Federal Food, Drug, and Cosmetic Act

Intelligent Bio Solutions Inc. Reports Fiscal 2023 Third Quarter Financial Results and Operational Highlights

Retrieved on: 
Thursday, May 11, 2023
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NEW YORK, May 11, 2023 (GLOBE NEWSWIRE) -- Intelligent Bio Solutions Inc. (“Intelligent Bio Solutions,” “INBS” or the “Company”) (Nasdaq: INBS), a medical technology company delivering intelligent, rapid, non-invasive testing solutions, today announced its financial results for its fiscal third quarter ended March 31, 2023, and provided a business update.

Key Points: 
  • - Filed 513(g) submission with U.S. FDA for Intelligent Fingerprinting Drug Screening Cartridge -
    - Completion of Milestone 7, key phase of biosensor platform development -
    NEW YORK, May 11, 2023 (GLOBE NEWSWIRE) -- Intelligent Bio Solutions Inc. (“Intelligent Bio Solutions,” “INBS” or the “Company”) (Nasdaq: INBS), a medical technology company delivering intelligent, rapid, non-invasive testing solutions, today announced its financial results for its fiscal third quarter ended March 31, 2023, and provided a business update.
  • “INBS delivered revenue growth during the third quarter and achieved several important milestones in line with our regional expansion plans,” said Harry Simeonidis, Chief Executive Officer at Intelligent Bio Solutions.
  • The results showed a record 4x improvement in time-to-result (TTR), enabling the biosensor to return test results in under one minute.
  • Third Quarter Ended March 31, 2023, Financial Results
    All amounts are expressed in U.S. dollars unless indicated otherwise.

Cingulate Inc. Reports First Quarter 2023 Financial Results and Provides Clinical and Business Update

Retrieved on: 
Wednesday, May 10, 2023
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KANSAS CITY, Kan., May 10, 2023 (GLOBE NEWSWIRE) -- Cingulate Inc. (NASDAQ: CING), a biopharmaceutical company utilizing its proprietary Precision Timed Release™ (PTR™) drug delivery platform technology to build and advance a pipeline of next-generation pharmaceutical products, today provided financial results for the three months ended March 31, 2023, as well as a clinical and business update. Among other highlights, the Company announced it has obtained an additional $3 million of debt financing, successfully completed the transfer of its proprietary PTR™ manufacturing processes to Societal CDMO, Inc. (Societal) and entered into a joint commercialization agreement with Indegene to provide commercial support for CTx-1301 upon approval from the U.S. Food and Drug Administration (FDA).

Key Points: 
  • CTx-1301: Cingulate advanced its clinical program for CTx-1301 on the streamlined approval pathway under Section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act.
  • Assuming positive clinical results from the Phase 3 trials, Cingulate plans to submit the NDA for CTx-1301 in mid-2024 under the Section 505(b)(2) pathway.
  • Cash Position: As of March 31, 2023, Cingulate had $1.7 million in cash and cash equivalents.
  • This decrease in manufacturing expense was slightly offset by an increase in clinical and regulatory costs as we initiated a Phase 3 clinical trial for CTx-1301 in the first quarter of 2023.

Hubly Surgical Receives 510k Clearance from FDA to Market Innovative Cranial Access Drill for Neurosurgical Safety in the ICU

Retrieved on: 
Tuesday, May 9, 2023
Epilepsy, Aneurysm, Federal Food, Drug, and Cosmetic Act, Emergency, Workflow, Neoplasm, Stroke, Brain, Assistant, Hubli, Hydrocephalus, Neurosurgery, Parkinson's disease, Patient, Physician, Traumatic brain injury, FDA, Subdural hematoma, SMART, Safety, Medical device, Medical imaging, Northwestern

A burr hole procedure is the prerequisite brain surgery for any time a physician needs to access the brain.

