China's Pharmaceutical Association Committee proposed guidelines intended to improve the country's clinical research system, including the implementation of a top-down design at the national level. The proposal recommended that the China FDA, the Human Genetic Resource Administration and institutional review boards review clinical study applications in parallel to improve efficiency.
UCB and Amgen's Evenity, or romosozumab, was accepted for review by the European Medicines Agency as a bone-boosting drug for postmenopausal women and men who have increased fracture risk. The application was supported by data from three late-stage studies.
NeuClone, an Australian biotech, said it is developing a biosimilar of denosumab, or Amgen's Prolia and Xgeva, intended to treat bone loss from osteoporosis or medical treatments. NeuClone is also developing biosimilars to trastuzumab, ustekinumab, adalimumab and palivizumab.
The Taiwan Food and Drug Administration granted Varian Medical Systems approval for its Halcyon image-guided volumetric intensity-modulated radiotherapy cancer treatment system. The system is intended for use in the treatment of various forms of cancer, including head and neck, breast, and prostate.
A memorandum of understanding on a strategic collaboration in China was signed by Varian Medical Systems with Ping An Health Technology, a health care equipment and financing company. The companies will study the use of cloud computing, artificial intelligence and big data technologies for cancer care in the country, as well as develop technology to make treatment methods more effective.
An early-stage clinical trial discussed in the journal Lancet Infectious Diseases found that human antibodies generated in genetically engineered cows were safe, and scientists say they show promise for treatment of Middle Eastern respiratory syndrome. The approach could dramatically reduce the time needed to create antibody treatments, as the process using human donors is slow and often small-scale, said John Beigel, who co-authored the study.
The US FDA granted Israel-based Trendlines Medical portfolio company STS Medical 510(k) clearance for its composite removable sinus stent, which is designed to prevent complications after functional endoscopic sinus surgery by maintaining the sinus cavity in an open position for up to 28 days. The stent, removed via a minimally invasive procedure in the physician's office without the need for anesthesia, lowers the likelihood of revision surgeries, improving surgery outcomes.
Teva Pharmaceutical Industries granted Alder BioPharmaceuticals rights to its migraine prevention candidate eptinezumab, which is the subject of a second late-stage trial. Under the terms of the agreement, Teva will get $25 million upfront, and is eligible for regulatory milestone and royalty payments.
Several multimillion dollar biopharmaceutical industry deals are already in the works this year, but FasterCures Senior Fellow Bernard Munos warns that large financing rounds sometimes end up discouraging innovation.
A Transparency Market Research report predicts the worldwide market for spine surgery products will hit $16.7 billion by 2025 with a 5.8% compound annual growth rate, driven by more spine surgeries using bone morphogenetic proteins, bone grafts and electrical stimulation devices. Among the key market players are Zimmer Biomet, Stryker, Medtronic, DePuy Synthes, K2M and RTI Surgical.
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