Sequana Medical NV scored a U.S. FDA breakthrough device designation last year for its fully implanted wireless device that automatically pumps fluids from the abdomen into the bladder. Now, it has released positive interim safety and efficacy data on that device, known as Alfapump, in the treatment of patients with recurrent or refractory ascites due to liver cirrhosis.
Positive top-line data from the pivotal phase III study of AAV5-based etranacogene dezaparvovec by Uniqure NV, shows 54 patients met the primary endpoint in treating severe to moderate hemophilia B.
HONG KONG – Final results of Takeda Pharmaceutical Co. Ltd.’s phase III open-label extension study of Takhzyro (lanadelumab) showed that continued treatment with the monoclonal antibody may help with the long-term prevention of hereditary angioedema attacks as well as reducing their frequency.
LONDON – Phase II data on Astrazeneca plc’s AZD-1222 COVID-19 vaccine show it prompts an equivalent immune response in healthy people aged 70, to that seen in people ages 18 to 55, despite the fact the elderly had fewer side effects from vaccination.
HONG KONG – Helio Health Inc. has new data that demonstrate the high accuracy and screening value of its cell-free DNA (cfDNA) methylation blood test for the detection of hepatocellular carcinoma (HCC).
Istar Medical SA, which is focused on minimally invasive ophthalmic implants for the treatment of glaucoma patients, revealed positive one-year results from the European STAR-II clinical trial of its micro-invasive glaucoma surgery (MIGS) device, Miniject.
With the FDA’s required safety milestone notched in their phase III study of COVID-19 vaccine candidate BNT-162b2, Pfizer Inc. and Biontech SE said they will request emergency use authorization “within days.”
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