PERTH, Australia – Regenerative medicine company Mesoblast Ltd. saw its stock drop 37% on the news that it received an FDA complete response letter to its BLA for Ryoncil (remestemcel-L) for the treatment of pediatric steroid-refractory acute graft-vs.-host disease.

PERTH, Australia – Brandon Capital announced the launch of Ena Respiratory Pty Ltd., which has developed a nasal treatment to boost the natural immune system to fight common colds and flu and has proved successful in reducing COVID-19 viral replication.

PERTH, Australia – Sydney-based Recce Pharmaceuticals Ltd. completed a placement of AU$27.95 million (US$19.69 million) to advance its synthetic anti-infective pipeline.

PERTH, Australia – Melbourne-based Telix Pharmaceuticals Ltd. has submitted its first new drug application to the FDA for TLX591-CDx, a radiopharmaceutical targeting prostate-specific membrane antigen (PSMA) for imaging prostate cancer using positron emission tomography (PET).

PERTH, Australia – Australian public health laboratories are collaborating to sequence the virus genomes of all positive COVID-19 tests in Australia to track the virus using genomics across the country. The Communicable Disease Genomics Network (CDGN) and Illumina Inc. will track COVID-19 by using next-generation genomic sequencing technology.

PERTH, Australia – With the launch of its lead product, Scenesse (afamelanotide), in the U.S. and Europe, Melbourne-based Clinuvel Pharmaceuticals Ltd. is expanding its global footprint and widening its pipeline as it opens a new R&D center in Singapore and builds up its franchise in photo medicine.

PERTH, Australia – Australia’s biopharma sector fared better than the country at large at the end of the financial year that ended June 30, as the country saw GDP fall 7% in the final quarter, the largest drop since 1959. Australia’s trading relationship with China helped the country sidestep the global financial recession of 2008, but the recent divide between the U.S. and China is also putting a wedge between Australia and China relations.

DUBLIN – Spybiotech Ltd. has secured a first vaccine deal for its proprietary Spytag/Spycatcher protein conjugation technology. The Serum Institute of India Pvt. Co. Ltd. (SIIPL) is employing the technology in a COVID-19 virus-like-particle (VLP)-based vaccine, which recently entered a phase I/II trial in Australia. An initial data readout is expected in October or November.

PERTH, Australia – After its initial public offering on the Australian Securities Exchange, soft tissue regeneration company Aroa Biosurgery Ltd. has received new clearances in the U.S. and Europe and is focusing on building up its commercial and manufacturing capacity.

PERTH, Australia – As Victoria suffers through a second COVID-19 wave, bringing the death toll to 430 for Australia, Prime Minister Scott Morrison said that Australians could be among the first in the world to receive a COVID-19 vaccine through an agreement with Astrazeneca plc. Under the deal, every Australian would be able to receive AZD-1222, which is being developed with the University of Oxford.