PERTH, Australia – Mesoblast Ltd. inked an exclusive global licensing deal with Novartis AG for the development, manufacture and commercialization of Mesoblast’s mesenchymal stromal cell product remestemcel-L, with an initial focus on the acute respiratory distress syndrome, including that associated with COVID-19, just six weeks after the FDA issued a complete response letter for the therapy as a treatment for steroid-refractory acute graft-versus-host disease.
HONG KONG – Haihe Pharmaceutical Co. Ltd. has outsourced the China rights to its non-opioid analgesics candidates, RMX-1001 and RMX-1002, to 3D Biomedicine Science & Technology Co. Ltd. in the latest collaboration between the two companies. “Haihe has now out-licensed our non-oncology assets and can now focus on our oncology therapeutics,” Ruiping Dong, CEO at Haihe, told BioWorld.
PERTH, Australia – Clinuvel Pharmaceuticals Ltd. announced two new pharmaceutical indications for its lead product, Scenesse (afamelanotide). “The company has until now focused on one drug and has slowly gathered evidence and is now in a position to add other products to its pipeline,” Clinuvel CEO Philippe Wolgen told BioWorld.
PERTH, Australia – With the approval of cystic fibrosis treatment Bronchitol (mannitol), Sydney-based Pharmaxis Ltd. joins a small group of elite Australian biotech companies to take their drugs all the way to FDA approval.
The large-scale failure of a handful of drugs repurposed for COVID-19 hasn’t slowed efforts to find existing – and new – therapies as well as vaccines that can fight the pandemic, with research updates continuing to roll out.
PERTH, Australia – During the COVID-19 pandemic, 90% of Australia’s clinical trials were put on hold, and the market cap of biotech and medical device companies on the Australian Securities Exchange dropped 5% to AU$11 billion (US$7.78 billion), according to a recent report by Australia’s Medical Technologies and Pharmaceuticals Industry Growth Centre.
LONDON – Clinical care guidelines recommending the use of the HIV/AIDS combination lopinavir-ritonavir for the treatment of patients hospitalized with COVID-19 must now be updated, say the authors of a paper reporting the full results of a randomized U.K. study.
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 – 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).
The aging portfolios of drug companies and the emergence of China as it moves to develop more innovative therapies are two signposts from an industry in flux, according to the newly released 2020 Centre for Medicines Research (CMR) International Pharmaceutical R&D Factbook.