Therapeutic Goods Administration

No, taking drugs like Ozempic isn’t ‘cheating’ at weight loss or the ‘easy way out’

Retrieved on: 
Wednesday, April 10, 2024
Eating, Reward, Diarrhea, Cardiovascular disease, Obesity, Exercise, Therapeutic Goods Administration, Cell, Hunger, Energy, Half-life, Indigestion, Abdominal pain, Gardening, Insulin, Risk, Diabetes, Weight loss, Stroke, Constipation, Research, Food, Meal, Pharmaceutical Benefits Scheme, Diet, Nausea, Gallbladder disease, Dance, Kidney failure, Hypoglycemia, TGA, BMI, Vomiting, Acute pancreatitis, STEP, Pharmaceutical industry

Hundreds of thousands of people worldwide are taking drugs like Ozempic to lose weight.

Key Points: 
  • Hundreds of thousands of people worldwide are taking drugs like Ozempic to lose weight.
  • As demand for semaglutide increases, so are claims that taking it is “cheating” at weight loss or the “easy way out”.
  • We don’t tell people who need statin medication to treat high cholesterol or drugs to manage high blood pressure they’re cheating or taking the easy way out.

How does it work?

  • GLP-1 gets secreted by cells in your gut when it detects increased nutrient levels after eating.
  • GLP-1 receptor agonist (GLP-1RA) medications like Ozempic help the body’s own GLP-1 work better by mimicking and extending its action.
  • Read more:
    The rise of Ozempic: how surprise discoveries and lizard venom led to a new class of weight-loss drugs

What can users expect? What does the research say?

  • Higher doses of semaglutide are prescribed to treat obesity compared to type 2 diabetes management (up to 2.4mg versus 2.0mg weekly).
  • A large group of randomised controlled trials, called STEP trials, all tested weekly 2.4mg semaglutide injections versus different interventions or placebo drugs.
  • Trials lasting 1.3–2 years consistently found weekly 2.4 mg semaglutide injections led to 6–12% greater weight loss compared to placebo or alternative interventions.
  • Weight reduction due to semaglutide also leads to a reduction in systolic and diastolic blood pressure of about 4.8 mmHg and 2.5 mmHg respectively, a reduction in triglyceride levels (a type of blood fat) and improved physical function.
  • Another recent trial in adults with pre-existing heart disease and obesity, but without type 2 diabetes, found adults receiving weekly 2.4mg semaglutide injections had a 20% lower risk of specific cardiovascular events, including having a non-fatal heart attack, a stroke or dying from cardiovascular disease, after three years follow-up.

Who is eligible for semaglutide?

  • Australia’s regulator, the Therapeutic Goods Administration (TGA), has approved semaglutide, sold as Ozempic, for treating type 2 diabetes.
  • The TGA has approved Wegovy to treat obesity but it’s not currently available in Australia.

What else do you need to do during Ozempic treatment?

  • In addition to taking medication, people had brief lifestyle counselling sessions with dietitians or other health professionals every four weeks as a minimum in most trials.
  • The aim of these trials was to show the effect of adding the medication on top of other lifestyle counselling.


A review of obesity medication trials found people reported they needed less cognitive behaviour training to help them stick with the reduced energy intake. This is one aspect where drug treatment may make adherence a little easier. Not feeling as hungry and having environmental food cues “switched off” may mean less support is required for goal-setting, self-monitoring food intake and avoiding things that trigger eating.

But what are the side effects?

  • In on study these led to discontinuation of medication in 6% of people, but interestingly also in 3% of people taking placebos.
  • More severe side-effects included gallbladder disease, acute pancreatitis, hypoglycaemia, acute kidney disease and injection site reactions.
  • Here are some potential risks and benefits

    To reduce risk or severity of side-effects, medication doses are increased very slowly over months.

  • Health, Meat and Livestock Australia, and Greater Charitable Foundation.
  • She has consulted to SHINE Australia, Novo Nordisk, Quality Bakers, the Sax Institute, Dietitians Australia and the ABC.

