Japan’s Ministry of Health, Labor and Welfare has cleared Japan Tissue Engineering Co. Ltd.’s (J-Tec) autologous cultured cartilage, called Jacc, after a seven-year re-examination period. Headquartered in Gamagori, in Japan’s Aichi prefecture, J-Tec was the first company in Japan to receive conditional clearance of regenerative medicine therapies under the new regenerative medicine pathway.
Rapid point-of-care (POC) diagnostics company Lumos Diagnostics Holdings Pty. Ltd. saw its stock plummet 65% on the news that the U.S. FDA rejected its Febridx 510(k) because the device was not substantially equivalent to the predicate device.
Australia’s Therapeutic Goods Administration (TGA) should better align its definitions and classifications for gene, cell and tissue frameworks with international regulators, stakeholders said.
Researchers have discovered how the tau protein turns from a normal to a disease state in Alzheimer's disease (AD) and have shown how the discovery could potentially deliver a therapeutic target.
Sumitovant Biopharma Ltd. subsidiary Urovant Sciences GmbH is out-licensing overactive bladder (OAB) treatment vibegron to Pierre Fabre Médicament to register and commercialize the drug in the EU, U,K, and Switzerland. Under the terms of the deal, Basel, Switzerland-based Urovant will receive up to $75 million in up-front payments, regulatory and sales milestones and royalties, while Urovant will retain full commercialization rights to vibegron in the U.S. and certain other markets.
Clarity Pharmaceuticals Ltd. is progressing three of its targeted copper theranostics through the clinic that are based on its sarcophagine technology that securely holds copper isotopes inside a cage-like structure, called a chelator. The SAR technology allows a unique pairing of copper isotopes, copper-64 and copper-67, for both cancer diagnosis and therapy.
The U.S. FDA has given Resapp Health Ltd. the green light for its 510(k) Sleepcheckrx app to detect moderate to severe sleep apnea in adults as a prescription-only software-as-a-medical device. The FDA cleared the app as a class II medical device. Brisbane, Australia-based Resapp submitted the 510(k) premarket notification to the FDA in November 2021 for Sleepcheckrx for at-home sleep apnea screening.
Sumitovant Biopharma Ltd. subsidiary Urovant Sciences GmbH is out-licensing overactive bladder (OAB) treatment vibegron to Pierre Fabre Médicament to register and commercialize the drug in the EU, U,K, and Switzerland. Under the terms of the deal, Basel, Switzerland-based Urovant will receive up to $75 million in up-front payments, regulatory and sales milestones and royalties, while Urovant will retain full commercialization rights to vibegron in the U.S. and certain other markets.
Volpara Health Technologies Ltd. joined forces with Microsoft Corp. to accelerate the research and development of software that uses mammograms to identify potential cardiovascular issues.
Clarity Pharmaceuticals Ltd. is progressing three of its targeted copper theranostics through the clinic that are based on its sarcophagine technology that securely holds copper isotopes inside a cage-like structure, called a chelator. The SAR technology allows a unique pairing of copper isotopes, copper-64 and copper-67, for both cancer diagnosis and therapy.
