Russia puts Ukrainian President Zelenskyy on its wanted list
Russia has put Ukrainian President Volodymyr Zelenskyy on its wanted list, Russian state media reported Saturday, citing the interior ministry’s database.
Eli Lilly is nearly ready to take another shot at getting approval for a possible Alzheimer's drug.
The drugmaker said Thursday that it plans to submit its potential treatment donanemab to the Food and Drug Administration later this year.
The announcement comes a few weeks after the FDA approved a treatment from rival Biogen, despite warnings from the agency's independent advisers that it hasn't been shown to help slow the brain-destroying disease.
The agency approved Biogen's Aduhelm based on study results showing it seemed “reasonably likely” to benefit Alzheimer's patients. It's the first new Alzheimer's drug in nearly 20 years and the only therapy that U.S. regulators have said can likely alter the course of the disease, rather than temporarily ease symptoms like thinking problems, memory lapses and anxiety.
Both Aduhelm and Lilly's potential treatment, donanemab, help clear a protein called beta-amyloid from the brain.
Lilly said Thursday that it will seek approval for donanemab based on results from a mid-stage clinical study of the drug involving 272 patients with an early form of the disease. Researchers said donanemab showed signs of slowing a decline in cognition and daily function for patients who took it compared to those who took a placebo or fake drug.
The FDA gave donanemab a “breakthrough therapy” designation, which is intended to speed the development and review of drugs that show signs of being an improvement over established treatments.
Lilly may be able to file its application for approval in the next two or three months since the drugmaker appears to have all the data it needs, said Dr. Vamil Divan, an analyst who covers the company for Mizhuho Securities USA.
The Indianapolis company also will examine the drug in a larger, late-stage study. A spokeswoman said Lilly plans to complete enrollment in that study by the end of the year, and an 18-month treatment period will follow.
Biogen said Wednesday that another experimental Alzheimer's treatment it developed with Japan's Eisai Co. also received a breakthrough therapy designation from the FDA. Researchers are examining that drug, lecanemab, in a late-stage study.
The companies gave no time frame for when they might seek regulatory approval.
Some 6 million people in the U.S. and many more worldwide have Alzheimer's disease, which gradually attacks areas of the brain needed for memory, reasoning, communication and basic daily tasks.
Lilly and several other drugmakers have previously failed in attempts to find a treatment that slows the progression of the mind-robbing disease.
More than four years ago, Lilly said another potential drug it developed called solanezumab did not work better than a placebo in a study of over 2,100 people.
That drug also aimed to clear potentially harmful protein from the brain.
Eli Lilly and Co. shares jumped nearly US$17, or almost 8 per cent, to $233.97 Thursday afternoon while the Standard & Poor's 500 index climbed less than 1 per cent.
Shares of Biogen fell more than 5 per cent, or US$20.29, to $351.61.
Russia has put Ukrainian President Volodymyr Zelenskyy on its wanted list, Russian state media reported Saturday, citing the interior ministry’s database.
A man was denied a $5,000 payout from his brother after a B.C. tribunal dismissed his claim disputing how many kittens were born in a litter.
A Chinese truck driver was praised in local media Saturday for parking his vehicle across a highway and preventing more cars from tumbling down a slope after a section of the road in the country's mountainous south collapsed and killed at least 48 people.
A man accused of arson in a January Old Strathcona apartment fire is expected to be charged with manslaughter after a body was discovered in the burned building late last month.
Ontario Provincial Police say two people were killed after a car and a transport truck collided in the westbound lanes of Highway 417 near Limoges, Ont. on Tuesday afternoon.
A Quebec man who pleaded guilty to threatening Prime Minister Justin Trudeau and Premier François Legault has been sentenced to 20 months in jail.
A candidate for Chancellor Olaf Scholz's center-left party in next month's election for the European Parliament was beaten up and seriously injured while campaigning in an eastern city, the party said Saturday.
Police are investigating after a BMW exploded in the St-Lambert Exo train station parking lot on Montreal's South Shore.
A group of lawyers has written what they call a groundbreaking book about how mental health is perceived in the legal profession.
Alberta Ballet's double-bill production of 'Der Wolf' and 'The Rite of Spring' marks not only its final show of the season, but the last production for twin sisters Alexandra and Jennifer Gibson.
A British Columbia mayor has been censured by city council – stripping him of his travel and lobbying budgets and removing him from city committees – for allegedly distributing a book that questions the history of Indigenous residential schools in Canada.
Three men in Quebec from the same family have fathered more than 600 children.
A group of SaskPower workers recently received special recognition at the legislature – for their efforts in repairing one of Saskatchewan's largest power plants after it was knocked offline for months following a serious flood last summer.
A police officer on Montreal's South Shore anonymously donated a kidney that wound up drastically changing the life of a schoolteacher living on dialysis.
Since 1932, Montreal's Henri Henri has been filled to the brim with every possible kind of hat, from newsboy caps to feathered fedoras.
Police in Oak Bay, B.C., had to close a stretch of road Sunday to help an elephant seal named Emerson get safely back into the water.
Out of more than 9,000 entries from over 2,000 breweries in 50 countries, a handful of B.C. brews landed on the podium at the World Beer Cup this week.
Raneem, 10, lives with a neurological condition and liver disease and needs Cholbam, a medication, for a longer and healthier life.