DIRS.INFO The most relevant business & tech news

☆ Eli Lilly says FDA delays approval of Alzheimer's drug in surprise move
▼ + stars: | 2024-03-08 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +3 min

Eli Lilly headquarters in Indianapolis, Indiana, US, on Wednesday, May 3, 2023. Eli Lilly said Friday that the Food and Drug Administration has pushed back its approval decision deadline for the drugmaker's experimental Alzheimer's treatment donanemab in a surprise move. The agency plans to call a last-minute meeting of its outside advisors to further review the treatment's safety and efficacy in a late-stage trial, Eli Lilly said. It's another setback for Eli Lilly, which is racing to compete with Biogen and Eisai. In 2021, the FDA approved an earlier, ill-fated Alzheimer's drug called Aduhelm from Biogen and Eisai, despite a negative recommendation from the agency's advisory panel.

Persons: Eli Lilly, Eli Lilly's, Leqembi, Anne White Organizations: and Drug Administration, FDA Locations: Indianapolis , Indiana, Biogen

☆ Stocks making the biggest moves midday: JetBlue Airways, Shopify, Biogen and more
▼ + stars: | 2024-02-13 | by ( Hakyung Kim | ) www.cnbc.com time to read: +4 min

Shopify — The e-commerce company saw shares slide more than 10% after it gave a mixed forecast for the current quarter. The company did beat fourth-quarter earnings and revenue estimates. Arista Networks — The computer networking stock fell 4% despite topping fourth-quarter estimates. Marriott International — The hotel chain stock declined 5.7% after missing fourth-quarter revenue estimates. Biogen — The biotechnology stock slumped more than 6% after missing Wall Street's fourth-quarter estimates as revenue and profit declined from a year ago.

Persons: WK Kellogg, Shopify, Goldman Sachs, Marriott's, ZoomInfo, Carl Icahn, Wall, Tripadvisor, Horton, Lennar, Bruker, Microstrategy, CleanSpark, —, Macheel, Samantha Subin, Yun Li, Sarah Min, Alex Harring Organizations: Arista Networks, Marriott, ZoomInfo, —, LSEG, JetBlue Airways —, Hasbro, &, Toll, Cadence, Systems, Cadence Design Systems, Miners, Iris Energy

☆ Biogen revenue and profit shrink on Aduhelm costs, slumping sales of multiple sclerosis therapies
▼ + stars: | 2024-02-13 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +3 min

Biogen on Tuesday reported fourth-quarter revenue and profit that shrank from a year ago, as it recorded charges related to dropping its controversial Alzheimer's drug Aduhelm and as sales slumped in its multiple sclerosis therapies, the company's biggest drug category. Biogen booked sales of $2.39 billion for the quarter, down 6% from the same period a year ago. Revenue from multiple sclerosis products fell 8% to $1.17 billion as the therapies face competition from cheaper generics. Adjusting for one-time items, the company reported $2.95 per share. But the company expects its pharmaceutical revenue, which includes product revenue and its 50% share of Leqembi sales, to be flat this year compared to 2023.

Persons: Biogen, LSEG, Biogen's, Leqembi Organizations: LSEG, Biogen, Food and Drug, Reata Pharmaceuticals, FDA Locations: U.S

☆ Biogen Abandons Its Controversial Alzheimer’s Drug Aduhelm
▼ + stars: | 2024-01-31 | by ( Rebecca Robbins | More About Rebecca Robbins | ) www.nytimes.com time to read: +1 min

The drug maker Biogen said on Wednesday it would abandon its ownership rights to Aduhelm, an Alzheimer’s drug that had provoked fierce criticism of the company and regulators after it was approved based on weak evidence that it would help patients. The company will also stop a clinical trial that the Food and Drug Administration had ordered to confirm whether the drug is effective in slowing the progression of Alzheimer’s disease. Biogen’s decision closes out a yearslong saga that generated outrage and eroded trust in the regulatory process for bringing new medicines to market. adviser called the approval of the drug perhaps “the worst approval decision that the F.D.A. has made that I can remember.” A congressional inquiry later found that the F.D.A.’s process for approving Aduhelm was “rife with irregularities” and involved “lapses in protocol,” including unusually close collaboration with Biogen.

