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).
Almost five years after the first patient-powered approvals for Clinuvel Pharmaceuticals Ltd.'s Scenesse (afamelanotide) arrived in Europe, the FDA has granted the company U.S. approval to increase pain-free light exposure in adults with a history of skin damage from the rare inherited disorder erythropoietic protoporphyria (EPP).
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.
WASHINGTON – Since 2012, Americans at risk of HIV-1 infection from sex have had just a single option for reducing their odds of acquiring it: a daily dose of Gilead Sciences Inc.'s Truvada (emtricitabine and tenofovir disoproxil fumarate). Now, about a year before Truvada goes generic, at least some of them have a second option in Gilead's Descovy (emtricitabine and tenofovir alafenamide). On Thursday, the FDA approved Descovy for HIV-1 pre-exposure prophylaxis, or PrEP, to reduce the risk of HIV-1 infection from sex, excluding those who have receptive vaginal sex.
WASHINGTON – In case any question remained about who shoulders the blame for the serious lack of viable innovation in the infectious disease specialty, a panel at the Infectious Disease Society of America's IDWeek 2019 came with a surprisingly accusatory subtitle: "How ID Killed Antibiotic Development." Observing what Vivo Capital Managing Partner Chen Yu called "an existential crisis for the specialty," the session served as a call for action for infectious disease (ID) doctors to take control of prescribing, put patient care ahead of cost management, and advocate for both faster changes to clinical guidelines and legislative improvements to better position the industry.
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.
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.
Shares of Seattle Genetics Inc. (NASDAQ:SGEN) rose 12.4% to $85.40 on news that an antibody-drug conjugate (ADC) it is developing with Tokyo-based Astellas Pharma Inc., when combined with Keytruda (pembrolizumab, Merck & Co. Inc.), shrank tumors in the majority of people participating in a phase I first-line bladder cancer study.
Top-line results from Enanta Pharmaceuticals Inc.'s Argon-1 phase IIa study of EDP-305 for the treatment of nonalcoholic steatohepatitis (NASH) found one of the two doses of the drug tested met the study's primary endpoint, alanine aminotransferase (ALT) reduction at week 12, contributing further evidence for the drug's mechanism of action, farnesoid X receptor (FXR) agonism. But the non-biopsy study appears to have left investors without proof for something more even more valuable: a clear case for differentiation vs. FXR first-mover Ocaliva (obeticholic acid, Intercept Pharmaceuticals Inc.). Appearing to reflect the sentiment, Enanta's shares (NASDAQ:ENTA) fell 15.1% to $60.51 on Thursday.
Versatope Therapeutics Inc., a company developing a universal influenza vaccine in Lowell, Mass., has been awarded a contract with the National Institute of Allergy and Infectious Diseases worth up to $17.9 million over five years to support completion of a phase I study slated to wrap up in 2022.
