Myriad Genetics Inc. is hoping to soon add prostate cancer to the growing list of indications for use of its BRACAnalysis CDx in combination with Lynparza (olaparib), following the announcement of positive results in a subset of prostate cancer patients. Astrazeneca plc and Merck & Co. reported Wednesday that their phase III PROfound study showed that men with castration-resistant prostate cancer (mCRPC) who tested positive for germline and somatic mutations in homologous recombination repair (HRR) genes responded well to the poly (ADP-ribose) polymerase (PARP) inhibitor. Based on that findings, Myriad said it will seek FDA approval of BRACAnalysis CDx as a companion diagnostic for Lynparza in men with mCRPC who have germline BRCA mutations.
Myriad Genetics is hoping to soon add prostate cancer to the growing list of indications for use of its BRACAnalysis CDx in combination with Lynparza (olaparib), following the announcement of positive results in a subset of prostate cancer patients.
The U.S. FDA has cleared the way for Physiq Inc., of Naperville, Ill., to market its continuous ambulatory respiratory rate algorithm, adding to the company's portfolio of cloud-based analytics for biopharma and health insurance companies. The 510(k) notification will allow Physiq to boost its higher-level artificial intelligence (AI) platform with validated vital signs inputs.
Chicago-based Hillrom said Friday that it will acquire Breathe Technologies Inc. for $130 million in cash. The Irvine, Calif.-based company developed and manufactures the Life2000 ventilation system, a volume-controlled, wearable, noninvasive technology for patients with chronic obstructive pulmonary disease (COPD), interstitial lung disease and restrictive thoracic disorder, as well as for those who require post-lung transplant rehabilitation. The news comes as Hillrom posted third-quarter results that exceeded Wall Street expectations.
Endotronix Inc. reported that the U.S. FDA has granted the company conditional IDE approval to begin the multicenter PROACTIVE-HF trial of the Cordella pulmonary artery pressure sensor system. The nod comes less than a month after Endotronix began enrolling patients in a European study of the device, paving the way for both CE mark and FDA approvals within the next couple of years.
London-based Smith & Nephew plc raised its 2019 revenue prospects, buoyed by strong second-quarter sales of sports medicine products in the U.S. and a spike in sales in China. Total revenue for the quarter hit $1.3 billion, up 3.1% from the same period a year ago, putting the company at $2.5 billion at the half-year mark and 1.8% above the 2018 six-month total of $2.4 billion, on a reported basis. Underlying growth for the first six months was 3.9%.
Cantel Medical Corp. is acquiring dental instruments and reprocessing specialist Hu-Friedy Mfg. Co. LLC for $725 million in upfront cash and stock considerations, plus up to $50 million in cash and stock earnouts tied to revenue milestones over the next 12 to 18 months. The deal, which is expected to close by Sept. 30, advances Cantel's goal of positioning itself as a major player in the global infection prevention and reprocessing workflow space for both dental and medical needs.
Exact Sciences Corp., of Madison, Wis., has inked a deal to acquire Redwood City, Calif.-based Genomic Health Inc., creating a combined cancer diagnostics company with an estimated revenue of $1.6 billion by the end of 2020. The acquisition brings together Exact Sciences' at-home stool DNA test for colorectal cancer, Cologuard, and Genomic Health's Oncotype Dx tests for breast and prostate cancer. The three areas comprise about 40% of all solid tumor cases, according to the companies.
Dialysis is a grueling ordeal, tethering patients with kidney failure to machines for hours on end while their blood is cleansed of waste and toxins. Imagine now that a tiny implant could purify the blood on a continual basis without the need for complex equipment, catheters and solutions. That's the idea behind new technology being developed by U.S. Kidney Research Corp. The Roseville, Calif., company's computer-assisted artificial kidney prototype is set to begin animal studies the last week of August.