Persons: Biogen, Aduhelm Organizations: and Drug Administration

☆ Biogen drops controversial Alzheimer's drug Aduhelm to focus on Leqembi, experimental treatments
▼ + stars: | 2024-01-31 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +2 min

Biogen on Wednesday said it will discontinue the sale and development of its older and highly controversial Alzheimer's drug Aduhelm to refocus the company's efforts to treat the memory-robbing disease. The biotech company will focus on rolling out Leqembi, a newly approved Alzheimer's drug it developed with Japanese drugmaker Eisai . The U.S. Food and Drug Administration greenlit Aduhelm in 2021 under a program that fast-tracks promising treatments. The company said it will redistribute a large portion of the resources associated with Aduhelm to the rest of its Alzheimer's drug portfolio. Among the other Alzheimer's drugs Biogen has in development is BIIB080, which targets a toxic protein called tau in the brain.

Persons: Biogen, Aduhelm Organizations: U.S . Food, Drug Administration, CNBC PRO Locations: U.S, Swiss

Biogen will stop developing its Alzheimer’s treatment Aduhelm, a drug once seen as a potential blockbuster before stumbling soon after its launch a couple years ago. The company also is helping Japanese drugmaker Eisai sell another Alzheimer’s treatment, Leqembi, which already has full FDA approval. Leqembi is the first medicine that’s been convincingly shown to slow the cognitive decline caused by Alzheimer’s disease, though only modestly. Political Cartoons View All 253 ImagesAduhelm was the first new Alzheimer’s disease drug introduced in nearly two decades. But doctors were hesitant to prescribe the intravenous drug, given weak evidence that the drug slows Alzheimer’s.

Persons: drugmaker, Biogen, that’s, Aduhelm Organizations: Food and Drug Administration, Regulators, FDA, Cambridge, Inc Locations: Japanese, Cambridge , Massachusetts

☆ New blood test that screens for Alzheimer’s may be a step closer to reality, study suggests
▼ + stars: | 2024-01-22 | by ( Jacqueline Howard | ) edition.cnn.com time to read: +11 min

Alzheimer’s disease, a brain disorder that affects memory and thinking skills, is the most common type of dementia, according to the National Institutes of Health. “A blood test being negative speeds up the investigation for other causes of the symptoms and this is just as important,” Ashton said. Isaacson, who has researched blood biomarkers in people with no or minimal cognitive complaints, likened testing blood samples for signs of Alzheimer’s disease to how people undergo routine blood tests for high cholesterol. It is possible that currently available treatments for Alzheimer’s disease would work better in those diagnosed early in this way,” he said. The combination of a simple screening test with an effective treatment for Alzheimer’s disease would have a dramatic impact for individuals and for society.”

Persons: ” Nicholas Ashton, Ashton, ”, Kaj Blennow, Henrik Zetterberg, antiamyloid, immunoassay, ” Ashton, Richard Isaacson, ” Isaacson, Isaacson, ‘, “, Dr, Sanjay Gupta, David Curtis, ” Curtis Organizations: CNN, University of Gothenburg, National Institutes of Health, Quest Diagnostics, Alzheimer’s, Alzheimer’s Association, Get CNN, CNN Health, University College London, Science Media Locations: Sweden, United States, Wisconsin, Pau, Florida

☆ Biogen cuts annual profit forecast on persistent higher costs
▼ + stars: | 2023-11-08 | by ( ) www.reuters.com time to read: +1 min

REUTERS/Dado Ruvic/Illustration Acquire Licensing RightsNov 8 (Reuters) - Biogen (BIIB.O) cut its annual profit forecast below Wall Street expectations on Wednesday, on rising costs related to the recent acquisition of rare disease drugmaker Reata Pharmaceuticals and the launch of its Alzheimer's treatment Leqembi. Biogen is banking on the success of Leqembi and tuck-in deals like its recent $6.5 billion buyout of Reata Pharmaceuticals to grow its revenue. The drugmaker expects full-year adjusted profit per share in the range of $14.50 to $15.00 compared with $15 to $16 forecast previously. On an adjusted basis, Biogen earned $4.36 per share, beating analysts' average estimate of $3.97, according to LSEG data. Reporting by Mariam Sunny and Bhanvi Satija in Bengaluru; Editing by Arun KoyyurOur Standards: The Thomson Reuters Trust Principles.

