TGA

The macroeconomics of liquidity in financial intermediation

Retrieved on: 
tisdag, maj 28, 2024
NBT, Yahoo!, E41, Private, Treasury, Interest, Social science, BAA, VIX, GDP, DF, American Economic Journal, Working, NBER, Credit, Great Recession, Calibration, Samsung Galaxy Note 4, Quantitative, Bankruptcy, American Economic Review, Central bank, Paper, Half-life, Business, ZT, Appendix, De Young, Macroprudential regulation, Silicon, Federal Reserve Bank, ESCB, Journal, G21, RBC, United States Treasury security, Failure, TFP, Tax, Kuttner, University, BHT, Journal of Economic Perspectives, ROE, Floor, ICUS, Macroeconomics, Empiricism, Knowledge, Economy, Aggregate demand, Process control block, University of Bern, OLS, Risk, Monetary economics, Rochet, PCE, Research Papers in Economics, Real, EEA, Congress, Quarterly Journal, Depreciation, Mark Gertler, Welfare, ECB, Labour, Friction, Reproduction, CUSIP, Sale, Convention (norm), Complementarity, Capital, Liskov substitution principle, Financial intermediary, Financial Crisis Inquiry Commission, Timeline, Finance, COVID-19, Peter, Bank failure, Ahnert, Policy, DNT, Website, Political economy, Working paper, Cobb–Douglas production function, Intermediation, LH, Government, Van de Weyer, TED, The Journal of Finance, Fear, Probability, Addiction, Observation, Elasticity, Noise, National bank, QT, Leverage, E51, JEL, Household, Interval (mathematics), Journal of Economic Theory, Conference, Monetary policy, London School of Economics, Shock, Proposition 1, Linearity, RHS, Use, Durham University, Uncertainty, Journal of Political Economy, Funding, Intuition, Quarterly Journal of Economics, Note 2, Bank regulation, AB, FST, EDS, Carlsson, FDIC, Motion, PDF, Loanable funds, Holding, XT, G01, FRED, Creditor, Partial, European Economic Association, N,N-Dimethyltryptamine, CHT, TGA, MB, Nash, Macroeconomic model, JT, Federal, Movement, JB, Wealth, DTS, Face, Outline, Fragility, European Central Bank, HBT, Business cycle, Literature, QE, Xavier Vives, Research, GC, Samsung Galaxy Note 3, Federal Deposit Insurance Corporation, Data, Heart, Shin, Quantitative easing, Bianchi, Acquisition, Logic, Bank
Key Points: 

    Axonics Receives Regulatory Approval for Recharge-Free SNM System in Australia

    Retrieved on: 
    torsdag, maj 16, 2024
    Biotechnology, Pharmaceutical, Health, Medical Devices, Patient, TGA, News, SNM, Longevity, Therapeutic Goods Administration, Calvary North Adelaide Hospital, Overactive bladder, Female, Pharmaceutical industry

    Axonics, Inc. (Nasdaq: AXNX) today announced that it has received regulatory approval from the Therapeutic Goods Administration (TGA) for marketing the Axonics F15™ recharge-free sacral neuromodulation (SNM) system in Australia to treat adults with overactive bladder.

    Key Points: 
    • Axonics, Inc. (Nasdaq: AXNX) today announced that it has received regulatory approval from the Therapeutic Goods Administration (TGA) for marketing the Axonics F15™ recharge-free sacral neuromodulation (SNM) system in Australia to treat adults with overactive bladder.
    • “Approval of the Axonics recharge-free system is welcome news for Australians with bladder and bowel dysfunction,” said Dr. Ailsa Wilson Edwards, a urologist at Calvary North Adelaide Hospital.
    • In Australia, in addition to its SNM products, Axonics markets Bulkamid®, the company’s unique hydrogel indicated for female stress urinary incontinence.
    • “We are delighted to receive regulatory approval for our latest SNM system in Australia,” said Raymond W. Cohen, chief executive officer of Axonics.

