Regulation of therapeutic goods

Vantage Hemp Co. Concludes Audit with Australia’s Therapeutic Goods Administration

Retrieved on: 
Thursday, September 21, 2023
GMP, Regulation of therapeutic goods, Good manufacturing practice, Vantage, Therapeutic Goods Administration, ICH, Government, PIC/S, Documentation, Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme, WHO, TGA, FDA, Cannabidiol, Medical device, Audit, CBD

Greeley, Colorado, Sept. 21, 2023 (GLOBE NEWSWIRE) -- Vantage Hemp Co. (“Vantage” or the “Company”) announces the completion of a rigorous four-day audit conducted by Australia's Therapeutic Goods Administration (TGA), the country’s government authority responsible for evaluating, assessing, and monitoring products that are defined as therapeutic goods.

Key Points: 
  • Greeley, Colorado, Sept. 21, 2023 (GLOBE NEWSWIRE) -- Vantage Hemp Co. (“Vantage” or the “Company”) announces the completion of a rigorous four-day audit conducted by Australia's Therapeutic Goods Administration (TGA), the country’s government authority responsible for evaluating, assessing, and monitoring products that are defined as therapeutic goods.
  • The audit, which took place from August 22-25, 2023, was a comprehensive assessment of Vantage’s operations, focusing on compliance with the Pharmaceutical Inspection Co-operation Scheme (PIC/S) and the Therapeutic Goods Order No.
  • The process leading up to the audit spanned several months and included steps such as applying for exporter status, submitting documentation, and gaining approval for inspection.
  • The TGA auditor conducted a thorough examination of the Company's facilities, processes, and quality management systems.

Recce Pharmaceuticals Completes Stage 1 Data Analysis of Phase I/II Clinical Trial for the Treatment of Burn Wound Infections

Retrieved on: 
Wednesday, August 23, 2023
Regulation of therapeutic goods, Infection, Antimalarial medication, Clinical trial, Foot, ASX, FSE, COVID, Burn, 2018 Vuelta a España, Stage 1 to Stage 11, Erythema, Patient, Swelling, Observation, Genetically modified bacteria, Burns, TGA, Safety, RCE, Pharmaceutical industry

“We thank the West Australian Government for sponsoring this investigator-led topical burn wound infection trial,” said James Graham, Chief Executive Officer of Recce Pharmaceuticals.

Key Points: 
  • “We thank the West Australian Government for sponsoring this investigator-led topical burn wound infection trial,” said James Graham, Chief Executive Officer of Recce Pharmaceuticals.
  • “The patient data received has paved the way to advance this new class of anti-infective as a topical application against deadly bacterial pathogens and a broad range of infectious diseases.
  • Endpoints of the trial include clinical wound assessment, graded for specific parameters such as erythema, hyper granulation, swelling, and discharge, and microbial cultures of wound swabs.
  • Stage 2 of the clinical trial is expected to be a randomized ‘head-to-head’ study in patients with infected burn wounds, where R327G will be compared to the current standard of care.

Recce Pharmaceuticals Achieves Positive Phase I Clinical Trial Data of RECCE® 327 as an Intravenous Infusion Formulation

Retrieved on: 
Thursday, July 20, 2023
Volunteering, Male, Regulation of therapeutic goods, Urinary tract infection, UTI, Respiratory rate, Infection, Kidney failure, Pharmacokinetics, ECG, PEG, Therapeutic Goods Administration, ASX, Escherichia coli, FSE, Toxicity, ATCC, Kidney, Gram-negative bacteria, Female, Sepsis, Șaeș, Thermoregulation, Death, Vital signs, MD, Patient, Bacteria, Heart rate, Health, Plasma (physics), Monitoring, Safety, RCE, Medical imaging, Pharmaceutical industry, Dietary supplement, Medical device, Phosphorus, Urine, Plasma

SYDNEY Australia, July 20, 2023 (GLOBE NEWSWIRE) -- Recce Pharmaceuticals Ltd (ASX: RCE, FSE: R9Q) (the Company), the Company developing a new class of synthetic anti-infectives, today announced positive results from a Phase I (R327-001) study of RECCE® 327 (R327) as an intravenous (IV) infusion formulation in 80 healthy male subjects.

Key Points: 
  • We look forward to building off these results by initiating a Phase II study in patients with early-stage sepsis.
  • A total of 80 subjects were randomized in eight single-dose cohorts, and 60 subjects received R327, with 20 receiving placebo.
  • Enrolled subjects completed dosing per the protocol and completed the trial without dosing interruptions.
  • The Company is currently conducting a Phase I/II UTI clinical trial evaluating R327 IV at faster infusion rates – recently announcing its first cohort dosed, including its first female subject.

