TGA

IPAX-1 Late Breaking Oral Presentation at the Congress of Neurological Surgeons (CNS) Meeting

Tuesday, October 19, 2021 - 11:12pm

The data confirms the study has met its primary objective, demonstrating safety and tolerability of TLX101 at doses tested.

Key Points: 
  • The data confirms the study has met its primary objective, demonstrating safety and tolerability of TLX101 at doses tested.
  • The results also show overall survival (OS) of 15.97 months, to date, in the second line (recurrent) GBM setting.
  • The primary objective of the study was to evaluate the safety and tolerability of intravenous 131I-IPA administered concurrently with second line XRT in patients with recurrent GBM.
  • All patients evaluated received similar total activity dose of ~2GBq (2000 MBq) of TLX101, either in a single administration or a triple-fractionated regime.

First Cyclotron Removed from Seneffe Production Facility by SCK CEN

Monday, October 18, 2021 - 6:21am

The cyclotron weighing approximately 22 tonnes was successfully removed by SCK CEN, a leader in nuclear safety and facility decommissioning.

Key Points: 
  • The cyclotron weighing approximately 22 tonnes was successfully removed by SCK CEN, a leader in nuclear safety and facility decommissioning.
  • Once the second cyclotron has been removed later this year, Telix will be able to formally commence the build-out of a new state-of-the-art facility for medical radioisotope production and drug product manufacturing.
  • The sooner Telix can start production, the sooner these important products can reach cancer patients," stated Michel Estas, decommissioning expert at SCK CEN.
  • Sbastien Linard de Guertechin, General Manager of the Seneffe Facility stated, Telix is delighted to be working with SCK CEN for the decommissioning.

Sonoma Pharmaceuticals and MicroSafe Group Announce that Nanocyn® Disinfectant & Sanitizer Has Been Approved by the Australia TGA with a 15 Second SARS-CoV-2 (COVID-19) Kill Time

Friday, October 15, 2021 - 12:00pm

It is also the only TGA registered hospital grade disinfectant of its kind to be certified by Good Environmental Choice Australia (GECA).

Key Points: 
  • It is also the only TGA registered hospital grade disinfectant of its kind to be certified by Good Environmental Choice Australia (GECA).
  • We are continuously seeking to add to our network of international distributors to increase the reach of Sonoma products worldwide.
  • The MicroSafe Group has operations in several international countries with its head office in Dubai, United Arab Emirates.
  • Sonoma Pharmaceuticals and Microcyn are trademarks or registered trademarks of Sonoma Pharmaceuticals, Inc. All other trademarks and service marks are the property of their respective owners.

Topelia Australia launches US$25M Series A call for COVID-19 ATT Ziverdox

Thursday, October 14, 2021 - 6:45am

- Based on current research, the ATT provides an inexpensive and medically efficacious treatment for the prevention and early treatment of COVID-19.

Key Points: 
  • - Based on current research, the ATT provides an inexpensive and medically efficacious treatment for the prevention and early treatment of COVID-19.
  • The company said: "Topelia proposes to offer the ATT treatment alongside the current vaccination program to treat and vaccinate our way out of this pandemic.
  • The novel Antiviral Triple Therapy, to be branded as Ziverdox, comprises TGA-approved medications prescribed for decades with exceptional safety profiles.
  • Topelia Australia was founded based on the wealth of experience in commercialising the ground-breaking triple therapy cure for peptic ulcers which has saved over 18 thousand lives in Australia alone.

Pearl to Introduce Groundbreaking AI to Australian and New Zealand Dentistry

Wednesday, October 13, 2021 - 11:00pm

Pearl , the leader in AI solutions for efficiency, accuracy, and consistency in dental care, today announced that it has received authorization to introduce its Second Opinion AI solution to the Australian and New Zealand dental markets.

Key Points: 
  • Pearl , the leader in AI solutions for efficiency, accuracy, and consistency in dental care, today announced that it has received authorization to introduce its Second Opinion AI solution to the Australian and New Zealand dental markets.
  • View the full release here: https://www.businesswire.com/news/home/20211013006161/en/
    Pearl today announced that it has received authorization to introduce its Second Opinion AI solution to the Australian and New Zealand dental markets.
  • Pearl a driving force behind AIs emergence in the dental category developed Second Opinion to aid dentists in their evaluation of patient x-rays.
  • Pearl is shaping the future of dental care by delivering AI and computer vision solutions that advance efficiency, accuracy, transparency and patient care.

BioCina expands into full-service CDMO with full control of Pfizer manufacturing facility in Adelaide, Australia

Tuesday, October 5, 2021 - 3:24pm

Added capabilities for BioCina now include manufacturing of cGMP-grade plasmid DNA, which is produced using microbial fermentation.

