIRE) -- Actuate Therapeutics, Inc. (Actuate), a clinical stage biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation for elraglusib for treatment of patients with pancreatic cancer.

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CHICAGO and FORT WORTH, Texas, Aug. 01, 2023 (GLOBE NEWSWIRE) -- Actuate Therapeutics, Inc. (Actuate), a clinical stage biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation for elraglusib for treatment of patients with pancreatic cancer.
“We are pleased with the FDA’s decision to grant Orphan Drug Designation to elraglusib for the treatment of pancreatic cancer.
The Orphan Drug Designation furthers our ability to advance development and regulatory interactions with the FDA to bring elraglusib to patients with this highly lethal malignancy,” said Daniel Schmitt, President & CEO.
“Additional investigator-led phase 2 studies for the front line treatment of patients with advanced pancreatic cancer in combination with a checkpoint inhibitor (NCT05239182) and in patients with metastatic pancreatic cancer in combination with FOLFIRINOX (NCT05077800) are also in progress, emphasizing our commitment to developing elraglusib for the pancreatic cancer population.”
The FDA’s Orphan Drug Designation FDA Orphan Drug Designation is granted to investigational therapies addressing rare medical diseases or conditions that affect fewer than 200,000 people in the United States.

Pipeline Therapeutics Announces First Subject Dosed with PIPE-791 in Phase 1 Study

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Tuesday, August 1, 2023

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Pipeline Therapeutics, a clinical-stage biopharmaceutical company pioneering precision neuroregeneration, today announced that the first subject was dosed in the Phase 1 clinical trial of PIPE-791 in healthy volunteers.

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Pipeline Therapeutics, a clinical-stage biopharmaceutical company pioneering precision neuroregeneration, today announced that the first subject was dosed in the Phase 1 clinical trial of PIPE-791 in healthy volunteers.
PIPE-791 is a potent, selective and brain-penetrant small molecule antagonist of the lysophosphatidic acid 1 receptor (LPA1).
“Initiating dosing in this first in human study with PIPE-791 is a significant milestone for Pipeline that brings us one step closer to transforming the treatment of CNS indications by addressing both remyelination and neuroinflammation,” said Carmine Stengone, President and CEO of Pipeline.
We expect to fully enroll the study by the end of 2023.”

Tyra Biosciences Announces FDA Orphan Drug Designation for TYRA-300 for the Treatment of Achondroplasia

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Tuesday, August 1, 2023

People living with achondroplasia may experience severe skeletal complications including cranial and spinal stenosis, hydrocephalus and sleep apnea.

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People living with achondroplasia may experience severe skeletal complications including cranial and spinal stenosis, hydrocephalus and sleep apnea.
TYRA-300 is an oral FGFR3 selective inhibitor whose design may have a meaningful impact on achondroplasia and other skeletal dysplasias.
"People living with achondroplasia can have significant health complications that are not adequately addressed with currently available therapies.
"The FDA's decision to grant Orphan Drug Designation to TYRA-300 is an important recognition of the potential of our approach to deliver benefit to the achondroplasia community.

Samsung Bioepis & Organon Announce Topline Results from Interchangeability Study of SB5 Humira Biosimilar

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Tuesday, August 1, 2023

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INCHEON, South Korea and JERSEY CITY, N.J., Aug. 01, 2023 (GLOBE NEWSWIRE) -- Samsung Bioepis Co., Ltd. and Organon & Co. (NYSE: OGN) today announced topline results from the interchangeability study for SB5, a biosimilar to Humira® (adalimumab).

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INCHEON, South Korea and JERSEY CITY, N.J., Aug. 01, 2023 (GLOBE NEWSWIRE) -- Samsung Bioepis Co., Ltd. and Organon & Co. (NYSE: OGN) today announced topline results from the interchangeability study for SB5, a biosimilar to Humira® (adalimumab).
The primary objective of the study was to assess the pharmacokinetic similarity between two treatment groups: patients with moderate to severe plaque psoriasis who switched multiple times between Humira (ADL) and high-concentration SB5 versus patients receiving ADL continuously.
All 371 patients who were enrolled in the study had no prior treatment with ADL and were treated in this study with ADL during a lead-in period of 13 weeks.
HADLIMA was introduced into the U.S. commercial market on July 1, 2023 and is marketed by Organon.

Tonix Pharmaceuticals Completes Enrollment in Potentially NDA-Enabling Phase 3 RESILIENT Trial of TNX-102 SL for Management of Fibromyalgia

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Tuesday, August 1, 2023

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CHATHAM, N.J., Aug. 01, 2023 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a biopharmaceutical company, today announced that it has completed enrollment of its potentially final, confirmatory Phase 3 RESILIENT trial of TNX-102 SL (cyclobenzaprine HCL sublingual tablets) 5.6 mg in fibromyalgia and expects topline data next quarter. A total of 457 participants were randomized. TNX-102 SL is in development as a non-opioid, centrally acting analgesic, to be taken daily at bedtime for the management of fibromyalgia. If successful, we believe this will be the final, well-controlled efficacy trial required for submission of a New Drug Application (NDA) for approval by the U.S. Food and Drug Administration (FDA).

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TNX-102 SL is in development as a non-opioid, centrally acting analgesic, to be taken daily at bedtime for the management of fibromyalgia.
“The completion of enrollment in our Phase 3 RESILIENT trial is a significant milestone for both Tonix and the fibromyalgia community,” said Seth Lederman, M.D., Chief Executive Officer of Tonix.
TNX-102 SL met its pre-specified primary endpoint in the Phase 3 RELIEF trial, significantly reducing daily pain compared to placebo (p=0.01) in participants with fibromyalgia.
TNX-102 SL was generally safe and well tolerated in patients with fibromyalgia, with overall adverse event profile comparable to prior fibromyalgia studies.

LEXEO Therapeutics Announces FDA Clearance of IND for LX2020, an AAV-based Gene Therapy Candidate for PKP2 Arrhythmogenic Cardiomyopathy

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Tuesday, August 1, 2023

NEW YORK, Aug. 01, 2023 (GLOBE NEWSWIRE) -- LEXEO Therapeutics (LEXEO), a clinical-stage gene therapy company advancing adeno-associated virus (AAV)-based gene therapy candidates for genetically defined cardiovascular diseases and a genetically defined sub-group of Alzheimer’s disease, today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for LX2020. LX2020 is an AAVrh10-based gene therapy candidate designed to intravenously deliver a functional PKP2 gene to cardiac muscle for the treatment of Arrhythmogenic Cardiomyopathy (ACM) caused by variants in the PKP2 gene (PKP2-ACM).

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LX2020 is an AAVrh10-based gene therapy candidate designed to intravenously deliver a functional PKP2 gene to cardiac muscle for the treatment of Arrhythmogenic Cardiomyopathy (ACM) caused by variants in the PKP2 gene (PKP2-ACM).
“This IND clearance marks an important step in advancing a potential one-time treatment for individuals with PKP2-ACM, who are in need of more effective options for this devastating disease.
Current clinical management strategies are only marginally effective and primarily focus on symptom management,” said Eric Adler, M.D., Chief Scientific Officer of LEXEO.
“LX2020 seeks to address the underlying cause of this disease by delivering a functional PKP2 gene to halt progression and reverse the disease phenotype.