Merck's Keytruda, or pembrolizumab, was approved by the FDA to treat patients with hepatocellular carcinoma following treatment with sorafenib. In a clinical trial, patients who received Keytruda achieved a partial response rate of 16% and a complete response rate of 1%.
The FDA has granted Cellectar Biosciences an exemption to the import alert placed on the Centre for Probe Development and Commercialization, which is the only supplier of the CLR 131 needed for Cellectar's hematology studies. Cellectar continues to work with the agency to seek an exemption for its pediatric program.
Izeen Pharma has received an FDA Form 483 for several issues, including problems with its validations and data handling. The FDA questioned the facility about the security and accuracy of its quality control lab's electronic data, the form notes.
The FDA has given priority review status to Roche Holding's Tecentriq in combination with chemotherapy Abraxane as an initial treatment for patients with metastatic triple-negative breast cancer whose tumor is PD-L1 positive. The agency is expected to make a decision by March 12.
The FDA has accepted AstraZeneca and Merck's application for Lynparza, or olaparib, under priority review. The drug is being developed as a maintenance therapy for patients with newly diagnosed BRCA mutation-positive advanced ovarian cancer who are in complete or partial response after first-line platinum-based chemotherapy.
The FDA has granted Halifax Biomedical clearance to market its radiostereometry upgrade, the first product to be launched under a joint development deal with GE Healthcare. The upgrade, which can be used to perform table and standing exams, allows for in vivo 3D measurements to be performed by GE's Discovery XR656/XR656 Plus X-ray imaging units.
A smart drainage device has been developed by a team of researchers at Purdue University to combat microorganism accumulation during and after insertion of surgical implants when treating patients with glaucoma. The device allows biomaterials that have accumulated in the implant to be cleared through the vibration of its built-in microactuators -- a process enabled when a magnet is waved in front of the patient's eye.
Ruck's Meat Processing has issued a recall for bologna and sausages after a routine inspection found the products could be contaminated with Listeria monocytogenes. The recalled products are sold under the Ruck's Meat Processing and Tollefson Family Pork brands.
UniQure announced that patient enrollment is underway for its global Phase III trial to evaluate its gene therapy candidate AMT-061 in men with severe or moderately severe hemophilia B. Three participants have already been dosed in a Phase IIb trial for the treatment.
Retrophin's marketing application for cystinuria drug candidate Thiola, or tiopronin, was accepted by the FDA for review, with an agency action date of June 30.
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