NEW Toxic forever chemicals in drinking water: Is Canada doing enough?
As the United States sets its first national limits on toxic forever chemicals in drinking water, researchers say Canada is lagging when it comes to regulations.
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.
As the United States sets its first national limits on toxic forever chemicals in drinking water, researchers say Canada is lagging when it comes to regulations.
Drivers in Eastern Canada face a big increase in gas prices because of various factors, especially the higher cost of the summer blend, industry analysts say.
Calgary police have arrested a man and a charge is pending in connection with the death of a toddler in 2022.
The journey to home ownership can be exciting, but personal finance columnist Christopher Liew warns about the trappings of becoming 'house poor' -- where an overwhelming portion of your income is devoured by housing costs. Liew offers some practical strategies to maintain better financial health while owning a home.
A Winnipeg woman was sentenced to house arrest after a single date with a man she met online culminated in her harassing him for years, and spurred false allegations which resulted in the innocent man being arrested three times.
New archeological investigations in Guatemala reveal that the ancient Maya people had a ritual of burning royal human remains as a public display of political regime change.
Almost 7,000 bars of pure gold were stolen from Pearson International Airport exactly one year ago during an elaborate heist, but so far only a tiny fraction of that stolen loot has been found.
Prince William will return to public duties on Thursday for the first time since his wife Kate revealed she was undergoing preventative chemotherapy for cancer.
Russian air defences downed what authorities described as five Ukrainian balloons overnight, the defence ministry in Moscow said Thursday, as the sides kept up long-range strikes that have featured heavily in what has largely become a war of attrition.
When Les Robertson was walking home from the gym in North Vancouver's Lower Lonsdale neighbourhood three weeks ago, he did a double take. Standing near a burrow it had dug in a vacant lot near East 1st Street and St. Georges Avenue was a yellow-bellied marmot.
A moulting seal who was relocated after drawing daily crowds of onlookers in Greater Victoria has made a surprise return, after what officials described as an 'astonishing' six-day journey.
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A high score on a Foo Fighters pinball machine has Edmonton player Dave Formenti on a high.
A compound used to treat sour gas that's been linked to fertility issues in cattle has been found throughout groundwater in the Prairies, according to a new study.
While many people choose to keep their medical appointments private, four longtime friends decided to undergo vasectomies as a group in B.C.'s Lower Mainland.
A popular highway in Alberta's Banff National Park now has a 'no stopping zone' to help protect two bears.
B.C. resident Robert Conrad spent thousands of hours on Crown land developing an unusual bond with deer.
A Sudbury woman said her husband was bringing the recycling out to the curb Wednesday night when he had to make a 'mad dash' inside after seeing a bear.