Essex Bio-Technology Posts Sound 2023 Annual Financial Results, Revenue Up 29.5%, Profit Up 22.1%

Retrieved on: 
Monday, March 18, 2024
Cloud, Research, SKQ1, Quality control, Weather, NMPA, Therapeutic Goods Administration, Environment, Best, Intelligence, Patent, Patient, Conditional sentence, Ophthalmology, Hospital, POCT, Acquisition, CMC, European Medicines Agency, GMP, City, QMS, Bevacizumab, Chemistry, Yoy, US FDA, Traction, Good, Therapy, Point-of-care testing, VISTA, Pharmaceutical industry

The Group weathered the headwinds and managed to deliver sound performances amidst the challenging trading environment in 2023.

Key Points: 
  • The Group weathered the headwinds and managed to deliver sound performances amidst the challenging trading environment in 2023.
  • As of 31 December 2023, the Group had cash and cash equivalents of approximately HK$509.8 million (2022: approximately HK$543.5 million).
  • Together with the interim dividend of HK$0.045 per ordinary share paid on 13 September 2023, the total dividend for 2023 would be HK$0.09 (2022: HK$0.065) per ordinary share.
  • The Group's turnover is primarily made up of the ophthalmology segment ("Ophthalmology") and surgical (wound care and healing) segment ("Surgical").

HYTN Welcomes Health Canada for Audit to Enhance GMP Capabilities

Retrieved on: 
Tuesday, April 9, 2024
Certification, Therapeutic Goods Administration, DEL, Sale, Psilocybin, IND, GMP, Cannabis, Investigational New Drug, Drug development, TGA, FDA, PIC/S, Pharmaceutical industry

VANCOUVER, British Columbia, April 09, 2024 (GLOBE NEWSWIRE) -- HYTN Innovations Inc. (CSE: HYTN, “HYTN” or “The Company”), a leader in the development, formulation, and manufacturing of products containing psychoactive and psychotropic compounds, including cannabis, welcomed Health Canada’s conduct of a Drug Establishment License (DEL) audit.

Key Points: 
  • VANCOUVER, British Columbia, April 09, 2024 (GLOBE NEWSWIRE) -- HYTN Innovations Inc. (CSE: HYTN, “HYTN” or “The Company”), a leader in the development, formulation, and manufacturing of products containing psychoactive and psychotropic compounds, including cannabis, welcomed Health Canada’s conduct of a Drug Establishment License (DEL) audit.
  • The audit, which aims to expand the Company's Good Manufacturing Practices (GMP) capabilities, follows the recent achievement of GMP certification for HYTN's Kelowna production facility by Australia's Therapeutic Goods Administration (TGA) under the Pharmaceutical Inspection Co-operation Scheme (PIC/S) standard.
  • Securing a DEL will enhance HYTN's current GMP manufacturing capabilities, facilitating the development and sale of additional compounds and product variations.
  • HYTN has demonstrated its ability to manufacture these products according to GMP guidelines.

Venus Concept Announces Australian Regulatory Approval for Venus Versa Pro

Retrieved on: 
Wednesday, April 3, 2024
Venus, Therapeutic Goods Administration, Communication, IPL, Intense, Annual report, TGA

TORONTO, April 03, 2024 (GLOBE NEWSWIRE) -- Venus Concept Inc. (“Venus Concept” or the “Company”) (NASDAQ: VERO), a global medical aesthetic technology leader, today announced that it has Therapeutic Goods Administration (TGA) clearance in Australia to market the Venus Versa Pro system.

Key Points: 
  • TORONTO, April 03, 2024 (GLOBE NEWSWIRE) -- Venus Concept Inc. (“Venus Concept” or the “Company”) (NASDAQ: VERO), a global medical aesthetic technology leader, today announced that it has Therapeutic Goods Administration (TGA) clearance in Australia to market the Venus Versa Pro system.
  • The Venus Versa Pro combines the applicator of the Venus Viva MD with the Venus Versa system which are both approved in Australia and registered in Australian Register of Therapeutic Goods (ARTG).
  • The Venus Versa Pro offers a total skin rejuvenation experience by offering three powerful technologies: Intense Pulsed Light (IPL) with SmartPulse™, NanoFractional Radio Frequency with SmartScan™, and Venus' proprietary (MP)2 technology.
  • “We look forward to bringing our Venus Versa Pro system to Australia, a major market to which we continue to commit investment with a growing direct office presence,” said Dr. Hemanth Varghese, President and Chief Operating Officer of Venus Concept.

