The ideological divide between Republicans and Democrats proved to be an uncrossable chasm Thursday as two U.S. House committees marked up H.R. 3, the Lower Drug Costs Now Act, and a third committee held its first hearing on the bill that was crafted behind the closed doors of Speaker Nancy Pelosi's (D-Calif.) office.

Briefing documents released ahead of Wednesday’s meeting of the FDA’s Antimicrobial Drugs Advisory Committee, slated to review Shionogi & Co. Ltd.’s cefiderocol for treatment of complicated urinary tract infections (cUTIs), spotlighted a finding of increased mortality among critically ill cefiderocol-treated patients in the company’s Credible-CR study.

CEO Mark McKenna told BioWorld Asia that San Diego-based Prometheus Biosciences Inc. has "cracked the code" in inflammatory bowel disease (IBD) – progress underscored by the firm's deal with Takeda Pharmaceutical Co. Ltd., of Osaka, Japan, which brings an undisclosed up-front payment and as much as $420 million more if development, regulatory and commercial milestones are reached in three programs.

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).

The FDA has granted 510(k) clearance to the first hernia mesh featuring a nanometer-level surface texture, enabling better post-implant tissue ingrowth and reducing the incidence of adverse reactions. The Exogenesis Hernia Mesh, by Billerica, Mass.-based Exogenesis Corp., is indicated for the repair of abdominal wall hernias and deficiencies that require reinforcement to stabilize the condition and achieve a positive surgical outcome. The company expects to launch the product nationwide in 2020.

HONG KONG – South Korean biomarker-based molecular diagnostic firm Genomictree Inc. has built a U.S. unit in Pasadena, Calif., with an investment of KRW12 billion (US$10 million). The Daejeon, South Korean-based company first disclosed its plan to build the U.S. branch in March.

Lisle, Ill.-based Endotronix Inc. scooped up $70 million in an expanded series D funding round led by Life Science Partners. The funds will support the company's PROACTIVE-HF IDE clinical trial of the Cordella Pulmonary Artery Sensor System and further commercialization of the Cordella Heart Failure (HF) System.

Sterigenics US LLC, of Oak Brook, Ill., has announced it will not reopen its ethylene oxide (EtO) sterilization plant in Willowbrook, Ill., a development that could strain the capacity for sterilization of devices such as duodenoscopes. Illinois is not the only state that is taking action on EtO, however, a predicament that suggests the U.S. federal government may have to insert itself into the discussion in order to avoid a shortage of critical, life-saving devices.

Functional Neuromodulation Ltd. is looking to help those suffering from mild Alzheimer's disease. To that end, it recently disclosed that it has kicked off the global ADvance II Study (NCT03622905), a pivotal clinical trial to assess deep brain stimulation (DBS) in these patients.