Patient Demand for Medicinal Cannabis in Australia Continues to Grow

Retrieved on: 
Thursday, December 1, 2022
SAS, Authorization, Prescription, Chronic pain, Patient, Movement, Anxiety, Regulation of therapeutic goods, Capsule, Sleep, CBD, TGA, Federation, Oil, Nasal spray, Health insurance, Pharmaceutical industry

In 2018, the TGA (Therapeutic Goods Administration) changed the system medical practitioners had to follow to apply for medicinal cannabis products.

Key Points: 
  • In 2018, the TGA (Therapeutic Goods Administration) changed the system medical practitioners had to follow to apply for medicinal cannabis products.
  • Levin Health says this highlights a major uplift in clinicians that want to make medicinal cannabis a regular treatment option.
  • With more than 200 different medicinal cannabis products available, patients can choose between oils, capsules, nasal sprays and oral sprays.
  • The average individual spend now sits at $278 a month for cannabis Melbourne and Australia wide, with the average price per mg of cannabinoid continuing to drop.

Immuron Executes Travelan Clinical Trial Agreement with US-based Pharmaron

Retrieved on: 
Tuesday, October 4, 2022
Enterotoxigenic Escherichia coli, Securities Exchange Act of 1934, Bloating, NASDAQ, Degenerative disease, AUST, SEC, Research, Regulation, Securities Act of 1933, Meal, Patent, Diarrhea, ASX, IMC, Fever, Pathology, Medicine, Infection, Regulation of therapeutic goods, NPN, Forward-looking statement, Risk, ETEC, Cholera, Vaccine

MELBOURNE, Australia, Oct. 04, 2022 (GLOBE NEWSWIRE) -- Immuron Limited (ASX: IMC; NASDAQ: IMRN), an Australian based and globally integrated biopharmaceutical company that has developed two commercially available oral immunotherapeutic products for the treatment of gut mediated diseases, is pleased to announce that it has executed a Master Service Agreement with US-based Pharmaron CPC, Inc. a Maryland Corporation located in Baltimore USA.

Key Points: 
  • Travelan is a highly purified tabletized preparation of hyper immune bovine antibodies and other factors, which when taken with meals bind to diarrhea-causing bacteria and prevent colonization and the pathology associated with travelers diarrhea.
  • In Australia, Travelan is a listed medicine on the Australian Register for Therapeutic Goods (AUST L 106709) and is indicated to reduce the risk of Travelers Diarrhea, reduce the risk of minor gastro-intestinal disorders and is antimicrobial.
  • In Canada, Travelan is a licensed natural health product (NPN 80046016) and is indicated to reduce the risk of Travelers Diarrhea.
  • In the U.S., Travelan is sold as a dietary supplement for digestive tract protection.

Little Green Pharma to Webcast Live at VirtualInvestorConferences.com June 7th

Retrieved on: 
Tuesday, June 7, 2022
LGP, VIC, Entrepreneurship, GLOBE, Regulation of therapeutic goods, Company, Education, ASX, Research, GMP, Security (finance), Generic drug, Pharmaceutical industry, EU

If attendees are not able to join the event live on the day of the conference, an archived webcast will also be made available after the event.

Key Points: 
  • If attendees are not able to join the event live on the day of the conference, an archived webcast will also be made available after the event.
  • Little Green Pharma is a global, vertically integrated and geographically diverse medicinal cannabis business with operations from cultivation and production through to manufacturing and distribution.
  • Little Green Pharma products comply with all required Danish Medicines Agency and Therapeutic Goods Administration regulations and testing requirements.
  • With a growing range of products containing differing ratios of active ingredients, Little Green Pharma supplies medical-grade cannabis products to Australian, European and overseas markets.

Sonoma Pharmaceuticals and MicroSafe Group DMCC Announce EPA Approval for Nanocyn® Hospital-Grade Disinfectant in the U.S.

Retrieved on: 
Tuesday, May 3, 2022
General Health, Other Health, Health, Pharmaceutical, Medical Supplies, COVID-19, Staphylococcus, U.S. Securities and Exchange Commission, Pseudomonas aeruginosa, EPA, Scar, Private Securities Litigation Reform Act, Pain, Category, Hypochlorous acid, Nasdaq, Toxicity, COO, Eye, Fungus, School, Patient, Infection, Security (finance), Virus, Partnership, Forward-looking statement, Patent, Norovirus, Hospital, Staphylococcus aureus, Skin, Severe acute respiratory syndrome coronavirus 2, Marketing, Medication, View, CEO, Spore, Bacteria, Research, Regulation of therapeutic goods, CFR, Cell, Risk, Itch, Pharmaceutical industry

Nanocyn hospital-grade disinfectant is currently sold by MicroSafe Group in Europe, the Middle East/West Africa and Australia.

Key Points: 
  • Nanocyn hospital-grade disinfectant is currently sold by MicroSafe Group in Europe, the Middle East/West Africa and Australia.
  • The EPA approval process was a coordinated effort by Sonoma and MicroSafe Group.
  • MicroSafe Group managed and financed the regulatory process with the EPA in exchange for non-exclusive rights to distribute Nanocyn in the United States.
  • The MicroSafe Group is very pleased with the EPA approval of Nanocyn hospital-grade disinfectant, known as MicroSafe disinfectant in Europe, the Middle East/West Africa and Australia.