HYTN Provides Corporate Update, Outlines New Global Direction

Retrieved on: 
Wednesday, April 3, 2024
Certification, Good manufacturing practice, Therapeutic Goods Administration, The Company, DAB, European Pharmacopoeia, Quality management system, GMP, Cannabis, TGA, PIC/S, Drug

HYTN is announcing two strategic commercial initiatives underscoring the company’s commitment to leading the GMP-certified cannabis products industry.

Key Points: 
  • HYTN is announcing two strategic commercial initiatives underscoring the company’s commitment to leading the GMP-certified cannabis products industry.
  • HYTN expects to commercialize both business to business and wholesale opportunities under this initiative.
  • Additionally, HYTN aims to unlock global markets for established cannabis brands by leveraging the company's regulatory compliance, supply chain capabilities and Quality Management System.
  • The authorization to process cannabis flower into pharmaceutical-grade products for export provides a significant advantage in a market actively seeking GMP-certified cannabis."

Junshi Biosciences Announces 2023 Full Year Financial Results and Provides Corporate Updates

Retrieved on: 
Friday, March 29, 2024
CPS, Patient, Lung cancer, IND, Infection, Cancer, Investment, Cisplatin, Paclitaxel, Melanoma, Marketing, RNA, New chemical entity, Gentlemen's agreement, NRDL, Food, Therapeutic Goods Administration, Biologics license application, Insurance, Research, Junshi, National Medical Products Administration, TGA, FDA, NMPA, Tablet, COVID-19, NPC, Spacecraft, DSM-IV codes, Dacarbazine, Axitinib, Total, Pharmaceutical industry

SHANGHAI, China, March 29, 2024 (GLOBE NEWSWIRE) -- Shanghai Junshi Biosciences Co., Ltd (“Junshi Biosciences,” HKEX: 1877; SSE: 688180), a leading innovation-driven biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies, announced its financial results for the full year of 2023 and provided corporate updates.

Key Points: 
  • SHANGHAI, China, March 29, 2024 (GLOBE NEWSWIRE) -- Shanghai Junshi Biosciences Co., Ltd (“Junshi Biosciences,” HKEX: 1877; SSE: 688180), a leading innovation-driven biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies, announced its financial results for the full year of 2023 and provided corporate updates.
  • Total research and development (“R&D”) expenses were approximately RMB1,937 million in 2023, representing a decrease of approximately 19% compared to 2022.
  • Loss attributable to owners was RMB2,282 million in 2023, representing a decrease of RMB104 million compared to the previous year.
  • This application was later approved for marketing in December 2023, marking the first and only approved perioperative therapy for lung cancer domestically.

HYTN Secures GMP Certification

Retrieved on: 
Thursday, March 21, 2024
Certification, Growth, Therapeutic Goods Administration, Good manufacturing practice, Psilocybin, GMP, Cannabis, TGA, Drug

VANCOUVER, British Columbia, March 21, 2024 (GLOBE NEWSWIRE) -- HYTN Innovations Inc. (CSE: HYTN "HYTN or The Company"), a Canadian company at the forefront of developing, formulating, and manufacturing products with psychoactive and psychotropic compounds, including those from cannabis and psilocybin, has been awarded Good Manufacturing Practice (GMP) certification by Australia's Therapeutic Goods Administration (TGA) for its Kelowna production facility.

Key Points: 
  • VANCOUVER, British Columbia, March 21, 2024 (GLOBE NEWSWIRE) -- HYTN Innovations Inc. (CSE: HYTN "HYTN or The Company"), a Canadian company at the forefront of developing, formulating, and manufacturing products with psychoactive and psychotropic compounds, including those from cannabis and psilocybin, has been awarded Good Manufacturing Practice (GMP) certification by Australia's Therapeutic Goods Administration (TGA) for its Kelowna production facility.
  • Effective March 15th, 2024, this certification enables HYTN to manufacture cannabis dried flower into bulk and finished GMP medical products.
  • Although the company has previously serviced limited export opportunities, compliance with the PIC/S Guide to Good Manufacturing Practice for Medicinal Products through this new GMP certification now enables HYTN to engage in broader international trade.
  • It also coincides with the emergence of a brand new and sizable market in Germany, also requiring GMP certification for medicinal cannabis products.

iECURE Announces FDA Clearance of Investigational New Drug Application for ECUR-506 to Initiate OTC-HOPE Trial for Treatment of Neonatal Onset Ornithine Transcarbamylase Deficiency in the U.S.

