DIRS.INFO The most relevant business & tech news

☆ Bayer Cancels Asundexian Phase III Study Program
▼ + stars: | 2023-11-19 | by ( Nov. | At P.M. | ) www.usnews.com time to read: +1 min

(Reuters) - Germany's Bayer AG said on Sunday it is cancelling a phase III study program to investigate the efficacy and safety of asundexian, an oral Factor XIa (FXIa) inhibitor. The decision to stop the study is based on the recommendation by the Independent Data Monitoring Committee (IDMC). IDMC monitoring showed an inferior efficacy of asundexian compared to the control arm of the study. "A phase III study investigating asundexian compared to Apixaban in patients with atrial fibrillation at risk for stroke is being stopped early," the company said in a statement. Bayer, which initiated the study in August 2022, said it will further analyze the data to understand the outcome and will take appropriate measures.

Persons: Bayer, Jose Joseph, Chris Reese Organizations: Reuters, Germany's Bayer AG, Independent Data Monitoring, Bayer Locations: Bengaluru

☆ Shares of dialysis providers drop after Ozempic's early kidney trial success
▼ + stars: | 2023-10-11 | by ( ) www.reuters.com time to read: +2 min

The outdoor sign seen at the DaVita Dialysis clinic in Denver February 16, 2016. U.S.-listed shares of Fresenius fell 16.4%, to $17.5, and Davita fell about 16%, to $76.7, in premarket hours. Shares of U.S.-based Baxter International (BAX.N), which makes products used by dialysis therapy providers, also fell about 9%, to $33.99 premarket. Davita and U.S.-listed shares of Fresenius Medical are among the top percentage losers on the New York Stock Exchange. As of Tuesday's close, U.S.-listed shares of Fresenius were up about 28.2%, Davita's shares were up 22.2%, while Baxter's shares were down about 27% so far this year.

Persons: Rick Wilking, Ozempic, Danish drugmaker, Veronika Dubajova, Davita, Eli Lilly's, Akash Tewari, Fresenius, Mariam Sunny, Janane Venkatraman, Pooja Desai Organizations: REUTERS, Novo Nordisk's, Citi, Baxter, Jefferies, Fresenius, New York Stock Exchange ., Thomson Locations: Denver, Danish, Fresenius, New York Stock Exchange . Frankfurt, U.S, Bengaluru

☆ Novo Nordisk stops Ozempic kidney trial after early signs of success
▼ + stars: | 2023-10-10 | by ( Patrick Wingrove | ) www.reuters.com time to read: +2 min

Pens for the diabetes drug Ozempic sit on a production line to be packaged at Danish drugmaker Novo Nordisk's site in Hillerod, Denmark, September 26, 2023. Novo said the trial would be halted almost a year early based on a recommendation from the independent data monitoring board overseeing the study. Independent monitors can recommend stopping a trial early if there is clear evidence that a drug was going to succeed or fail based on interim analyses. Semaglutide is also the active ingredient in Novo Nordisk's powerful weight-loss drug Wegovy. Novo's success has also created an economic boom for Denmark, according to Danish economists, analysts, and executives at the Novo Nordisk Foundation.

Persons: Tom Little, Novo, Danish drugmaker, Wegovy, Emily Field, Patrick Wingrove, Sriparna Roy, Bill Berkrot Organizations: REUTERS, Novo Nordisk, Barclays, Novo Nordisk Foundation, Thomson Locations: Hillerod, Denmark, Danish, New York, Bengaluru

☆ PrEPVacc: HIV vaccine trial that could be ‘the last roll of the dice’ this decade is underway
▼ + stars: | 2023-08-28 | by ( Tom Page | Thomas Page | ) edition.cnn.com time to read: +24 min

CNN —A novel trial that has been described as “the last roll of the dice” for a generation of HIV vaccines has entered its latter stages. Nearly 40 years since HIV was identified as the cause of AIDS, and 36 years since the first HIV vaccine trial, the medical community still does not have a working vaccine. But that is not necessarily why they were chosen to participate, said Eugene Ruzagira, PrEPVacc trial director. Evaluating the combination of a trial HIV vaccine and PrEP is a first, say organizers. “I did my very first HIV vaccine trial in 1991,” recalled Weber.

Persons: PrEPVacc, ”, Jonathan Weber, Frank, Helena Herholdt, Eugene Ruzagira, Ruzagira, “, Weber, ” Ruzagira, “ We’ve, Mark Runnacles, Edward Jenner, Louis Pasteur, Galileo, Win McNamee, Humphry Davy, JEAN, SEBASTIEN EVRARD, Haydn West, Joe Raedle, ANNE, CHRISTINE POUJOULAT, Alexander Fleming, Fleming, wasn't, Louise Joy Brown, Sandy Huffaker, Daniel Acker, James Watson, Francis Crick, Rosalind Franklin, Watson, Crick, Raphael GAILLARDE, Sean Gallup, Wilhelm Conrad Röntgen, Thomas Edison's, INDRANIL MUKHERJEE, Descovy, Luwano Geofrey, Dr, Luke Dray, Geofrey, Nishanta Singh, Sharon Lewin, Lewin, “ it’s, it’s, ” Lewin, ” Geofrey Organizations: CNN, Imperial College Academic Health Science Centre, PrEPVacc, Medical Research, Uganda Virus Research Institute, European Union, Smithsonian National Museum of, Cleveland Clinic, Volvo, Bayer, U.S . Food, Drug Administration, Getty, Keystone, — Farmers, Food and Drug Administration, FDA, Bloomberg, PANTHAKY, PrEP, US Centers for Disease Control, Independent, The University of Melbourne, International AIDS Society, Muhimbili University of Health, Allied Sciences, Dar Locations: Entebbe, Uganda, Thailand, London, Mbeya, Tanzania, South Africa, Ugandan, Durban, Masaka, Salam, African, Africa, China, FPG, AFP, United States, America, U.S, Peoria , Illinois, Europe, “, Dar es Salaam, Rwanda

Search resuls for: "Independent Data Monitoring"

4 mentions found