Key Points: 
  • A burr hole procedure is the prerequisite brain surgery for any time a physician needs to access the brain.
  • This is done for patients with traumatic brain injury, hydrocephalus, ruptured aneurysm, stroke, subdural hematoma, epilepsy, Parkinson's, and brain cancer and tumors.
  • The Hubly Drill aims to mitigate the challenges of bedside cranial access by being the first and only cordless single-use cranial drill with advanced features for safety and efficiency in any setting.
  • Grage added, "We believe the facilities that add the Hubly Drill into their workflow will recognize significant value by reducing operating room dependence and increasing access at the bedside, thus lowering hospital costs."

Applied BioCode Announces Distribution Agreement with Medline Industries

Retrieved on: 
Monday, May 8, 2023
Infectious Diseases, Biotechnology, Hospitals, Health, EUA, Hair, Bachelor, BMB, Allergy, RPP, Medline Industries, SARS-CoV-2, COVID-19, Infection, CE marking, Applied Food Technologies, MEDLINE, Nomenclature codes, Lower respiratory tract infection, Immunochemistry, Emergency Use Authorization, Federal Food, Drug, and Cosmetic Act, Hospital, RSV, Analyte-specific reagent, Laboratory, Autoimmune disease, Molecular Probes, LDT, IVD, Diagnosis, GPP, FDA, Virus, Pharmaceutical industry, Vaccine

Applied BioCode today announced an agreement with Medline Industries, a leading manufacturer and distributor of healthcare products, to distribute the MDx-3000 System and its comprehensive menu.

Key Points: 
  • Applied BioCode today announced an agreement with Medline Industries, a leading manufacturer and distributor of healthcare products, to distribute the MDx-3000 System and its comprehensive menu.
  • Under the terms of the distribution agreement, Medline will offer the MDx-3000 System to clinical laboratory customers across the U.S.
    “Applied BioCode is thrilled to partner with Medline Industries, and we look forward to continuing our expansion into hospitals and reference laboratories in the U.S.,” said Chris Bernard, CEO of Applied BioCode.
  • For more information on the Applied BioCode’s platform and products, visit: https://apbiocode.com/products.htm
    Applied BioCode is an IVD manufacturer that designs, develops, and commercializes multiplex testing products.
  • Applied BioCode, Inc. has also been granted an Emergency Use Authorization (EUA) from the U.S. FDA for its BioCode® SARS-CoV-2 Flu Plus Assay ⱡ, BioCode® SARS-CoV-2 Assay*, and an additional EUA for Pooled COVID-19 Testing*.

HAPPE Spine Announces FDA Clearance for the INTEGRATE-C™ Interbody Fusion System

Retrieved on: 
Monday, May 8, 2023
Spine, Federal Food, Drug, and Cosmetic Act, Orthopedic surgery, Anatomy, Porosity, ACDF, PEEK, FDA, Environment, Ceramic, MD

GRAND RAPIDS, Mich., May 8, 2023 /PRNewswire/ -- HAPPE Spine , a medical device company focused on bringing innovative materials to orthopaedic implants, announces that the company's INTEGRATE-C™ Interbody Fusion System has received 510k clearance from the FDA.

Key Points: 
  • GRAND RAPIDS, Mich., May 8, 2023 /PRNewswire/ -- HAPPE Spine , a medical device company focused on bringing innovative materials to orthopaedic implants, announces that the company's INTEGRATE-C™ Interbody Fusion System has received 510k clearance from the FDA.
  • HAPPE Spine's INTEGRATE-C Interbody Fusion System has received 510k clearance from the FDA.
  • Powered by the HAPPE® platform, INTEGRATE-C™ is the first interbody fusion cage that is fully integrated with porosity and hydroxyapatite to provide a superior healing environment.
  • We have achieved our goal of developing an ACDF that is distinguished from all other existing devices used for interbody fusion.

