The pandemic-driven FDA guidance for device shortages addressed a topic that has been discussed for devices for some time despite lack of congressional action, but shortages may be ordinarily interpreted as a consequence of reduced or terminated production that crimps supplies. That interpretation has been expanded for the duration of the COVID-19 pandemic, however, to include circumstances in which demand exceeds supply even when the manufacturer sustains normal production levels, in which case the manufacturer is liable for reporting the shortage to the FDA.

Just days after Clovis Oncology Inc.'s Rubraca (rucaparib) became the first PARP inhibitor approved by the FDA to treat certain cases of metastatic prostate cancer (mCPRC) in third-line care, the agency granted an even broader label in the indication to its first-in-class competitor, Lynparza (olaparib). Endorsement of second-line use of Lynparza in mCPRC and an overall survival (OS) benefit listed in its updated label will help rapidly establish it as "the drug of choice in the [second] line, leaving little commercial opportunities for Rubraca downstream," SVB Leerink analyst Andrew Berens said.

LONDON – Heart disease is now known to be both a cause and an effect of serious COVID-19 infection, with more than 1 in 10 patients who have underlying cardiac conditions being killed by the virus, while others with no previous record of cardiovascular problems are suffering significant COVID-19 induced weakening of their hearts.

Two judges with the U.S. Court of Appeals for the Federal Circuit sided with the Patent Trial and Appeal Board (PTAB) in a patent dispute between Oticon Medical and Cochlear, but the third judge, Pauline Newman took issue with the decision. Newman said the majority applied “an improper analytical technique” to determine that the preamble to a patent does not limit the related claims, despite that prior art cited to dispute the patent had been “disavowed by the preamble.”

Waltham, Mass.-based Thermedical Inc. has received a breakthrough device designation from the U.S. FDA for its saline enhanced radiofrequency (SERF) ablation system and Durablate catheter in the treatment of ventricular tachycardia (VT). The system uses a new means of biological heat to precisely deliver ablation therapy to the heart.

Quidel Corp., of San Diego, has scored another win at the U.S. FDA, receiving emergency use authorization (EUA) for the Lyra Direct SARS-CoV-2 Assay to allow direct sample processing. What’s special about this assay is that it does not require an up-front sample extraction. Instead, it uses a reformulated buffer that replaces that process with a simple 10-minute heat step, saving about 50 minutes in processing time.