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☆ Insight: Promising new Alzheimer's drugs may benefit whites more than Blacks
▼ + stars: | 2023-07-31 | by ( Julie Steenhuysen | ) www.reuters.com time to read: +11 min

The company told Reuters that 49% of Black volunteers did not meet the trial's amyloid threshold requirements compared to 22% for whites and 55% for Hispanics. "Is it because MCI (mild cognitive impairment) or early dementia type-symptoms in Blacks are caused by other reasons more so than Alzheimer's?" In 96 dementia trials from 2000-2017, diverse populations only made up around 11% of enrollment, according to a 2018 study. Among Black people who died of Alzheimer's, their dementia was more likely to result from multiple causes, such as vascular disease. "Is it that it's not Alzheimer's disease?

Persons: Barrington, Vickie Riley, Charlie, Harriet Shaffer, Barrington Riley, –, Eli Lilly, Lilly, Crystal Glover, Eisai, Ivan Cheung, Cheung, Shobha, Biogen, Mark Mintun, Alzheimer's, Dr Lisa Barnes, Barnes, Joshua Grill, we're, Reisa Sperling, Brigham, Julie Steenhuysen, Caroline Humer, Suzanne Goldenberg, Daniel Flynn Organizations: Emory University Brain Health, Americans, Reuters, Prospective Black, Rush, Disease Research, and Drug Administration, FDA, Black, MCI, National Institutes of Health, Rush Center, University of California, Women's Hospital, Thomson Locations: Atlanta , Georgia, U.S, Chicago, Tokyo, Irvine, United States

Signage for Eisai Co. at the company's headquarters in Tokyo, Japan, on Friday, Feb. 3, 2023. Bloomberg | Bloomberg | Getty ImagesShares of Japanese pharmaceutical giant Eisai sank Friday after the company's Alzheimer's drug was formally approved by U.S. regulators overnight, prompting questions over investor sentiment surrounding the move. Eisai shares closed 4.67% lower after paring some of its earlier losses. Leqembi is the first Alzheimer's antibody treatment to receive full FDA approval. "The odds for brain swelling and hemorrhage are far higher than any actual improvement," Espay, who launched a petition in June calling for the Alzheimer's treatment to not get full approval, told NBC News.

Persons: Biogen, Dr, Alberto Espay, Espay, Ivan Cheung, CNBC's, Cheung Organizations: Bloomberg, Getty, U.S, . Food, Medicare, University of Cincinnati College of, NBC News, Eisai U.S Locations: Tokyo, Japan, Eisai

☆ Many health systems are already ready for 'Leqembi' roll out, says Eisai CEO Ivan Cheung
▼ + stars: | 2023-07-06 | by ( ) www.cnbc.com time to read: 1 min

In this videoShare Share Article via Facebook Share Article via Twitter Share Article via LinkedIn Share Article via EmailMany health systems are already ready for 'Leqembi' roll out, says Eisai CEO Ivan CheungIvan Cheung, Eisai U.S. CEO, joins 'Fast Money' to discuss the FDA approving Biogen's 'Leqembi' Alzheimer's drug.

Persons: Ivan Cheung Ivan Cheung Organizations: Eisai U.S

Trial data showed that the treatment slows progression of the brain-wasting disease by 27% for patients in the earliest stages of Alzheimer's. The FDA placed its strongest "boxed" safety warning on Leqembi's label, flagging the risk of potentially dangerous brain swelling for Alzheimer's drugs in the same class. Leqembi is an antibody designed to remove sticky deposits of a protein called amyloid beta from the brains of Alzheimer's patients. Biogen and Eisai stock has risen since FDA granted accelerated approval to Alzheimer's drug Leqembi earlier this yearLeqembi's new label explains the need to monitor patients for potentially dangerous brain swelling and bleeding associated with amyloid-lowering antibodies. The first FDA-approved disease-modifying Alzheimer's drug, Aduhelm, was also developed by partners Eisai and Biogen, but Medicare coverage restrictions have severely limited its use.