Persons: Dado Ruvic, Eisai, Christopher Viehbacher, Biogen, Mariam Sunny, Bhanvi, Arun Koyyur Organizations: REUTERS, Pharmaceuticals, Reata Pharmaceuticals, Thomson Locations: Bengaluru

July 28 (Reuters) - Biogen (BIIB.O) agreed to buy rare disease drugmaker Reata Pharmaceuticals (RETA.O) for nearly $6.5 billion, the first large acquisition under new CEO Christopher Viehbacher as he seeks to return the drugmaker to growth. Through the deal, Biogen said it will gain Texas-based Reata's recently approved drug Skyclarys to treat a rare genetic disorder that causes progressive damage to the nervous system. It already makes Spinraza, a treatment for the rare muscle-wasting disorder called spinal muscular atrophy, and a treatment for a rare type of amyotrophic lateral sclerosis. Biogen said it will pay Reata $172.50 per share in cash, which represents a 58.9% premium to the stock's last closing price. Reuters GraphicsShares of Reata surged nearly 52% to $164.76 in early trading, while Biogen's shares fell marginally to $261.14.

Persons: Christopher Viehbacher, Viehbacher, Biogen, Eisai, Baird, Brian Skorney, Manas Mishra, Bhanvi, Shinjini Organizations: Pharmaceuticals, Reuters, Thomson Locations: Texas, United States, Bengaluru

☆ Biogen to cut 1,000 jobs to save costs as Alzheimer's drug launch gathers pace
▼ + stars: | 2023-07-25 | by ( ) www.reuters.com time to read: +2 min

Investors have pinned their hopes on Leqembi as sales of multiple sclerosis drug Tecfidera take a hit from cheaper generic rivals while spinal muscular atrophy drug Spinraza faces rival treatments by Novartis (NOVN.S) and Roche (ROG.S). "Biogen's business is in transition," said CEO Christopher Viehbacher, who was hired in November to help power up growth and put behind a series of setbacks for older Alzheimer's drug Aduhelm. Multiple sclerosis treatments Avonex and Vumerity, as well as SMA therapy Spinraza, beat analyst estimates, while Tecfidera missed expectation as it faced generic rivals. "We see no unexpected surprises in Q2 results, allowing investors to focus on Alzheimer's," said Wells Fargo analyst Mohit Bansal. Reporting by Manas Mishra and Mariam Sunny in Bengaluru; Editing by Sriraj KalluvilaOur Standards: The Thomson Reuters Trust Principles.

Persons: Roche, Christopher Viehbacher, Tecfidera, Wells, Mohit Bansal, Manas Mishra, Mariam Sunny, Sriraj Organizations: Biogen, Novartis, Thomson Locations: Massachusetts, Bengaluru

☆ Medicare Part B premiums may increase in 2024, prompted by a new Alzheimer's treatment
▼ + stars: | 2023-07-20 | by ( Lorie Konish | ) www.cnbc.com time to read: +2 min

If Part B premiums go up next year prompted by the new Alzheimer's drug, it will not be the first time. However, Part B premiums dropped by 3% for 2023 in response to Medicare's decision to limit Aduhelm coverage. How Part B premiums affect Social Security checksThe Senior Citizens League is currently predicting a 3% Social Security cost-of-living adjustment for 2024, based on the latest government inflation data. Medicare Part B premium payments are typically deducted directly from monthly Social Security checks. Medicare patients may pay more than $5,000 annually for the treatment, according to KFF.

Persons: Juliette Cubanski, Mary Johnson, Johnson, KFF, Cubanski, Jasmin Merdan Organizations: Senior Citizens League, Social Security, Medicare, Security

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

☆ FDA advisors weigh whether Alzheimer's drug Leqembi should receive full approval
▼ + stars: | 2023-06-09 | by ( Spencer Kimball | ) www.cnbc.com time to read: +1 min

A panel of independent advisors to the Food and Drug Administration is meeting Friday to make a recommendation on whether the Alzheimer's drug Leqembi, made by Eisai and Biogen , should receive full approval. The FDA is not required to follow the advisors' recommendation, but a panel vote in favor of Leqembi would help pave the way for the treatment's approval this summer. The FDA is expected to make a final decision on Leqembi on July 6. Leqembi is the second Alzheimer's treatment from Eisai and Biogen to come under FDA review, after the controversial approval of the drug Aduhelm in the summer of 2021. Leqembi slowed cognitive decline in early Alzheimer's patients by 27% in the trial, but the treatment also carries serious risks of brain swelling and bleeding.

Persons: Eisai, Leqembi, Biogen, Aduhelm Organizations: Food and Drug Administration, FDA Locations: Leqembi, Eisai

The drug, donanemab, met all goals of the trial. "These are the strongest phase 3 data for an Alzheimer's treatment to date," said Maria Carrillo, chief science officer for the Alzheimer's Association. In the donanemab treatment group, Lilly said brain swelling, a known side effect of drugs of this type, occurred in 24% of the participants, with 6.1% experiencing symptoms. In the Leqembi Phase 3 trial, the drug was associated with brain swelling in nearly 13% of its study participants. It also said 47% of donanemab patients in the 18-month trial had no disease progression at 12 months, compared with 29% of the placebo group.

