PERTH, Australia – With FDA approval of its Guardian system to detect early heart attacks, Angel Medical Systems Inc. (Angelmed) will launch the device in the next six weeks in the U.S., and partner Hydrix Ltd. will launch the devices in eight Asia Pacific markets.
PERTH, Australia – Cyclopharm Ltd. said it received a complete response letter (CRL) from the FDA for its Technegas NDA for pulmonary embolisms. The CRL relates to better defining and validating production and delivery of the Technegas particle and other aspects of crucible manufacturing and dosimetry that need to be addressed before the NDA can be approved.
PERTH, Australia – Australia will be phasing out the Astrazeneca COVID-19 vaccine by October and will rely on Pfizer Inc./Biontech SE and Moderna Inc. vaccines to ramp up lagging vaccination rates.
PERTH, Australia – Startup Currus Biologics Pty Ltd. has launched with a AU$10 million (US$7.5 million) series A round with the mission of improving the success of CAR T-cell therapies against solid tumors such as breast, ovarian and pancreatic cancers.
PERTH, Australia – Cyclopharm Ltd. said it received a complete response letter (CRL) from the FDA for its Technegas NDA for pulmonary embolisms. The CRL relates to better defining and validating production and delivery of the Technegas particle and other aspects of crucible manufacturing and dosimetry that need to be addressed before the NDA can be approved.
PERTH, Australia – Researchers at RMIT University and St. Vincent's Hospital in Melbourne have flipped traditional 3D printing to create more intricate biomedical structures, advancing new technologies for regrowing bones and tissue. Instead of making the bioscaffolds directly, the team 3D printed molds with intricately patterned cavities and then filled them with biocompatible materials, before dissolving the molds away.
Boehringer Ingelheim GmbH has begun a three-year collaboration with researchers at Australia’s WEHI, looking into a potentially powerful approach to targeted protein degradation also being studied by its German rival Merck KGaA.
PERTH, Australia – Australia will be phasing out the Astrazeneca COVID-19 vaccine by October and will rely on Pfizer Inc./Biontech SE and Moderna Inc. vaccines to ramp up lagging vaccination rates.
PERTH, Australia – Starpharma Holdings Ltd. is pausing sales of its antiviral nasal spray, Viraleze (SPL-7013), in the U.K. after its retail partner, Lloydspharmacy, received a letter from the U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA) related to promotional claims made about the antiviral with respect to SARS-CoV-2 and COVID-19.
PERTH, Australia – Immutep Ltd. announced a AU$60 million (US$45.1 million) capital raise via two tranches to progress two clinical programs of its lead immunotherapy, eftilagimod alpha, to registration studies.
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