Persons: Leqembi, drugmakers, Ivan Cheung, Chiquita Brooks, LaSure, Babak Tousi, Tousi, Biogen, Dr, Erik Musiek, Eli Lilly, Co's, Cheung, Joanne Pike, Eisai, Leqembi's, Deena Beasley, Julie Steenhuysen, Bill Berkrot, Matthew Lewis Organizations: U.S . Food, Drug Administration, FDA, Medicare, Medicaid Services, Cleveland Clinic, Washington University, Barnes, Jewish, Alzheimer’s Association, Alzheimer's Association, Thomson Locations: ANGELES, U.S, Los Angeles, Chicago

CNN —The US Food and Drug Administration is expected to decide on Thursday whether to grant traditional approval to the Alzheimer’s drug Leqembi, the first medicine proven to slow the course of the memory-robbing disease. Leqembi, from drugmakers Eisai and Biogen, received accelerated approval in January based on evidence that it clears amyloid plaque buildups in the brain that are associated with Alzheimer’s disease. But because of an earlier coverage decision by CMS, which provides insurance coverage for many elderly patients with Alzheimer’s through Medicare, the drug hasn’t been widely used. People with more advanced forms of the disease may not benefit from the drug, he said, and may face increased safety risks. Broad Medicare coverage of Leqembi and similar types of medications to slow the progression of Alzheimer’s disease would probably have a big impact on the program’s spending.

Persons: drugmakers, hasn’t, “, ’ ”, Joe Montminy, Lawrence Honig, “ It’s, ”, Honig, it’s, Leqembi, ” Honig, Georges Naasan, Sue Rottura, ” Drugmaker Eisai, “ You’re, Ivan Cheung, Eisai, ” Montminy, Dr, Sanjay Gupta Organizations: CNN, Food and Drug Administration, Medicare, Services, CMS, Columbia University Irving Medical Center, Alzheimer’s, Behavioral, CNN Health, Kaiser Family Foundation Locations: Mount, Florida

☆ Alzheimer’s patients may wait years to get treated with new drugs, putting them at risk of more severe disease
▼ + stars: | 2023-04-30 | by ( Spencer Kimball | ) www.cnbc.com time to read: +17 min

But time spent waiting robs early patients of their memory and ability to live independently. This condition is often, though not always, a sign of early Alzheimer's disease. PET scans cumbersomeTwo types of tests can diagnosis Alzheimer's disease: PET scans and spinal taps. Early Alzheimer's disease can also be diagnosed with a spinal tap, in which fluid around the spinal cord is extracted with a catheter and tested. He believes big players like CVS will provide infusions for Alzheimer's disease on a major scale if they see there's a large and stable market.

HONG KONG, March 11 (Reuters) - Three former members of a Hong Kong group that organised annual vigils to mark China's 1989 Tiananmen Square crackdown, were jailed on Saturday for four and a half months for not complying with a national security police request for information. Chow Hang-tung, 38, a prominent Hong Kong pro-democracy activist and former vice-chairperson of the Hong Kong Alliance in Support of Patriotic Democratic Movements in China, was among those convicted by a magistrate's court. The now-disbanded Alliance was the main organiser of Hong Kong's June 4 candlelight vigil for victims of China's Tiananmen Square crackdown. The national security law, which punishes acts including subversion and collusion with foreign forces, has been criticised by some Western governments as a tool to crush dissent. The Hong Kong and Chinese governments say the law had brought stability since it was enacted in 2020 in response to mass pro-democracy protests in 2019.

☆ Hong Kong court convicts 3 members of Tiananmen vigil group for security offence
▼ + stars: | 2023-03-04 | by ( Jessie Pang | ) www.reuters.com time to read: +3 min

HONG KONG, March 4 (Reuters) - Three former members of a Hong Kong group that organised annual vigils to mark China's 1989 Tiananmen Square crackdown, were found guilty on Saturday of not complying with a national security police request for information. Prominent Hong Kong pro-democracy activist and barrister Chow Hang-tung, 38, was among those convicted by the magistrate court. Chow is a former vice-chairperson of the Hong Kong Alliance in Support of Patriotic Democratic Movements in China. The national security law, which punishes acts including subversion and collusion with foreign forces has been criticised by some Western governments as a tool to crush dissent. Chinese and Hong Kong officials say the law is necessary to restore stability to the city after the city's protracted anti-China protests in 2019.

