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☆ Exclusive: US to build $300 mln database to fuel Alzheimer's research
▼ + stars: | 2023-04-03 | by ( Julie Steenhuysen | ) www.reuters.com time to read: +4 min

The platform will draw on data from medical records, insurance claims, pharmacies, mobile devices, sensors and various government agencies, they said. The database could help identify healthy people at risk for Alzheimer's, which affects about 6 million Americans, for future drug trials. The U.S. Medicare health plan for older adults will likely require such tracking in a registry as a condition of reimbursement for Leqembi. Silverberg said the data platform could also help researchers working in other disease areas understand which patients are most at risk and the impact of medications. The system would be built in a secure computing environment with a number of restrictions to ensure the privacy of people's health data, Silverberg said.

☆ 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.

☆ FDA staff says safety issues with Biogen's ALS drug to not prevent approval
▼ + stars: | 2023-03-21 | by ( Bhanvi Satija | ) www.reuters.com time to read: +2 min

March 20 (Reuters) - The U.S. health regulator's staff said on Monday safety issues with Biogen Inc's (BIIB.O) drug to treat an ultra-rare form of amyotrophic lateral sclerosis or ALS, also known as Lou Gehrig's disease, should not prevent its accelerated approval. The drug, tofersen, failed to meet its main goal of reducing symptoms but reduced protein neurofilament levels during a late-stage study. The risks related to Biogen's drug, such as spinal cord inflammation and optic nerve swelling, observed in trial patients "are acceptable to the patient population", the staff said. They added that a majority of these risks may be related to the way in which the drug is administered, rather than the drug itself. The company is seeking approval for the drug in ALS patients with mutation in a gene known as superoxide dismutase 1.

☆ US FDA staff flags no new safety concerns for Biogen's ALS drug
▼ + stars: | 2023-03-20 | by ( ) www.reuters.com time to read: +1 min

March 20 (Reuters) - Staff reviewers of U.S. drug regulator on Monday did not raise any new safety concerns about Biogen Inc's (BIIB.O) experimental drug for treating a rare type of amyotrophic lateral sclerosis, also known as Lou Gehrig's disease. The risks related to Biogen's drug, tofersen, "are acceptable to the patient population" and would not "preclude approval", staff reviewers said in briefing documents published on the agency's website. The agency has asked advisers to weigh in on approving the use of the drug based on available data, which shows it reduces a key protein related to the disease, and not disease symptoms. In October 2021, tofersen failed to meet the main goal of a late-stage study, but the company said trends of reduced disease progression were observed. Reporting by Raghav Mahobe and Bhanvi Satija in Bengaluru; Editing by Krishna Chandra Eluri and Shinjini GanguliOur Standards: The Thomson Reuters Trust Principles.

☆ Want to invest in companies that empower women? Here's what you need to know
▼ + stars: | 2023-03-17 | by ( Michelle Fox | ) www.cnbc.com time to read: +8 min

Known as gender lens or gender equity investing, the idea is to invest for financial return, while promoting gender diversity. Yet those funds represent less than 0.01% of total equity fund assets in the United States, according to the firm. Her women CEO and CFO clients were getting tremendous results, she said. In January, the asset management firm launched the Hypatia Women CEO exchange-traded fund (WCEO). Women in leadership matters, but we need a more robust scorecard to assess gender equity.

The Alzheimer's Association and the pharmaceutical industry say the drug companies are not directly involved in the campaign. But the Alzheimer's Association says patients simply don't have the time to spare. The agency did not address the Alzheimer's Association campaign. Association members have met 30 times with staffers for the state's 20 members of Congress, Ryan Schiff, the chapter's public policy manager, said. Spokespeople for all three companies said they do not work with the Association on its campaign to expand Medicare coverage of the drugs.

☆ US VA to cover Eisai, Biogen Alzheimer's treatment Leqembi
▼ + stars: | 2023-03-14 | by ( ) www.reuters.com time to read: +1 min

March 13 (Reuters) - Eisai Co Ltd and Biogen Inc (BIIB.O) said on Monday that the U.S. Department of Veteran Affairs (VA) will provide coverage of their Alzheimer's treatment Leqembi to veterans at an early stage of the memory-robbing disease. Leqembi has so far been approved in the U.S. under the Food and Drug Administration's accelerated review program. The treatment is currently undergoing the FDA's standard review process, which will weigh its impact on cognitive function. Eisai and Biogen have said they expect full U.S. approval for Leqembi by summer or late this year, which would likely open up coverage by Medicare and other health insurers. Reporting by Ahmed Aboulenein in Washington and Pratik Jain in Bengaluru; Editing by Bill BerkrotOur Standards: The Thomson Reuters Trust Principles.

