Roche Holding will begin marketing FoundationOne Liquid, a blood test from Foundation Medicine that can analyze the presence of 70 common gene mutations in a patient's blood sample from circulating tumor DNA that comes from solid tumors. The new assay also has features that can pinpoint which patients have a higher chance of benefiting from cancer immunotherapy.
MicuRx Pharmaceuticals' MRX-I, or contezolid, and MRX-4, or contezolid acefosamil, being developed to treat patients with acute bacterial skin and skin structure infections, was granted fast-track and qualified infectious disease product designations by the FDA.
A clinical trial has been launched by the NIH that will evaluate a regimen consisting of two HIV-specific antibodies to be given through periodic infusions in 30 people who started taking antiretroviral therapy during the early stage of their HIV infection and 15 patients with slowly advancing HIV infections who are not undergoing ART.
Avita Medical's Recell autologous cell harvesting device has secured FDA approval to be used for treatment of severe thermal burns in individuals age 18 and older. The system uses the patient's own skin to make spray-on skin cells within 30 minutes.
University of North Carolina at Chapel Hill researchers are assessing immunotherapy as a way to stamp out HIV reservoirs in the body, according to a study in Molecular Therapy. The investigators are looking into a technique that involves collecting T cells from HIV patients, growing them, combining the cells with drugs to make hidden HIV reservoirs more visible and infusing the cells into patients so they can locate and wipe out the reservoirs.
Enrollment is set to begin in the fourth quarter for the US trial of the transfemoral mitral valve replacement system developed by Cardiovalve. The company has also begun recruitment for its EU study and plans to seek clearance for the device in the US and EU.
The FDA issued a warning letter to Dolezal Dairy after finding incomplete records, excessive antibiotic levels and conditions that could allow illegal cows to enter the human food supply. Also warned was Thailand-based seafood processor Natural Sea Product because of failure to fix previous violations, including lack of a safety plan on dried fish products and failure to control refrigerated storage.
The European Medicines Agency's Committee for Medicinal Products for Human Use has recommended approval of Bayer's Jivi, or damoctocog alfa pegol, as a treatment for the rare genetic disorder hemophilia A. Jivi has been shown to prevent and control bleeding when used as needed and during surgical procedures.
Seattle Genetics' Adcetris, or brentuximab vedotin, in combination with dacarbazine, doxorubicin and vinblastine, has received approval from the Japanese Ministry of Health, Labor and Welfare as a first-line treatment for patients diagnosed with CD30-positive Hodgkin lymphoma. Co-developer Takeda Pharmaceutical will now make a $10 million milestone payment to Seattle Genetics.
Liam Condon, Bayer's crop division president, says that over-regulating gene editing could slow down innovation. "This actually helps big companies who can afford to spend money on [research and development], but it prolongs in any case registration, making everything much more expensive," Condon says, adding that such regulation will make small and midsize companies unable to afford the research and development costs of such products.
- Page 1