☆ Medicare rejects Alzheimer's Association request for unrestricted coverage of treatments like Leqembi
▼ + stars: | 2023-02-23 | by ( Spencer Kimball | ) www.cnbc.com time to read: +6 min

The Alzheimer's drug LEQEMBI is seen in this undated handout image obtained by Reuters on January 20, 2023. Due to the drug's high price and Medicare's coverage restrictions, seniors are unable to access the treatment. The letter the Alzheimer's Association sent to CMS in December calling for unrestricted coverage was signed by more than 200 researchers and experts. CMS said it would provide broader coverage of Leqembi on the same day should the FDA fully approve the treatment. Medicare adopted the coverage restrictions after controversy over the Alzheimer's antibody treatment Aduhelm, which was also developed by Eisai and Biogen.

☆ Maker of promising Alzheimer's drug Leqembi expects full FDA approval this summer, expanded Medicare coverage
▼ + stars: | 2023-02-17 | by ( Spencer Kimball | ) www.cnbc.com time to read: +7 min

Early Alzheimer's typically hits people ages 65 and older, causing cognitive impairment and other issues. Medicare beneficiaries who agree to participate in CMS-backed research studies, which are broader than clinical trials, would get coverage if Leqembi receives full approval. Drug rollout will take yearsIf everything goes according to Eisai's expectations, the FDA would grant full approval and CMS would provide unrestricted coverage of Leqembi. In that scenario, Eisai anticipates that about 100,000 diagnosed early Alzheimer's patients will be eligible by year three of the drug's rollout. Private insurers are largely waiting for a CMS coverage decision though some may decide to make their coverage decisions earlier, he said.

☆ Senators call on Medicare to offer broad coverage of Alzheimer's treatments as public pressure grows
▼ + stars: | 2023-02-17 | by ( Spencer Kimball | ) www.cnbc.com time to read: +5 min

U.S. senators on Friday called for Medicare to offer broad coverage of Alzheimer's treatments approved by the Food and Drug Administration, warning that current restrictions cost patients precious time as their disease progresses. The 20 senators told CMS that Alzheimer's will cost the nation $1 trillion by 2050 if the U.S. does not take decisive action. As a consequence, Medicare coverage for the expensive drug is basically nonexistent. The Alzheimer's Association wrote CMS in December calling for the agency to provide unrestricted Medicare coverage for Leqembi. "We believe Medicare beneficiaries should have unimpeded access, broad and simple access to Leqembi because the data fulfill those criteria."

A newly approved drug intended to slow the progression of Alzheimer’s disease offers patients hope, but it will come with a steep price tag: $26,500 a year. That drug initially cost $56,000 per year before Biogen slashed the price in half, to $28,000 annually. Dr. David Rind, the institute's chief medical officer, said an appropriate cost for the drug is $8,500 to $20,600 a year. John Domeck, 60, of Aurora, Ohio is currently enrolled in a phase 3 clinical trial testing Leqembi. But right now, the clinical trial for Leqembi shows that the drug provides "modest efficacy at a big, big price," Caplan said.

The Food and Drug Administration on Friday approved an Alzheimer’s drug shown in clinical trials to slow cognitive decline in patients in the early stages of the illness. The FDA approved Leqembi for use in people with mild cognitive impairment or early Alzheimer’s disease. Most drugs approved by the FDA for Alzheimer’s are aimed at helping symptoms, not actually slowing the progression of the disease. Friday's announcement comes on the heels of a scathing congressional report released last week detailing the approval of a different Alzheimer’s drug, called Aduhelm. The Alzheimer's Association has said that based on the Eisai and Biogen phase 3 clinical trial results, the FDA should approve Leqembi for early-stage Alzheimer’s.

☆ The FDA just approved a new Alzheimer's drug that's set to be a blockbuster
▼ + stars: | 2023-01-06 | by ( Yeji Jesse Lee | ) www.businessinsider.com time to read: +6 min

The FDA just approved a new treatment for Alzheimer's disease from Eisai and Biogen. Alzheimer's disease affects roughly 6.5 million Americans and has no cure. The FDA granted an accelerated approval of the drug, meaning the companies will have to conduct additional follow-up studies. While the drug has been approved, questions about cost remainWhile Leqembi has been approved by the FDA, the drug will have to face other key hurdles before it becomes widely available to patients. Aduhelm, an Alzheimer's drug also developed by Biogen and Eisai and approved by the FDA in 2021, failed to garner support from the Centers for Medicare and Medicaid Services, even after it was approved by the FDA.