☆ Eisai, Biogen say FDA grants priority review for Alzheimer's drug Lecanemab
▼ + stars: | 2023-03-06 | by ( ) www.reuters.com time to read: 1 min

TOKYO, March 6 (Reuters) - Japanese drugmaker Eisai Co Ltd (4523.T) and its U.S. partner Biogen Inc (BIIB.O) said on Monday that the U.S. Food and Drug Administration granted priority review for traditional approval of their Alzheimer's treatment Lecanemab. The FDA accepted Eisai's supplemental Biologics License Application for the drug, supporting transition from the accelerated approval granted in January, the drugmaker said in a statement. Reporting by Rocky Swift; editing by Diane CraftOur Standards: The Thomson Reuters Trust Principles.

☆ 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.

☆ These 13 beaten-down stocks offer a 'margin of safety' from a possible credit shock, according to a top-1% fund manager
▼ + stars: | 2023-02-28 | by ( James Faris | ) www.businessinsider.com time to read: +7 min

Higher-than-anticipated interest rates could lead to economic pain and even a credit shock. Top-1% fund manager James Abate explained why he hasn't given up on stocks yet. Here are 13 value stocks to buy in this shaky environment, according to Abate. Leading fund manager James Abate isn't predicting a repeat of the financial crisis, but he is worried that banks could get their biggest test in years if interest rates keep rising. While nothing is guaranteed in markets, Abate said that 2023 will provide many opportunities for fund managers like him to outperform.

Feb 28 (Reuters) - The U.S. Food and Drug Administration on Tuesday approved Reata Pharmaceuticals Inc's (RETA.O) drug for the treatment of a rare genetic disorder that causes progressive damage to the nervous system, sending shares up nearly 160% after the bell. The drug, Skyclarys, is Reata's first product to gain approval, and Jefferies analyst Maury Raycroft projected that U.S. sales of the drug could reach $400 million by 2030. Reata estimates the disorder, called Friedreich's ataxia, affects about 5,000 patients in the United States. Raycroft, before the FDA decision, estimated the drug could be priced at about $425,000 per patient annually. The FDA has previously approved drugs for neurological conditions based on limited data such as for Biogen Inc's (BIIB.O) Alzheimer's drug Aduhelm and Amylyx's ALS drug.

☆ FDA neurosciences chief Billy Dunn to leave immediately, analysts raise concern
▼ + stars: | 2023-02-28 | by ( ) www.reuters.com time to read: +2 min

Feb 28 (Reuters) - The U.S. Food and Drug Administration neurosciences head Billy Dunn will retire from his role effective immediately, the health regulator told Reuters on Tuesday. Wall Street analysts said Dunn's departure could impact the regulator's stance on neurological drug decisions in the near term, sending down shares of Reata Pharmaceuticals Inc (RETA.O) 30% on Monday when media reports on the exit surfaced. Texas-based Reata is expecting FDA's decision by Tuesday on its drug to treat a rare neuromuscular disorder called Friedreich's ataxia. The departure of Dunn, 53, was announced in an internal message to the agency's employees on Monday. Newly appointed deputy director Teresa Buracchio will also serve in Dunn's role on an interim basis at the Office of Neuroscience, the agency told Reuters.

☆ Biogen CEO bets on Alzheimer's drug, pipeline to return to growth
▼ + stars: | 2023-02-15 | by ( Manas Mishra | ) www.reuters.com time to read: +2 min

Feb 15 (Reuters) - Biogen Inc (BIIB.O) Chief Executive Officer Christopher Viehbacher said on Wednesday he is banking on high-profile launches of Alzheimer's disease treatment Leqembi and depression drug zuranolone, as well as deals, to help the company return to revenue growth. A controversial approval and problematic launch of previous Alzheimer's disease drug Aduhelm, which like Leqembi was developed with Eisai Co Ltd (4523.T), have further dented investor sentiment. Biogen is also hoping to gain U.S. approval of depression treatment zuranolone this year. Biogen forecast full-year adjusted profit of $15 to $16 per share, compared with analysts' estimates of $15.72 per share. The company reported a fourth-quarter adjusted profit of $4.05 per share, beating estimates compiled by Refinitiv IBES by 57 cents.

☆ Biogen sees modest 2023 revenue from Alzheimer's disease drug
▼ + stars: | 2023-02-15 | by ( Manas Mishra | ) www.reuters.com time to read: +2 min

Feb 15 (Reuters) - Biogen Inc (BIIB.O) said on Wednesday that Alzheimer's disease drug Leqembi would bring in modest revenue for the year although it might not be enough to offset costs tied to its launch. Biogen has a 50% share of U.S. profits on Leqembi, which it developed with lead partner Eisai Co Ltd (4523.T). "Over the last couple of years, the company has lost its way somewhat and now it is in a declining revenue," Viehbacher said. Biogen expects full-year adjusted profit of $15 to $16 per share, compared with analysts' estimates of $15.72 per share. The company reported a Q4 adjusted profit of $4.05 per share, above Refinitiv IBES estimates of $3.48 per share.

