Torrent Pharma sent a letter to the National Stock Exchange of India earlier this week with word that the manufacturer has received a “communication from the FDA determining the inspection classification as ‘Official Action Indicated’ (OAI)” for one of its sites. An OAI classification from the FDA comes after the agency has completed an inspection and determines if the facility complies with the applicable laws and regulations. Being given an OAI classification means that regulatory or administrative actions will be recommended to Torrent. However, the details on the recommended actions have not been given.
The Washington-based CDMO AGC Biologics has been tapped to manufacture the type 1 diabetes treatment Tzield from Provention Bio.
Magenta Therapeutics is pausing an early-stage clinical trial after a patient died. The death was deemed to be possibly related to its drug, MGTA-117.
The biotech said the pause of the Phase I/II trial is voluntary and gives it time to review all available data before deciding what to do next. It’s also reported the known information to the FDA.
The dose-escalation trial was designed to test whether MGTA-117, an antibody-drug conjugate, could serve as a more targeted alternative to high-intensity chemotherapy as a conditioning agent for cancer patients who are set to receive a stem cell transplant. It recruited patients with relapsed/refractory acute myeloid leukemia and myelodysplastic syndrome.
Merck is slamming the brakes on a late-stage Keytruda study in prostate cancer after an interim analysis showed no improvement in survival, the company announced on Wednesday. However, the pharma giant cushioned the blow with a positive look at a separate study in biliary tract cancer.
An independent data monitoring committee reviewing the Phase III KEYNOTE-991 trial saw no improvement in overall survival or radiographic progression-free survival in a Keytruda combination group compared to the control group, Merck said in a news release. The trial was conducted in more than 1,200 patients with metastatic hormone-sensitive prostate cancer (mHSPC), or those whose cancer is controlled by keeping testosterone levels as low as would be expected after castration.
XyloCor Therapeutics says patients with heart disease who got its gene therapy could exercise for longer and had fewer chest pain attacks. The biotech announced it completed a Phase I/II trial of the gene therapy Thursday morning, and plans to move forward with a pivotal trial.
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