☆ An experimental drug just showed it can help slow Alzheimer's, offering new hope for patients and a major boost to pharma giant Eli Lilly
▼ + stars: | 2023-05-03 | by ( Yeji Jesse Lee | ) www.businessinsider.com time to read: +6 min

The pharma giant Eli Lilly said donanemab slowed cognitive decline in people with Alzheimer's. The news comes months after the FDA approved an Alzheimer's drug called Leqembi. On Wednesday, the pharma giant Eli Lilly said its experimental drug donanemab had successfully slowed cognitive and functional decline in patients with early-stage Alzheimer's, offering some hope to people with a condition that lacks good treatment options. In the trial, patients received donanemab until scans showed their brains were clear of those proteins, called beta-amyloid. Leqembi slowed the rate of cognitive decline in Alzheimer's patients by 27% over 18 months in a late-stage study.

☆ F.D.A. Approves Drug for Rare Form of A.L.S.
▼ + stars: | 2023-04-25 | by ( Rebecca Robbins | ) www.nytimes.com time to read: +1 min

Biogen will be required to provide confirmatory evidence, from ongoing clinical research, to keep the drug on the market. The decision is the first conditional approval granted for a medication for A.L.S., or amyotrophic lateral sclerosis, which generally causes paralysis and death within a few years. The approval is based on evidence that the drug can significantly reduce levels of a protein that has been linked to damage to nerve cells. Despite the uncertainty about its benefit, Qalsody’s approval is widely seen as more justifiable than that of Aduhelm, another drug from Biogen. unanimously recommended that the agency grant conditional approval of Qalsody, even though a majority of advisers concluded that there was not convincing evidence that it was effective.

☆ Biogen isn't concerned about competing with Eli Lilly in the Alzheimer’s drug space, CEO says
▼ + stars: | 2023-04-25 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +3 min

Biogen isn't worried about competing with Eli Lilly as they both attempt to bring an Alzheimer's drug to the market, Biogen's CEO said Tuesday. Researchers argue that the accumulation of amyloid plaque is a crucial first step toward the cognitive decline observed in Alzheimer's disease. Eli Lilly didn't immediately respond to a request for comment. He said that will likely require Eli Lilly and Biogen to roll out maintenance doses that will keep plaque levels low. Biogen is banking on the success of its drug leqembi after the disastrous approval and rollout of its old Alzheimer's drug aduhelm last year.

Lilly has not previously discussed its Medicare coverage optimism publicly. The U.S. Centers for Medicare & Medicaid Services (CMS) did not immediately respond to a request for comment. Such "coverage with evidence development" requirements are rare and historically used by Medicare to evaluate medical devices. Amyvid, Lilly's Alzheimer's imaging agent that can detect amyloid plaques on PET scans, has been subject to CMS' evidence development program for a decade. "It shuts out many patients," said Dr. Maria Carrillo, chief science officer of the Alzheimer’s Association, "especially minorities and rural patients."

Piper Sandler said several positive catalysts are in sight for Biogen over the next several quarters. The firm named the foremost catalyst for Biogen as Alzheimer's treatment Leqembi , which it co-developed with Japanese pharmaceutical company Eisai. Specifically, while share today is minimal (0.7% of patients), docs project this share to almost quadruple within 6 months," Raymond wrote in a Monday note. Aduhelm is the controversial Alzheimer's treatment developed by Biogen and Eisai, whose sales fell below Wall Street's expectations as its efficacy was called into question. "For our part, we think Leqembi has set a high bar – especially with regard to safety," said Raymond.

☆ Alzheimer’s patients retain the benefits of Leqembi even when they stop the drug, Eisai says
▼ + stars: | 2023-04-06 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +4 min

Alzheimer's patients who take Leqembi retain the benefits of the treatment even when they stop taking it, new research by Eisai shows. The findings also come as Eisai and Biogen try to regain their footing after the polarizing approval and disastrous rollout of its other Alzheimer's disease therapy, aduhelm, last year. In the analysis, Alzheimer's patients stopped taking Leqembi after 18 months in a phase two clinical trial and later resumed the treatment in an extension trial. Amyloid is a protein that builds up on the brain in Alzheimer's patients and disrupts cell function. That means Alzheimer's disease progressed at a slower rate in patients who received Leqembi compared to those who took the placebo during the clinical trial.