☆ Investors need to embrace these stocks that we love
▼ + stars: | 2023-02-12 | by ( Paul R. La Monica | ) edition.cnn.com time to read: +8 min

I’ve typically done this stock picking feature in early to mid February as a Stocks We Love type of story, pegging it to Valentine’s Day. The restaurant stocks in particular could do well. Inflation is obviously still a concern for big consumer brands. Consumer prices rose 6.5% over the past 12 months through December, down from a 7.1% pace in November. Up nextMonday: Earnings from TreeHouse Foods (THS), Avis Budget (CAR), FirstEnergy (FE), IAC (IAC) and PalantirTuesday: US CPI; Japan GDP; UK employment report; earnings from Coca-Cola, Asahi Group, Marriott (MAR).

☆ Key inflation data in the week ahead will offer clues to future Fed rate moves and the market's path
▼ + stars: | 2023-02-11 | by ( Zev Fima | ) www.cnbc.com time to read: +8 min

Looking forward The January consumer price index (CPI) , which calculates the average change over time in prices that shoppers pay for goods and services, is slated for Tuesday. Economists and investors will use the number to gauge the odds of a soft landing or hard landing for the economy. The producer price index (PPI) for January, which calculates the change in selling prices received by producers of goods and services, is out on Thursday. As a subscriber to the CNBC Investing Club with Jim Cramer, you will receive a trade alert before Jim makes a trade. Jim waits 45 minutes after sending a trade alert before buying or selling a stock in his charitable trust's portfolio.

☆ Factbox: Bayer's new CEO: long-time Roche, Genentech executive, Bill Anderson
▼ + stars: | 2023-02-08 | by ( ) www.reuters.com time to read: +1 min

LONDON, Feb 8 (Reuters) - Bayer (BAYGn.DE) bowed to investor pressure on Wednesday and named Bill Anderson, most recently head of Roche's (ROG.S) pharmaceuticals business, to take over from Werner Baumann as its CEO in June. Here are some key facts about the career about the 56-year-old American who will run the nearly 160-year-old German drugmaker:He is a chemical engineer by education and has worked for Genentech and its parent Roche since 2006CAREER:1989: started his career at Ethyl Corp, a U.S.-based fuel additives company, with postings in Belgium and the Netherlands1995: joined Raychem Corp., a U.S. technology and electronics firm1997-2006: worked at Biogen (BIIB.O) in the United States, UK and Ireland; roles included running its neurology unit, its largest business2006: joined Genentech as senior vice president, immunology and ophthalmology2010: became svp BioOncology2013: left Genentech to become global product strategy head/chief marketing officer at Genentech's parent company, Roche (ROG.S)2016: returned to Genentech as head of North American operations2017: appointed chief executive officer at Genentech2019-2023: CEO of Roche PharmaceuticalSources: Roche and BayerCompiled by Josephine Mason. Editing by Jane MerrimanOur Standards: The Thomson Reuters Trust Principles.

☆ EU regulator accepts Biogen-Eisai's Alzheimer's treatment lecanemab for review
▼ + stars: | 2023-01-26 | by ( ) www.reuters.com time to read: 1 min

Jan 26 (Reuters) - Eisai Co Ltd (4523.T) and Biogen Inc (BIIB.O) said on Thursday the European Medicines Agency (EMA) had accepted a marketing authorization application for their Alzheimer's disease drug for review. The drug, lecanemab, was recently granted accelerated approval in the United States. Reporting by Sriparna Roy in Bengaluru; Editing by Subhranshu SahuOur Standards: The Thomson Reuters Trust Principles.

☆ Eli Lilly Alzheimer's drug setback extends rival Biogen's lead - analysts
▼ + stars: | 2023-01-20 | by ( ) www.reuters.com time to read: +2 min

Jan 20 (Reuters) - The U.S. health regulator's rejection of accelerated approval for Eli Lilly and Co's Alzheimer's disease drug extends the market lead for rivals Eisai and Biogen's treatment by months, analysts said. "This is a modest positive for Biogen" because it delays donanemab's launch, Jefferies analyst Michael Yee said, adding that Eli Lilly could file for traditional approval by mid-2023. The setback for Lilly comes just weeks after the FDA granted Biogen Inc (BIIB.O) and Japanese drugmaker Eisai Co Ltd's (4523.T) accelerated approval for their Alzheimer's drug Leqembi. read moreAnalysts are waiting for the traditional approval of Biogen's drug and for wider health insurance coverage before they expect sales of the drug to pick up. "But if there is anything wrong with the (Eli Lilly) data set, it is easier to reject an unapproved drug than remove an approved drug from market," said Skorney.

