In a post-pandemic world, South Korean molecular diagnostics firm Seegene Inc. is looking to ignite a new paradigm in the diagnostics business. Seoul-based Seegene is rolling out a new strategy of open innovation under its newfound initiative coined the “SG Onesystem,” which pledges to not only accelerate global partnerships for novel diagnostics but also “free the world of all disease.”
Researchers at ETH Zurich have identified a proteomic signature that could recognize long COVID six months after acute infection. Biologically, the signature indicated that the complement system remained active in patients with long COVID six months after infection. Translationally, it could lead to a diagnostic test for long COVID, and suggests that targeting the complement system could be a therapeutic approach to prevent or treat the disorder.
Eisai Co. Ltd. and Oita University in Oita Prefecture, Japan, developed a first-of-its-kind machine learning model to predict amyloid beta accumulation in the brain using a wristband sensor. The model, which collects biological and lifestyle data from daily life, is expected to enable screening for brain amyloid beta accumulation to identify those at risk for Alzheimer's disease, particularly because amyloid beta begins to accumulate in the brain about 20 years before the onset of the disease.
After receiving a U.S. FDA complete response letter nearly two years ago, Cyclopharm Ltd. said the agency has accepted its response and reset the clock for the NDA review of its Technegas combination product for pulmonary embolisms, with a new PDUFA date set for Sept. 29.
The possibilities of cures for cancer and other tough-to-treat diseases and the ability to further personalize medicine are creating a lot of excitement about the future of radiopharmaceuticals as both therapy and diagnostics. To reach that future, industry and researchers will have to overcome a lot of challenges, not the least of which stem from the multiple government agencies involved in regulating the source material, development, distribution and use of radioactive drugs and devices.
Global interest in radiopharmaceuticals is growing, and some big deals in the space have sparked interest in the last few years. Novartis AG has spent about $6 billion in acquisitions and is seen as the global leader.
During the first round of discussion at its two-day hearing on a World Trade Organization proposal to expand the intellectual property (IP) waiver from COVID-19 vaccines to diagnostics and therapies, the U.S. International Trade Commission (USITC) got an earful from both sides of the debate.
Any decision on whether to expand a five-year World Trade Organization (WTO) waiver of intellectual property rights for COVID-19 vaccines to diagnostics and therapies likely will be delayed longer than proponents had hoped. WTO members originally were scheduled to vote on expanding the waiver in December, but the deadline was extended indefinitely when key members, including the U.S., pushed for a delay.
Global interest in radiopharmaceuticals is growing, and some big deals in the space have sparked interest in the last few years. Novartis AG has spent about $6 billion in acquisitions and is seen as the global leader.
Radiopharmaceutical company Telix Pharmaceuticals Ltd’s TLX250-CDx (Zirconium (89Zr) TX250) met both primary and secondary endpoints in the phase III Zircon study in clear cell renal cell carcinoma, according to top-line data.