The FDA granted approval to Teva Pharmaceutical's Trisenox, or arsenic trioxide, injection as a first-line treatment for patients with acute promyelocytic leukemia. The decision was backed by data from the company's global safety database for arsenic trioxide.
The opioid epidemic is one of the deadliest problems facing the US today. "A key solution to the current national crisis of opioid abuse is providing access to alternative pain management solutions for the people who need them," said Shaye Mandle, CEO of the Minnesota-based Medical Alley Association. "The medical device industry currently delivers many non-opioid alternatives and can play a leadership role in addressing this epidemic." For example, Myoscience uses cryoablation therapy to ablate signal-carrying members of nerves, stopping pain signals from traveling to the brain. Nevro, Stimwave and St. Jude Medical (now part of Abbott) are just a couple of companies that are currently marketing spinal cord stimulation or neurostimulation to treat acute and chronic pain. Read the story.
Investigators from St. Jude Children's Research Hospital created a new gene therapy designed to develop fully functioning immune systems for infants and young children diagnosed with severe combined immunodeficiency, or "bubble boy," disease. The therapy involves taking the patient's bone marrow and incubating it with a re-engineered virus that carries a normal copy of the gene to replace mutations, which resulted in patients building immune systems and developing antibodies for the first time four months after treatment.
Benitec's BB-301, which is being developed as a treatment for patients with oculopharyngeal muscular dystrophy, was given orphan drug status by the FDA. The company intends to file an investigational new drug application for the drug by the end of 2018.
Shire's Adynovi, or rurioctocog alfa pegol, was approved by the European Commission as an on-demand and prophylactic treatment for patients at least 12 years old who have hemophilia A. The drug was modified to last longer in the blood, requiring less frequent injections -- from daily to just twice weekly.
Norgine's bowel cleanser Plenvu gained marketing approval from regulatory authorities in Austria, Ireland, France, Italy and Portugal, and the company expects to launch the drug in those countries this year. The approval, which was supported by data from a late-stage trial, mean Plenvu is now approved in 10 European countries, plus Iceland and Australia.
Two-year outcome data from a trial presented at the North American Neuromodulation Society meeting showed that among 42 patients who used Abbott Laboratories' implantable spinal cord stimulators for chronic pain, the company's BurstDR stimulation waveform was preferred by 81%, compared with traditional stimulation that was preferred by 10%. A company spokeswoman said the results are "consistent with Abbott's vast breadth of clinical evidence and continues to yield strong results, especially in the real world."
A first-in-human study of RenalGuard Solutions' RenalGuard System, presented at the Device Therapies for Heart Failure Congress, showed the technology, intended for contrast-induced acute kidney injury prevention, can manage fluids in diuretic therapy in patients with heart failure. Meanwhile, another presentation showed the system did not demonstrate a fluid loss rate higher than the rate set by clinicians in the system.
A round of Series A funding raised approximately $27.5 million for vaccine company Vaccitech, which has six products under development. Studies include a Phase IIb trial of MVA-NP+M1 for influenza infection in adult patients at least 65 years old and a Phase I study of a prostate cancer drug.
- Page 1