☆ Eli Lilly says U.S. FDA rejects accelerated approval for Alzheimer's drug
▼ + stars: | 2023-01-19 | by ( Deena Beasley | ) www.reuters.com time to read: +3 min

REUTERS/Mike SegarJan 19 (Reuters) - Eli Lilly and Co on Thursday said the U.S. Food and Drug Administration had rejected accelerated approval of its experimental Alzheimer's drug because it had not submitted enough trial data from patients who were treated for at least a year. That study, Lilly said, would form the basis of donanemab's application for traditional FDA approval shortly thereafter. The FDA can grant "accelerated" approval to drugs based on their impact on a measurement, in this case amyloid brain plaques, likely to correlate with patient response. Donanemab is in the same class as aducanumab and lecanemab, the latter being a treatment for early Alzheimer's that was given accelerated approval by the FDA earlier this month. Sales of amyloid-lowering Alzheimer's drugs, which need to be given by infusion, are expected to be minimal until they receive standard FDA approval.

☆ Here's where to look for the next developments in the fight against Alzheimer's disease
▼ + stars: | 2023-01-17 | by ( Christina Cheddar Berk | ) www.cnbc.com time to read: +10 min

The Centers for Disease Control and Prevention estimates 5.8 million Americans were living with the disease in 2020 . BIIB 6M mountain Biogen's stock is trading well above its lows Leqembi treats Alzheimer's disease by targeting amyloid-beta plaques in the brain. Attention shifts to Eli Lilly Shares of other Alzheimer's drug developers have often mirrored Biogen's moves. Small drug developers Smaller Alzheimer's drug developers have also been boosted by research developments. Still in an early stage of its research, Prothena has traded as a proxy for developments in Alzheimer's treatment.

☆ EMA seeks to issue guidance on liver damage from Novartis' gene therapy
▼ + stars: | 2023-01-13 | by ( ) www.reuters.com time to read: +1 min

Jan 13 (Reuters) - The European Medicines Agency (EMA) said on Friday it plans to issue advice for physicians using Novartis AG's (NOVN.S) Zolgensma, calling on them to monitor patients for any liver injury after treatment. The statement follows two deaths due to liver failure after treatment with the gene therapy against spinal muscular atrophy, reported by Novartis in August. Spinal muscular atrophy is a group of rare genetic disorders which affect the nerve cells and cause muscle wasting and weakness. The advice for healthcare professionals has yet to be approved by further expert panels at EMA, which typically takes a few weeks. In Europe, however, such letters had been the subject of discussions with EMA, but Novartis would soon be cleared to send them in EU member states, it added.

☆ Eisai, Biogen's Alzheimer's drug price should not dent demand, analysts say
▼ + stars: | 2023-01-09 | by ( ) www.reuters.com time to read: +2 min

Jan 9 (Reuters) - The $26,500-per-year price tag for Eisai Co Ltd (4523.T) and Biogen Inc's (BIIB.O) newly approved Alzheimer's disease drug is slightly above expectations, but should not dent demand for the promising therapy, Wall Street analysts said. The U.S. health regulator on Friday granted accelerated approval to the drug, Leqembi, and the decision was hailed by patient groups. However, the price tag is lower than that of Eisai and Biogen's first Alzheimer's disease drug, Aduhelm, which was initially priced at $56,000 annually before the drugmakers halved the price amid controversy over its approval. Eisai and Biogen said on Saturday the Japanese drugmaker had applied for full approval by the U.S. Food and Drug Administration. Some analysts expect broader coverage by Medicare if the drug is granted full approval.

☆ U.S. FDA approves Eisai, Biogen Alzheimer's drug
▼ + stars: | 2023-01-06 | by ( Deena Beasley | ) www.reuters.com time to read: +2 min

[1/2] The logo of Eisai Co Ltd is displayed at the company headquarters in Tokyo, Japan, March 8, 2018. REUTERS/Issei KatoJan 6 (Reuters) - The U.S. Food and Drug Administration on Friday approved the Alzheimer's drug lecanemab developed by Eisai Co Ltd (4523.T) and Biogen Inc (BIIB.O) for patients in the earliest stages of the mind-wasting disease. Eisai said the drug would launch at an annual price of $26,500. Eisai officials have said the company also plans to submit data from a recent successful clinical trial in 1,800 patients as the basis for a full standard review of Leqembi. That trial found that Leqembi, which is given by infusion, slowed the rate of cognitive decline in patients with early Alzheimer's by 27% compared to a placebo.

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