Genetron Holdings Ltd. said its blood-based, early screening test for hepatocellular carcinoma (HCC) demonstrated 88% sensitivity and 93% specificity in 1,615 subjects in China vs. 71% sensitivity and 95% specificity with the use of ultrasound plus alpha-fetoprotein (AFP). The primary outcome, unveiled on March 25, came from a multicenter prospective trial that Beijing-based Genetron initiated together with The National Cancer Center China in 2019.

LONDON – After the extraordinary public accusation by the National Institute of Allergy and Infectious Diseases that it published “outdated” information on the interim results of the phase III U.S. trial of its COVID-19 vaccine, Astrazeneca plc has rushed through the full primary analysis, showing 76% efficacy in preventing symptomatic disease. That is 3% lower than the headline figure in the interim data published on March 22. But with the confidence interval ranging from 68%-82%, it is consistent with the pre-specified interim analysis claim of 79% efficacy – and would appear to indicate the data safety monitoring board’s (DSMB) concern that the company, “may have provided an incomplete view,” was misplaced.

With so many headlines touting drugs in development for the likes of nonalcoholic steatohepatitis and nonalcoholic fatty liver disease, an illness in the same ballpark has been back-seated: alcoholic hepatitis (AH), which is on the rise, under-recognized and brings a one-month mortality rate that averages 26%.

RNA therapy developer Proqr Therapeutics NV’s phase I/II study of adults with Usher syndrome and non-syndromic retinitis pigmentosa met all its key objectives, prompting the company to plan two parallel pivotal phase II/III studies that could start by year-end. The company wasted no time as it has already discussed next steps with the FDA to support the therapy’s registration “as soon as possible,” Aniz Girach, Proqr’s chief medical officer, told investors during a March 24 investor call.

LONDON – A U.K.-wide study has found that seven out of 10 patients hospitalized with COVID-19 infection were continuing to suffer physical and mental health problems five months after discharge.

LONDON – Astrazeneca plc promised to publish the primary analysis of the phase III U.S. trial of its COVID-19 vaccine by the morning of March 25, after chastisement from the data safety monitoring board (DSMB) for using “outdated” information in the interim results published on March 22.

Insulet Corp. reported positive results from a pivotal trial of its Omnipod 5 automated insulin delivery system for patients with type 1 diabetes. The tubeless, wearable insulin delivery system lowered hemoglobin A1c (HbA1c) – a critical diabetes measure – in children, adolescents, and adults, and improved the time that patients were in the target blood glucose range. The data was presented at ENDO 2021, the Endocrine Society’s annual meeting, which was held virtually this year.