☆ Lilly says experimental Alzheimer's drug reduces amyloid in small study
▼ + stars: | 2023-03-31 | by ( Deena Beasley | ) www.reuters.com time to read: +3 min

The higher the dose of the antibody drug, which was given by subcutaneous injection, the larger the effect, Lilly said. The Indianapolis-based drugmaker is launching a Phase III study of the experimental antibody, remternetug, but declined to comment on which doses will be selected for larger, later-stage trials. Lilly, at a medical conference in Gothenburg, Sweden, presented interim data from 41 study participants. Trial results published last year showed that, in patients with early Alzheimer's, Leqembi reduced the rate of cognitive decline by 27% compared with a placebo. Brooks said that sharing its early remternetug data "reinforces Lilly's commitment and investment in the Alzheimer's disease space ...

☆ US FDA proposes more rigorous trials for accelerated nod of cancer therapy
▼ + stars: | 2023-03-24 | by ( ) www.reuters.com time to read: +2 min

March 24 (Reuters) - The U.S. health regulator on Friday proposed cancer drug developers in most cases conduct more rigorous trials to seek accelerated approval for their candidates. Accelerated approvals allow quicker nod for therapies that target serious and life-threatening conditions. The FDA proposed using "randomized controlled trials" (RCT) where patients receive either a therapy or another alternate treatment, compared to conducting a trial testing the drug without a comparator, known as single-arm studies. "Given the limitations of single-arm trials, a randomized controlled trial is the preferred approach to support an application for accelerated approval," the FDA said. Drug developers usually depend on such "single-arm" studies to gain accelerated approval, and then conduct another trial post-nod to confirm clinical benefits.

☆ Reata shares triple after surprise FDA nod for rare disease drug
▼ + stars: | 2023-03-01 | by ( ) www.reuters.com time to read: +2 min

March 1 (Reuters) - Shares of Reata Pharmaceuticals Inc (RETA.O) tripled in value on Wednesday after the U.S. Food and Drug Administration (FDA) approved its rare disease drug, ending years of uncertainty over its future. The U.S. biotech firm's shares jumped to $93, the highest since late 2021, on more than 16 million shares traded, a record one-day volume for the stock. Reata's drug Skyclarys is the first approved treatment for Friedreich's Ataxia, a rare genetic disorder that causes progressive damage to the nervous system and can lead to premature death. The nod follows years of back and forth between Reata and the FDA. Reata's shares had tumbled 30% following Dunn's resignation as investors fretted about the possibility of approval under a new division head.

☆ Reata shares hit 1-year high after surprise FDA nod for rare disease drug
▼ + stars: | 2023-03-01 | by ( ) www.reuters.com time to read: +2 min

March 1 (Reuters) - Shares of Reata Pharmaceuticals Inc (RETA.O) soared 175% to hit a one-year high in early trading on Wednesday, after the U.S. Food and Drug Administration (FDA) approved its rare disease drug and ended years of uncertainty over its future. The U.S. biotech firm's shares jumped to $86, their highest since December 2021. The nod follows years of back and forth between Reata and the FDA. Reata's shares had tumbled 30% following Dunn's resignation as investors had fretted about the possibility of approval under a new division head. "We've followed some pretty dramatic stories in the past, but the Reata odyssey is in the Hall of Fame," said Baird analyst Brian Skorney.

☆ Reata shares surge after surprise FDA nod for rare disease drug
▼ + stars: | 2023-03-01 | by ( ) www.reuters.com time to read: +1 min

March 1 (Reuters) - Shares of U.S. biotech firm Reata Pharmaceuticals Inc (RETA.O) more than doubled in premarket trading on Wednesday, a day after the Food and Drug Administration (FDA) approved its rare disease drug and ended years of uncertainty over its future. The drug Skyclarys is the first approved treatment for Friedreich's Ataxia, a rare genetic disorder that causes progressive damage to the nervous system and can lead to premature death. The approval follows years of back and forth between Reata and the FDA, which in 2020 said the data from a mid-stage trial was not enough to support an approval. The FDA has previously approved drugs for neurological conditions based on limited data such as for Biogen Inc's Alzheimer's drug Aduhelm and Amylyx's (AMLX.O) ALS drug. Reata's shares were up 174.2% to $85.47 before the bell.

Search resuls for: "Aduhelm"

25 mentions found