Retrieved on: 
Thursday, April 4, 2024
FDA, Health, Genetics, Clinical Trials, Pharmaceutical, Biotechnology, Gene editing, Therapeutic Goods Administration, University, Patient, Gene, MD, Quality of life, IND, GTP, Liver, MHRA, OTC, Pediatrics, Safety, Pharmacokinetics, TGA, Food, Medication, Pharmaceutical industry

ECUR-506 will be evaluated in the OTC-HOPE study in newborn males with genetically confirmed neonatal onset OTC deficiency.

Key Points: 
  • ECUR-506 will be evaluated in the OTC-HOPE study in newborn males with genetically confirmed neonatal onset OTC deficiency.
  • The OTC-HOPE study was previously cleared to begin in the United Kingdom by the Medicines & Healthcare Products Regulatory Agency (MHRA) and Australia by the Therapeutic Goods Administration (TGA).
  • “There is a significant need for clinical research and treatment options for newborns with severe, neonatal onset OTC deficiency,” said Gabriel M. Cohn, MD, Chief Medical Officer of iECURE.
  • “We hope that treatment with this investigational therapeutic will show promise for clinically meaningful improvements for infants with neonatal onset OTC deficiency and their families.”

HYTN Clears PIC/S GMP Audit, Primed for Global Expansion

Retrieved on: 
Monday, March 4, 2024
TGA, Growth, PIC/S, GMP, Psilocybin, Therapeutic Goods Administration, Certification, THC, Cannabis, Drink, Partnership

The positive outcome of the audit has set the stage for the subsequent issuance of formal GMP certification allowing the company to access international medical markets.

Key Points: 
  • The positive outcome of the audit has set the stage for the subsequent issuance of formal GMP certification allowing the company to access international medical markets.
  • The GMP audit conducted by the TGA was performed in accordance with the standards of the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme ("PIC/S").
  • Once issued, GMP certification under the PIC/S framework allows HYTN to engage with international medical markets that recognize the PIC/S standard, through established reciprocal agreements.
  • This step also allows us to elevate our existing systems, bringing our current and future product offerings into compliance with GMP standards.”

Vantage Hemp Co. Achieves GMP Certification from Australia's Therapeutic Goods Administration

Retrieved on: 
Thursday, February 29, 2024
Standard, TGA, Calibration, GMP, Documentation, Quality control, Therapeutic Goods Administration, Certification, CBD, TGO, Vantage, Good manufacturing practice, Quality assurance

Greeley, Colorado, Feb. 29, 2024 (GLOBE NEWSWIRE) -- Vantage Hemp Co. (“Vantage” or “the Company”), a globally accredited plant-based extractor and finished product manufacturer, is proud to announce that it has successfully obtained Good Manufacturing Practice (GMP) certification from Australia's Therapeutic Goods Administration (TGA).

Key Points: 
  • Greeley, Colorado, Feb. 29, 2024 (GLOBE NEWSWIRE) -- Vantage Hemp Co. (“Vantage” or “the Company”), a globally accredited plant-based extractor and finished product manufacturer, is proud to announce that it has successfully obtained Good Manufacturing Practice (GMP) certification from Australia's Therapeutic Goods Administration (TGA).
  • Vantage is establishing a leadership position in key international markets by obtaining formal approval for importation through its demonstration of manufacturing excellence.
  • This milestone not only marks Vantage’s adherence to long-standing GMP pharmaceutical manufacturing standards but also industry-specific regulations including Therapeutic Goods (Standard for Medicinal Cannabis) (TGO 93) Order 2017 (TGO 93).
  • The final evaluation concluded that Vantage operates in accordance with the relevant GMP requirements.