Key Points: 
  • Added capabilities for BioCina now include manufacturing of cGMP-grade plasmid DNA, which is produced using microbial fermentation.
  • "Our vision is to be a trusted CDMO partner to the biopharma industry that helps save the lives of patients worldwide.
  • The BioCina Adelaide facility, formerly the Pfizer/Hospira plant, has a physical footprint of almost 60,000 ft2 for GMP manufacturing, process development, warehouse and administration.
  • Unique to Australia, the BioCina Adelaide site is currently the only TGA, EMA, Health Canada and US-FDA approved commercial facility of its kind in Australia.

First Patient Dosed in Phase II Study of TLX250-CDx in Triple-Negative Breast Cancer

Monday, October 4, 2021 - 10:34pm

TNBC has a poorer prognosis than other breast cancer subtypes and is characterised by its aggressive behaviour and distinct patterns of metastasis.

Key Points: 
  • TNBC has a poorer prognosis than other breast cancer subtypes and is characterised by its aggressive behaviour and distinct patterns of metastasis.
  • Telixs core CA9 program is focused on ccRCC, the most common form of kidney cancer, and is the subject of the ZIRCON Phase III (imaging) and STARLITE Phase II (therapy) studies.
  • Telix Chief Medical Officer, Dr. Colin Hayward stated, Telix is very pleased to see a first patient dosed in this important study of TLX250-CDx in TNBC, an aggressive breast cancer subtype that is poorly served by current tracers.
  • Principal Investigator for the OPALESCENCE study, Dr. Caroline Rousseau stated, Theranostic approaches to diagnosis and treatment are transforming prostate cancer.

Microbix Makes Early Repayment of 9% Interest Debenture

Monday, October 4, 2021 - 12:00pm

MISSISSAUGA, Ontario, Oct. 04, 2021 (GLOBE NEWSWIRE) -- Microbix Biosystems Inc. (TSX: MBX, OTCQX: MBXBF, Microbix), a life sciences innovator and exporter, announces that it has completed the early repayment of a debenture series on which it owed C$ 1.3 million and was paying an interest rate of 9.0%.

Key Points: 
  • MISSISSAUGA, Ontario, Oct. 04, 2021 (GLOBE NEWSWIRE) -- Microbix Biosystems Inc. (TSX: MBX, OTCQX: MBXBF, Microbix), a life sciences innovator and exporter, announces that it has completed the early repayment of a debenture series on which it owed C$ 1.3 million and was paying an interest rate of 9.0%.
  • The repayment was made on the basis of a debenture provision permitting early repayment given at least 90 days notice.
  • It therefore made little sense to keep this 9% debenture outstanding until its scheduled maturity date of January 31, 2029.
  • This one-time and non-cash charge is created due to this early and complete repayment expunging capitalized costs associated with the terms of issuance of the debenture that were being expensed over the full term of the debenture.

Telix Establishes Commercial Hub in Geneva, Switzerland

Monday, October 4, 2021 - 8:17am

MELBOURNE, Australia and GENEVA, Switzerland, Oct. 04, 2021 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today announces that it has established a new commercial hub in Geneva through its subsidiary, Telix Pharmaceuticals (Switzerland) GmbH.

Key Points: 
  • MELBOURNE, Australia and GENEVA, Switzerland, Oct. 04, 2021 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today announces that it has established a new commercial hub in Geneva through its subsidiary, Telix Pharmaceuticals (Switzerland) GmbH.
  • The Companys Geneva office will become a key locale for Telixs commercial activities in the EMEA operating region, as well as being the legal entity responsible for commercialisation of Telixs products in Switzerland.
  • Telix Group CEO Dr. Christian Behrenbruch added, We see a highly motivated and accessible commercial talent pool in Switzerland, including deep radiopharmaceutical expertise.
  • Telix is headquartered in Melbourne, Australia with international operations in Belgium, Switzerland, Japan, and the United States.

New treatment for severe corneal inflammation from DED now listed on PBS

Thursday, September 30, 2021 - 8:00pm

(8,9)

Key Points: 
  • (8,9)
    MELBOURNE, Oct 1, 2021 - (ACN Newswire) - Today, adults living with severe corneal inflammation from DED (dry eye disease) gain access to a new treatment on the PBS.
  • Ikervis(R), Australia's first PBS listed disease-modifying ciclosporin eye drop treatment for severe keratitis in adults with DED, is now available (October 1, 2021).
  • "Artificial tears aim to provide symptom relief for DED, but don't address the underlying cause of severe corneal inflammation.
  • Executive Chair of The B Team Australasia, Lynette has spent the past 16 years living with severe corneal inflammation from DED.