After nearly two years of waiting, Withings SA won FDA clearance for its Scanwatch, a smartwatch that can take an electrocardiogram and monitor for sleep disturbances indicative of sleep apnea or respiratory illnesses such as chronic obstructive pulmonary disease. The FDA action makes the watch the first cleared for both functions.

TORONTO – Smart Biomedical Inc. has developed a tool it said will vastly improve the chances of recovery for patients suffering from a collapsed lung.

In the year’s second biggest M&A deal, Merck & Co. Inc. will take over pulmonary and hematologic specialist Acceleron Pharma Inc. for $11.5 billion. The acquisition brings Merck a pair of potential blockbuster drugs, one of them already marketed. There is sotatercept, in development for treating pulmonary hypertension (PH), and also Reblozyl (luspatercept-aamt), the first and only erythroid maturation agent approved in the U.S., Europe and Canada for treating anemia in certain blood disorders.

Broncus Holding Corp.’s shares tumbled more than 20% on its first trading day on Friday, Sept. 24, in Hong Kong. It raised HK$1.55 billion (US$199.1 million) at HK$18.70 a share, the top end of its target range. Nearly half of the proceeds will be used for the R&D and commercialization of its two core interventional pulmonology products: the Intervapor system and the RF Generator + RF Ablation Catheter (RF-II).

A multicenter study has found that a multiplex diagnostic panel developed by Opgen Inc. can reduce the use of inappropriate antibiotic therapy by 45.1%. Opgen’s Unyvero Hospitalized Pneumonia (HPN) panel uses PCR technology that can detect 21 pathogens and 17 antibiotic resistance markers in less than five hours. During the European Respiratory Society conference, Rockville, Md.-based Opgen presented data showing that combined with antibiotic stewardship, its HPN panel decreased time on inappropriate antibiotic therapy in hospitalized patients with pneumonia at risk for Gram-negative rods.

Following two clinical trial disappointments, the newest being the phase III failure of ampreloxetine, Theravance Biopharma Inc. will restructure by laying off three-quarters of its staff and will stop developing all but two of its non-respiratory disease programs. The ampreloxetine study for treating symptomatic neurogenic orthostatic hypotension failed to meet its primary endpoint, the company announced Sept. 15. In late August, data from a phase IIb dose-finding study showed izencitinib, a gut-selective pan-JAK inhibitor for treating ulcerative colitis, failed to meet its primary endpoint.