Pfizer Inc. and Biontech SE submitted new data to the FDA showing its COVID-19 vaccine’s stability can be maintained at temperatures often found in pharmaceutical freezers and refrigerators: -13°F to 5°F (-25°C to -15°C).
Astrazeneca plc officials, during the firm’s Feb. 11 conference call on fourth-quarter earnings, highlighted the oral selective estrogen receptor degrader (SERD) camizestrant in breast cancer (BC), which Cristian Massacesi, head of late-stage oncology development, said bears “best-in-class potential, in terms of providing superior clinical benefit at a well-tolerated dose” of 75 mg once per day.
Hopes that a second clinical win for Otonomy Inc.'s phase III Meniere's disease candidate, Otividex, might set the stage for a third-quarter registration of the drug in the U.S. have been dashed, sending company shares (NASDAQ:OTIC) down 44.3% to $3 on Feb. 22. For the intent-to-treat (ITT) population, the trial missed its primary endpoint, the count of definitive vertigo days in month three for the sustained-exposure dexamethasone therapy vs. placebo. The trial also failed to achieve statistical significance for a per-protocol analysis. It was déjà vu for the company, which suffered a harsh reaction to an earlier setback for the program from which its stock has yet to recover, years later.
Although progressive familial intrahepatic cholestasis (PFIC) tends to draw more hoopla in the race, and Mirum Pharmaceuticals Inc. looks due to beat Albireo Pharma Inc. to market in Alagille syndrome (ALGS), the most revenue likely lies in a third rare pediatric liver disease where the firms compete: biliary atresia (BA). Mirum, of Foster City, Calif., completed its rolling NDA several weeks ago for maralixibat – an inhibitor of the apical sodium-dependent bile acid transporter designed to drive more excretion of bile acids as a way of lowering their level systemically – in cholestatic pruritus in patients with ALGS one year of age and older.
LONDON – The first population-level real-world data on COVID-19 vaccines indicate they are having a dramatic impact on severe disease, with a study in Scotland showing a fall of 85% in hospital admissions for people who received the Pfizer Inc./Biontech SE product, and a drop of 94% for those who had Astrazeneca plc’s vaccine, four weeks after receiving the first dose.
Patensee Ltd. initiated a first-in-human trial of its machine vision-based surveillance system for stenosis in hemodialysis patients. The trial will evaluate the imaging system's ability to perform contact-free surveillance of the access points or fistulas essential for dialysis, which nearly all narrow or become blocked over time. The surveillance system aims to mimic the central components of a dialysis nurse's exam using technology.
Last year, artificial intelligence (AI)-focused Caption Health Inc. won the U.S. FDA’s nod for software that guides untrained clinicians step-by-step in providing a cardiac ultrasound exam, a process normally performed by a highly skilled specialist. Now, the Brisbane, Calif.-based company has published data showing nurses without prior ultrasound experience who used Caption Guidance software captured ultrasound images of diagnostic quality to assess known cardiac conditions.
As developers continue their race in the anti-CD47 space, Gilead Sciences Inc. remains high profile with magrolimab, which has reached phase III development for myelodysplastic syndromes. Meanwhile, Alx Oncology Inc., of Burlingame, Calif., is emerging with potentially the first drug targeting the CD47-SIRPa axis to treat solid tumors as well as hematologic malignancies.
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