CJ Biomaterials' Amorphous Polyhydroxyalkanoate (PHA) Added to FDA's Inventory of Food Contact Substances

Retrieved on: 
Wednesday, May 3, 2023
Home composting, Food, Federal Food, Drug, and Cosmetic Act, FCN, Accor, Organization, NatureWorks, PHA, Agency, Compost, CJ CheilJedang, TUV, FDA, Environment, FCS, Biopolymer, Safety, Thermoplastic, Medical device

FDA listing clears the way for CJ Biomaterials' amorphous PHA to be used in the manufacture of food contact materials sold in the US

Key Points: 
  • Woburn, Massachusetts--(Newsfile Corp. - May 3, 2023) - Amorphous polyhydroxyalkanoate (PHA) produced by CJ Biomaterials, Inc., a division of South Korea-based CJ CheilJedang, is now included in the U.S. Food and Drug Administration Inventory of Effective Food Contact Substances (FCS).
  • Assigned Food Contact Notification (FCN) 2281, CJ Biomaterials' amorphous PHA, branded PHACT™ A1000P, can now be used to make packaging materials sold in the United States that come into contact with food, including rigid and flexible packaging, serviceware and other products.
  • CJ Biomaterials introduced its amorphous PHA in early 2022, and the biopolymer is already being used to develop various end products, including cosmetic containers .
  • "The inclusion of our amorphous PHA in the FDA Inventory of Effective Food Contact Substances marks a major milestone for CJ Biomaterials, and it underscores our commitment to providing innovative, sustainable solutions that benefit both our customers and the environment.

Clinical Study Shows 92% of Patients Report Resolution of Migraine Headaches Using Vivos’ POD® Appliance Treatment

Retrieved on: 
Monday, May 1, 2023
MIDAS, Temporomandibular joint dysfunction, Federal Food, Drug, and Cosmetic Act, Migraine, Headache, TMD, Depression, Neck pain, Ear, Dentist, Anxiety, Sleep, Bruxism, Jaw, Pain, Dizziness, Patient, FDA, Therapy, Pharmaceutical industry, Dentistry, Vivos

The study demonstrated statistically significant results, with ninety-two percent (92%) of study patients reporting their migraine symptoms were completely resolved following completion of treatment.

Key Points: 
  • The study demonstrated statistically significant results, with ninety-two percent (92%) of study patients reporting their migraine symptoms were completely resolved following completion of treatment.
  • Prior to treatment patients had an average MIDAS score of 23.96 +/- 21.34 and following treatment had a MIDAS score of 2.58 +/- 4.87, a reduction of 89.2%.
  • Migraine headaches affect over 39 million people in the United States alone according to the American Migraine Foundation.
  • Dentists who are using this technology report migraine resolution in about 9 out of 10 migraine sufferers.

RadNet’s Quantib B.V. Subsidiary Receives FDA Clearance for its Quantib Prostate™ 3.0 Software

Retrieved on: 
Monday, May 1, 2023
Federal Food, Drug, and Cosmetic Act, Communication, Workflow, Prostate, Movement, Radiology, MRI, Urology, Physician, Diagnosis, FDA, PSA, Prostate cancer, Software, Medical device, AI

Quantib Prostate™ software for MRI reading support was first introduced in the US, followed by a class IIb CE marking in Europe in 2021.

Key Points: 
  • Quantib Prostate™ software for MRI reading support was first introduced in the US, followed by a class IIb CE marking in Europe in 2021.
  • Quantib Prostate™ 3.0 is a state-of-the-art AI-based software solution that advances the MRI prostate reporting workflow and its output for radiologists and urologists.
  • The FDA 510k special clearance introduces a major upgrade to the latest Quantib Prostate 2.1 release.
  • We strive to regularly and continuously improve our software in order to support radiologists and urologists in the best possible way,” said Arthur Post Uiterweer, CEO of Quantib.

Biosynex Completes Acquisition of Chembio Diagnostics, Inc.

Retrieved on: 
Thursday, April 27, 2023
Transfer, LLP, Federal Food, Drug, and Cosmetic Act, White & Case, Infection, EPA, CLIA, PMA, Acquisition, R, WHO, FDA, Cryptocurrency

STRASBOURG, France, April 27, 2023 (GLOBE NEWSWIRE) -- Biosynex SA (“Biosynex”) (EPA: ALBIO), a French market leader specializing in the design and distribution of rapid tests, today announced it has completed its acquisition of Chembio Diagnostics, Inc. (“Chembio”), a leading point-of-care diagnostics company focused on infectious diseases. Chembio is now part of Biosynex Group. The complementary nature of the technologies and product portfolio as well as the combination of market opportunities will be important growth drivers for the combined company. In addition, significant operational synergies are anticipated in procurement, R&D logistics and production.

