Abraxis Bioscience on Health Canada Inspection List
The US Food and Drug Administration (FDA) blasted Abraxis Biosciences in a recent warning letter for not addressing recurring media fill failures in its aseptic processing operations of the sterile drug Abraxane and for failing to conduct robust follow-up investigations to determine the root cause of these multiple failures.
Abraxis Bioscience LLC Receives FDA Warning Letter
Sun Pharma Advanced Research Company (SPARC) on August 20 notified exchanges that a plea has been filed against it by US-based Abraxis Biosciences LLC.
Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the Phase III IMpower131 study met its co-primary endpoint of progression-free survival (PFS) and demonstrated that the combination of TECENTRIQ® (atezolizumab) plus chemotherapy (carboplatin and ABRAXANE® [albumin-bound paclitaxel; nab-paclitaxel]) reduced the risk of disease worsening or death (progression-free survival; PFS) compared with chemotherapy alone in the initial (first-line) treatment of people with advanced squamous non-small cell lung cancer (NSCLC).
In a setback to US-based Abraxis Bioscience, the country’s patent office has refused to grant a patent to the company’s invention related to a combination of Taxane – a type of cancer drug that blocks cell growth by stopping cell division in the body – with an additional chemotherapeutic agent.
The U.S. Food and Drug Administration today ordered Custom Ultrasonics to recall all of its automated endoscope reprocessors (AERs) from health care facilities due to the firm’s continued violations of federal law and a consent decree entered with the company in 2007. The identified violations could result in an increased risk of infection transmission. The FDA ordered this recall under the terms of the consent decree. The agency also issued a safety communication today recommending that health care facilities currently using Custom Ultrasonics AERs transition away from their use to alternative methods to reprocess flexible endoscopes as soon as possible.