    Avance Clinical Expands Further into APAC with New Clinical Operations in South Korea

    Retrieved on: 
    onsdag, maj 8, 2024
    FDA, Therapeutic Goods Administration, MFDS, EMA, Drug development, TGA, Pharmaceutical industry

    Avance Clinical CEO, Yvonne Lungershausen said the decision to open clinical operations in Seoul followed increasing demand from later phase US biotechs, as well as CRO partners for access to the region's scientific excellence and patient populations.

    Key Points: 
    • Avance Clinical CEO, Yvonne Lungershausen said the decision to open clinical operations in Seoul followed increasing demand from later phase US biotechs, as well as CRO partners for access to the region's scientific excellence and patient populations.
    • "The new South Korean operations also offer a strategic presence for Avance Clinical's CRO partners conducting multi-regional or global trials.
    • Avance Clinical is focussed on accelerating drug development for its biotech clients, from preclinical stages through to Phase III.
    • Book a meeting with the team at the Australian Pavilion at BIO Korea to meet with our team of clinical trial experts.

    Avance Clinical Showcases Clinical Excellence at World Orphan Drug Conference in Boston, April 23-25

    Retrieved on: 
    fredag, april 19, 2024
    FDA, Congress, Heart, Rett syndrome, Conference, Research, Duchenne muscular dystrophy, ChromeOS, Patient, EMA, Erythropoietic protoporphyria, Drug development, Fragile X syndrome, Clinical trial, TGA, Pharmaceutical industry

    Avance Clinical CEO, Yvonne Lungershausen said that Avance Clinical is dedicated to advancing research and ensuring faster access to therapies that can make a significant difference in patients' lives.

    Key Points: 
    • Avance Clinical CEO, Yvonne Lungershausen said that Avance Clinical is dedicated to advancing research and ensuring faster access to therapies that can make a significant difference in patients' lives.
    • "Avance Clinical is focussed on accelerating drug development for its biotech clients, from preclinical stages through to Phase III," she said.
    • Visit Booth #730 to discuss your upcoming clinical trial, and find out more about the Avance Clinical Advantage, supporting biotechs globally in their clinical development programs.
    • Visit Booth #730 to discuss your drug development program at the World Orphan Drug Congress in Boston, April 23- 25

    Avance Clinical at World Vaccine Congress to Share Latest Vaccine Clinical Trial News Including an HIV-1 Study

    Retrieved on: 
    torsdag, mars 28, 2024
    FDA, Congress, Psoriasis, News, Food, Infection, GMO, Cell, Vaccine, Knowledge, OMICS Publishing Group, Hypertension, EMA, Drug development, Clinical trial, OGTR, COVID-19, TGA, RSV, Pharmaceutical industry

    (Booth #267)

    Key Points: 
    • (Booth #267)
      Avance Clinical CEO, Yvonne Lungershausen said the World Vaccine Congress was an important event for the company's US and Australian teams as they continue to excel in biotech vaccine CRO services.
    • Lungershausen said Avance Clinical is a mid-sized, agile, and responsive CRO with a proven track record of swiftly advancing high-quality clinical programs.
    • She said Avance Clinical is proud to be working with many innovative vaccine biotech companies including Uvax Bio who have just announced another milestone in their Phase I HIV study.
    • Lungershausen said Avance Clinical is focussed on accelerating drug development for its biotech clients, from preclinical stages through to Phase III.

    Blue Mountain Achieves SOC 2 Compliance, Demonstrating Commitment to Data Security and Trustworthiness

    Retrieved on: 
    onsdag, april 10, 2024
    FDA, Certification, RAM, Service, EAM, Software, Software as a service, SOC 2, Privacy, SOC, Trust, MHRA, Confidentiality, GMP, TGA

    The SOC 2 Type 2 (Service Organization Control 2) compliance certification is recognized globally as a benchmark for demonstrating an organization's commitment to safeguarding sensitive information and ensuring the privacy and security of client data.

