WASHINGTON – Hot on the heels of July's FDA approval of Recarbrio (imipenem, cilastatin and relebactam) in complicated urinary tract infections (cUTIs), Merck & Co. Inc. rolled out pivotal phase III data at the Infectious Disease Society of America's IDWeek 2019 that could support expanding its label to another high-need group, people with hospital-acquired or ventilator-associated bacterial pneumonia (HABP/VABP).

Something of a duel may be shaping up between Menlo Park, Calif.-based Adverum Biotechnologies Inc. with ADVM-022, the phase I gene therapy candidate for wet age-related macular degeneration (AMD) and Regenxbio Inc., of Rockville, Md., with a similar candidate.

The routine application of medical device technology to neurological indications beyond pain remains challenging in all but the most severe patients. Micro-cap Neuronetics Inc. is aiming to change all that with its Neurostar transcranial magnetic stimulation (TMS) system that is noninvasive and used in the physician's office.

William Kaelin, Peter Ratcliffe, and Gregg Semenza have jointly won the 2019 Nobel Prize "for their discoveries of how cells sense oxygen," the Nobel Assembly at Karolinska Institutet announced today.

Investors sorting through NGM Biopharmaceuticals Inc.'s interim results from the fourth and final cohort of the adaptive phase II trial with aldafermin in nonalcoholic steatohepatitis (NASH) may have felt let down when comparing the data to previous cohorts' outcomes. Shares of the South San Francisco-based firm (NASDAQ:NGM) closed Monday at $10.78, having sunk $2.77 or 20.4%.

WASHINGTON – While the vast majority of people infected with respiratory syncytial virus (RSV) muddle through with mild, cold-like symptoms, for infants, the associated bronchiolitis can make it extremely difficult to breathe and feed. Thousands require inpatient care for the infection each year, necessitating hospitals to be built with a winter surge of admissions in mind, driven in large part by RSV in both the very young and old.

Arm and hand prosthetics have long been the focus for researchers aiming to offer sensation as well as more precise and easily controlled movement by connecting patient nerves to sensors in the prosthetic. But now that effort has been extended to leg prosthetics as well.

WASHINGTON – Hot on the heels of July's FDA approval of Recarbrio (imipenem, cilastatin and relebactam) in complicated urinary tract infections (cUTIs), Merck & Co. Inc. rolled out pivotal phase III data at the Infectious Disease Society of America's IDWeek 2019 that could support expanding its label to another high-need group, people with hospital-acquired or ventilator-associated bacterial pneumonia (HABP/VABP). Shionogi & Co. Ltd., which is advancing its investigational antibiotic, cefiderocol, in the same indications, also shared new phase III data supporting its use in the high-risk population.

WASHINGTON – A little more than a year after first reporting phase IIb results showing oral TORC1 inhibitor RTB-101 reduced the number of respiratory tract infections (RTIs) in older adults, Restorbio Inc. is illuminating what may be the mechanism behind its efficacy: the up-regulation of innate antiviral immunity. The data, presented at the Infectious Disease Society of America's IDWeek 2019, put the company on track to move into two phase III data readouts next year. 

HONG KONG – Hutchison China Meditech Ltd. (Chi-Med) is preparing for the next step after surufatinib achieved its primary endpoint in a phase III SANET-ep study in extra-pancreatic advanced neuroendocrine tumors (NETs) in China.