MGC Pharma

MGC Pharma has received a US$1 million order for its ArtemiC Rescue nutraceutical product from US strategic partner AMC Holdings.

Production will begin immediately and delivered to AMC over the next three months.

The deal follows an amendment of a distribution agreement to include ArtemiC.

Roby Zomer
Roby Zomer: ‘a great step for MGC’

MGC managing director and chief executive Roby Zomer said: “The inclusion of ArtemiC in the AMC Supply and Distribution agreement recognises the progress that MGC Pharma has made in the development of this product.

“The receipt of AMC’s initial US$1m order is a great step for the company as it further expands its reach into the global market for a product which has demonstrated great potential from clinical trial data to date.”

MGC said a 2020 phase II clinical of ArtemiC Rescue demonstrated a range of benefits for patients suffering from moderate COVID-19.   

The company also released the results of a trial which showed its CannEpil drug is safe for “post-treatment driving activities”.  

Emyria

Emyria has received human research ethics committee approval (HREC) for a multi-site phase 3 clinical trial as it continues to pursue registration for a schedule 3 over-the-counter product.

The double-blind, randomised, placebo-controlled study will target the symptoms of psychological distress in patients with a background of chronic pain.

The primary endpoint are changes in validated psychological distress symptom scores with the secondary endpoints measuring sleep, pain and other quality of life scores.

A total of 300 participants aged 18 to 70 will receive either 50mg of Emyria’s EMD-RX5 capsule, 150mg or a placebo. It will be administered over one month.

Participants will be recruited through Emyria’s Emerald Clinic network.       

Emyria managing director Dr Michael Winlo said: “The commencement of our pivotal phase 3 trial is a significant milestone for Emyria and for the many patients managing symptoms of psychological distress but without a registered over-the-counter treatment option.

“We believe a successfully registered OTC medicine in this category represents a large opportunity for Emyria to address a major unmet health need.

“We look forward to further evaluating EMD-RX5 for other indications and registration opportunities while we continue to expand our ultra-pure cannabinoid product portfolio, advance our MDMA-inspired drug discovery program and pursue commercialism.”      

Incannex

Incannex Healthcare has appointed former Pfizer executive Robert B Clarke to its board in a move it said will bring “invaluable” knowledge to the company.

Clarke has almost 40 years’ experience of US and global regulatory structures, and is currently vice president of US regulatory affairs for Danish pharmaceutical firm Novo Nordisk.

“Bob is amongst the best credentialed regulatory affairs experts in the world and we’re delighted that he has joined our board of directors because it is a strong vote of confidence in our drug candidates and development strategy,” Incannex managing director and chief executive Joel Latham said.

“He brings dep knowledge of the US regulatory environment and decades of experience at the highest level of large pharmaceutical organisations. His experience will be invaluable to us now our interactions with the FDA have become more frequent whilst we pursue our mission to bring cannabinoid and psychedelic pharmacological solutions to patients with unmet medical needs.”   

IvyMed Clinic

A new cannabis clinic has opened in Adelaide.

IvyMed Clinic, in Pasadena, is run by Dr Hsin-Pei Lin and Dr Sheng-Wen Cheng.       

    

Steve has reported for a number of consumer and B2B titles over a journalism career spanning more than three decades. He is a regulator contributor to health journal, The Medical Republic, writing on...

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