Immuron Travelan® Global sales up 216%

Retrieved on: 
Wednesday, April 27, 2022
Regulation of therapeutic goods, Travel, Medicine, Food and Drug Administration, COVID-19, NASDAQ, ASX, YTD, AUST, Diarrhea, GLOBE, Yoy, Growth, Infection, Technology, American, IMC, Immuron, Amazon, FDA, NPN, Risk, Time, Department store, Dietary supplement

MELBOURNE, Australia, April 27, 2022 (GLOBE NEWSWIRE) -- Immuron Limited (ASX: IMC; NASDQ: IMRN), an Australian biopharmaceutical company focused on developing and commercializing oral immunotherapeutics for the treatment of gut mediated diseases, today announced the sales results of its commercially available and over-the-counter gastrointestinal and digestive health immune supplement Travelan® for the third quarter of the fiscal year 2022, ending on March 31, 2022.

Key Points: 
  • YTD March 31, FY22 worldwide Travelan sales reached AU $392K, increasing 340% YoY.
  • North American Travelan sales were up by 185% and worldwide gross sales grew by 216% YoY in the third quarter of FY22, reaching AU $193K compared to AU $61K in Q3 FY21.
  • YTD March 31 FY22 worldwide Travelan sales reached AU $392K marking a healthy 340% increase on the same time last year.
  • In Australia, Travelan sales increased to AU $24K in Q3 FY22, representing an increase over Q3 FY21 (AU $2K).

The Australian Natural Therapeutics Group Signs a US$7.8M Product Agreement With Clever Leaves to Accelerate Medical Cannabis Access in Australia

Retrieved on: 
Monday, February 28, 2022
GLOBE, Therapeutic Goods Administration, Depression, GMP, BOCA, PTSD, Pain management, Good, Regulation of therapeutic goods, CBD, Diversified Specialty Institute Holdings, Inc., Twitter, Growth, Inflammation, Dementia, API, NASDAQ, Sleep apnea, Industry, Heart, LinkedIn, THC, Good agricultural practice, Nature, Anxiety, Cancer, GACP, Patient, Collecting practices of the Al-Thani Family, CEO, Research, Seizure, Leaf, Drug, Pharmaceutical industry, Facebook

This marks the largest supply agreement Clever Leaves has signed with an Australian cannabis company, assisting the companys growth as an emerging global leader in medical cannabis supply.

Key Points: 
  • This marks the largest supply agreement Clever Leaves has signed with an Australian cannabis company, assisting the companys growth as an emerging global leader in medical cannabis supply.
  • The Australian medical cannabis market is rapidly expanding and is expected to grow to US $1.2 billion by 2027, the 5th largest in the world.
  • Australia is a rapidly expanding market, and increasing product shipments to the country allows Clever Leaves to accelerate market growth further, said Andrs Fajardo, President and incoming CEO of Clever Leaves.
  • Both Clever Leaves and ANTG are devoting considerable efforts to ensure all clinically approved Australians can access high-quality, certified and affordable medicinal cannabis products.

US DoD Naval Medical Research Center Clinical Update

Retrieved on: 
Wednesday, November 10, 2021
Securities Exchange Act of 1934, ETEC, Medicine, Infection, NASDAQ, Meal, Enterotoxigenic Escherichia coli, Technology, Bloating, Regulation of therapeutic goods, Degenerative disease, Diarrhea, Research, IMC, Securities Act of 1933, Forward-looking statement, Regulation, NPN, Limited, Immuron, SEC, Fever, Pathology, ASX, Patent, AUST, Risk, Food and Drug Administration, FDA, Cholera, Dietary supplement, Vaccine

MELBOURNE, Australia, Nov. 10, 2021 (GLOBE NEWSWIRE) -- Immuron Limited (ASX: IMC; NASDAQ: IMRN), an Australian biopharmaceutical company focused on developing and commercializing oral immunotherapeutic products for the prevention and treatment of gut pathogens, today is pleased to provide shareholders and the market with an update on the company’s clinical development portfolio.

Key Points: 
  • In Canada, Travelan is a licenced natural health product (NPN 80046016) and is indicated to reduce the risk of Travellers Diarrhea.
  • In the U.S., Travelan is sold as a dietary supplement for digestive tract protection in accordance with section 403 (r)(6) of the Federal Drug Administration (FDA).
  • In Canada, Travelan is a licensed natural health product (NPN 80046016) and is indicated to reduce the risk of Travelers Diarrhea.
  • Travelers diarrhea is a gastrointestinal infection with symptoms that include loose, watery (and occasionally bloody) stools, abdominal cramping, bloating and fever.