The majority of patients with acromegaly who switched from therapy with injected somatostatin receptor ligands to Crinetics Pharmaceuticals Inc.’s once-daily, oral drug paltusotine maintained stable levels of insulin-like growth factor 1 in a phase III trial, moving the company’s first-in-class lead closer to becoming the potential new standard of care for the rare hormonal disorder.
The U.S. Federal Trade Commission (FTC) reported a settlement with San Francisco-based 1Health.io Inc. for allegations that the consumer gene testing company failed to properly secure customers’ data, an oversight that will cost the company only $75,000 in fines.
With a goal of manufacturing biotechnology in the U.S. that’s invented in the U.S., President Joe Biden signed an executive order Sept. 12 launching a National Biotechnology and Biomanufacturing Initiative that’s intended to strengthen the country’s bioeconomy, build stronger supply chains, and better utilize and secure biological data.
Data privacy laws are springing up more regularly in the past couple of years, including in several U.S. states, but Congress seems inclined to step in to avoid a patchwork of regulations across the 50 states. The House Energy and Commerce Committee gave a ringing endorsement of new legislation via a 53-2 vote for H.R. 8152, a bill that would largely preempt the growing list of state privacy laws, but makers of health apps and other digital products might eventually be subject to private litigation under the terms of the bill.
Ark Biopharmaceutical Co. Ltd.’s phase III testing its ziresovir in infants hospitalized with respiratory syncytial virus (RSV) infection produced positive top-line results, meeting both the primary endpoint of reduction in signs and symptoms (S&S) score (p=0.002) and a key secondary endpoint of reduction in viral load (p=0.006) compared with placebo. The company said it is the first oral RSV antiviral to be successful in phase III.
Ark Biopharmaceutical Co. Ltd.’s phase III testing its ziresovir in infants hospitalized with respiratory syncytial virus (RSV) infection produced positive top-line results, meeting both the primary endpoint of reduction in signs and symptoms (S&S) score (p=0.002) and a key secondary endpoint of reduction in viral load (p=0.006) compared with placebo. The company said it is the first oral RSV antiviral to be successful in phase III.
HONG KONG – New data from Beigene Ltd. recently presented at the ESMO Virtual Congress 2020 showed its PARP inhibitor pamiparib helped shrink tumors in almost 65% of people with platinum-sensitive ovarian cancer treated with the candidate during a pivotal trial.
HONG KONG – New data from Beigene Ltd. recently presented at the ESMO Virtual Congress 2020 showed its PARP inhibitor pamiparib helped shrink tumors in almost 65% of people with platinum-sensitive ovarian cancer treated with the candidate during a pivotal trial.
While COVID-19 dominated the clinical data news during the month of April, with 45% due to trial delays, suspensions and terminations, and another 12% focused on therapeutic and vaccine development targeting the deadly infection, a number of companies still posted positive phase III data for other indications and are preparing for regulatory filings and commercialization.
COVID-19 has disrupted science in the way it has disrupted everything else. In the short term, universities have largely closed shop as a way to maximize social distancing, and lots of science – or at least, lots of bench work – is not getting done.