    Key Points: 
    • The SOC 2 Type 2 (Service Organization Control 2) compliance certification is recognized globally as a benchmark for demonstrating an organization's commitment to safeguarding sensitive information and ensuring the privacy and security of client data.
    • This accomplishment reaffirms Blue Mountain’s unwavering commitment to providing clients with a secure and reliable platform while adhering to industry best practices.
    • “Our team at Blue Mountain is proud to be recognized for SOC 2 certification.
    • Our SOC 2 achievement is another proof point to our ongoing commitment and leadership in the life sciences industry,” said David Rode, CEO, Blue Mountain.

    Tougher merger laws will boost competition and improve performance and productivity

    Retrieved on: 
    onsdag, april 10, 2024
    ACCC, Reserve Bank, Federation, Public policy, Policy, Leg, Competition, Competition Tribunal, GDP, TGA, Treasury, Government, Tobacco

    This is because a market economy, based on companies and individuals pursuing their own interests, only works if those companies and individuals face sufficient competition.

    Key Points: 
    • This is because a market economy, based on companies and individuals pursuing their own interests, only works if those companies and individuals face sufficient competition.
    • If Treasury and the Reserve Bank are now doing analysis, this indicates they clearly understand Australia’s competition problem.
    • The increased competition that will result will drive better performance and so productivity.

    What’s in the reforms?

    • And the ACCC should decide if a merger will substantially lessen competition.
    • These are economic judgements that are poorly suited to first instance decision making by a court.
    • Third, and also hugely important, the reforms mean a merger cannot proceed if it creates, strengthens or entrenches substantial market power.
    • They have wanted proof it will be used in ways that reflect inadequate competition, even though the merger has not happened yet.
    • It recognises that substantial market power should be prevented, and certainly not strengthened or entrenched.
    • The latest merger that triggered the investigation can be stopped, as presumably will be others that may have followed.

    What’s not yet in the reforms?

    • The treasurer has, however, indicated the thresholds will be set to capture the number of merger assessments the ACCC does now.
    • The ACCC’s approach to this was to be able to “call in” problematic mergers below the thresholds, but the treasurer has rejected this idea.
    • This suggests the thresholds should be set at a lower level than seems to be envisaged.
    • They reflect a healthy approach to increased competition in our economy which will benefit consumers, most businesses, and the wider economy.


    Professor Rod Sims is an expert adviser to the Commonwealth Treasury’s Competition Task Force. He was Chair of the ACCC from 2011-2022.

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

    Retrieved on: 
    onsdag, 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.

    IMM-1-104 is Synergistic with Chemotherapy in Pancreatic Cancer Models

    Retrieved on: 
    tisdag, april 9, 2024
    BID, Patient, Fluorouracil, 3D, MIA, Cancer, AACR, TGI, Pancreatic cancer, Paclitaxel, TGA, Annual general meeting, Medical imaging

    CAMBRIDGE, Mass., April 09, 2024 (GLOBE NEWSWIRE) -- Immuneering Corporation (Nasdaq: IMRX), a clinical-stage oncology company seeking to develop and commercialize universal-RAS/RAF medicines for broad populations of cancer patients, today presented preclinical data at the American Association for Cancer Research (AACR) Annual Meeting, which the company views as supportive of its ongoing Phase 2a clinical trial of IMM-1-104 in RAS-mutated advanced or metastatic solid tumors.

    Key Points: 
    • “We are evaluating a broad range of combinations for a variety of cancer types in our humanized 3D tumor growth assays, together with animal models.
    • The data we are sharing today at AACR clearly demonstrates IMM-1-104’s potential in combination with chemotherapy for pancreatic cancer.
    • IMM-1-104 showed promising combination effects when treated with gemcitabine (GEM), paclitaxel (PAC) or fluorouracil (5FU) in 3D-tumor growth assay (TGA) pancreatic cancer models.
    • IMM-1-104 was synergistic with chemotherapy in animal models of pancreatic cancer.

    HYTN Welcomes Health Canada for Audit to Enhance GMP Capabilities

    Retrieved on: 
    tisdag, 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.