☆ CNBC Exclusive: Eisai U.S. CEO on Alzheimer's drug approval
▼ + stars: | 2023-01-06 | by ( Melissa Lee | ) www.cnbc.com time to read: 1 min

Share Share Article via Facebook Share Article via Twitter Share Article via LinkedIn Share Article via EmailCNBC Exclusive: Eisai U.S. CEO on Alzheimer's drug approvalCNBC's Meg Tirrell talks to Ivan Cheung, Eisai U.S. CEO on the company's Alzheimer's drug receiving approval from the FDA today. With CNBC's Tyler Mathisen and the Fast Money traders, Tim Seymour, Bonawyn Eison, Steve Grasso and Jeff Mills.

☆ Eisai, Biogen Alzheimer's drug slows cognitive decline, safety for some becomes focus
▼ + stars: | 2022-11-30 | by ( Deena Beasley | ) www.reuters.com time to read: +5 min

The drug, lecanemab, was associated with a type of brain swelling in 12.6% of trial patients, a side effect previously seen with similar drugs. He suggested that could be because homozygous study patients who were given a placebo fared better than expected. Overall, lecanemab patients benefited by 23% to 26% compared with a placebo on these secondary trial goals. Detailed data from the study were presented at the Clinical Trials on Alzheimer's Disease meeting in San Francisco and published in the New England Journal of Medicine. Dr. Howard Fillit, chief science officer at the Alzheimer’s Drug Discovery Foundation, said doctors always balance the benefits and risks of therapies.

☆ We believe the risk-benefit profile for our Alzheimer's drug is acceptable, says Eisai U.S. CEO
▼ + stars: | 2022-11-30 | by ( ) www.cnbc.com time to read: 1 min

Share Share Article via Facebook Share Article via Twitter Share Article via LinkedIn Share Article via EmailWe believe the risk-benefit profile for our Alzheimer's drug is acceptable, says Eisai U.S. CEOIvan Cheung, Eisai U.S. CEO, joins 'Closing Bell' to discuss the results of Eisai's experimental Alzheimer's phase three trial, the side effects associated with the Alzheimer's drug and more.

☆ Biogen and Eisai's latest clinical trial just crossed the finish line. Here's why analysts say the results could disrupt the future of Alzheimer's care.
▼ + stars: | 2022-09-28 | by ( Yeji Jesse Lee | ) www.businessinsider.com time to read: +7 min

It's a complicated, debilitating illness and drug companies have struggled for years to come up with viable treatments. On Tuesday September 27, Biogen and Eisai announced that lecanemab slowed the rate of cognitive decline in Alzheimer's patients by 27%. Analysts say that this positive result could lead to it becoming a blockbuster drug for the companies. Other big drug companies such as Roche Holdings and Eli Lilly are pursuing similar treatments, with results expected to come later this year and early next year, respectively. "I think people's confidence in the amyloid hypothesis would go down even further, but ultimately people would wait to see what those other data events show," he said.

☆ Eisai's Alzheimer's drug reduces cognitive decline by 27% in trial patients
▼ + stars: | 2022-09-28 | by ( ) www.cnbc.com time to read: 1 min

Share Share Article via Facebook Share Article via Twitter Share Article via LinkedIn Share Article via EmailEisai's Alzheimer's drug reduces cognitive decline by 27% in trial patientsEisai Co. Chairman and CEO for the U.S. Ivan Cheung joins 'Closing Bell' to discuss promising results from the company's latest drug trial for Alzheimer's, and the anticipated cost of the drug if it becomes publicly available.

☆ Biogen's latest clinical trial is inching towards the finish line. Here's why analysts say the results could disrupt the future of Alzheimer's care.
▼ + stars: | 2022-09-19 | by ( Yeji Jesse Lee | ) www.businessinsider.com time to read: +7 min

It's a complicated, debilitating illness and drug companies have struggled for years to come up with viable treatments. Other big drug companies such as Roche Holdings and Eli Lilly are pursuing similar treatments, with results expected to come later this year and early next year, respectively. "I think people's confidence in the amyloid hypothesis would go down even further, but ultimately people would wait to see what those other data events show," he said. Negative results might give a boost to companies that are exploring alternate ways to treat Alzheimer's disease. And though Biogen's drug is furthest along in development, it's far from being the only treatment being tested for Alzheimer's.

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