Key Points: 
  • STRASBOURG, France, April 27, 2023 (GLOBE NEWSWIRE) -- Biosynex SA (“Biosynex”) (EPA: ALBIO), a French market leader specializing in the design and distribution of rapid tests, today announced it has completed its acquisition of Chembio Diagnostics, Inc. (“Chembio”), a leading point-of-care diagnostics company focused on infectious diseases.
  • "The success of the Chembio acquisition marks a major step in the history of Biosynex," remarked Larry Abensur, CEO of Biosynex.
  • Following the acceptance of the tendered shares, Purchaser completed the acquisition of Chembio on April 27, 2023 through the merger of Purchaser with and into Chembio in accordance with Nevada Revised Statute 92A.133 without a vote of Chembio stockholders.
  • White & Case LLP served as legal counsel to Biosynex and K&L Gates LLP served as legal counsel to Chembio.

Challenging the FDA's authority isn't new – the agency's history shows what's at stake when drug regulation is in limbo

Retrieved on: 
Wednesday, April 26, 2023
Vaccine, Taste, Reproductive rights, HIV, Zolpidem, Marketing, Misoprostol, Public, Thalidomide, National Institute of Allergy and Infectious Diseases, COVID-19, Cancer, Abortion, National Institute, Pure Food and Drug Act, Diphtheria, Goal, Matthew J. Kacsmaryk, Medicine, Tobacco, Infection, Life expectancy, Terminal, Sale, Science, Congress, Prednisone, Appeal, United States courts of appeals, Man, General practice, Emergency Use Authorization, AIDS, Federal Food, Drug, and Cosmetic Act, Mifepristone, Patient, Blood, Supreme court, Tetanus, Law of the United Kingdom, Ethics, Program, Federation, Pregnancy, Birth, Health, FDA, Biologics Control Act, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Food, Safety, Disease, Pharmaceutical industry

The agency has frequently come under fire for its drug approval decisions, but attacks on its decision-making process and science itself have increased during the COVID-19 pandemic.

Key Points: 
  • The agency has frequently come under fire for its drug approval decisions, but attacks on its decision-making process and science itself have increased during the COVID-19 pandemic.
  • Recent challenges to the FDA’s authority have emerged in the context of reproductive rights.
  • I am a legal scholar whose research focuses in part on the law and ethics of the FDA’s drug approval process.
  • Examining the FDA’s history reveals the unprecedented nature of the current challenges to the agency’s authority.

Events shaping FDA’s focus on safety

    • In its early years, the FDA focused primarily on balancing the competing goals of consumer safety with access to experimental treatments.
    • For instance, at the turn of the 20th century, Congress passed the Biologics Control Act of 1902, providing the federal government the authority to regulate vaccines.
    • This act marked the beginning of modern drug regulations and the birth of the FDA as a regulatory agency.

FDA’s turn toward expanding access

    • During the 1970s, questions about the limits of safety versus an individual’s right to access arose when cancer patients who wanted access to an unapproved drug derived from apricots, Laetrile, sued the FDA.
    • The 1980s, however, marks the FDA’s shift toward increasing access following reports of an emerging disease – AIDS – which primarily affected gay men.
    • After massive protests, Dr. Anthony Fauci, then director of the National Institute of Allergy and Infectious Diseases, proposed a parallel track program allowing eligible patients access to unapproved experimental treatments.

Future of the FDA

    • While the FDA approves drugs for consumer use, it does not regulate the general practice of medicine.
    • Doctors can prescribe FDA-approved drugs off-label, meaning they could prescribe a drug with a different dose, in a different way or for a different use than what the FDA has approved it for.
    • The mifepristone case has broad implications for the FDA’s future and could have devastating effects on health in the U.S. Due in part to FDA involvement, public health interventions have led to a 62% increase in life expectancy in the 20th century.